Magazine article Drug Topics

Patient Information Leaflets Come under Fire

Magazine article Drug Topics

Patient Information Leaflets Come under Fire

Article excerpt

A consumer watchdog group believes many patient information leaflets (PILs) pharmacists dispense with prescription drugs are dangerously deficient, and it wants the Food & Drug Administration to regulate PILs' content. "False, incomplete or out-of-date safety information is leading to needless drug-induced deaths," said Sidney Wolfe, M.D., director of Public Citizen's Health Research Group (HRG). "Commercial information vendors, pharmacists, and drug companies are all responsible for the information in these leaflets, and the FDA has the legal authority to ensure that PILs do not mislead the public but has failed to meet its responsibility."

HRG's petition for FDA action was signed by the parents of a sevenyear-old Houston boy who died from cardiac arrhythmia that the medical examiner attributed to an overdose of imipramine. The parents, Ben and Patricia Christen, charged that the PIL they received from Medi-Span Inc., Indianapolis, omitted critical pieces of information about adverse reactions, pediatric dosages, and approved indications. The lawsuit was settled out of court on undisclosed terms.

The U.S. Pharmacopeia and ASHP, both of which market PILs, rejected calls for more FDA regulation and said their imipramine PILs contained the information the HRG said should be included. …

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