FDA: Abbott Delayed Adverse Reports

Abbott Laboratories failed to quickly report some potentially serious reactions to drugs, including its obesity medicine Meridia and antibiotic Biaxin, the Food and Drug Administration said in a warning letter.

The FDA letter, dated July 19, said Abbott “did not submit serious and unexpected adverse drug experience reports” within 15 days of learning of the reactions. The letter also said some Abbott reports were inaccurate or did not reflect all information, such as three reports of deaths associated with Meridia.

The FDA isn’t questioning the safety and effectiveness of the products, Abbott said. The company said the delays stem from the integration of reporting systems for Abbott’s international business and its Knoll unit, purchased last year from BASF. The company has acted to correct deficiencies that inspectors found this year, though some of its responses were inadequate, the FDA said.

Shares of Abbott Park, Ill.-based Abbott rose 22 cents to $38.07 on the New York Stock Exchange.