The QMN Weekly Bulletin
Pharmaceuticals / Quality / Regulatory Affairs / Postmarket Safety

FDA Bans Sales of High-Strength Acetaminophen Combo Drugs

Jan. 24, 2014

The FDA’s ban on the sale of prescription acetaminophen/opioid combination drugs that use more than 325 mg of acetaminophen per tablet went into effect Jan. 14, and the agency will soon begin withdrawing approvals for products made by companies defying the ban.

More than half of affected brand and generic drugmakers met the deadline, the FDA said. The regulatory action impacts mostly generic drugmakers, but brand pain products would also be affected by the sales ban.

The FDA declined to list those manufacturers that missed the deadline, and many companies QMN contacted Jan. 15 did not return requests for comment on the issue. The agency says it has received many requests for withdrawal over the past several days and is processing them. Once that is finished, the FDA will publish a list of companies that have withdrawn their applications and a list of those that have not, spokesman Eric Pahon said.

The agency in January 2011 gave manufacturers three years to phase out the products due to the risk of severe liver injury from inadvertent acetaminophen overdose.
“There are no available data to show that taking more than 325 mg of acetaminophen per dosage unit provides additional benefit that outweighs the added risks for liver injury,” the FDA said.

The FDA now requires a boxed warning on all prescription acetaminophen products that highlights the potential risk for severe liver injury. Acetaminophen is combined in many prescription pain medicines with other ingredients, usually opioids such as codeine, oxycodone and hydrocodone.

The FDA’s action affected six of Endo Pharmaceuticals’ drugs, including the popular painkiller Percocet (oxycodone hydrochloride/acetaminophen), which had sales of $103 million in 2012.

To comply with the agency’s Jan. 14, 2014, deadline Endo phased out the manufacture of higher doses of the drug and ramped up production of lower-dose versions of affected products.

The agency said it will address efforts to reduce acetaminophen in OTC drugs in a separate regulatory action. Information about the potential for liver injury is already required on OTC product labeling.

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