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drug_recall acetaminophenThere are very serious dangers of acetaminophen that have not been adequately communicated to consumers according to some groups. As far back as 1977, the FDA’s own advisory committee recommended warnings be put on acetaminophen-containing products because of the dangers of acetaminophen that included severe liver damage. The advisory committee’s recommendation was to have the warning, “Do not exceed recommended dosage or take for more than 10 days, because severe liver damage may occur.” The FDA did not take the advice to include these dangers of acetaminophen on labels.
In September 2002, the Public Citizen consumer group questioned the FDA’s failure to adequately address the dangers of acetaminophen, despite the lapse of time that had taken place since the advisory committee’s first recommendation. The reports of fatal acetaminophen-associated poisonings in the years since the 1977 recommendation had allowed consumers to be “facing an epidemic” of deadly effects.
The consumer group made a six-point plan to address the dangers of acetaminophen before the Nonprescription Drugs Advisory Committee. By allowing consumers better access to risk information, the group believed the dangers of acetaminophen, especially regarding liver-toxicity, could finally be communicated properly to consumers. Since a quarter of acetaminophen patients with liver toxicity collected by the FDA had taken more than one acetaminophen product, better warnings issued for the dangers of acetaminophen may reduce a substantial amount of risk.
Other safety recommendations included standardizing liquid formulations. Some cases of pediatric liver toxicity were the result of unintentional overdose. Instead of administering droppers full of the medications, teaspoonfuls were given, thus exposing children to the serious dangers of acetaminophen. The dangers of acetaminophen have put consumers at risk for years. Tylenol is the highest selling painkiller that sells 8 billion pills a year in America alone. Acetaminophen is contained in over 200 medications over the counter and is the most common cause of drug-induced liver failure.