March 5

US Marshals Seize Millions of Defective Paxil & Avandamet pills – NYT

US Marshals Seize Millions of Defective Paxil & Avandamet pills_NYT

Mon, 7 Mar 2005

The FDA and federal marshals yanked millions of tablets of the antidepressant, Paxil CR (Seroxat, controlled release) and the diabetes drug, Avandamet, off the market because they are defective. The Paxil pills split during manufacturing, and the medication in Avandamet is not evenly distributed. GlaxoSmithKline has not resolved these manufacturing issues for three years.

Although the FDA plays down the risk to patients in its public statement on FDA’s website, there is a potential danger for patients taking the wrong dose of Paxil or abruptly interrupting the intake of Paxil.

“FDA is not aware of any harm to consumers by the products subject to this seizure and it does not believe that these products pose a significant health hazard to consumers. Consequently, FDA urges patients who use these two drugs to continue taking their tablets and to talk with their health care provider about possible alternative products for use until the manufacturing problems have been corrected.”

If advised to take two halves of a pill‹each might contain a full day’s dose‹this would put the patient at risk of taking double the prescribed dose. Or, the two halves might contain no active ingredient‹thereby putting the patient at risk from sudden withdrawal symptoms. In either case, the patient would be at increased risk of suffering severe side effects. Most patients who suffered severe adverse drug side effects from Paxil, did so when doses were increased or abruptly decreased. Susceptible patients became irritable, hostile, aggressive, impulsive, violent and suicidal.

Even when properly manufactured, the severe adverse side effects of Paxil require extensive warnings‹including a Black Box warning for under 18 year olds. Clearly a defective version of this product puts patients at increased risk of harm. FDA’s advice to “continue taking their tablets” seems irresponsible.

Indeed, Dr. Jeffrey Lieberman, a psychopharmacologist who chairs the department of psychiatry at Columbia University, alluded to the possibility of severe withdrawal from Paxil, when he told the New York Times:

“Paxil was the wrong drug to skip for a day. Paxil remains in the bloodstream far shorter than Prozac.”

Drug companies’ failure to comply with product control safety standards is a continuing battle about which physicians and the public are mostly unaware. The Times reports: “Schering-Plough, Eli Lilly, Wyeth and Abbott Laboratories all have run afoul of F.D.A. manufacturing rules in recent years. Schering-Plough paid a $500 million fine in 2002.” Drugs manufactured in sub-standard plants are marketed in the US‹thereby contradicting the administration’s argument that drugs imported from Canada would pose a health hazard.

Contact: Vera Hassner Sharav

March 5, 2005
F.D.A. Seizes Millions of Pills From Pharmaceutical Plants

WASHINGTON, March 4 – Angered by quality-control problems it said had dragged on for more than two years, the Food and Drug Administration used armed federal marshals to seize millions of tablets of two medicines from facilities in Tennessee and Puerto Rico operated by GlaxoSmithKline, the agency said Friday.

The drugs are the antidepressant Paxil CR, which had $725 million in sales last year and is used by some 450,000 patients in the United States each month; and Avandamet, a diabetes medicine, whose sales are undisclosed but are far smaller.

The F.D.A. said that neither pill was medically necessary and that many alternatives existed for both. It added that it knew of no patients harmed by the poorly made pills and said patients could safely take any pills they had left.

Officials at both the agency and GlaxoSmithKline said they could not predict when or how the manufacturing problems would be resolved, though the company said it satisfied the agency’s concerns about Paxil CR last November.

Despite the absence of evidence that the pills had harmed anyone, the agency said, a drug maker must be able to assure the public that its products are properly made.

“F.D.A. 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 agency’s associate commissioner for regulatory affairs.

GlaxoSmithKline’s shares slid $1.59 Friday, to $48.91, a decline of 3.15 percent.

The problems were detected when inspections beginning in February 2002 at the plant in Cidra, P.R., revealed that Paxil CR tablets tended to split, leaving patients with half a tablet with no medicine and another half with no buffering substance.

Avandamet is a combination of two diabetes drugs, Avandia and metformin. GlaxoSmithKline could not guarantee the potency of the Avandia portion, the agency said.

Officials said the problems persisted despite an F.D.A. warning letter and more inspections. The company’s inability to figure out what was going wrong was worrisome, they said.

Nancy Pekarek, a GlaxoSmithKline spokeswoman, said the company believed that it had resolved its dispute with the drug agency by recalling many of the pills made before November and inspecting those made afterward.

Paxil CR is a “controlled release” version of the antidepressant. Many analysts say GlaxoSmithKline created it to fight off generic competitors to Paxil in the United States, where the CR version is almost exclusively sold. The company said that version was easier to tolerate than Paxil.

Still, Dr. James McGough, a professor of psychiatry at the University of California, Los Angeles, said, “Most patients who are currently receiving Paxil CR could easily switch to generic versions of Paxil without any loss of benefit.”

Ms. Pekarek said that all “bi-layer” tablets like Paxil CR tended to split and that the company’s new inspection process ensured that damaged tablets were not shipped to pharmacies.

F.D.A. officials and a top drug manufacturing consultant dismissed that explanation, saying many companies were able to make bi-layer tablets that are not prone to splitting. They added that inspections were unlikely to catch all the damaged pills.

“You cannot just say you’ll pick out the bad ones,” said a top former GlaxoSmithKline manufacturing executive, speaking on condition of anonymity because he now consults for drug companies. “We’re not making strawberries here.”

Schering-Plough, Eli Lilly, Wyeth and Abbott Laboratories all have run afoul of F.D.A. manufacturing rules in recent years. Schering-Plough paid a $500 million fine in 2002.

“We felt that we have been working with the firm for a couple of years now, and although they have made some progress in correcting the problems we felt that without our intervention we couldn’t get them to where they needed to be,” said an F.D.A. official, who spoke on condition of anonymity.

Ms. Pekarek said the problems with the pills were unlikely ever to hurt patients. Patients who took an inert half of Paxil CR would be no worse off than if they had simply skipped a day’s dose – something that happens often, she said.

But Dr. Jeffrey Lieberman, a professor of psychiatry at Columbia University, said Paxil was the wrong drug to skip for a day. Paxil remains in the bloodstream far shorter than Prozac.

Copyright 2005 The New York Times Company

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