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| August 19, 2011 |
| Actoplus Met Bladder Cancer Risk |
| Posted By DeCarli Law |
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The FDA has warned that long-term use of the diabetes drug Actoplus Met and its extended release form, Actoplus Met XR, comes with an increased risk of bladder cancer. Although most of the coverage in the news and on the internet has focused on Actos, the FDA has also warned that the use of Actoplus Met and Actoplus Met XR increases the risk of bladder cancer.
Actoplus Met and Actoplus Met XR are the brand names for tablets that combine Actos (pioglitazone) with the more common diabetes drug, metformin hydrocholride. Actoplus Met was approved for sale in the United States in 2005. Actoplus Met XR was approved in 2009. Like
Actos, Actoplus Met and Actoplus Met XR are manufactured by a Japanese pharmaceutical company, Takeda Pharmaceuticals. Also like
Actos, studies have shown that long-term use of Actoplus Met and its extended release form increase the risk of developing bladder cancer.
If you or a loved one developed bladder cancer after using Actoplus Met or Actoplus Met XR for more than one year, there is a possibility the cancer was caused by Actoplus Met or Actoplus Met XR. Because Takeda Pharmaceuticals did not warn that using these drugs might cause bladder cancer, Takeda Pharmaceuticals may be legally liable for the injury.
Learn more about the risks of Actoplus Met and Actoplus Met XR HERE.
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| August 18, 2011 |
| Duetact Bladder Cancer Side Effect |
| Posted By DeCarli Law |
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The FDA has warned that long-term use of the diabetes drug Duetact comes with an increased risk of bladder cancer. Although most of the coverage in the news and on the internet has focused on Actos, Duetact has the same bladder cancer side effect potential, and was included in the FDA's warning.
Duetact is the brand name for Actos (pioglitazone) when combined with another diabetes drug called glimepiride. Duetact was approved for sale in the United States in 2006. Like
Actos, Duetact is manufactured by a Japanese company called Takeda Pharmaceuticals. Also like
Actos, studies have shown that long-term use of Duetact increases the risk of developing bladder cancer.
If you or a loved one developed bladder cancer after using Duetact for more than one year, there is a possibility that Duetact was the cause. Because Duetact contained no warning that using it might cause bladder cancer, Takeda Pharmaceuticals may be legally liable for the injury.
Learn more about the risks of Duetact and Actos HERE.
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| August 09, 2011 |
| FDA: Actos Must Warn of Bladder Cancer Risk |
| Posted By DeCarli Law |
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The U.S. Food and Drug Administration (FDA) now requires diabetes drug Actos, generic name pioglitazone, to warn that using it can cause bladder cancer. Unfortunately, the FDA declined to go as far as several European countries that have outright banned
Actos.
On August 4, 2011, the FDA announced drugs containing pioglitazone, such as Actos, will have new labels warning that the use of pioglitazone for more than one year is associated with an increased risk of bladder cancer.
The updated drug labels recommend that healthcare professionals should:
- Not use pioglitazone in patients with active bladder cancer.
- Use pioglitazone with caution in patients with a prior history of bladder cancer.
Further, the label recommends that patients:
- Contact their healthcare professional if they experience any sign of blood in the urine or a red color in the urine or other symptoms such as new or worsening urinary urgency or pain on urination since starting pioglitazone, as these may be due to bladder cancer.
This new warning label falls short of the actions taken by European countries to protect their citizens from developing bladder cancer from
Actos. First
France, then
Germany, banned Actos because of the heightened risk for bladder cancer.
If you are taking Actos, and notice blood in your urine, worsening urges to urinate, or pain while urinating, contact your doctor immediately. These could be signs of bladder cancer. Other drugs containing
Actos include Actoplus Met, Actoplus Met XR and Duetact.
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| July 25, 2011 |
| Germany Halts Actos Sales for Bladder Cancer Risk |
| Posted By DeCarli Law |
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Germany has followed the lead of France and suspended the sale of diabetes drug Actos (generic name pioglitazone) because of its link to bladder cancer. The German regulatory agency warned that doctors should not put new patients on
Actos.
Germany's Federal Institute for Drugs and Medical Devices (BfArM) made its decision after receiving results of a study by France's national health insurance body, which tracked patients on diabetes drugs between 2006 and 2009. The French study found that long-term use of Actos increases the risk of bladder cancer.
The European Medicines Agency, based in London, initiated a review of the safety of Actos in March. The agency's experts are now discussing the latest safety data on
Actos at a meeting that began on June 20, 2011. Regulators in Britain and Denmark are awaiting the results of the European Medicines Agency meeting before taking action in their countries.
The U.S. Food and Drug Administration has not yet removed Actos from the market in the United States, despite actions by its European counterparts. The FDA has only released a safety announcement regarding the link between bladder cancer and
Actos.
Patients in the U.S. concerned about the risk of bladder cancer from Actos should consult their physicians regarding alternative treatments. Other drugs containing
Actos include Actoplus Met, Actoplus Met XR and Duetact.
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| July 22, 2011 |
| Actos Bladder Cancer Risk Brings France Ban |
| Posted By DeCarli Law |
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The French Health Products Safety Agency (AFSSAPS) has now banned the sale of the diabetes drug Actos in France because of an increased risk of bladder cancer. Although the ban became effective on July 11, 2011, the agency had given advance notice of the ban on June 6, 2011, so patients taking the drug could consult their physicians regarding alternative treatments.
