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Plant Problems In Puerto Rico Could Lead To Drug Shortage
By Donna Leinwand
7 March 2005
WASHINGTON -- Diabetics who use Avandamet and patients with depression and panic disorders who use Paxil may experience shortages of the two medications until the company that makes the drugs fixes problems at its Puerto Rico plant.
U.S. marshals Friday seized millions of tablets of both drugs at a GlaxoSmithKline plant in Cidra, Puerto Rico, and distribution facilities in Puerto Rico and in Knoxville, Tenn., according to the Food and Drug Administration.
In Tennessee, they seized 311,348 30-tablet bottles of Paxil CR worth about $23 million and 235,000 bottles of Avandamet. In Puerto Rico, they seized about half of the company's inventory, including much of the medicine, which was still in granular form, says Dave Sacks, a spokesman for the U.S. Marshals Service. The FDA obtained court orders to seize the drugs after the company failed to recall all the drugs deemed defective by the agency.
Paxil CR is a controlled-release anti-depressant and anti- anxiety drug. Avandamet is used to control Type II diabetes. In the short term, the FDA action could "result in a shortage of patient supplies for both these medicines," GlaxoSmithKline said in a statement. The company said it is working with the FDA to resolve problems at the plant quickly. It did not say when it would restart drug distribution.
Shares closed at $48.91 on Friday, down $1.59, or 3.1%.
The FDA said it seized the drugs because the company failed to meet federal standards for product safety, strength, quality and purity. FDA inspections found "significant violations" at the manufacturing plant, the statement said.
The FDA in its latest inspection found that the Paxil tablets could split apart, making it possible for patients to get a portion of tablet without any medicine in it or get all the medicine at once without the time-release element. The FDA also found that some Avandamet tablets did not have accurate doses of its active ingredient, rosiglitazone.
The FDA sent the company a warning letter about the Puerto Rico plant on July 1, 2002. The letter was based on inspections in 2001 and 2002. The FDA conducted follow-up inspections in November and December 2003 and between September and November 2004 and continued to find violations.
The company recalled 78,000 30-count bottles of Paxil tablets in December 2004 because the tablets were found to be subpotent.
The FDA said it is not aware of anyone who has been harmed by the drugs and does not believe the drugs pose a significant health risk. The FDA said patients should keep taking the drugs and talk to their doctors about alternatives until the manufacturing problems are fixed.