Children's Tylenol Recall Result of 'Abundance of Caution': FDA

"Speaking as a parent and a pharmacologist, the frequency of these recalls does not foster great confidence in the manufacturing standards for these medicines in that they are being released before quality testing is completed," said Dr. David Kroll, professor of Pharmaceutical Sciences at North Carolina Central University in Durham. "I was struck in particular by the comment from the FDA that parents consider substituting generic versions of the child medicines, rather than use adult strength medicines."

Another potential problem is that the recall affects the same category of medications that came under fire from an FDA advisory committee in 2007.

"The FDA non-prescription drug advisory committee [at the time] found that there was little to no compelling evidence that cough and cold medications are efficacious in children under 6, and they may pose a meaningful risk," said Dr. William Shrank of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital and member of the FDA OTC drug advisory panel.

More Information on Recall Forthcoming

Though Jacobs refused to say why the information linking specific problems to specific drugs had not yet been released, Bobo said the FDA hopes to release the report making those links as early as today.

"What parents need to do is not have a heart attack over it," Bobo said. "If they have already given it to their child, they will be perfectly fine. But now that we know about this, it is best not to give it to your child until we learn the specifics."

Still, Kroll said he was disappointed that information linking specific medications to specific problems was not available at the time of the recall.

"So, we have no idea which ones are being recalled for potential overdose risk versus those with 'tiny particles,'" he said. "For example, a product with a higher-than-labeled dose of acetaminophen [Tylenol] might be of greater risk than a product with a higher-than-labeled dose of cetirizine [Zyrtec]."

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