Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.
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Wall Street Journal - August 7, 2002
Stephanie M. Horvath and Susan Carey Staff Reporters of The Wall Street Journal
The FDA, in a warning letter July 19, said the North Chicago, Ill., company didn't quickly and accurately report "serious and unexpected" adverse reactions among patients taking several of its products, including the diet drug Meridia and the HIV treatment Norvir.
FDA spokeswoman Laura Bradbard said companies must report adverse reactions because they often reveal side effects that don't show up in clinical trials. Once a drug is on the market, millions of people use it and rarer side effects come to light. She said side-effect reports allow the FDA to modify warning labels on drugs and sometimes pull a drug from the market.
"If a company is not passing this information on to us, it's putting the public in danger," Ms. Bradbard said.
The letter, which cited reporting processes and not product safety, said Abbott failed to meet the FDA's 15-day deadline for reporting adverse reactions 18 times between Jan. 1, 2000, and Oct. 31, 2001.
The letter said poor internal communication was to blame for the missed deadlines in many of the cases.
The agency also found that some report information Abbott submitted was inaccurate and differed from company records. In one example, Abbott's records listed a Meridia patient to be in her early 30s and not known to have heart disease.
In the form submitted to the FDA, the patient's age was listed as unknown and there was no mention of the patient's lack of heart disease.
The warning letter was based on a review of reports made earlier this year during FDA inspections of Abbott.
Abbott said it has instituted a number of information-system improvements to bring international and domestic adverse-reaction reporting data together.
The company also said it has increased training for employees with reporting duties.
Abbott said it will respond to the letter within the specified 15-day period and will discuss with the FDA whether any additional action is required.
Write to Stephanie M. Horvath at stephanie.horvath@wsj.com and Susan Carey at susan.carey@wsj.com
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