Posted on 03/04/2005 9:21:44 AM PST by OrangeDaisy
U.S. Seizes Batches of Two Glaxo Drugs Over Quality
Friday March 4, 11:33 AM EST
WASHINGTON (Reuters) - The U.S. Food and Drug Administration said on Friday that officials had seized batches of GlaxoSmithKline Plc's (GSK) diabetes drug Avandamet and the controlled-release antidepressant Paxil CR because of concerns over manufacturing quality.
The FDA said in a statement that the manufacturing practices for the two drugs failed to meet standards for safety, strength, quality and purity.
However, the agency said it was not aware of any harm to consumers and did not believe there was a significant health hazard.
Patients taking the two drugs were advised to continue taking their medication but talk to their doctor about possibly using alternative products until the manufacturing problems have been corrected.
"FDA and the Department of Justice will not allow drug manufacturers to ignore our high public health standards for drug manufacturing," said John Taylor, FDA Associate Commissioner for Regulatory Affairs.
GlaxoSmithKline, Europe's biggest drugmaker, said it was working to resolve manufacturing problems with the drugs. It warned both drugs would be in short supply in the United States.
"GSK believes that the manufacturing issues do not pose a health risk to patients," the British-based company said in a statement. "The company is working with the FDA to resolve these issues as quickly as possible."
Shares of GlaxoSmithKline were down 90 cents, or 1.8 percent, to $49.60 in morning trading on the New York Stock Exchange.
Are they manufacturing these drugs overseas to reduce costs?
Speaking of marketing, will Eli Lilly shares now go up?
Yes, they are rosiglitazone and metformin. The problem is that rosiglitazone is marketed by the same lab that sells avandamet, so any quality concerns with this particular drug would also affect avandia (trade name for rosiglitazone). I'm still searching for the second drug, but at least it's not marketed by the same lab! The question is, did the problem involve both drugs or only one? My husband is diabetic and is doing great on avandamet. I wouldn't be too concerned about switching to avandia, because that is the main drug of the two. But it will be very upsetting if he has to give it up all together! Why do these things always happen on Friday evenings, where we cannot reach our doctor until Monday?
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.