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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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| 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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| May 19, 2011 |
| Avandia No Longer To Be Sold in Retail Pharmacies |
| Posted By DeCarli Law |
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The U.S. Food and Drug Administration (FDA) announced on May 18, 2011, new and strict restrictions on the prescribing and use of Avandia and other rosiglitazone-containing medicines. After November 18, 2011, the drugs will no longer be available in retail pharmacies. Instead, both healthcare providers and patients must enroll in a special program in order to prescribe and receive these drugs.
Rosiglitazone-containing medicines include Avandia, Avandamet, and Avandaryl, and are used to treat type II diabetes. The FDA is imposing these restrictions because of data suggesting an elevated risk of heart attacks among users of Avandia and its generic forms. The restrictions are an implementation of the Risk Evaluation and Mitigation Strategy (REMS), an FDA program to manage serious risks of marketed drugs.
The complete FDA Drug Safety Communication on the new restrictions, and additional information from the FDA, may be found HERE.
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| April 14, 2011 |
| Topamax Recall for Contamination From TBA, By-Product of Wood Treating Chemical |
| Posted By DeCarli Law |
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Drugmaker Johnson & Johnson today recalled 57,000 bottles of its Topamax epilepsy and migraine drug due to complaints of an “uncharacteristic odor” associated with the tablets. A spokesman stated that the odor is caused by trace amounts of a compound called TBA, a by-product of a chemical used to treat wood in some countries. The wood is used to construct pallets on which products are transported and stored.
The two lots involved in the recall were shipped between Oct. 19, 2010, and Dec. 28, 2010, and distributed in the U.S. and Puerto Rico. The recall includes Topamax with NDC code 50458-641-65 and lot numbers OKG110 with an expiration date of 06-2012 and OLG222 with an expiration date of 09-2012. Although Johnson & Johnson claims TBA is not considered toxic, some patients taking the contaminated drug have reported gastrointestinal symptoms.
This recall follows shortly after the FDA safety announcement we previously reported that
Topamax can cause birth defects such as cleft lips and cleft palates in the children of women who took
Topamax while pregnant. To learn more about the potential dangers of
Topamax, go
HERE.
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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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| Continue reading "URGENT: Finasteride Mislabeled as Depression Drug Citalopram: Finasteride Causes Genital Abnormalities" » |
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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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| Continue reading "Recalled Drug Sibutramine in Slimming Beauty Bitter Orange Slimming Capsules" » |
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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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| 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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| September 13, 2010 |
| Recalled Diet Drug Solo Slim Contains Synephrine |
| Posted By DeCarli Law |
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The FDA recently ordered the recall of diet drug Solo Slim because it contains an undeclared drug ingredient, Didesmethyl Sibutramine, a risk for people with a history of heart disease. However, Solo Slim also contains Synephrine, another potentially dangerous drug that can cause heart attacks, heart palpitations, strokes, and even death.
Synephrine (or oxydrine) has a chemical structure similar to ephedrine. Because of its similarity to ephedrine, Synephrine can cause similar side effects. Based on the potential for cardiovascular toxicity of Synephrine, Health Canada in January 2010 issued guidelines limiting the maximum dose of Synephrine, and prohibiting the sale of health products containing both Synephrine and caffeine without prior submission of clinical evidence of the product’s safety.
Thus, Solo Slim contains two different drugs that can cause heart attacks and strokes. Further, Solo Slim also contains caffeine, which in combination with Synephrine was regarded as potentially dangerous in itself by the Canadian health agency. This chemical makeup makes Solo Slim particularly dangerous for people with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
As we reported in an earlier post, consumers should return Solo Slim immediately to the place of purchase for a full refund, and contact their physician if they experience any side effects as a result of taking the product. |
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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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| 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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