FDA Says Generic Wellbutrin Antidepressant is Ineffective
Teva Pharmaceuticals has stopped shipping its generic version of the popular antidepressant Wellbutrin, after a federal analysis demonstrated that the pill does not work properly.
The Food and Drug Administration announced on Wednesday it has asked Teva to withdraw Budeprion XL 300 from the market, after new testing revealed the drug releases its key ingredient more quickly than the original drug Wellbutrin XL 300, made by GlaxoSmithKline.
Teva stopped shipping the drug last Thursday, according to a spokeswoman for the company.
This decision is especially interesting considering that the FDA previously reviewed the drug back in 2008, and determined that there were no substantial differences between Wellbutrin and Budeprion. The review came after hundreds of patients complained of ineffectiveness from Budeprion, as well as side effects like anxiety, headaches and insomnia.
But the differences were known long before the 2008 review. According to Fox News:
In 2007, the website ConsumerLab published an analysis of the two drugs, indicating Budeprion XL released 34 percent of its active ingredient in just two hours, compared to 8 percent for the original drug. ConsumerLab is a small privately-held company that independently tests drugs and nutrition products.
“We’re proud we were able to help uncover this problem, but it’s unfortunate that it’s taken the FDA five years to get the product removed,” said Dr. Tod Cooperman, president of ConsumerLab. “I believe the majority of generics are fine, but there are certainly situations where some aren’t equivalent.”
The FDA explained its reversal on Wednesday. “Based on the information we had available at that time we concluded that the 150 milligram strength was doing what it should, and that it was acceptable to extrapolate those findings to the 300 milligram strength,” said a spokeswoman for the FDA.
The FDA now advises patients with a prescription for Budeprion XL 300 to contact their doctor for instructions on how to proceed
Wellbutrin, known chemically as bupropion, is prescribed for the treatment depression and anxiety. But it’s known to carry some severe side effects. In rare instances, it has even been linked to seizures, paranoia, elevated depression and suicide. To think that a generic drug is releasing the active ingredient even more quickly than Wellbutrin is very alarming.
We applaud the FDA for taking steps to remove this potentially dangerous–and at the very least, ineffective–drug from the market. Each year, we see far too many Americans suffering needlessly due to antidepressant side effects, and we encourage the FDA to continue reviewing these drugs and their side effects.
If you have taken Wellbutrin or any generic variation, and have suffered serious antidepressant side effects as a result, you may be entitled to monetary compensation. At Nadrich & Cohen, our attorneys are aggressive and committed to fighting for you. Give us a call at 800-718-4658 to receive a free case evaluation. Your consultation is completely confidential. Call us today.