CHPA President Suydam Highlights Safety of OTC Medicines

States position before FDA advisory committee meeting on risk considerations for NSAIDs

Washington, D.C. (February 17, 2005)—On February 17, Consumer Healthcare Products Association President Linda A. Suydam, D.P.A., presented the over-the-counter (OTC) manufacturers’ perspective on the safety of nonsteroidal anti-inflammatory drugs (NSAIDs) before the U.S. Food and Drug Administration’s (FDA) joint meeting of the Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. While the meeting focused on the overall benefit-to-risk considerations for COX-2 selective NSAIDs, Suydam drew a clear distinction between use of prescription drugs and OTCs, emphasizing that OTCs differ from prescription drugs in indication, dose, and duration of use:

  • All OTC analgesics are safe and effective when taken properly. No one should take more than the recommended dose or take an OTC analgesic for an extended period of time without consulting a physician.
  • One important facet to the difference between OTC medicines and prescription drugs is the OTC label, which contains information deemed necessary by both the manufacturer and FDA, and provides important information consumers use to decide if the medicine is appropriate for use, how to take the product, and when to see a physician, if necessary.
  • Naproxen was thoroughly reviewed in 1993 at a joint meeting of the Arthritis Drugs and Over-the-Counter Drugs advisory committees, was confirmed as effective and safe, and FDA switched the drug from prescription to over-the-counter status the following year.
  • The OTC naproxen label clearly states, among other warnings, to stop use and ask a doctor if any new symptoms appear or if pain becomes worse or lasts more than 10 days.
  • OTC analgesics are not intended to be used for long duration unless under the direction of a physician, which is clearly stated on the label.

As with any medicine, concluded Suydam, carefully reading and following label directions on over-the-counter medicines are the best tools to ensure that consumers use these medicines safely and effectively.

EDITOR’S NOTE: Dr. Suydam’s testimony and some frequently asked questions on NSAIDs are available online.

Contacts: Elizabeth Assey and Virginia Cox, 202.429.9260

CHPA is the 124-year-old trade association representing U.S. manufacturers and distributors of over-the-counter medicines and nutritional supplement products.