GlaxoSmithKline says US FDA halts distribution of Paxil and Avandamet

LONDON - British pharmaceutical group GlaxoSmithKline said Friday the US Food and Drug Administration had halted distribution of two of its medicines -- depression and anxiety treatment Paxil CR tablets and type 2 diabetes treatment Avandamet, also in tablet form -- due to unspecified "manufacturing issues."
The company said the FDA-enforced halt relates to all strengths of Paxil CR as well as Avandamet one-milligram, two-milligram and four-milligram pills and added that it was working with the regulator to resolve the issue as quickly as possible.
"In the short term, it is expected that the FDA action will result in a shortage of patient supplies for both of these medicines," the group said.
"GSK believes that the manufacturing issues do not pose a health risk to patients."
The company said the FDA agreed that patients who are using the medicines should continue taking their tablets and talk with their healthcare provider if they have questions.

03/04/2005 17:12 GMT - AFP