FDA panel to vote on painkiller restrictions
By MATTHEW PERRONE, AP Business Writer
ADELPHI, Md. – Government experts are scheduled to vote Tuesday on a range of options to curb deadly overdoses with Tylenol and other pain relievers, including reducing dosages and even pulling certain products off the market.
As the second day of the Food and Drug Administration's meeting began, the agency is asking more than 35 experts to discuss and vote on ways to prevent overdose with acetaminophen — the pain-relieving, fever-reducing ingredient in Tylenol and dozens of other prescription and over-the-counter medications.
Acetaminophen is one of the most widely used drugs in the U.S. Many patients find it easier on the stomach than other painkillers like ibuprofen and aspirin, which can cause ulcers.
Despite years of educational campaigns and other federal actions, acetaminophen remains the leading cause of liver failure in the U.S., sending 56,000 people to the emergency room annually, according to the FDA. There are about 200 acetaminophen-related deaths each year.
"It can happen to anybody, but it's very rare," said Dr. Lee Simon, an associate professor at Harvard Medical School, who attended Monday's meeting. "Obviously it's important that we improve the communication about these products because they are ubiquitous, and we still see people inadvertently overdosing."
The drugs that could be pulled off shelves are combination medications, such as Procter & Gamble's NyQuil or Novartis' Theraflu, which mix acetaminophen with other ingredients that treat cough and runny nose.
The FDA is not required to follow the advice of its panels, though it usually does. The vote is scheduled for Tuesday afternoon.
Manufacturers could lose hundreds of millions of dollars in sales if combination drugs are pulled from the market. Total sales of all acetaminophen drugs reached $2.6 billion last year, with 80 percent of the market comprised of over-the-counter products.
The FDA says patients often pair the cold medications with pure acetaminophen drugs, like Tylenol, exposing themselves to unsafe levels of the drug.
But the industry group that represents Johnson & Johnson and other companies defended the products Monday, saying they pose a relatively small risk to patients.
Only 10 percent of deaths linked to acetaminophen medications involved over-the-counter combination cold medications, according to the Consumer Healthcare Products Association.
The majority of deaths were caused by either single-ingredient drugs or prescription strength combination drugs like Endo Pharmaceutical's Percocet, which combines oxycodone and acetaminophen.
"We believe there is a clear health benefit of over-the-counter combination products containing acetaminophen," said Linda Suydam, the group's president.
The FDA panel also will vote on a series of other proposals, including changing the packaging, labeling and dosing of the medications. All three ideas are designed to prevent patients from taking more than the recommended dose of the drug.
On Monday, Tylenol-maker Johnson & Johnson pushed back against a proposal to lower the maximum daily dose of acetaminophen, which is currently 4 grams daily, or eight pills of a medication like Extra Strength Tylenol.
While taking more than 4 grams per day can cause liver injury, J&J argued that taking the exact dose is proven to treat osteoarthritis pain.
J&J also warned panelists that any new restrictions on acetaminophen would force patients to switch to nonsteroidal anti-inflammatory drugs, such as aspirin and ibuprofen. Those drugs carry their own risks of gastrointestinal bleeding and sometimes fatal kidney injury.
Top-sellers in the anti-inflammatory drug market include Wyeth's Advil.
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