|
 |
 |
| August 19, 2011 |
| Actoplus Met Bladder Cancer Risk |
| Posted By DeCarli Law |
 |
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.
|
|
| Continue reading "Actoplus Met Bladder Cancer Risk" » |
|
Permalink  |
| |
| August 18, 2011 |
| Duetact Bladder Cancer Side Effect |
| Posted By DeCarli Law |
|
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.
|
|
| Continue reading "Duetact Bladder Cancer Side Effect" » |
|
| Permalink |
| |
| August 09, 2011 |
| FDA: Actos Must Warn of Bladder Cancer Risk |
| Posted By DeCarli Law |
|
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.
|
|
| Continue reading "FDA: Actos Must Warn of Bladder Cancer Risk" » |
|
| Permalink |
| |
| July 13, 2011 |
| FDA Warns of Surgical Mesh Complications |
| Posted By DeCarli Law |
|
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.
|
|
| Continue reading "FDA Warns of Surgical Mesh Complications" » |
|
| Permalink |
| |
| June 16, 2011 |
| Diabetes Drug Actos Increases Risk of Bladder Cancer After Long-Term Use |
| Posted By DeCarli Law |
|
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.
|
|
| Continue reading "Diabetes Drug Actos Increases Risk of Bladder Cancer After Long-Term Use" » |
|
| Permalink |
| |
| June 10, 2011 |
| FDA Alert on Increased Risk of Prostate Cancer From Proscar and Avodart |
| Posted By DeCarli Law |
|
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.
|
|
| Continue reading "FDA Alert on Increased Risk of Prostate Cancer From Proscar and Avodart" » |
|
| Permalink |
| |
| June 08, 2011 |
| Label Change for Cholesterol-Lowering Drug Zocor, Recommending Lower Maximum Dose |
| Posted By DeCarli Law |
|
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). |
|
| Continue reading "Label Change for Cholesterol-Lowering Drug Zocor, Recommending Lower Maximum Dose" » |
|
| Permalink |
| |
| April 18, 2011 |
| FDA Orders Clinical Trials for Asthma Drugs |
| Posted By DeCarli Law |
|
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.
|
|
| Continue reading "FDA Orders Clinical Trials for Asthma Drugs" » |
|
| Permalink |
| |
| April 11, 2011 |
| Migraine/Epilepsy Drug Topamax Causes Cleft Lip and Cleft Palate Birth Defects |
| Posted By DeCarli Law |
|
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.
|
|
| Continue reading "Migraine/Epilepsy Drug Topamax Causes Cleft Lip and Cleft Palate Birth Defects" » |
|
| Permalink |
| |
| September 09, 2010 |
| FDA Orders Label Changes for Gadolinium-Based Contrast Agents |
| Posted By DeCarli Law |
|
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:
-
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.
-
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. |
|
| Continue reading "FDA Orders Label Changes for Gadolinium-Based Contrast Agents" » |
|
| Permalink |
| |
| August 13, 2010 |
| FDA Orders Label Change for Lamictal (lamotrigine) to Disclose Risk of Aseptic Meningitis |
| Posted By DeCarli Law |
|
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.
|
|
| Continue reading "FDA Orders Label Change for Lamictal (lamotrigine) to Disclose Risk of Aseptic Meningitis" » |
|
| Permalink |
| | |
|
 |