The French agency took this action based on a study linking Actos use to increased incidents of bladder cancer. The study compared 155,000 patients in France taking the generic version of
Actos, with 1.3 million diabetics who were not using the drug. The study found that receiving a cumulative dose of 28,000 mg or more of
Actos resulted in an increased risk of bladder cancer.
Despite recognition of the link between Actos and bladder cancer,
Actos remains on the market in the United States. The U.S. Food and Drug Administration released a
safety announcement earlier this month regarding the link, but the FDA has not taken any substantive action to restrict the sale of
Actos in the U.S. or remove it from the market.
Patients in the U.S. concerned about the risk of bladder cancer from Actos should consult their physicians regarding alternative treatments. Other drugs containing
Actos include Actoplus Met, Actoplus Met XR and Duetact.
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| July 13, 2011 |
| FDA Warns of Surgical Mesh Complications |
| Posted By DeCarli Law |
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The FDA issued an alert today about complications that can arise from transvaginal placement of surgical mesh to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). Over the past three years, the FDA has received over 1,000 reports of complications when surgical mesh was used in these procedures.
Surgical mesh is used to provide a reinforcing structure in various surgical procedures. The FDA alert said the complications had been associated with surgical mesh from all nine manufacturers of the product.
According to the FDA's alert, the most common complications are erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. In the worst cases, vaginal scarring and mesh erosion led to a significant decrease in the women's quality of life due to discomfort and pain, including dyspareunia (pain during sexual intercourse).
You may read the entire FDA safety alert HERE.
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| June 16, 2011 |
| Diabetes Drug Actos Increases Risk of Bladder Cancer After Long-Term Use |
| Posted By DeCarli Law |
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The FDA announced yesterday that use of the diabetes medication Actos (generic name pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. The warning label for drugs containing pioglitazone will be updated to disclose this risk, and the patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer. Other drugs containing
Actos include Actoplus Met, Actoplus Met XR and Duetact.
The new warnings are based on the FDA's five-year interim review of the results of an ongoing ten-year epidemiological study. The interim results showed that although there was no overall increased risk of bladder cancer with pioglitazone use, an increased risk of bladder cancer was noted among patients with the longest exposure to pioglitazone, and in those exposed to the highest cumulative dose of pioglitazone.
Go HERE
to read the complete announcement from the FDA.
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| June 10, 2011 |
| FDA Alert on Increased Risk of Prostate Cancer From Proscar and Avodart |
| Posted By DeCarli Law |
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The FDA issued a safety announcement yesterday on the connection between prostate cancer and two drugs used to treat an enlarged prostate, Proscar and Avodart. Data suggests that while they reduce the risk of less serious forms of prostate cancer, they INCREASE the risk of more dangerous forms of prostate cancer.
Proscar (generic name finasteride) and Avodart (generic name dutasteride) are members of a class of drugs called 5-alpha reductase inhibitors (5-ARI). The FDA announced that the
Warnings and Precautions sections of 5-ARI labels are being changed to include information about the increased risk of being diagnosed with a more serious form of prostate cancer (high-grade prostate cancer).
The label change follows the FDA’s review of two large, randomized controlled trials. The trials demonstrated an overall reduction in prostate cancer diagnoses with finasteride 5 mg and dutasteride treatment. This overall reduction was due to a decreased incidence of lower risk forms of prostate cancer. However, both trials showed an increased incidence of high-grade prostate cancer with finasteride and dutasteride treatment. The complete safety announcement, along with additional information, can be found
HERE.
Finasteride is also marketed under the brand name Propecia for treatment of male pattern hair loss. Finasteride has recently been shown to have a potential
side effect of permanent erectile dysfunction (ED), along with other sexual side effects. Furthermore, the FDA classifies finasteride as a pregnancy category X drug, the drug category with the greatest risk of causing birth defects. A risk of birth defects can come with a woman just touching a finasteride pill.
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| June 08, 2011 |
| Label Change for Cholesterol-Lowering Drug Zocor, Recommending Lower Maximum Dose |
| Posted By DeCarli Law |
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The FDA announced today safety label changes for the cholesterol-lowering medication simvastatin, brand name Zocor, because the highest approved dose -- 80 milligram (mg) -- has been associated with an elevated risk of muscle injury or myopathy, particularly during the first 12 months of use.
The FDA now recommends that simvastatin 80 mg be used only in patients who have been taking this dose for 12 months or more and have not experienced any muscle toxicity. It should not be prescribed to new patients. There are also new contraindications and dose limitations for when simvastatin is taken with certain other medications.
The label changes are based on the FDA's review of the results of a seven-year clinical trial, along with other clinical trial data and adverse events reported to the agency. All showed that patients taking simvastatin 80 mg daily had an increased risk of muscle injury compared to patients taking lower doses of simvastatin or other statin drugs. The risk of muscle injury is highest during the first year of treatment with the 80 mg dose of simvastatin, is often the result of interactions with certain other medicines, and is frequently associated with a genetic predisposition for simvastatin-related muscle injury.
Simvastatin is sold under the brand-name Zocor and as a single-ingredient generic product. It is also sold in combination with ezetimibe as Vytorin, and in combination with Niacin as Simcor.
