FDA seizes medications at 2 facilities
Federal regulators conducted highly unusual raids yesterday at GlaxoSmithKline Inc. facilities in Puerto Rico and Tennessee and seized large supplies of two of the pharmaceutical company's prescription drugs, the antidepressant Paxil CR and the diabetes drug Avandamet.
The Food and Drug Administration, which worked with the Department of Justice and the US Marshals Service on the seizures, cited manufacturing problems at a GlaxoSmithKline plant in Puerto Rico that resulted in substandard pills reaching the market.
FDA seizures from major pharmaceutical companies are rare, former FDA officials said. In this case, the agency said it took the dramatic step because GlaxoSmithKline had repeatedly failed to correct problems at its Cidra, Puerto Rico, factory that were first identified in 2002.
''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, FDA associate commissioner for regulatory affairs, in a statement.
The drugs did not pose a significant health hazard in either case but still presented ''potential risk to consumers," the agency said.
In the case of Paxil CR, a 24-hour-release version of its big-selling antidepressant, the pills sometimes split apart and a patient could take a portion of a tablet that contains either no active ingredient or no timed-release ingredient. The result would be similar to missing a dose or getting two doses at once.
The FDA said some Avandamet tablets did not contain accurate doses of the active ingredient. GlaxoSmithKline said some batches of Avandamet -- a combination pill of two diabetes drugs, Avandia and metformin -- contained too much of Avandia's main ingredient.
The FDA and the company said patients on these drugs can safely take remaining tablets in their medicine cabinets but warned of expected disruptions in supply. Patients should consult with their doctors about finding alternative treatments, which physicians said are readily available.
Neither the government nor the firm disclosed how many drugs agents seized. GlaxoSmithKline recalled some batches of both drugs in a limited action in February, but the FDA said it did not recover all of the problem tablets.
The morning seizures at a manufacturing facility in Puerto Rico and a Knoxville, Tenn., distribution facility did not apply to supplies in pharmacies around the country, and there was no general recall.
CVS Inc., the nation's largest retail pharmacy chain by number of stores, said it was advising customers that the FDA said it was safe to keep taking the pills.
''We are continuing to dispense what we have on our shelves," said CVS spokesman Todd Andrews.
A 2002 FDA warning letter following inspections at the plant cited poor quality control, review procedures, and decision making by plant managers. A former FDA official, James Farley, who is now principal of Cardinal Consulting and Training, in St. David's, Pa., said the language in the 2002 warning letter indicated significant problems at the plant.
''FDA believes there is something seriously wrong with their quality system," Farley said. ''It is surprising GlaxoSmithKline would have a seizure. The cases where I have seen it occur were borderline firms."
GlaxoSmithKline, based in Great Britain with US headquarters in Philadelphia, is the world's second-largest drug company. It sold $725 million worth of Paxil CR in 2004 and about $500 million worth of Avandamet.
The company's stock fell 3.1 percent yesterday, to $48.91.
The company began inspecting each Paxil CR pill in November 2004 to weed out any split tablets, GlaxoSmithKline spokeswoman Nancy Pekarek said. It has also developed a solution to prevent excess active ingredient from getting into its Avandamet tablets; the problem occurred in a combination dose that included 1 mg of Avandia and 500 mg of metformin, she said.
The firm brought both problems to the attention of the FDA and had been keeping the agency abreast of progress, she said.
Physicians said the problems with pills cited by the FDA did not appear dangerous for patients. Additionally, in both cases, when patients' supplies run out they can switch to other prescriptions, they said.
Depression sufferers on Paxil CR can switch to regular Paxil, which comes in brand and generic forms, and adjust the dose to mimic the 24-hour release, said Dr. J. Alexander Bodkin, chief of clinical psycopharmacology at McLean Hospital in Belmont.
Diabetes patients on Avandamet can switch to individual doses of Avandia and metformin, which is what they took before Avandamet was introduced in 2002, said Dr. David Nathan, director of the diabetes center at Massachusetts General Hospital.
Nathan said he thought the FDA's statements about the health issues associated with the seizures were confusing because they downplayed dangers while emphasizing potential risks to patients.
He said the FDA's statements had about as much value as the orange and yellow terror alert levels issued by the Department of Homeland Security.
''That's bothersome. They should either say there is a problem or not," said Nathan. ''They are obviously trying not to panic the public."
Christopher Rowland can be reached at crowland@globe.com. 