FDA SAYS CONSUMERS SHOULD KNOW DRINKING, PAIN RELIEVERS DON'T MIX

Agency plans to require warning labels on overthecounter drugs

WASHINGTON The Food and Drug Administration announced Friday that it
intends to require warning labels on all overthecounter pain relievers
including aspirin advising consumers of them of potential health
problems if they also 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, 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 overthecounter 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 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 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 NonPrescription Drug Manufacturers Association, the
trade group for overthecounter 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 that comprise 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 90public 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 even infrequent users of alcohol and
painrelievers 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 were 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 billionayear overthecounter painrelief 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
overthecounter 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 overthecounter products containing acetaminophen would lead
drinkers to switch to products with other analgesic ingredients that
potentially posed different but equally significant health dangers.