FDA approves combination ibuprofen-acetaminophen drug for U.S.

Photo of Dr. Maria Geisinger
Dr. Mia Geisinger
The Food and Drug Administration has approved the first over-the-counter ibuprofen and acetaminophen combination drug for the U.S.

The product — called Advil Dual Action — will be available nationwide later in 2020 and contains 250 mg of ibuprofen and 500 mg of acetaminophen, said GlaxoSmithKline, the drug’s manufacturer, in a news release.

The ADA has long advocated for the development of a single strength-controlled acetaminophen-ibuprofen combination drug to be available over-the-counter for dental patients — particularly as the nation continues to battle the opioid epidemic.

Dr. Mia Geisinger, chair, ADA Council on Scientific Affairs, cheered the news and pointed to the ADA Science Institute’s 2018 overview of systematic reviews of acute pain medications that concluded combinations of ibuprofen and acetaminophen “offered the most favorable balance between benefits and harms” for treating dental pain.

“Many other studies point to using nonsteroidal medications with or without acetaminophen as being safe, effective and a preferred alternative to opioid medications in most patients,” said Dr. Geisinger, who also cited studies led by past and present CSA members published in the Journal of the American Dental Association. “The introduction of this medication may simplify this medication protocol for use in dental practice and further reduce the use of opioid prescriptions as first-line pain control therapy.”

The approval was based on data from several clinical studies, including three efficacy and safety trials, for the product, according to GlaxoSmithKline. The company also noted the data demonstrated “a fixed-dose combination of ibuprofen and acetaminophen achieves a superior level of pain relief compared to the individual components alone.”

“For decades, many consumers have been using ibuprofen and acetaminophen to get the benefits of both active ingredients when safely treating their headaches, muscle aches, backaches, arthritis and other joint pain,” said Franck Riot, head of research and development, GlaxoSmithKline, Consumer Healthcare. "[Advil Dual Action] will offer U.S. consumers the first-ever alternative option – a single, fixed-dose combination pain reliever.”

For information about the ADA’s advocacy efforts with opioids education, visit ADA.org/opioids. The ADA Catalog also features "The ADA Practical Guide to Substance Use Disorders and Safe Prescribing.”