DATE: Saturday, November 15, 1997           TAG: 9711150331

SECTION: FRONT                   PAGE: A1   EDITION: FINAL 

SOURCE: FROM WIRE REPORTS 

DATELINE: WASHINGTON                        LENGTH:   98 lines

FDA TO MANDATE ALCOHOL WARNINGS ON PAIN PILLS

The Food and Drug Administration announced Friday it intends to require warning labels on all over-the-counter pain relievers, including aspirin, advising consumers of potential health problems if they also have three or more alcoholic drinks a day.

``Consumption of excessive alcohol while taking pain relievers can be dangerous to your health,'' Deputy FDA Commissioner Michael Friedman said in a statement.

For instance, acetaminophen - most commonly known by the trade name Tylenol - can cause liver damage if taken by heavy drinkers, agency officials said, while aspirin, drugs such as Advil containing ibuprofen and other analgesics can result in stomach bleeding.

Despite experts' repeated warnings that all drug products pose some side effects, consumers generally have regarded over-the-counter pain-killers as benign. But disturbing reports in recent years have linked the use of certain of these products to a variety of problems when used for long periods by themselves or combined with heavy alcohol use.

Some manufacturers voluntarily have placed alcohol warnings on their products, but the FDA's proposed label would require consistent and universal wording.

For example, the label for acetaminophen products would say: ``Alcohol warning: If you drink three or more alcoholic beverages daily, you should ask your doctor whether you should take (product name) or other pain relievers. (Product name) may increase your risk of liver damage.''

For aspirin and other pain relievers, known as analgesics, the FDA proposes the same wording, except it substitutes ``stomach bleeding'' for ``liver damage.''

For products containing combinations of those ingredients, the label would warn of both possible complications.

Few people are hurt by mixing alcohol and pain pills each year, said Dr. David Flockhart of Georgetown University. But those who are, are hurt severely, and there's no way to predict who can tolerate the mix, he said.

``You're talking literally the death of their liver or a dangerous ulcer that could kill somebody,'' said Flockhart, who called these at-risk patients ``sitting ducks.''

A spokesman for the Non-Prescription Drug Manufacturers Association, the trade group for over-the-counter drug-makers, said his group had no immediate comment on the FDA proposal.

But the Aspirin Foundation of America issued a statement saying it does not believe ``warnings for heavy drinkers or alcoholics are warranted for aspirin products.'' The foundation said it plans ``to take part fully in the rule-making process'' to persuade the FDA of its position.

Ron Schmid, a spokesman for one of the companies of Johnson & Johnson, maker of Tylenol, stressed that the company had ``voluntarily put an alcohol warning on the entire acetaminophen product line. . . . We felt right from the start that all manufacturers should have an alcohol warning.''

The wording on the Tylenol products, while similar to that proposed by the FDA, does not specifically mention liver damage. Schmid refused to comment on the specifics of the proposed FDA label.

The proposal is open to a 90-day public comment period and is expected to become effective within six months after that.

While the agency's proposed labels are directed at heavy drinkers, FDA officials said studies have shown that even infrequent users of alcohol and pain-relievers could suffer from the various ailments they are warning about, depending on an individual's overall health and genetic factors.

But the officials stressed that their conclusions are based upon case reports involving those ``who had a long history of drinking heavily and who were regular users of these products,'' said Debbie Lumpkins, an FDA scientist. ``Those were the reports that triggered our concern.''

The nearly $3 billion-a-year over-the-counter pain-relief industry has become an increasingly popular one in recent years; millions of Americans regularly take these products to relieve everything from occasional muscle sprains to chronic pain conditions, such as headaches, back ailments and arthritis.

Until the 1970s, most Americans relied on aspirin for pain relief. But doctors began switching their patients to other compounds because of a variety of complaints about aspirin, ranging from allergic reactions to gastrointestinal bleeding.

At the same time, many substances such as ibuprofen, previously available only by prescription, were approved at lower doses for over-the-counter sales.

The issue of potentially harmful interactions between pain-killers and alcohol first became the focus of FDA attention in June 1993 when an agency advisory committee concluded that alcohol abusers or heavy drinkers were at an increased risk of liver toxicity when using acetaminophen.

At the time, committee members were worried that putting an alcohol warning only on those over-the-counter products containing acetaminophen would lead drinkers to switch to products with other analgesic ingredients that potentially posed different but equally significant health dangers. MEMO: This story was compiled from reports by The Los Angeles Times and

The Associated Press. ILLUSTRATION: Graphic

THE DANGERS

Acetaminophen - most commonly known by the trade name Tylenol -

can cause liver damage if taken by heavy drinkers.

Aspirin, drugs containing ibuprofen (such as Advil) and other

analgesics can result in stomach bleeding.

Send Suggestions or Comments to webmaster@scholar.lib.vt.edu