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Abbott Warned On Side-Effect Report

Aug 6, 2002 | AP

Drug giant Abbott Laboratories failed to report the death of a user of its diet drug Meridia and inaccurately reported other serious reactions among users of three other medicines, federal inspectors said in a warning letter released Tuesday.

The warning letter marks the second time in three months that the Food and Drug Administration has made public complaints about Abbott's violations of federal side-effect reporting rules.

The violations were uncovered during FDA's spring inspection of Abbott. The agency reiterated the complaints in a warning letter dated July 19 but posted on FDA's Web site Tuesday.

"Although your firm has taken some corrective actions ... you have not addressed many of our concerns," the letter said.

Abbott had previously said one of several deaths among Meridia users went unreported because it was considered "a rumor." But the FDA said that didn't excuse the company from reporting the case so it could be considered.

In three other deaths among Meridia users, Abbott submitted inaccurate information to the government, FDA inspectors concluded.

Other violations included improper reporting of serious reactions among users of the antibiotic Biaxin, the AIDS drug Norvir and the insomnia drug ProSom.

Federal law requires manufacturers to promptly report serious or unexpected reactions among users of their medications so that FDA can investigate whether the drugs are causing unforeseen side effects.

Abbott spokeswoman Jennifer Smoter said the violations raise no questions about the drugs' safety, but that Abbott has begun a new system to ensure proper reporting to FDA.

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