The FDA has revised the drug labels for simvastatin and Vytorin to include the new 80 mg dosing restrictions. The agency also revised the labels for simvastatin, Vytorin and Simcor to include new dosing recommendations when these drugs are used with certain medications that interact to increase the level of simvastatin in the body, which can increase the risk for myopathy. Patients who are unable to adequately lower their level of LDL-C on simvastatin 40 mg should not be given the higher 80 mg dose of simvastatin; instead, they should be placed on an alternative LDL-C lowering treatment(s). |
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| June 01, 2011 |
| FDA Announces New Scrutiny on Blood Clot Risk From Birth Control Pills With Drospirenone |
| Posted By DeCarli Law |
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Two recently-published studies on YAZ and other birth control pills containing Drospirenone have caught the attention of the U.S. Food and Drug Administration. The FDA announced yesterday that it is aware of the studies, which conclude that women using birth control pills containing
Drospirenone have a 2-to-3 times greater risk of developing blood clots compared to women using other forms of birth control.
Although the most recent studies, along with several older ones, conclude there is a significantly greater risk of blood clots from Drospirenone, a few others have found no increased risk. Prompted by the most recent studies, the FDA announced it “will look at all currently available information to fully assess the risks and benefits of drospirenone-containing birth control pills.”
Drospirenone is a type of synthetic progestin used in
YAZ and Yasmin oral contraceptives. Drospirenone is unique because it is a potassium-sparing diuretic. It’s diuretic properties mean that its use leads to less weight gain than other birth control pills. However, it also means women using it can develop abnormally high potassium levels, which itself can cause a dangerous condition called hyperkalemia.
Yasmin is also sold under the generic names Zarah,
Ocella and Zyeda. Generic forms of YAZ are Gianvi and Loryna. Both YAZ and Yasmin contain the same amount of
Drospirenone. They differ in their dosing schedule because of the amount of ethinyl estradiol (estrogen) they contain.
The FDA’s announcement states that it will continue to communicate any new safety information to the public as it becomes available. We, in turn, will pass on any further announcements from the FDA.
The complete announcement from the FDA may be found HERE.
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| May 25, 2011 |
| FDA Warns Not to Feed SimplyThick to Premature Infants |
| Posted By DeCarli Law |
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The FDA has warned that a thickening product called “SimplyThick” should not be fed to infants born before 37 weeks because it may cause a life-threatening condition. The FDA’s warning is based on reports of infants with necrotizing enterocolitis (NEC), in which tissue in the intestines becomes inflamed and dies. Parents should stop using the product even if their babies don’t appear sick.
SimplyThick is a thickening agent to help with swallowing difficulties. It is added to breast milk and infants’ formula to help premature babies swallow their food and keep it down, without spitting up.
So far, the FDA is aware of 15 cases of necrotizing enterocolitis (NEC), including two deaths. This is unusual because NEC most often occurs in babies while they are in the hospital early in their premature course. But some of the ill babies that FDA is aware of got sick after they had been discharged from the hospital and sent home on a feeding regimen that included SimplyThick.
For the complete FDA warning, click HERE.
If your baby has developed necrotizing enterocolitis (NEC) after being fed SimplyThick, please report it to the FDA, so the agency is aware of the full scope of the problem. You may make the report online HERE.
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| April 28, 2011 |
| FDA Proposes Studies on How Drug Maker Websites Influence Consumers |
| Posted By DeCarli Law |
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The FDA has proposed three studies to test how consumers react to promotional websites for prescription drugs based on the content and format of the website. The FDA published its proposal on April 28, 2011, and is seeking public comment.
The proposal explains that FDA regulations require that advertisements for prescription drugs “include a ‘fair balance’ of information about the benefits and risks of advertised products, both in terms of the content and presentation of the information.” The concern is that the old rules governing drug advertisements for print media are not adequately crafted to insure that online advertising discloses the potential risks from the drugs promoted online.
As an initial step toward creating new rules, the proposed studies seek to determine how website content and organization impact consumers’ understanding of the risks associated with prescription drugs. For example, one study will test consumers’ comprehension of drug risks based on how many clicks away from the home page risk information is located. It also will compare consumer comprehension of bulleted lists vs. paragraph text. Another study will scrutinize the use of personal testimonial videos.
The FDA will be accepting public comment on the proposed studies for the next 60 days. A complete copy of the FDA proposal may be found HERE. |
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| April 18, 2011 |
| FDA Orders Clinical Trials for Asthma Drugs |
| Posted By DeCarli Law |
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The FDA has ordered clinical trials to test the safety of Long-Acting Beta-Agonists (LABAs) when used in combination with inhaled corticosteroids. The clinical trials will involve 53,000 patients. The specific drugs to be studied are Symbicort (budesonide and formoterol), Advair Diskus (fluticasone and salmeterol), Dulera (mometasone and formoterol), and Foradil (formoterol).
LABAs are used to treat asthma by relaxing the muscles of the airways. However, they can increase the risk of severely worsening asthma symptoms that can lead to hospitalizations and death.
The FDA previously issued a safety announcement on LABAs on June 2, 2010 regarding their use in asthma treatment. The FDA ordered that the LABA labels be changed to state the following:
- Use of a LABA alone without use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated (absolutely advised against) in the treatment of asthma.
- LABAs should not be used in patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.
- LABAs should only be used as additional therapy for patients with asthma who are currently taking but are not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid.
- Once asthma control is achieved and maintained, patients should be assessed at regular intervals and step down therapy should begin (e.g., discontinue LABA), if possible without loss of asthma control, and the patient should continue to be treated with a long-term asthma control medication, such as an inhaled corticosteroid.
- Pediatric and adolescent patients who require the addition of a LABA to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA, to ensure adherence with both medications.
