The Food and Drug Administration gathered over 35 experts for a two day meeting to find ways to prevent acetaminophen overdose. Acetaminophen is the pain reliving and fever reducing ingredient that is found in drugs like Tylenol and many other prescription and over the counter medications.
Companies such as Johnson & Johnson, Procter & Gamble and other drug manufacturers on Monday tried to dissuade U. S. regulators from placing new restrictions on these popular pain relief medications.
Consumer Healthcare Products Association (CHPA) President Linda Suydam, whose group represents the two companies along with others, told an FDA advisory panel meeting to discuss the risks, "We believe there is a clear public health benefit with OTC (over-the-counter) products containing acetaminophen."
The FDA is considering a ban on such combination products as too much acetaminophen has been known to cause liver damage and combining it with other medications could lead consumers to unknowingly overdose either by taking too much medication or too many different products together.
Earlier this year the agency called for stronger liver warnings and companies agreed to comply. The FDA said despite years of educational campaigns and other federal actions, acetaminophen is the leading cause of liver failure in the U. S., sending 56,000 people to the emergency room annually.
In a memo released before the meeting the agency said the ingredient are safe when taken as directed but the number of liver failure cases that continue to be reported despite various interventions since the 1990s show "overdose remains a serious public health problem."
Citing IMS Health the FDA said, in case a total ban on combination products is implemented it could affect sales of acetaminophen-containing products, which were $2.6 billion in 2008 and almost 80% of this is from combination products sold directly to consumers.
The CHPA said Johnson & Johnson's McNeil Consumer Healthcare division, would feel the impact as it constitutes 27% with its Tylenol brand as well as its Sudafed and Benadryl products.
On Monday the agency asked the panel of experts to consider a variety of options ranging from adding a strong "black box" warning label, lowering the drug dosage in some over the counter products or even banning some medications.
Edwin Kuffner, McNeil's senior director for medical affairs, said his company recommended lowering the instructions for adults from two tablets every four to six hours to try one tablet first.
However Tylenol's Johnson & Johnson countered the proposal to lower the maximum daily dose of acetaminophen, as 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 non-steroidal anti-inflammatory drugs, which carry risks of gastrointestinal bleeding and sometimes fatal kidney injury.
Paul Desjardins, a vice president for Wyeth Consumer Healthcare said a further ban on certain products would be "overly drastic," and the FDA should instead require approval of nonprescription acetaminophen products before they could be sold.
The FDA said its only goal is to reduce liver injury, "not to decrease appropriate acetaminophen use or to drive people to use NSAIDS instead."
The panel is scheduled to vote Tuesday afternoon and although the FDA is not required to follow the advice of its panels, it usually does.
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