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FDA Halts Distribution of Drugs Paxil CR, Avandamet

Manufacturing concerns prompted the agency to seize batches of the antidepressant and diabetes medicines

Mar 5, 2005 | Los Angeles Times

The Food and Drug Administration halted distribution Friday of the popular antidepressant Paxil CR and the diabetes drug Avandamet, citing concerns about manufacturing problems.

FDA officials said the medications made by the British pharmaceutical company Glaxo-SmithKline Inc. showed signs of failing to meet federal production standards designed to ensure safety, strength, quality and purity.

But the drugs do not pose a significant hazard to consumers, the FDA said.

The agency recommended that patients continue taking their supplies of the medications and talk to their doctors about alternatives until the drugs are returned to the market.

Company officials warned consumers that the FDA action, which included seizing batches at manufacturing and distribution facilities, probably would cause a short-term shortage of the medications.

FDA officials found that some Paxil CR, or controlled release, tablets could split apart. As a result, the tablet may not release the drug in a controlled manner, or a portion of it may lack the active ingredient altogether.

The immediate release form of Paxil was not included in the seizure.

Paxil came under fire last year when New York's attorney general charged that Glaxo- SmithKline had misled the public about whether the drug caused an increase in suicidal tendencies in teenagers. The company settled the suit in August, but maintained that the charges were unfounded.

FDA officials also found a higher dose of the active ingredient in some lots of Avandamet, a drug that helps people with diabetes control their sugar levels.

Company officials said they were surprised by the government's action.

Nancy Pekarek, a spokeswoman for GlaxoSmithKline, said the company had informed the FDA of the problems and was moving to solve them.

She said the problems with both medications involve only a small amount of pills.

She also said that for consumers taking the Paxil pills that are split, the effect would be like skipping a dose or taking one a few hours early.

With Avandamet, the company only identified problems in the low-dose version of the pills, although all versions were seized.

FDA officials said the problems surfaced during an inspection in 2002. The agency informed the company of inconsistencies in the quality of the drugs and improper recall procedures for faulty products. The agency performed inspections in 2003 and one in 2004.

Despite some progress, continuing problems required Friday's action, the officials said.

"FDA and the Department of Justice will not allow drug manufacturers to ignore our high public health standards for drug manufacturing, " said John M. Taylor, the FDA's associate commissioner for regulatory affairs.


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