Healthy Skepticism Library item: 847
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Publication type: news
Schaefer MUÑOZ, Whalen J.
FDA Seizes Two Glaxo Drugs On Production-Quality Concerns
THE WALL STREET JOURNAL 2005 Mar 7
Full text:
British drug-maker GlaxoSmithKline PLC said it is working with the U.S. Food and Drug Administration toward a quick resolution of production problems that led law enforcement officials to seize thousands of bottles of two of its drugs.
The company said that in the meantime, customers could face a shortage of two drugs, Paxil CR, extended-release tablets used to treat anxiety and depression, and Avandamet, for diabetes. Production of the drugs has been halted at its Cidra, Puerto Rico, plant, company officials said.
The FDA, citing a three-year history of concerns over manufacturing processes of Paxil CR and Avandamet, called for a seizure of “thousands of bottles” of the medications at the Cidra plant and distribution facilities in Puerto Rico and Knoxville, Tenn., an agency spokeswoman said. The seizure comes amid FDA efforts to show its muscle on safety issues, and two years after the agency began an overhaul of its manufacturing regulations.
The drugs aren’t thought to pose a health risk to consumers but were confiscated after officials concluded that quality problems in their manufacturing process eventually could result in potential risks, FDA officials said. The agency said substitutes for the drugs are available, including versions of the individual components of Avandamet and the immediate-release form of Paxil.
Problems with the extended-release Paxil stem from the tablets breakage during production, FDA officials said. A patient taking half that contained the active ingredient would receive a direct dose, or one that wasn’t slowly released. Taking a half with the inactive ingredient, however, would be like skipping a dose. A Glaxo spokeswoman said that is something that happens from time to time with all drugs.
The FDA said the problem with Avandamet, the diabetes drug, was that the active ingredient, rosiglitazone, wasn’t uniformly distributed throughout the tablet. The Glaxo spokeswoman said the company believes the problem is occurring only in the low-dose strength, and has recalled that dose from the market. She said the slightly increased level of active ingredient still was within the dose range approved for sale by the FDA and therefore wouldn’t pose a health risk to patients.
In November, Glaxo began inspecting Paxil CR tablets to sort out the split pills and voluntarily recalled from certain markets lots of Paxil CR that had been produced before the inspections began, the spokeswoman said, adding that it therefore would be very unlikely for a patient today to receive a split pill.
FDA officials said problems at the plant date to February 2002, when the agency began a three-month review of the facility. After additional warnings and more inspections, the last of which was completed in November 2004, U.S. district attorneys in Tennessee and Puerto Rico filed a complaints in their district courts and obtained seizure warrants for the drugs, FDA officials said.
The FDA sporadically initiates seizures of drugs, food and medical equipment to block their distribution and protect public health. Several weeks ago, the FDA seized in Pennsylvania $13,500 of a dietary supplement that contained illegal ingredients.
Sales of Paxil CR totaled £396 million ($761.8 million) last year. Avandamet is a version of diabetes drug Avandia containing an extra ingredient, metformin HCI, for the treatment of Type II diabetes in obese patients. Combined U.S. sales of Avandia and Avandamet rose 26% to £852 million in 2004. Glaxo declined to disclose sales of Avandamet only.
