Tylenol recall warrants thorough, public investigation, says ISMP

pharmafile | November 15, 2010 | News story | Manufacturing and Production |  FDA, ISMP, Institute for Safe Medication Practices, Johnson & Jonson, MedWatch, Tylenol, Tylenol recall 

Johnson & Jonson’s recall of Tylenol painkiller products was one of the key safety trends identified in the last quarter by the Institute for Safe Medication Practices (ISMP), which is calling for a “complete and thorough” probe into the case by the FDA.

The Tylenol tablet/caplet recalls were prompted by a musty smell linked to contamination with 2,4,6-tribromoanisole (TBA), an antifungal originating from wood pallets on which empty bottles had been delivered.

There were 492 cases of “serious injury” reported in the wake of the Tylenol (acetaminophen) recall submitted via the FDA’s MedWatch adverse event reporting system, says the ISMP, including “cases involving hospitalisation and reported patient deaths”.

Overall, Tylenol in tablet or caplet form was associated with the biggest portion of 1,066 total adverse event reports involving acetaminophen during the quarter.

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Previous FDA reports based on earlier data suggested that no serious injuries had occurred from the contaminated tablets, notes the ISMP, adding that J&J says it has carried out animal toxicity studies indicating the level of contamination was too small to cause human illness.

While the review just looks at the MedWatch reports as filed – so cannot support or rule out a link between the recalled Tylenol  products and the observed side effects – the number of reports “requires further investigation”, according to the ISMP.

“Given the large Tylenol product recall, a newly discovered form of contamination, and so many adverse event reports, we believe the FDA should insure that [an] investigation is conducted and the complete results are made public,” it says.

J&J has not made its toxicity studies public so it has not been possible to review its methods, says the report, and there remain three possible reasons for a causal link, including patients being unusually sensitive to TBA, the possibility that some tablet might have contained higher levels of the contaminant, or some other contamination issued caused by J&J’s “known manufacturing quality problems.”

Other adverse events highlighted in the ISMP’s latest QuarterWatch report included potential safety concerns about Sanofi-Aventis’ heart drug Multaq (dronedarone), and increased reports of complications associate with the use of botulinum toxin products.

Phil Taylor

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