FDA Asks Manufacturer to Pull Generic Antidepressant

The Washington Post has noted that concerns regarding the use of generic drugs could again be raised with the revelation that the U.S. Food and Drug Administration (FDA) mistakenly approved a defective generic antidepressant. 

In an October 3 release, the FDA announced that it has asked Teva Pharmaceuticals to take off the market Budeprion XL 300, which was previously approved as a genetic form of Wellbutrin XL. Further testing showed that its key ingredient wasn’t properly released when processed by the body.  

The approval for the generic antidepressant was given back in 2006. Despite the approval, complaints were filed regarding side effects. These side effects hadn’t been experienced with Wellbutrin XL. 

The Budeprion XL 300 side effects included: 

  • insomnia;
  • anxiety; and
  • headaches. 

Although the manufacturer has stopped production, it insists there are no safety issues with the drug. Some are saying that this is a single case that shouldn’t be cause for alarm when it comes to the safety of other generic medications. 

The FDA indicates its mistake in approving the drug was based on the fact that the 150 milligram (mg) dose of Budeprion tested well and the 300mg dose was assumed to do the same. Yet further testing revealed that just 75 percent of the key ingredient was absorbed into the bloodstream in the 300mg dose. 

This is now leading to changes, in that instead of just testing the lower doses of generic antidepressants, the highest doses will also be tested. At the same time, they are asking manufacturers to do a better job at focusing on quality. 

If you believe you have been harmed by a dangerous drug, contact the lawyers at New York’s Gacovino, Lake & Associates to set up a consultation to discuss your case. Call 1-800-246-HURT (4878). 

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