Medications Available Without a Prescription : Part 3

by Food and Drug Administration (FDA)

(Page 3 of 3)

Today's emphasis on self-care fuels the popularity of nonprescription drugs. But OTC products are intended to supplement the medical options of the consumer, not substitute for a prescriber's medical knowledge. If a health problem persists or worsens while using an OTC drug, consult a health-care provider.

"People must be in a partnership with their health-care providers for optimal health," Bowen says. "Many situations aren't appropriate for self-treatment, and others may require professional guidance for self-treatment."

If you do choose OTC treatment, heed Bowen's warning: "Drugs aren't candy; they aren't risk-free. You have to follow the label and take appropriate responsibility for your own self-care."

9-0 Vote for OTC Nicotrol

Nicotrol was the first nicotine patch for smoking cessation approved by FDA.

It received an advisory committee's unanimous recommendation for a prescription-to-OTC switch on April 19, 1996. Worn for 16 hours a day, the patch reduces nicotine cravings by providing a constant, controlled flow of nicotine into the bloodstream.

The committee concluded that the benefits of the stop-smoking aid outweigh its risks, but only after considering manufacturer McNeil Consumer Products' proposed labeling and marketing plans, and the company's studies comparing quit rates for OTC and prescription patches.

The company presented data showing that prescription and OTC patch users achieved similar quit rates (19 percent of OTC users abstained in weeks 2 through 6, versus 16.6 percent of Rx users) and experienced no serious adverse reactions.

McNeil demonstrated that smokers understood the proposed labeling, including the warning not to smoke while using the patch and directions on how to apply and remove the patch. According to the company, more than 80 percent of consumers used the behavioral modification materials, including handbooks, an audiotape, and toll-free help-line.

The committee was told that abuse was not expected to be a problem, especially for adults. The patches are not to be sold to minors and will not be distributed through vending machines. Advertising will be targeted to adults.

FDA agreed that the benefits of the patch — an increased chance for people to quit smoking — outweighed any slight risks, and approved the product for OTC sale last July 3. The OTC patches became available in retail stores July 18.

12-4 Vote for OTC Rogaine

An FDA advisory committee voted "yes" on Nov. 17, 1995, to a prescription-to-OTC switch for Rogaine for treatment of common hereditary hair loss.

This wasn't the first time an FDA advisory committee had considered the switch. A July 1994 meeting ended in a 10-to-4 vote against OTC availability. Ten of fourteen advisory committee members weren't convinced that the benefit of Rogaine outweighed the drug's risks. Mainly, the committee was concerned that consumers would misdiagnose their hair-loss problem, and in some cases dangerously delay needed treatment.

To address this issue, Rogaine's manufacturer, Pharmacia & Upjohn, conducted six studies to see whether consumers could understand the labeling and determine if they had the common hereditary hair loss for which the product is intended. The studies showed, to the second committee's satisfaction, that consumers could self-diagnose their condition and comprehend the directions and other labeling information.

Upjohn also previewed the marketing campaign for the committee. The television ads, the company said, would be designed to educate consumers about whether the product is right for them. A toll-free number for consumers and an educational brochure at the place of purchase would be available, too.

The brochure graphically depicts the hair loss at the top of the head for which the drug is most effective. It states, in bold lettering, "If you have no family history of gradual thinning hair or hair loss, or if you are unsure of the cause of your hair loss, talk to your doctor."

The second time, members voted 12-to-4 in favor of the switch. Following the committee's recommendation, FDA approved OTC Rogaine on Feb. 9, 1996.

The product, which has been marketed since 1988 and used by over 3 million people, is now available over the counter.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.