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FDA approves first OTC pain reliever with fixed-dose of ibuprofen and acetaminophen in the same formulation

March 23, 2020

The combination of two non-opioid analgesic medications used to treat pain and inflammation will soon be available over-the-counter (OTC), according to the U.S. Food and Drug Administration (FDA) and an announcement from GlaxoSmithKline (GSK) on March 2, 2020. This will be the first OTC pain reliever approved by the FDA with a fixed-dose of ibuprofen and acetaminophen in the same formulation. It will be marketed as Advil Dual Action with Acetaminophen.

Availability
According to GSK Consumer Healthcare, Advil Dual Action with Acetaminophen is expected to hit retail pharmacy shelves in 2020, although the launch date and cost have not yet been published. In addition, the new drug application (NDA), approved under the Pfizer name as a joint venture with GSK, indicates this OTC pain reliever contains ibuprofen 125 mg and acetaminophen 250 mg in each tablet.

Usage and safety information
Advil Dual Action with Acetaminophen is intended to be used for the temporary relief of minor aches and pains due to headache, toothache, backache, menstrual cramps, muscular aches and minor arthritis pain. Ibuprofen (Advil®, Motrin®) is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain and inflammation, while acetaminophen (Tylenol®) is a non-opioid analgesic used to treat pain.

This OTC pain reliever will carry the same safety warnings as ibuprofen and acetaminophen, including but not limited to risk of heart attack, heart failure, stroke, severe stomach bleeding, as well as kidney and liver damage. Therefore, taking the lowest effective dose for the shortest period of time is recommended. Furthermore, consumers should not take ibuprofen, another NSAID or acetaminophen, including any prescription medications that contain these active ingredients, at the same time to avoid the risk of adverse drug events.

Impact on workers’ compensation and auto no-fault
In our book of business, both ibuprofen and acetaminophen have been commonly prescribed to treat a variety of conditions for many years. The generic formulations are cost-effective, non-opioid analgesic treatment options for pain. Because the cost of this new OTC combination pain reliever is not yet known and long-term use to treat chronic pain is not recommended, claimants should talk to their prescriber and/or pharmacist before taking Advil Dual Action with Acetaminophen.

As a reminder, an OTC formulation is allowed and can be dispensed at the pharmacy if the prescription formulation is allowed on the formulary. To encourage use of the OTC formulation, prescribers should mark “OTC” on the front of the prescription.

To learn more about Advil Dual Action with Acetaminophen, click here.

If you have any questions, please contact your account manager, clinical liaison or our Clinical Services team at 1-877-275-7674 ext. 8612.


Sources:

  1. GSK Press Release. FDA approves GSK’s Advil Dual Action with Acetaminophen for over-the-counter use in the United States. March 2, 2020. Available at: https://www.gsk.com/en-gb/media/press-releases/fda-approves-gsk-s-advil-dual-action-with-acetaminophen-for-over-the-counter-use-in-the-united-states/.
  2. 2. U.S. Food and Drug Administration (FDA). FDA-Approved Drugs. New Drug Application. Advil Dual Action. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211733.

 


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