Last year's label change came after hospitalizations and deaths from the use of LABAs in asthma treatments. The complete announcement from the FDA may be found
HERE.
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| April 15, 2011 |
| Benzocaine Topical Products Can Cause Rare and Potentially Fatal Blood Disease Warns FDA |
| Posted By DeCarli Law |
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The FDA is warning the public about a potentially fatal side effect associated with Benzocaine, the main ingredient in over-the-counter gels and liquids applied to the gums or mouth to reduce pain. The over-the-counter products containing Benzocaine include Anbesol, Hurricaine, Orajel, Baby Orajel, Orabase, and store brand equivalents. These products are marketed to be used for pain relief from teething, canker sores, and irritation of the mouth and gums.
These and other Benzocaine products have caused a drug side effect called Methemoglobinemia.
Methemoglobinemia results in the amount of oxygen carried through the blood stream being greatly reduced. In the most severe cases,
Methemoglobinemia can result in death.
Signs and symptoms of Methemoglobinemia can appear within minutes to one or two hours after using Benzocaine. They include pale, gray or blue colored skin, lips, and nail beds; headache; lightheadedness; shortness of breath; fatigue; and tachycardia. Symptoms can appear after just one use of a Benzocaine product, or after multiple previous uses where there was no side effect before. You may read more about
Methemoglobinemia
HERE.
Even though Benzocaine products are sold over-the-counter, they should not be used on children under two years of age, except on advice and direct supervision of a physician. Instead of Benzocaine, the American Academy of Pediatrics recommends more natural remedies for teething pain. For example, give the child a teething ring chilled in the refrigerator, or gently rub or massage the child's gums with your fingers to relieve the symptoms of teething pain.
If a Benzocaine product has caused you, your child, or your family member to develop Methemoglobinemia, PLEASE report this to the FDA so the agency knows the extent of the problem. You may do so online
HERE, at
the FDA's website. Also, please save the product package, any unused portion of the product, and your purchase receipt if you still have it. Keeping these items will strengthen your ability to assert a legal claim if you choose to do so.
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| April 11, 2011 |
| Migraine/Epilepsy Drug Topamax Causes Cleft Lip and Cleft Palate Birth Defects |
| Posted By DeCarli Law |
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The FDA has announced that when pregnant women take Topamax (generic name Topiramate), there is an increased risk their babies will have cleft lips and cleft palates (oral clefts).
Topamax is approved for treating epilepsy and migraines.
The FDA’s safety announcement cautions that “[t]he benefits and risks of topiramate should be carefully weighed when prescribing this drug to women of childbearing age, particularly for conditions not usually associated with permanent injury or death. Alternative medications that have a lower risk of oral clefts and other adverse birth outcomes should be considered for these patients.” The FDA further warned that women should use effective birth control if they do take Topamax/Topiramate. This is particularly important because oral clefts occur in the first trimester of pregnancy, before many women know they are pregnant.
Although the FDA has only approved Topamax/Topiramate for use in treating epilepsy and migraines, unapproved or “off label” uses include bipolar disorder, cluster heahaches, weight loss, PTSD, and alcoholism. In April 2010, Topamax manufacturer Ortho-McNeil agreed to pay $6.14 million in criminal fines, and $75.37 million in civil penalties for illegally promoting
Topamax for treatment of psychiatric conditions.
Women of childbearing age who are currently taking Topamax or a generic equivalent should immediately consult their physicians. If women who gave birth to children with cleft lips or cleft palates were taking
Topamax while pregnant, these birth defects may have been caused by
Topamax.
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| March 28, 2011 |
| URGENT: Finasteride Mislabeled as Depression Drug Citalopram: Finasteride Causes Genital Abnormalities |
| Posted By DeCarli Law |
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Pregnant women may have unknowingly ingested anti-balding drug Finasteride (
Propecia) because it was mislabeled as Citalopram, a drug used to treat depression. Pregnant women merely touching
Finasteride place their babies at risk of developing genital abnormalities.
The manufacturer, Greenstone LLC, today announced a recall of medicines with lot number F10510058. This includes Citalopram 10mg Tablets (100-count bottle) and Finasteride 5mg Tablets (90-count bottle), both distributed in the U.S. The recall is due to the possibility that incorrect labels have been placed on the bottles by a third-party manufacturer. In other words, they mistakenly swapped the two labels.
Patients who have ingested lot number FI0510058-A of either Citalopram or Finasteride should immediately contact their physicians. The complete FDA press release may be found
HERE. |
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| March 23, 2011 |
| Recalled Drug Sibutramine in Slimming Beauty Bitter Orange Slimming Capsules |
| Posted By DeCarli Law |
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The FDA has announced that Slimming Beauty Bitter Orange Slimming Capsules contain Sibutramine, a stimulant recently recalled by the FDA and previously only available by prescription.
Sibutramine is not listed on the product label as an ingredient.
Because it contains Sibutramine, Slimming Beauty poses a particularly heightened risk for people with cardiovascular conditions because it can lead to elevated blood pressure, stroke, and heart attack. However, even people who are otherwise healthy who take Slimming Beauty can experience anxiety, nausea, heart palpitations, a racing heart, insomnia, and elevated blood pressure, given the amount of
Sibutramine it contains. The
Sibutramine in Slimming Beauty also may interact with other medications and can cause serious side effects.
