FDA seizes Wyeth drugs, citing quality standards Friday, June 16, 2000

The action followed repeated warnings that the Marietta, Pa., plant was not in compliance with agency standards. By Susan Warner

After repeated warnings, the U.S. Food and Drug Administration yesterday seized thousands of preloaded syringes manufactured by Wyeth-Ayerst Laboratories at its Lancaster County plant.

The drugs seized were vaccines for tetanus and diphtheria, and antihistamines.

The syringes were seized at a warehouse in Vonore, Tenn., after the FDA complained in U.S. District Court that the drugs were not made in compliance with the agency's manufacturing standards.

FDA spokesman Larry Bachorik declined to comment on whether people who used these drugs were at risk.

"In general, a failure to follow good manufacturing practices does not automatically translate into bad patient outcomes," he said. "But it does mean we can't have as much confidence in the overall quality of the product."

Wyeth spokesman Doug Petkus said that for several months the Marietta, Pa., plant has been undergoing "substantial improvements" following earlier FDA concerns. During that time, he said, the facility has not produced drugs for shipment.

"We are discussing with the regulatory authorities the nature and scope of their concerns," he said.

Last year, the FDA's Office of Regulatory Affairs initiated 25 seizures similar to yesterday's action.

Wyeth-Ayerst, a division of American Home Products Corp. headquartered in St. Davids, has experienced other regulatory problems in recent years. In 1997 it withdrew its obesity drugs Redux and Pondimon, which were part of the "fen-phen" combination, after some patients developed heart problems.

Last year, the company recalled 600,000 allergy kits made in West Chester, and withdrew a vaccine for rotavirus after some children developed dangerous bowel obstructions.

Bob Kirby, a drug analyst with Edward Jones in St. Louis, said yesterday's seizure did not raise immediate concerns for American Home.

"None of these drugs are really major," Kirby said. "The bigger question is whether there is an underlying problem in manufacturing and quality control."