Posts Tagged ‘Defective Drugs’

Prostate Cancer Drugs That May Cause Sudden Death Now Require Warning Labels

Monday, November 8th, 2010

This year an estimated 32,050 men will die from prostate cancer and more than 200,000 men will be diagnosed with the disease, according to the Centers for Disease Control. Prostate cancer is the second most common type of cancer among men in the U.S. after skin cancer.

Prostate cancer drugs that can cause heart attack, stroke, diabetes and even sudden death must now carry labels to warn patients of their potential risks, according to a new U.S. Food and Drug Administration rule.

In May, the FDA first announced the drugs’ links to the health problems, saying patients taking gonadotropin-releasing hormone (GnRH) agonists were at a small increased risk for the health complications.

“I think this was long due,” said Dr. David Samadi, vice chair of Urology at Mount Sinai School of Medicine in New York City. “A lot of times the risks [of taking the medication] outweigh the benefit; as more and more patients read about side effects, they will choose surgery over radiation.”

Not only are the drugs bad especially for men with heart problems, but they induce symptoms of “male menopause,” he said, causing depression, fatigue and weight gain. These changes occur naturally as men age and their testosterone drops, but the drugs bring them on sooner, he said.

However, in very serious prostate cancer, the drugs still work wonders, said Dr. Ana Aparicio, an assistant medical oncology professor at the University of Texas’ M.D. Anderson Cancer Center.

“These drugs are extremely effective for treating this disease, and in all do make people feel better,” Aparicio said.

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Meridia Withdrawn from U.S. Market

Friday, October 8th, 2010

Pharmaceutical manufacturer Abbott Laboratories agreed today to withdraw its obesity drug, Meridia (sibutramine), from the U.S. market, according to the Division of Drug Information (DDI). The decision was made due to clinical data showing an increased risk of heart attack and stroke. The announcement was made by the U.S. Food and Drug Administration (FDA).

Approved in 1997 for patients suffering from obesity, Meridia has been under scrutiny for some time due to reports of patients suffering heart attacks and stroke after taking the drug. Meridia was approved after clinical data illustrated that more people taking the drug were able to lose 5 percent of their body weight than those taking a placebo along with diet and exercise.

Abbott agreed to withdraw Meridia at the request of the FDA, which completed a review of data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT). This trial showed a 16 percent increase in the risk of serious heart problems among patients taking sibutramine when compared to patients who were given a placebo. Heart problems included non-fatal stroke, non-fatal heart attack, the need for resuscitation once the heart stopped, and in some cases, death.

Drug manufacturers are required to ensure the safety of their products. Adverse health effects resulting from a defective drug may be grounds for a defective drug lawsuit. Personal injury lawyers may cite pharmaceutical liability, product liability, strict liability and other legal theories to argue your case. To find a lawyer or learn more about pharmaceutical liability and defective drug deaths, please refer to Your Legal Guide’s defective drug section.

FDA Committee Delivers Split Verdict on the Diabetes Drug Avandia

Wednesday, July 21st, 2010

Avandia, which was put on the market in 1999, is also known as rosiglitazone. Avandia is a drug taken once or twice daily to manage type 2 diabetes. It is prescribed to those who need more than one medicine to help treat their diabetes in different ways.

Most of the committee members voted to leave Avandia on the market but recommended that changes be made in how it is prescribed. Additionally, 12 out of the committee’s 33 members voted to pull Avandia off the market altogether, while only three supported leaving it on the market with its current labeling. Seven voted to add stiffer warnings to the current label, and 10 wanted both stiffer language and restrictions on its use.

A 2007 study, published in the New England Journal of Medicine, linked the drug to a 43 percent higher chance of heart attack as well as in increased risk of stroke and, in some cases, death. After that, federal regulators mandated that GlaxoSmithKline (GSK) add more warnings to the drug’s labeling.

GSK is facing more than 13,000 legal challenges, and has already awarded $60 million to settle some of them. A Philadelphia court will hear the first American cases in October.

If you or a loved one has suffered adverse side effects as a result of taking Avandia and other defective drugs, click here to locate a personal injury lawyer in your area. If a loved one has died as a result of taking a defective drug, a wrongful death lawyer can guide you through the process of filing a wrongful death lawsuit.