Phyllis De Sort almost died. Yet until the moment she passed out on the bathroom floor of her spacious Bel-Air home early one hazy June morning, the former nurse had no inkling that shewas so ill. Throughout the previous week, she'd felt lightheaded and nauseous, with severe stomach cramps. Her husband kept nagging her to go to the doctor, but she was too busy running their TV-commercial production company to take any time off. It's probably nothing more serious than the flu, she thought. Until she collapsed.
Her husband found her unconscious and rushed her to the UCLA Medical Center's Emergency Room, where it was swiftly determined that she had a bleeding ulcer. Once her condition was stabilized, she was shipped up to the intensive-care unit, where doctors quickly staunched the bleeding, and a total of three pints of blood were pumped into her tiny 104-pound frame. If she hadn't made it to the hospital on time, De Sort reflects today, "I might have bled to death.'
What's especially chilling was the culprit behind De Sort's almost fatal bout of internal bleeding: ibuprofen, an over-the-counter medication she'd been popping every night to relieve her arthritis. Ibuprofen, the active ingredient in such pain relievers as Advil, Nuprin and Motrin IB, is one of a class of medications known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs like ibuprofen, a powerful analgesic that was available only by prescription until 1984, are tiny miracle workers that can ease inflammation and pain. But they have a downside if they're consumed habitually for prolonged periods: They can wreak havoc on the stomach by eating away at the lining until an ulcer forms, which may then perforate the stomach walls and provoke serious bleeds. Ulcers can be silent, says De Sort, "so I never had the slightest idea that I was bleeding. But I nearly did myself in.'
What happened to Phyllis De Sort is surprisingly common. Doctors have known for years that chronic pain sufferers who take NSAIDs like ibuprofen regularly to ease their symptoms are prone to gastric disorders. "There's an epidemic of adverse drug reactions to NSAIDs,' says Dr. James F. Fries, one of the country's leading arthritis experts and a professor of medicine at Stanford University School of Medicine. "The Food and Drug Administration believes anywhere from 10,000 to 20,000 deaths each year are the result of severe bleeding caused by NSAIDs. It's a big problem.'
What's a bigger problem is that ibuprofen is by no means the only potent medication with potentially fatal side effects that is now available without a prescription. More than 600 over-the-counter medications, including Advil and Motrin, allergy and cold medications such as Sudafed, Allerest and Benadryl, sleep aids, anti-itch skin creams and shampoos that eradicate head lice, use ingredients or dosages that could be dispensed only by prescription 20 years ago.
And while prescription drugs have been switched to OTC status for more than 40 years, nothing has ever approached the magnitude of the recent avalanche. In 1995, six drugs were cleared to leave the sanctuary of the pharmacy counter; as of August 1996, seven had switched. "This last year was quite a year for OTC switches, probably the most we've approved in one year,' says Dr. Debra L. Bowen, director of the FDA's division of OTC products.
In the past three years, three new entrants muscled into the overcrowded pain-reliever market--Aleve, Actron and Orudis KT. Another four--Zantac 75, Tagamet HB, Pepcid AC and Axid AR--joined the already ample OTC heartburn arsenal. New also are creams to treat yeast and fungus infections, others to cure baldness, and several aids to ease smoking withdrawal. And with as many as 20 drugs, such as cholesterol-lowering medications and treatments for genital herpes, awaiting FDA clearance, next year promises to be the biggest switchover year ever.
While the drug firms tout these changes as providing consumers more control over their own health, the deluge has consumer watchdog groups, pharmacists and physicians worried that drugs with potentially dangerous or even life-threatening side effects could be misused by an uneducated public. "The more drugs there are out there for people to use without a prescription, the more you increase the risk of potential problems,' says Philip Hansten, professor of pharmacy at the University of Washington School of Pharmacy and an expert on drug interactions.
The voices of protest are scattered and reactive; studies on individual OTC drugs are often done after a problem, like bleeding ulcers, has emerged in a significant number of people.