Relieving the Analgesic Headache

'Take two aspirins and call me in the morning." Those familiar words, spoken as often by jesting laymen these days as by doctors, still contain more than a grain of truth. Some 75 years after its introduction, aspirin remains the world's leading painkiller, used for easing aches of every type, from headache to hangover, arthritis to athlete's elbow.

Americans alone ingest more than 50 million tablets of aspirin nature a day. In addition, aspirin, known chemically as acetylsalicylic acid, is the primary ingredient--and often the only active one--in nearly 50,000 over-the-counter (nonprescription) drugs now available in the U.S. Unlike many other drugs, aspirin is so mild that most people can take it for years in proper doses without suffering any serious problems or developing resistance to it. Even more remarkable, doctors seem to be finding promising new uses for the trusty old remedy--for example, as a possible preventive for heart attacks and strokes (TIME, April 14, 1975).

Still, while it remains the champion of analgesics, aspirin has lately become a subject of considerable controversy. Doctors and health officials are becoming increasingly worried that many people may be overdoing a good thing. Taken in excess, aspirin can cause ringing in the ears, dizziness, mental confusion, stomach bleeding and, as an anticoagulant, special problems for those with blood-clotting difficulties. Not the least of its hazards is its interaction with other drugs. As the Food and Drug Administration's Dr. William Gilbertson puts it: "Aspirin is safe, effective, but must be respected."

The medical profession's concern about the use of analgesics has been heightened by the aggressive introduction of aspirin substitutes such as Tylenol and Datril, which contain the drug acetaminophen. Though this drug has the advantage of not causing the stomach irritation associated with aspirin and though it can be taken by the few people sensitive to aspirin, it also has drawbacks: in large doses it can cause liver damage. In addition, since it is not an anti-inflammatory agent, it does not work against the swollen joints characteristic of arthritis.

But the market for over-the-counter analgesics is $720 million a year, and competing manufacturers have shed almost all advertising restraints in an attempt to capture a larger percentage of buyers. At times they have made claims that are exaggerated, misleading or downright false. The battle of words has, in fact, become openly aggressive ("Tylenol, shame on you!" scolds a Bayer ad). The Federal Government, which began to crack down on deceptive advertising of over-the-counter drugs by pharmaceutical companies in 1972, is now threatening other measures as well.

In a 1,200-page study on analgesics just released by the FDA, a six-member advisory panel confirms that both aspirin and acetaminophen relieve minor aches and reduce fever, but it also issues a sharp warning against extravagant claims. "Adjective-itis," FDA Commissioner Donald Kennedy calls it, and urges new caveats to protect unwary consumers from potential dangers that could accompany overzealous use of analgesics. Among other things, the panel suggests:

P: Eliminating from labels fuzzy and clinically dubious claims. That would mean manufacturers could no longer say their products relieve "fretfulness," "jumpy nerves," "cold symptoms" or being "under the weather." Instead, they would be limited to the assertions "for the temporary relief of occasional minor aches, pains and headache" and "for reduction of fever."

P: Including warnings against taking aspirin while under treatment for ulcers or other bleeding problems, during the last three months of pregnancy, or except under a doctor's guidance while taking prescription drugs for thinning of the blood or for diabetes, gout or arthritis.

P: Abolishing all recommendations on labels to use aspirin for arthritis or rheumatism. The panel did not dispute the fact that aspirin helps sufferers of these ailments and is often the only drug advised by doctors, but warned that many people are courting disaster by using it without first seeking medical attention. In some cases, self-medication with aspirin may be inadequate and in others totally wrong. In gonorrhea, for example, arthritis-like pains are sometimes the only obvious symptom. Anyone relying on aspirin who has this disease is thus doing nothing to control the dangerous underlying bacterial infection.

P: Fixing a standard dose so each tablet of aspirin or acetaminophen for adults contains 325 mg. and those given to children 80 mg. The panel pointed out that such standardized quantities will not only help avoid misuse of the drugs but also assure consumers that they are getting the same quantities of analgesics in different brands.

The panel's recommendations must still run the usual bureaucratic gauntlet, including a public airing, and could be modified after drug companies weigh in with their objections. But the FDA seems determined to deal with the national headache of analgesic misuse. As the FDA's Kennedy put it: "Consumers must be assured that the drugs they buy are rationally formulated with safe and effective ingredients and labeled and advertised with information that is complete, honest and understandable."

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