You should stop taking Slimming Beauty immediately. If you believe you believe you have suffered a side effect or adverse reaction from Slimming Beauty, you should report it to the FDA. You may do so online HERE
. Also, save the product packaging, as it may help your ability to make a legal claim if you desire to do so. |
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| March 21, 2011 |
| Undeclared Drug Ingredient Leads to Recall of Joyful Slim Herb Supplement |
| Posted By DeCarli Law |
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FDA lab analysis in mid-2010 found that Joyful Slim Herb Supplement, an over-the-counter diet supplement, contained an undeclared drug, desmethyl sibutramine. This finding has renewed importance now, because Sibutramine has since been recalled from the market because it substantially increases blood pressure and/or pulse rate among some patients, and may present a significant risk for patients with coronary artery disease, congestive heart failure, arrhythmias or stroke.
Joyful Slim Herb was marketed as a natural herb for weight loss, and was packaged in plastic bottles containing 30 capsules per bottle with UPC 8 97966 00200 7. The affected lot/code being recalled is 101408.
Consumers should not use the affected lot/code. If you believe you believe you have suffered a side effect or adverse reaction from using this product, you should report it to the FDA. You may do so online HERE
. Also, save the product packaging, as it may help your ability to make a legal claim if you desire to do so. |
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| March 18, 2011 |
| Slim-30 Weight Loss Drug Recall Update |
| Posted By DeCarli Law |
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Slim-30 Herb Supplement was recalled in mid-2010 because it contained undeclared drug ingredients. This recall now has heightened importance because one of those drugs, Sibutramine, has now itself been recalled.
FDA lab analysis of Slim-30 Herb Supplement in July 2010 revealed that it contained N-Desmethyl Sibutramine and traces of Sibutramine. Since then, Sibutramine has been recalled by the FDA.
Sibutramine was previously used as an appetite suppressant for weight loss, but available only by prescription. Slim-30 posed a threat to consumers because
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Slim-30 Herb Supplement was marketed as a Natural Herb for Weight Loss. Slim-30 Herb Supplement is packaged in plastic bottles containing 30 capsules per bottle and bears UPC 8 31457 005009 2. The affected lot/codes recalled are 032009 and 6032101. The product was sold to distributors and retail stores nationwide and China and via internet sales.
Consumers should immediately stop using Slim-30. If you believe you have experienced any side effects from Slim-30, you should report them to the FDA. You may do so online HERE. Also, save the product packaging, as it may help your ability to make a legal claim if you desire to do so. |
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| March 16, 2011 |
| Weight Loss Product Fruta Planta Contains Recalled Drug Sibutramine |
| Posted By DeCarli Law |
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The FDA has received multiple reports of adverse events from the use of Fruta Planta, including several cardiac events and one death. FDA laboratory analysis confirmed that Fruta Planta contains Sibutramine, a controlled substance that was withdrawn from the market in October 2010.
Fruta Planta was promoted and sold on various websites as a dietary supplement for weight loss. The product poses a threat to consumers because Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Fruta Planta may also interact in life threatening ways with other medications a consumer may be taking.
Consumers should stop using Fruta Planta immediately. Consumers who have experienced any negative side effects should consult a health care professional as soon as possible. Consumers also should report negative side effects to the FDA. You may do so online HERE. Also, save the product packaging, as it may help your ability to make a legal claim if you desire to do so. |
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| March 15, 2011 |
| FDA Warns Que She Herbal Supplement Contains Undisclosed and Recalled Drugs |
| Posted By DeCarli Law |
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In mid-2010, the FDA warned consumers and healthcare professionals that Que She contained multiple undisclosed drug ingredients. This warning has renewed importance now because one of those drugs, Sibutramine, has since been recalled from the market.
The FDA initially warned that Que She, marketed as an herbal weight loss supplement, contains unlisted and active pharmaceutical ingredients that could harm consumers, especially those with cardiovascular conditions. These active pharmaceutical ingredients also may interact with other medications and result in a serious adverse event.
FDA analysis of Que She found that it contains:
- Fenfluramine – a stimulant drug withdrawn from the U.S. market in 1997 after studies demonstrated that it caused serious heart valve damage.
- Propranolol – a prescription beta blocker drug that can pose a risk to people with bronchial asthma and certain heart conditions.
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Sibutramine – a weight loss drug recalled from the market in October 2010.
Sibutramine was the subject of a recent study whose preliminary findings showed an association between sibutramine use and increased risk of heart attack and stroke in patients who have a history of heart disease
- Ephedrine – a stimulant drug that is legally marketed over-the-counter for temporary relief of asthma but can pose a risk to people with certain cardiovascular conditions.
Que She, advertised as “Slimming Factor Capsule” and as “an all-natural blend of Chinese herbs,” has been widely distributed on Internet sites such as the Bouncing Bear Botanicals website, and at retail outlets, including Sacred Journey in Lawrence, Kansas. People who purchased Que She should stop taking the product immediately and consult a health care professional.
If you believe you have suffered a side effect or adverse reaction from using this product, you should report it to the FDA. You may do so online HERE. Also, save the product packaging, as it may help your ability to make a legal claim if you desire to do so. |
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| Continue reading "FDA Warns Que She Herbal Supplement Contains Undisclosed and Recalled Drugs" » |
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| March 11, 2011 |
| Celerite Slimming Capsules Recalled Because They Contain the Recalled Drug Sibutramine |
| Posted By DeCarli Law |
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FDA laboratory analysis confirmed that Celerite Slimming Capsules contain Sibutramine, a controlled substance that was withdrawn from the market in October 2010 for safety reasons.
