FDA approves OTC naproxen - Food and Drug Administration, over-the-counter - Rx News

Healthfacts, April, 1994 by Arthur Aaron Levin

In an unusual move, the FDA disregarded the advice of two of its own expert advisory committees and approved an over-the-counter (OTC) version of the prescription drug naproxen, sold under the brand names Naprosyn and Anaprox (HHS News, 11 January 1994). Naproxen's 750 million dollars in sales made it the best-selling prescription nonsteroidal anti-inflammatory drug (NSAID) in the U.S. But, Naprosyn and Anaprox lost their patent protection this past December. Drug companies have increasingly sought OTC approval when a patent for a best selling prescription drug expires and profits are threatened by competition.

In June 1993, FDA advisors recommended OTC naproxen not be approved because of a history of dose-related kidney and gastrointestinal problems, particularly for children and the elderly. Because it works slowly, experts worried that consumers might be tempted to take naproxen in dangerously excessive doses. The FDA says it has addressed these concerns by limiting the OTC dose to 200 milligrams per pill (prescription naproxen is available in 250 to 550 milligrams doses) and having OTC labeling specify longer time intervals between doses and specifically warn about risks to the young and the elderly.

Dosages considered safe by the FDA (but apparently not the FDA's expert advisors) are: adults -- no more than 3 tablets daily, 8 to 12 hours apart; adults over 65 -- only two tablets daily, 12 hours apart; children under 12 should not be given the drug at all, except under a doctor's supervision.