Too Much of a Good Thing Improper doses of over-the-counter drugs may harm

April 21, 1992|By Jean Marbella | Jean Marbella,Staff Writer

It was a drug overdose noteworthy as much for what it wasn't as what it was: It didn't involve crack or heroin or any other illegal street drug. It wasn't even an excess of legal prescription drugs like Valium or Demerol.

Instead, the culprits were two drugs easily obtained at any pharmacy without a doctor's prescription and commonly taken by many a cold sufferer or insomniac.

University of Maryland student Jennifer Lynn Jones, 21, died two weeks ago from an overdose of diphenhydramine and doxylamine, said Dr. John Smialek, the chief medical examiner. Diphenhydramine is an antihistamine and sleep aid marketed under brand names such as Benadryl and Sominex, and doxylamine is a nighttime cold and sleep aid sold under brand names such as Unisom. (Police, however, said they did not find any packages that would identify actual brands in Ms. Jones' dorm room in College Park.)

Hers was an exceedingly rare death: As often as it is used,diphenhydramine was linked to just three reported deaths in 1990, the most recent year for which statistics were available, according to the American Association of Poison Control Centers' survey of 70 of its member centers, and doxylamine was never reported in a fatality.

Yet Ms. Jones' death highlights concerns that have arisen in recent years as the Food and Drug Administration has loosened controls on increasing numbers of drugs by converting them from prescription to non-prescription status. Diphenhydramine once was available only by doctor's prescription.

While conversions undoubtedly benefit some consumers -- allowing them, for example, to treat minor illnesses on their own rather than making a doctor's appointment to get a prescription -- they also entail some risks.

"With the costs of health care going up, people are self-medicating more and more," said Babette Prince, Pharm.D., co-director of the University of Maryland's Drug Information Center. "But people have instilled in them that if it's available over-the-counter [OTC], it must be safe. Nothing's safe. Any drug that is not taken correctly can have side effects and toxicity associated with it."

Since 1972, the FDA has switched about 46 drugs from prescription to non-prescription status. Some have enjoyed quick success: Advil, for example, a non-prescription brand of ibuprofen introduced eight years ago, has become the second best-selling painkiller in America. And, Benadryl, a brand of diphenhydramine which received over-the-counter approval in 1985, has become the nation's top-selling non-prescription antihistamine.

Additionally, even a drug like aspirin, which is certainly not new to OTC status, is nonetheless being used in new ways by self-medicators convinced by studies indicating that it might prevent heart attacks, certain kinds of strokes and perhaps even death from colon cancer.

Increased availability and new uses of old drugs have combined to make non-prescription drug sales an $11.2 billion industry. But this increase in unsupervised self-medication has raised some concerns.

"When the drug becomes available over the counter, reduced intervention by trained health care professionals and reduced FDA monitoring increase the potential for overuse and misuse of the drug," said a report issued in January by the General Accounting Office.

The GAO, which investigated the FDA's procedures for approving and monitoring over-the-counter drugs, said it found "numerous examples of the health hazards that can be associated with the use and abuse of widely used OTC drugs." More specifically, the report listed side effects associated with long-term or overuse of non-prescription painkillers, such as bleeding ulcers (aspirin), liver or kidney damage (acetaminophen) and kidney problems and ulcers (ibuprofen).

And, the GAO criticized the FDA for collecting far less safety data on over-the-counter drugs after they're introduced on the marketplace than it does for prescription medications.

Sharon Snyder, an FDA spokeswoman, said that the agency does not switch drugs to over-the-counter status unless they already have a proven track record of safety and effectiveness as prescription drugs and low potential for serious side effects.

"It has to have at least three or four years as a prescription drug before it will considered as a candidate [for conversion]," Ms. Snyder said. "The bottom line is, can it be used safely without a doctor's supervision."

Jack Walden, spokesman for the Nonprescription Drug Manufacturers Association, said problems with over-the-counter drugs tend to come from misuse or abuse by the consumer. "We know of no fatalities with the use of these medications as indicated or as described on the label," he said.

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