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FDA Meets On Acetaminophen

Jul 1, 2009 | Parker Waichman LLP

In addition to other suggestions, U.S. health advisers recommended yesterday that the maximum dose of over-the-counter (OTC) acetaminophen, be lowered.

Exceeding recommended acetaminophen dosages could increase risks for severe liver damage. In 1977, the U.S. Food & Drug Administration (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 previously. 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.

This week’s vote followed last month’s FDA report that concluded severe liver damage and death could occur due to a lack of consumer awareness about acetaminophen, said HealthDay News. Educational campaigns do not appear to have had an impact in lowering liver failure in this country, said the FDA, according to the Associated Press (AP. Consumers often mistakenly believe more is better without understanding the serious risks associated with misuse, noted HealthDay News, adding that consumers are not fully aware of how ubiquitous the medication is in other drugs, which can contribute to overdosing.

Although the FDA has sponsored consumer education campaigns for over five years, said HealthDay News, "recent studies indicate that unintentional and intentional overdoses leading to severe hepatotoxicity [liver damage] continue to occur," citing the FDA report.

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 drugs that contain the medication, or strengthening prescription drug labeling, said Dow Jones previously.

Yesterday, said the AP, the FDA panel voted 21-16 to lower current maximum dosages of OTC acetaminophen, currently at four grams, the equivalent of eight pills in a product such as Extra-Strength Tylenol, said the AP. The group agreed (24-13) 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 also 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. The FDA panel also voted 20-17 that prescription drugs combining acetaminophen with other painkillers be eliminated and voted—36-1—to include a black box warning—the agency’s strongest—if the drugs remain on the market, said the AP.

Acetaminophen is, said Dow Jones, the most “widely used drug in America,” and is found in OTC painkillers, fever reducers, and cough medications such as Excedrin, Tylenol, NyQuil, and Theraflu, to name just some and is used in combination with powerful prescription medications such as Vicodin and Percocet. While the 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.

Although panel votes do not require acceptance by the agency, the FDA generally complies with panel findings.


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