DEFECTIVE GENERIC PILL REVIVES QUALITY CONCERNS

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http://hosted.ap.org/dynamic/stories/U/US_GENERIC_DRUGS_QUALITY?SITE=AP&SECTION=HOME&TEMPLATE=DEFAULT&CTIME=2012-10-04-18-42-17

WASHINGTON (AP) -- More Americans than ever are taking generic drugs, as blockbuster medicines like Plavix and Lipitor become available in low-cost versions. But the government's revelation this week that it mistakenly approved a defective generic antidepressant could stoke longtime concerns about the quality of knockoff drugs.

The Food and Drug Administration on Wednesday asked Teva Pharmaceuticals to withdraw its drug Budeprion XL 300 after testing showed the drug did not properly release its key ingredient. The drug is supposed to be equivalent to GlaxoSmithKline's popular antidepressant Wellbutrin XL, which is prescribed to treat depression, anxiety and symptoms of nicotine withdrawal.

The announcement marked an about-face for regulators, who said in 2008 that the two drugs were essentially the same, despite hundreds of complaints from patients who said they experienced side effects such as headaches, anxiety and insomnia after switching to the generic drug. The FDA has withdrawn generic drugs before, but this appears to be the first case driven by consumer complaints, which continued to pile up after the FDA said the drug was working correctly.

"The lesson is that everyone - from pharmacists to physicians to the FDA - needs to take these reports seriously," said Dr. Tod Cooperman of ConsumerLab, a privately-held company that independently tests drugs and nutrition products. Cooperman added that the vast majority generic drugs work appropriately but that, "consumers will be the first to know when there is a problem."

[HuckleB]

1. This problem seems to be increasing.

Clinicians know that many people struggled after going to a generic version of Celexa. Others, who started on a generic version of the drug, also struggled when their pharmacy changed to different maker of the generic version. There are now reports of side effects for some who have moved to a generic version of Lexapro.

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2. nothing beats proper oversight and inspection. nt

[Odin2005]

3. I've noticed that different generic brands of Paxil have different effects.

The one I take now, with a pink pill, seems to have less side effects than a previous generic brand with a blue pill.