News You Can Use 7/13/98
New labels could give needed information
BY STACEY SCHULTZ
When people who suffer from chronic headaches feel one coming one, they grab a few tablets of common pain relievers such as aspirin or acetaminophen, the generic name for Tylenol. The pain returns and they grab a few more. It's an over-the-counter drug, so how dangerous can it be?
Quite dangerous. Doctors call these recurrences "rebound headache," and say they are caused by the pain relievers themselves as the amount of the medication builds up in the body, sometimes to toxic levels.
|Many people treat themselves for common ailments
with drugs they can buy without a prescription. They often assume there
is little danger in frequent or sustained use of the drugs, such as Tagamet,
the stomach acid reducer, or Afrin, the nasal decongestant. The warnings
on the containers may be inconspicuous, and advertisements may not spell
them out--or mention them at all. That's because over-the-counter drug
advertising is regulated by the Federal Trade Commission. As long as claims
can be backed up by studies, nonprescription drug manufacturers are free
to declare the benefits of their products without disclosing possible
dangers. That stands in contrast to the strict rules for prescription
drug ads, applied by the Food and Drug Administration, that require communicating
both benefits and risks.
"When you don't have to mention any risks, then the public's perception becomes that there are no risks," says Larry Sasich, a pharmacologist with Public Citizen's Health Research Group. The Migraine Awareness Group, a patient advocacy group, has focused on ads placed by Bristol-Myers Squibb for its nonprescription migraine treatment, Excedrin Migraine. The product is intended to treat mild to moderate migraine pain, but ads say that it "actually relieves migraine headache pain." The fear is that if the pain is too severe, the medicine won't alleviate it, and people may then take too much.
The group, based in Alexandria, Va., is concerned that people suffering from severe migraines might try to treat themselves. "If people are not aware of all the medical facts, they can put themselves in jeopardy," says executive director Michael John Coleman, who has experienced rebound headaches from trying to treat his migraines with over-the-counter drugs. An editorial on migraines posted in April on the Web site of the Journal of the American Medical Association ( www.ama-assn.org/) by Robert Smith, a neurologist with the University of Cincinnati Medical Center, warns that "repeated use of nonprescription analgesics should be supervised; overuse may produce chronic daily headache and rebound headache."
No details. Not all headache experts agree that there is a public-health risk. And Bristol-Myers Squibb stands by its ads. Company spokeswoman Nancy Goldfarb says that "the ad doesn't get into all of the details." She says that conveying all of the risk information to consumers "is not the place of consumer advertising."
Over-the-counter, or OTC, drugs' product labels could display more understandable information on its proper, safe use, says Cazemiro Martin, an FDA scientist. "The labeling doesn't take the place of the doctor, but it has to provide the information that the physician would." The wording of the labels on many OTC drugs is confusing, and often nearly impossible to read because of the tiny type, says Sasich.
In February of last year, the FDA (which retains authority over the information on the product labels) proposed sweeping changes to the look and content of over-the-counter drug labels. The precise format and typography are still being debated, but the nutritional labels on processed foods the FDA instituted in 1992 would be a model. The goal is to set a recognizable and standardized format for the nonprescription drug label that will provide clear information. "This is going to be entertaining to the eye, in a size that is large enough to see," says the FDA's Martin.
Sasich says the FDA is going in the right direction. "With the new labeling, consumers can quickly compare and see what is actually in the product," he says. And in making comparisons, "patients can say, 'I already have an antihistamine at home. I don't need another one.' "
Until that time, the best thing to do is ask a pharmacist for advice. And the latest edition of The People's Pharmacy by Joe and Theresa Graedon (1996, St. Martin's, $16.95) includes information on prescription and over-the-counter drugs, including warnings about possible drug interactions. No headaches there.