The Food and Drug Administration on Friday halted distribution of supplies of antidepressant Paxil CR and diabetes drug Avandamet because of concerns about manufacturing and quality.
FDA officials said manufacturing practices for the two drugs, made by British-based GlaxoSmithKline, failed to meet the standards laid out by FDA that ensure product safety, strength, quality and purity.
However, both the FDA and GSK said they do not believe these products pose a significant health hazard to consumers. Furthermore, GSK said the FDA action would probably result in a shortage of patient supplies for Paxil CR and Avandamet.
Among the violations noted during FDA’s latest inspection was the finding that the Paxil CR tablets could split apart and patients could receive a portion of the tablets that lacks any active ingredient, or alternatively a portion that contains active ingredient and does not have the intended controlled-release effect. Additionally, FDA found that some Avandamet tablets did not have an accurate dose of rosiglitazone, an active ingredient in this product.
The FDA urges patients who use these two drugs to continue taking their tablets and to talk with their health care provider about possible alternative products for use until the manufacturing problems have been corrected.
(via PR Newswire)












1 response so far ↓
Edward Wojtysiak // Mar 31, 2005 at 3:27 pm
How long will the disruption be and when will consumers know all the problems have been solved? What about reimbursement for defective Avandamet? I have been taking this medication for a year, how much of the medication has been substandard or defective?
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