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FDA seizes GSK drugs

The Food and Drug Adminstration has seized stocks of two GSK drugs, and accused the company of failing to meet manufacturing standards.

The Food and Drug Adminstration (FDA) has seized stocks of two top-selling GlaxoSmithKline (GSK) drugs, after the regulator accused the company of failing to meet manufacturing standards.

Officials said that supplies of Paxil CR and Avandamet from manufacturing and distribution sites in Puerto Rico and a distribution facility in Tennessee did not meet standards set out by the FDA to ensure product safety, strength, quality and purity.

GSK believes the move, which follows warnings from the FDA about the manufacturing violations, will lead to a shortage of patient supplies for antidepressant Paxil CR - which is not marketed in the UK - and diabetes drug, Avandamet. The company does not manufacture Paxil CR anywhere other than at its site in Puerto Rico and produces only a small quantity of Advandamet from a plant in Spain, which could exacerbate patient supply issues.

An inspection by the regulator revealed that the affected Paxil CR tablets could split apart. This may result in patients receiving treatment that does not contain the active ingredient; alternatively, they could receive part of the drug containing the active components but not the compound necessary for its controlled release, the FDA concluded.

In the case of Avandamet, the FDA found that tablets did not contain an accurate dose of the active ingredient, rosiglitazone.

A spokesman for GSK told PMLive.com that only a `handful' of Paxil CR tablets were splitting and these had been removed by hand - a solution that was working well for the company. He added that the 1mg dose of Avandamet, in which the small molecules had been `clumping', has already been withdrawn from the market.

GSK has noted that the manufacturing issues are not a public health issue and the FDA has conceded that it is not aware that patients have been harmed by the drugs and does not believe that the affected stocks pose a significant threat to consumers.

It is urging patients who use Paxil CR and Avandamet to continue taking the medication and to consult a healthcare professional about possible alternatives until the manufacturing issue has been resolved.

According to the Medicines and Healthcare products Regulatory Agency (MHRA), the Puerto Rican plant did not supply drugs into the UK market. While the pharma giant had voluntarily recalled some of the affected drugs from the market, it failed to withdraw all the affected stock, prompting the seizure of the two drugs by the FDA.

John M Taylor, FDA associate commissioner for regulatory affairs, said that the regulator and the Department of Justice would not allow companies to ignore high standards of drug manufacturing.

ìOnce we discover a company is not following the standards, which were created to ensure safety and quality, we expect them to correct the deficiencies in an expedited manner.î

GSK shares fell 2.2 per cent on the news.

30th September 2008

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