FDA repeats Tylenol warning

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In an unusual move, the Food and Drug Administration repeated the acetaminophen warning it had issued several months ago. Acetaminophen is the active ingredient in Tylenol, the leading brand of acetaminophen on the market.

In January 2014, an FDA Safety Communication recommended that doctors “consider prescribing combination drug products that contain 325 mg. or less of acetaminophen.” It appears that the FDA believes that recommendation was not being heeded, leading the agency to reissue the warning with even stronger language. The FDA reminded health care professionals to stop prescribing, and pharmacists to stop dispensing, prescription combination drug products containing more than 325 mg. of acetaminophen per tablet, capsule or other dosage unit. If a pharmacist receives a prescription for a combination product with more than 325 mg. of acetaminophen per dosage unit, the FDA recommends that the pharmacist contact the prescribing physician to discuss substituting a product containing a lower dosage of acetaminophen.

“These products are no longer considered safe by FDA and have been voluntarily withdrawn. We encourage pharmacists to return them to the wholesaler or manufacturer,” said the FDA press release.

At the FDA’s request, products containing more than 325 mg. of acetaminophen per dosage unit were withdrawn from the market by manufacturers in January 2011. The FDA has now also requested that wholesalers remove the product codes for all prescription combination drug products containing more than 325 mg. of acetaminophen per dosage unit and that they return all products to the manufacturers.

According to the FDA, dosages higher than 325 mg. have shown no superiority over lower doses of acetaminophen and pose the risk of liver damage.

Acetaminophen overdose is the most common cause of acute liver failure and the second most common cause of liver failure requiring transplantation in the United States. The risk of liver damage occurs primarily in patients taking multiple acetaminophen products within a 24-hour period. Acetaminophen has become a staple of home medicine cabinets and is an ingredient in many combination medications including prescription pain medications such as Percocet and Vicodin as well as common over-the-counter products Nyquil, Robitussin, Theraflu, Benadryl, Excedrin and Vicks.

The Ohio Tylenol injury attorneys at Clark, Perdue & List are investigating personal injury and wrongful death claims involving liver damage and failure arising from Tylenol ingestion. If you or a loved one has suffered liver damage that you believe was caused by Tylenol, call Clark, Perdue & List.