NABP advises pharmacies not to dispense combination drugs with more than 325 mg of APAP per dose

MOUNT PROSPECT, Ill. — The National Association of Boards of Pharmacy on Wednesday recommended that pharmacies no longer dispense combination drugs containing more than 325 mg of acetaminophen per dosage unit in light of recent regulatory action.  

NABP also advises that pharmacists consult with prescribers to discuss alternative products with lower acetaminophen doses.

The Food and Drug Administration is withdrawing approval of 108 abbreviated new drug applications for prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit. For the 108 ANDAs, the manufacturers asked to withdraw their applications, as announced in the March 27, 2014 Federal Register notice. A second Federal Register notice addresses the applications of six manufacturers who have discontinued marketing their products, but who have not withdrawn their applications. 

The notice also announces FDA’s intention to begin the process of withdrawing approval of those applications.

FDA asked manufacturers to voluntarily withdraw these products from the market to reduce the risk of severe liver injury from inadvertent acetaminophen overdose. In January 2014, FDA recommended that providers consider prescribing acetaminophen products containing 325 mg or less per dose.

Comments

- 10:57 AM
autismepi says

The list of risks for acetaminophen is long and growing. The most serious concerns are two new studies which show adverse neurodevelopment in children whose mothers used acetaminophen while they were pregnant. The study in 3 year olds (Brandlistuen et al. 2013) found a 70% increased risk of motor and behavioral problems and double the risk of communication problems (autism phenotypes). The study in 7 year olds (Liew et al. 2014) found increased risk of ADHD behaviors and Hyperkinetic Disorders. This is in addition to close to 30 studies finding an association to asthma and allergic disorders, 4 studies finding an association to male congenital malformations (cryptorchidism) and additional studies finding associations to skin disorders and mind numbing (relief of existential dread).

- 10:59 AM
autismepi says

Quoting an FDA report, acetaminophen's narrow safety margin places "a large fraction of users close to a toxic dose in the ordinary course of use. Taken over several days, as little as 25 percent above the maximum daily dose – or just two additional extra strength pills a day – has been reported to cause liver damage", according to the agency. http://www.propublica.org/article/tylenol-mcneil-fda-use-only-as-directed

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