FDA to Require Alcohol Warnings on Pain Relievers

The Food and Drug Administration announced Friday that it intends to require warning labels on all over-the-counter pain relievers--including aspirin--advising users of potential health problems if they consume 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, heavy drinkers’ use of acetaminophen--most commonly known by the trade name Tylenol--can cause liver damage, agency officials said, while their use of aspirin, ibuprofen and other analgesics can cause stomach bleeding.

Despite experts’ repeated warnings that all drug products pose some side effects, consumers generally have regarded over-the-counter painkillers 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 already have placed alcohol warnings on their products, but the FDA’s label proposal requires 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, 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.

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

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

Ron Schmid, a spokesman for one of the divisions of Johnson & Johnson, maker of Tylenol, stressed that the firm 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 acknowledged 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 on 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. Millions of Americans regularly take the products to relieve everything from occasional muscle strain 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, sold under such brand names as Advil--previously available only by prescription were approved at lower doses for over-the-counter sales.

The issue of potentially harmful interactions between painkillers 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 pose different but equally significant health dangers.