Feds Announce Limits on Acetaminophen in Vicodin, Percocet, Other Prescription Drugs

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California pharmaceutical injury attorneys, who have been concerned with the high risk of liver injuries arising from accidental overdoses of acetaminophen, will welcome a new ruling by the Food and Drug Administration. This week the agency announced a cap on the amount of acetaminophen that can be contained in prescription drugs. This new limit comes in response to a large number of reports of liver injuries from accidental overdoses of acetaminophen, after patients combined two or more acetaminophen-containing drugs.

Acetaminophen is one of the most common and popular painkillers, and may be present in a number of brand-name medications used to treat everything from headaches and fever to sore throat. Unfortunately, many prescription medications that contain acetaminophen don’t clearly mention this on their labels, often using the chemical compound abbreviation APAP instead. As a result, users may be at risk of an accidental overdose when they combine one acetaminophen-containing medication with another. The accumulation of acetaminophen in the system can cause serious liver damage.

The FDA’s new rule will apply to prescription drugs like Abbott Laboratories’ Vicodin and Endo Pharmaceuticals’ Percocet and their generic equivalents. Under this rule, prescription painkillers cannot have more than 325 mg of acetaminophen in a single capsule or pill, effective January 4, 2014.  Acetaminophen-containing painkillers will also have to include a boxed warning regarding potential liver injuries. The cap on acetaminophen content will not apply to over-the-counter medications.

The only thing about this rule that puzzles many Los Angeles pharmaceutical liability lawyers is why the FDA is hedging on placing a similar cap on over-the-counter acetaminophen pills. According to the agency, it is still considering a limit on over-the-counter pills like Tylenol. Currently, over-the-counter acetaminophen may contain up to 500 mg of the drug–a huge amount when you consider that a person taking these pills could also be taking another over-the-counter formulation or prescription medication that also contains acetaminophen.  Ultimately, in order for the rule to be optimally successful, the FDA should have acetaminophen limits and warnings on both prescription and over-the-counter drugs.  Stay tuned for further updates regarding this pivotal new law.

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