FDA To Discuss Acetaminophen Liver Damage Next Week

Government regulators will be taking an even closer look next week at <"http://www.yourlawyer.com/practice_areas/defective_drugs">painkillers such as Tylenol and how these medications affect the liver. Dow Jones reported that acetaminophen, an ingredient found in a vast array of over-the-counter drugs is at the center of the issue.

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 some.

According to a U.S. Food & Drug Administration (FDA) statement we discussed in April, new warnings will be required on OTC versions of acetaminophen and NSAIDs. Acetaminophen OTC painkillers include the brand name Tylenol, while NSAIDs include aspirin (such as Bayer), ibuprofen (such as Advil), and naproxen (such as Aleve).

The new labeling requirement imposed in April, applies to all OTC pain relievers and fever reducers, including products such as cold medicines that contain acetaminophen or an NSAID in combination with other ingredients. Under the final rule, manufacturers must ensure that the active ingredients of these drugs are prominently displayed on the drug labels on both the packages and bottles. The labeling also must warn of the risks of stomach bleeding for NSAIDs and severe liver damage for acetaminophen. According to the FDA, the new rule gives the manufacturers of the affected drugs one year to re-label their products.

Under the final rule, manufacturers must ensure that the active ingredients of these OTC drugs are prominently displayed on the drug labels on both the packages and bottles. The labeling also must warn of the risks of stomach bleeding for NSAIDs and severe liver damage for acetaminophen.

Now, in addition to the mandated labeling change, next week federal regulators will look at a number of choices, such as reducing dosing levels, eliminating medicines that combine the drug 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.

According to Dow Jones, approximately 100 people die each year from accidental acetaminophen overdoses. And, 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 medications at the same time with the drug, 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 the labeling recommends. Others unknowingly take multiple products containing acetaminophen at the same time. Alcohol use can also increase the risk of liver damage with acetaminophen, the agency said.

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