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and presents a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. This product may also interact in life threatening ways with other medications a consumer may be taking.
Celerite Slimming Capsules, marketed as a dietary supplement for weight loss, is sold on various websites. Claims made for the product falsely state that it is “safe” and an “all-natural herbal weight loss remedy.”
Consumers should stop using Celerite Slimming Capsules. If you believe you have suffered a side effect or adverse reaction from using this product, you should report it to the FDA. You may do so online HERE. Also, save the product packaging, as it may help your ability to make a legal claim if you desire to do so. |
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| Continue reading "Celerite Slimming Capsules Recalled Because They Contain the Recalled Drug Sibutramine" » |
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| March 10, 2011 |
| Svelte 30 Weight Loss Product Recalled, Contains Banned Drug Sibutramine |
| Posted By DeCarli Law |
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FDA lab analysis of Svelte 30 revealed that it contains Sibutramine, once a prescription-only appetite suppressant that has now been withdrawn from the market. Svelte 30 may pose a threat to consumers because
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and presents a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Svelte 30 orange & gray capsules are marketed as a natural herb for weight loss. Svelte 30 Herb Supplement is packaged in plastic bottles containing 30 capsules per bottle and bears UPC #s from 04-3000 to 04-5999. They bear the manufacture date of 10/22/2010, with an expiration date of 10/21/2012.
Consumers should stop using the affected lots of Svelte 30 immediately. If you believe you have suffered a side effect or adverse reaction from using this product, you should report it to the FDA. You may do so online HERE. Also, save the product packaging, as it may help your ability to make a legal claim if you desire to do so.
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| March 09, 2011 |
| Meridia (Sibutramine) Withdrawn From Market Because of Heart Attack and Stroke Risk |
| Posted By DeCarli Law |
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Abbott Laboratories and the FDA reported that the obesity drug Meridia, generic name
Sibutramine, has been voluntarily withdrawn from the market. Clinical trial data indicates the use of
Meridia/Sibutramine increases the risk of heart attack and stroke.
The FDA requested that Meridia be withdrawn from the market after reviewing data from the Sibutramine Cardiovascular Outcomes Trial. The clinical trial was part of a postmarket requirement to look at cardiovascular safety of Sibutramine after its initial approval in Europe. The trial found a 16-percent increase in the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, the need to be resuscitated once the heart stopped, and even death, in a group of patients given Sibutramine, compared with those given only a placebo. There also was only a small difference in weight loss between the placebo group and the group that received Sibutramine.
Physicians have been advised to stop prescribing Meridia, and patients should stop taking any Meridia/Sibutramine previously prescribed to them. If you believe you have suffered a side effect or adverse reaction from
Meridia/Sibutramine, you should report it to the FDA. You may do so online
HERE.
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| February 11, 2011 |
| Recall of Nexgen Complete Knee Solution Knee Replacement Components |
| Posted By DeCarli Law |
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Zimmer Inc. has initiated a Class 2 recall of the Nexgen Complete Knee Solution MIS tibial components, locking screw and stem extensions. The U.S. Food and Drug Administration issued a notice regarding the recall on September 13, 2010. The FDA Notice may be found HERE, which lists the specific codes for the recalled devices.
As of the date of the notice, there had been 114 reports filed with the FDA reporting that the device loosened, requiring patients to undergo surgery to replace the device. Immediately after the recall, Zimmer sent an “URGENT DEVICE CORRECTION” letter to orthopedic surgeons who had used the device. Zimmer warned surgeons to destroy or disregard all previous versions of the surgical technique and to review and familiarize themselves with the revised technique in light of the recall.
If you or a loved one underwent knee replacement surgery in which a Nexgen device was used, you ultimately may need to undergo surgery to replace the defective Nexgen device. Symptoms that may indicate a failure of the device include knee and joint pain, difficulty standing or walking, decreased range of motion, and soreness or stiffness.
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| February 03, 2011 |
| More Information on Association Between Anaplastic Large Cell Lymphoma (ALCL) and Breast Implants |
| Posted By DeCarli Law |
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More information is available on the link between Anaplastic Large Cell Lymphoma (ALCL) and breast implants. As noted in an earlier blog post, the U.S. Food and Drug Administration announced last week the
link between ALCL and breast implants.
It is important to note that ALCL is not breast cancer. ALCL is a type of lymphoma, a cancer of the cells of the immune system. In the cases where women with breast implants developed ALCL, ALCL was not found in the breast tissue itself, but in the fibrous scar capsule surrounding the implant. Over time, a fibrous scar tissue called a capsule develops around a breast implant, separating the implant from the rest of the breast. The ALCL is found within this fibrous capsule.
ALCL has been diagnosed most frequently in women undergoing implant revision operations for late onset, persistent seroma (collection of fluid). Most patients are diagnosed when they seek medical treatment for implant related symptoms such as pain, lumps, swelling, or asymmetry that developed long after their initial surgical sites were fully healed. These symptoms were due to persistent seroma, hardening of breast area around the implant (capsular contraction), or masses surrounding the breast implant.
Importantly, the FDA is NOT recommending prophylactic breast implant removal in patients without symptoms or other abnormalities. However, the risk of ALCL should be considered by any woman considering whether to undergo breast implant surgery.
The FDA is requesting that healthcare professionals and patients report any confirmed cases of ALCL in women with breast implants. You may report a confirmed case to the FDA online HERE.
