FDA Panel Votes To Eliminate Two Popular PainkillersJul 1, 2009 | Parker Waichman LLP
A government panel voted that two popular prescription painkillers be taken off of the market because of their alleged impact in dangerous, sometimes fatal, overdoses. The Associated Press reported that Vicodin and Percocet, which are combined with the popular medication acetaminophen, should be removed because of issues linked with acetaminophen, a component in a variety of other common medications.
Acetaminophen is, said Dow Jones previously, the most “widely used drug in America” and is found in over-the-counter (OTC) painkillers, fever reducers, and cough medications such as Excedrin, Tylenol, NyQuil, and Theraflu, to name just some. Acetaminophen is also used in combination with powerful prescription medications such as Vicodin and Percocet.
According to Dow Jones, approximately 100 people die annually from accidental acetaminophen overdoses. And, while the U.S. Food & Drug Administration (FDA) says acetaminophen is safe when taken at recommended levels, the problem is the medication’s pervasiveness, which can lead to one patient taking a number of acetaminophen-containing medications at the same time, noted Dow Jones, an issue since the 1970s.
Exceeding the recommended dosage of acetaminophen may increase the risks for severe liver damage. In 1977, the FDA—which has long been struggling with OTC acetaminophen use and overuse—wanted labels issued to indicate the potential liver damage that can occur when acetaminophen is not used correctly, explained Dow Jones. According to a prior FDA statement, safety data reported in medical literature indicates that people sometimes take more acetaminophen than labeling recommends. Others unknowingly take multiple products containing acetaminophen concurrently. Alcohol use can increase the risk of liver damage with acetaminophen, the agency noted.
Yesterday, said the AP, an FDA panel voted 20-17 that prescription drugs combining acetaminophen with other painkillers be eliminated. In addition to a recently mandated labeling change, federal regulators—in an attempt at reducing acetaminophen-related liver damage—looked at a number of choices, such as reducing dosing levels, eliminating medicines that combine acetaminophen with other ingredients, reducing the quantity of acetaminophen in each drug that contains the medication, or strengthening prescription drug labeling for medications containing the drug to include strong language about liver risks, said Dow Jones previously.
Educational campaigns do not appear to have had an impact in lowering liver failure in this country, said the FDA, according to the AP, citing FDA data that notes most—60 percent—of acetaminophen-related fatalities are linked to prescription medications.
The group also voted—36-1—to include a black box warning if the drugs remain on the market, said the AP. A black box is the agency’s strongest warning. The group also voted 21-16 to lower current maximum dosages of OTC acetaminophen, which is currently at four grams, the equivalent of eight pills in a product such as Extra-Strength Tylenol, said the AP. In another vote—24-13—the group agreed on a maximum single dose of 650 milligrams, a drop in, for instance, the current single dose of Extra-Strength Tylenol, which is 1,000 milligrams for two tablets, said the AP, citing the group as saying the current dose should be available by prescription only. The panel voted 24-13 to keep other OTC products containing acetaminophen—cough and cold products, for example—on the market, citing lower overdose rates with these products, said the AP.
Although panel votes do not require acceptance by the agency, the FDA generally complies with such panels.