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FDA Delay Of Plan B Triggers Complaints

Posting Date: 09/12/2005

The FDA is caught on the horns of a dilemma. If over-the-counter safety is truly the issue, then the agency may need to re-evaluate many other products.

New research suggests that regular use of popular pain relievers, such as acetaminophen and ibuprofen, can raise blood pressure in women. Aspirin and drugs like ibuprofen and naproxen can cause life-threatening ulcers. Dextromethorphan, the DM in many OTC cough medicines, can be abused.

Yet all of these medicines are widely available to the public, including teenagers, without prescription.

One solution to the morning-after pill problem might also solve other safety concerns. Many countries permit behind-the-counter sale of various pharmaceuticals. In England, for example, people can buy the cholesterol-lowering drug simvastatin (Zocor) without a prescription. But they first have to discuss the drug with a pharmacist.

The FDA has been unwilling to consider pharmacist supervision for drugs such as Plan B or the herpes medicine acyclovir (Zovirax). Even pain relievers like ibuprofen, naproxen or codeine might be sold from behind the counter. This approach would allow easier access to some drugs but still improve safety through counseling.

The FDA may not like this idea, but until it finds a way out of its current predicament, it will continue to take criticism from all sides.

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Joe Graedon is a pharmacologist. Teresa Graedon holds a doctorate in medical anthropology and is a nutrition expert. Their syndicated radio show can be heard on public radio. In their column, Joe and Teresa Graedon answer letters from readers. Write to them in care of this newspaper or e-mail them via their Web site: www.PeoplesPharmacy.org.

2005 King Features Syndicate, Inc.