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| January 27, 2011 |
| Anaplastic Large Cell Lymphoma (ALCL) Linked to Breast Implants |
| Posted By DeCarli Law |
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The U.S. Food and Drug Administration announced yesterday a possible association between saline and silicone gel-filled breast implants, and anaplastic large cell lymphoma (ALCL). Data suggests that patients with breast implants have a very small, but significant, risk of ALCL in the scar capsule adjacent to the implant.
ALCL is a relatively uncommon type of non-Hodgkin’s lymphoma that arises from T-cells. ALCL is diagnosed in about 1 out of 500,000 women in the United States each year. ALCL located in breast tissue is even less common. The FDA is aware of only about 60 cases of ALCL worldwide in women with breast implants. However, the exact number is uncertain because it is likely that not all cases have been reported.
At present, breast implant manufacturers do not warn of the risk of ALCL. However, in an effort to ensure that patients receiving breast implants are informed of this risk, the FDA will be working with manufacturers in the coming months to update their product labeling materials to add a warning.
The FDA is requesting that healthcare professionals and patients report any confirmed cases of ALCL in women with breast implants. You may report a confirmed case to the FDA online HERE
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| January 12, 2011 |
| Drug Companies Hide Side Effects From Investors As Well As Consumers |
| Posted By DeCarli Law |
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From our work representing people injured by dangerous drugs, we’ve learned the hard way that drug companies often conceal drug side effects from consumers. According to a lawsuit now on appeal to the Supreme Court of the United States, they also sometimes hide them from their own investors, which underscores the importance of reporting drug side effects to the FDA.
A posting on the Wall Street Journal’s Law Blog reports on a lawsuit filed by investors against Matrixx Initiatives, Inc., whose wholly-owned subsidiary manufacturers Zicam. Investors brought a securities-fraud class-action lawsuit against Matrixx. The lawsuit alleges the company failed to disclose reports from consumers that they lost their sense of smell after using Zicam Cold Remedy nasal gel and swabs. Matrixx received at least a dozen reports between 1999 and 2003, but did not disclose this to potential investors.
The fact that pharmaceutical companies do not disclose reports of drug side effects to their own investors, as well as to the consumers who use their products, reinforces the importance of reporting injuries to the FDA. If you experience a side effect after using a prescription or over-the-counter drug, you should immediately report it to your physician and to the drug manufacturer, but ALSO report it to the FDA. You can easily do this online HERE.
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| September 09, 2010 |
| FDA Orders Label Changes for Gadolinium-Based Contrast Agents |
| Posted By DeCarli Law |
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The U.S. Food and Drug Administration (FDA) announced today that it will require significant label changes for gadolinium-based contrast agents (GBCAs) in order to reduce the risk of nephrogenic systemic fibrosis (NSF).
The most significant label change is the recommendation that Omniscan, Magnevist and Optimark NOT be used on people with chronic, severe kidney disease, such as dialysis patients, or those with acute kidney injury (AKI). This follows the determination by FDA staff last fall that Omniscan, Magnevist and Optimark are the gadolinium-based contrast agents most likely to cause NSF.
The new labeling also recommends that healthcare professionals:
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Screen patients prior to administration of a GBCA to identify those with AKI or chronic, severe, kidney disease. These patients appear to be at highest risk for NSF.
- Use the clinical history to screen patients for features of AKI or risk factors for chronically reduced kidney function.
- Avoid use of GBCAs in patients suspected or known to have impaired drug elimination unless the need for the diagnostic information is essential and not available with non-contrasted MRI or other alternative imaging modalities.
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Monitor for signs and symptoms of NSF after a GBCA is administered to a patient suspected or known to have impaired elimination of the drug.
- Not repeat administration of any GBCA during a single imaging session.
The complete text of the FDA's Safety Announcement may be found HERE.
Unfortunately, this label change comes too late for some people with kidney disease or AKI who were injected with Omniscan, Magnevist and Optimark and as a result, developed NSF. Symptoms of NSF include scaling, hardening and tightening of the skin; red or dark patches on the skin; and joint stiffness. NSF can also cause fibrosis of internal organs that may lead to death. There is no effective treatment for NSF.
If you or a loved one developed any of the NSF symptoms listed above after treatment with a gadolinium-based contrast agent, you may have a legal claim. However, these and all personal injury claims are subject to statutes of limitations -- laws that place deadlines on when a claim may be made. Call the NSF lawyers at DeCarli Law for a free, no-obligation telephone consultation to learn your legal options. We are experienced helping people stricken with NSF, and can provide you with additional information about NSF and your legal rights. |
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| August 13, 2010 |
| FDA Orders Label Change for Lamictal (lamotrigine) to Disclose Risk of Aseptic Meningitis |
| Posted By DeCarli Law |
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The FDA has issued a safety alert disclosing that Lamictal (lamotrigine) can cause aseptic meningitis. Lamictal (lamotrigine) is a medication commonly used to treat seizures in children two years and older, and bipolar disorder in adults. Symptoms of meningitis may include headache, fever, stiff neck, nausea, vomiting, rash, and sensitivity to light. In cases of meningitis, it is important to rapidly diagnose the underlying cause so that the correct treatment can be promptly begun.
The label change to disclose the risk of aseptic meningitis came after the FDA identified 40 cases of aseptic meningitis in patients who took Lamictal between December 1994 and November 2009.
Patients should immediately contact their healthcare professional if they experience signs and symptoms of meningitis while taking Lamictal. Patients or their parents can report Lamictal side effects to the FDA online HERE.
