FDA Claims Pfizer Failed to Report Drug Side Effects
WASHINGTON — The government has accused pharmaceutical giant Pfizer Inc. of failing to report serious side effects of its drugs, saying it found violations dating to 1983.
Federal law requires drug makers to tell the Food and Drug Administration of serious side effects within 15 days so the government can decide quickly if the problem is a fluke or threatens public health.
But Pfizer apparently repeatedly failed to report side effects from eight drugs, including such big sellers as the heart medicine Procardia XL and the antidepressant Zoloft, the FDA said in a warning letter mailed April 26 to Pfizer Chief Executive William Steere Jr.
Last year and in 1994, New York-based Pfizer reported the side effects between 77 and 514 days late, the FDA said its inspection concluded.
When the agency reviewed company records, it found similar violations dating to 1983, it said.
The “problems continue to recur, even though you have made promises to correct them,†the warning letter says. “Pfizer’s repeated history of failure to comply . . . is a major concern to the agency.â€
Pfizer spokesman Brian McGlynn said the company had received the letter and would respond promptly.
The FDA has no indication in this case that patients were harmed by the delays, agency spokesman Larry Bachorik said. But companies are required to report side effects because the FDA--not the manufacturer--decides when such effects are risky enough to require that other patients be warned, he explained.
The six other drugs cited in the FDA’s letter are Diabinese, Minipress XL, Feldene, Norvasc, Diflucan and Terramycin.
Pfizer shares rose 75 cents to close at $65.375 on the NYSE.
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