FDA Panel Approves Painkiller Restrictions

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An FDA panel voted, Tuesday, to lower the maximum daily dose listed on Tylenol and other painkillers made with a widely-used ingredient that could be harmful.

The group, however, voted against the idea to remove the popular drugs from store shelves

The goal is to prevent accidental overdoses that claim hundreds of lives each year.

It's one of the most widely used drugs in the U.S.  Acetaminophen is the key pain-relieving and fever-reducing ingredient in dozens of prescription and over-the-counter drugs like Tylenol, NyQuil and other combination cold medicines.

"This isn't the usual sort of advisory committee where we're trying to figure out if the signal is real," said Dr. Judith Kramer of the Clinical Trials Transformation Initiative.  "We actually have a substantial number of fatalities that are occurring and, at least the data suggests that many of them are unintentional."

Acetaminophen is the leading cause of liver failure in the U.S.  There are 200 related deaths each year and, according to the FDA, 56,000 people are sent to the emergency room.

For two days, 35 experts have poured over the data to figure out how to keep best protect Americans.  Despite years of educational campaigns, some patients aren't reading the warnings and some say doctors need to do a better job looking out for their patients.

"Everyday I fill prescriptions from physicians where there is a dose between six to eight doses of acetaminophen and everyday I'm trying to correct and be that middle man between the physician and the patient," said pharmacist Winnie Landis.

Manufacturers of the drugs are fighting back, saying they pose a relatively small risk to patients.  They stand to lose hundreds of millions of dollars as a result of the pending federal changes.

last year, total sales of all acetaminophen drugs reached $2.6 billion.

"I personally think that our very snails pace of progress over the last two decades to address this public health problem is really a step back (and) not very acceptable," Kramer charged.

The final decision is up to the Food and Drug Administration.  The group is not required to take the panel's advice, but usually does.

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