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| August 13, 2010 |
| Prolactis, an Over-the-Counter Male Enhancement Supplement, Recalled Today for Containing Undeclared Drug Ingredient |
| Posted By DeCarli Law |
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 The Food and Drug Administration (FDA) today ordered the recall of the male enhancement supplement Prolactis because it contains an undeclared drug ingredient. Lab analysis has found that Prolactis contains Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). This makes Prolatis' an unapproved drug. The Prolactis label does not disclose this ingredient.
Sildenafil is the active ingredient in Viagra. Sildenafil's analogue, Sulfoaildenafil, may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.
The product subject to the recall was manufactured prior to August 9, 2010. The FDA is encouraging patients to report any side effects they suffer as a result of using Prolactis. Side effects can be reported to the FDA online HERE.
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| Continue reading "Prolactis, an Over-the-Counter Male Enhancement Supplement, Recalled Today for Containing Undeclared Drug Ingredient" » |
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| August 12, 2010 |
| After Years of Delay, Bayer Asks the FDA for Approval of Gadovist, its Safer Gadolinium-Based Contrast Long Available in Europe |
| Posted By DeCarli Law |
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The FDA has just accepted Bayer Schering Pharma's New Drug Application for Gadovist, a gadolinium-based contrast agent currently sold in Europe and other parts of the world, but not in the United States. A New Drug Application is the procedure a drug company uses to formally request the FDA to allow it to sell a drug in the United States.
Although Bayer's application for Gadovist is new, Gadovist itself is not. Gadovist has been approved for sale in the European Union since 1998. However, until recently, Bayer has not sought approval for selling it in the United States. This decision -- whatever its basis -- has put Americans at risk.
Gadovist has a macrocyclic molecular structure, which means the gadolinium ion is surrounded by an organic chelate. In contrast, Magnevist, the Bayer contrast agent sold in the United States, has a linear ionic molecular structure. Magnevist's molecular structure is less stable than Gadovist's macrocyclic structure. As a result, European regulatory agencies recognize than Magnevist is less safe than Gadovist. The EU equivalent of the FDA requires the Magnevist label to state that it is contraindicated (not recommended) for use on people with severe renal impairment. Gadovist does not have this restriction.
A gadolinium-based contrast agent's molecular stability has dire health consequences, especially for people with impaired renal function, like those on dialysis. If a gadolinium-based contrast agent breaks down within the human body, the person is at risk of developing nephrogenic systemic fibrosis (NSF). NSF, also known as nephrogenic fibrosing dermopathy (NFD), is an incurable disease characterized by hardening of the skin and other body tissues. The only known cause of NSF/NFD is the use of gadolinium-based contrast agents in medical procedures such as MRI, MRA and CT scans (CAT scans).
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| August 09, 2010 |
| Recall of Appetite Suppressant “Solo Slim” |
| Posted By DeCarli Law |
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The FDA announced today the recall of appetite suppressants “Solo Slim” and “Solo Slim Extra Strength.” FDA lab analysis revealed that Solo Slim contains an undeclared drug ingredient, Didesmethyl Sibutramine. Sibutramine is an FDA-approved drug used as an appetite suppressant for weight loss. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients, and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Solo Slim Extra Strength is packaged in a white plastic bottle with a blue screw-on cap, as pictured to the left. Each bottle contains 30 capsules, and bears UPC 8 35470 00220 5. All lots of these products with expiration dates including and prior to August 2013 currently available on the market are being recalled. The products were sold to distributors and retail stores nationwide, and on the internet.
Consumers should return the product immediately to the place of purchase for a full refund, and contact their physician if they have experienced any side effects as a result of taking the product.
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| May 11, 2010 |
| FDA Announces “Bad Ad Program” to Help Health Care Providers Detect and Report Misleading Drug Ads |
| Posted By DeCarli Law |
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Today, the U.S. Food and Drug Administration announced the launch of what it calls the “Bad Ad Program.” The program is designed to educate health care providers about their role in ensuring that prescription drug advertising and promotion is truthful and not misleading.
The program is aimed at drug ads that target doctors and other health care providers. The pharmaceutical industry spends three times as much on advertising directed at health care professionals as it spends on advertising directed at consumers. Advertising directly to health care professionals is called “detailing,” and most frequently occurs in locations such as medical offices, hospitals, and pharmacies, as well as at medical meetings and symposia.
A document released today by the FDA describes the main purpose of the Bad Ad Program as raising “awareness among health care professionals about the importance of helping FDA in its efforts to prevent misleading promotion of prescription drugs.” According to Thomas Abrams, director of the FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC), “the Bad Ad Program will help health care providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency.”
When reports of misleading ads are filed, the DDMAC will determine whether it meets the criteria necessary for taking regulatory action. If the DDMAC determines the ad to be a violation, it will move forward with an appropriate enforcement action, which could include sending a Warning Letter or referring the matter to law enforcement for a criminal investigation.
Although the Bad Ad Program is mainly aimed at health care professionals, anyone can submit a complaint to the FDA. The FDA has a similar educational campaign designed to educate consumers about misleading drugs advertisements. This program is called EthicAd and may be accessed on the internet HERE.
If you believe you have been injured by a prescription drug or over-the-counter drug, you also can report this to the FDA HERE. This is not necessary to preserve your legal rights, but it is the right thing to do, because it can bring dangerous drug side effects to the attention of the FDA, and make sure the FDA is aware how dangerous a particular drug is.
FDA Documents on the Bad Ad Program:
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