Acetaminophen products to undergo changes following advisory committee’s votes

7/6/2009

ADELPHI, Md. Three Food and Drug Administration advisory committees voted on sweeping changes regarding the marketing, merchandising and formulation of acetaminophen products last week, though the proposed changes fell short of pulling combination products containing APAP off the market.

Among the changes: committee members recommend by a vote of 21-16 that the maximum total daily dose of 4 grams/day of APAP in nonprescription single ingredient and combination products be lowered; 24-13 recommended the maximum nonprescription single adult dose be limited to 650 mg; 26-11 recommended that acetaminophen doses above that be reverse-switched to prescription-only; and 36-1 suggested that only one strength of APAP in liquid form be available OTC.

However, advisory committee members recommended against imposing pack-size limitations on products containing acetaminophen (17-20); and the committee also did not support the recall of OTC APAP combination products (13-24).

On that note, OTC manufacturers of APAP products breathed a sigh of relief. “[The Consumer Healthcare Products Association] strongly believes that patients and physicians should continue to have access to the current range of over-the-counter acetaminophen-containing products, and we are pleased the committee did not recommend eliminating these important nonprescription products,” Linda Suydam, CHPA president, stated following the meeting. “While we are pleased with the committee’s recommendation to allow continued access to OTC combination medicines containing acetaminophen because we know they provide real benefits to consumers, we are disappointed in their divided vote to lower the maximum daily dose and the single dose of 1,000 mg acetaminophen,” she added.

According to CHPA, there was a notable lack of data referenced by the committee to support these recommendations.

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