FDA Links High Dosages of Acetaminophen to Possible Liver Failure

FDAThe FDA had concluded that high dosages of the painkiller acetaminophen may lead to liver failure. In 2011, the US regulating agency put in a request to drug companies to reduce the amount of acetaminophen in drugs containing it; that request went largely ignored.

As of Jan 14, 2014, a recommendation was issued that will force the drug industry into compliance. Only 50% of drug companies are in compliance since the recommendation was handed down. The FDA  plans on revoking licenses of drug companies who continue to ignore the recommendation.

On Tuesday, the FDA made a recommendation based on findings that lower dosages work just as well in reducing pain as dosages of 325 mg. They conclude that the higher dosages can lead to liver failure and overdose as a result of stress being placed on the organ as it metabolizes post-surgery drugs.

Pharmacists are encouraged to reach out to doctors to determine if lower dosages can be used when they note prescriptions written for more than 325 mg. Pharmacists fill prescriptions for consumers and are accountable as health care professionals to help consumers avoid harm.

With the FDA connecting high dosages of acetaminophen to liver failure, consumers will have to become responsible advocates for family and loved ones by paying attention to prescribed medications. Those under a doctor’s care who anticipate surgery will need to have discussions with medical professionals about drugs prescribed for both inpatient stays and for after care, once released.

Drugs like Percocet, a very strong painkiller containing acetaminophen, become a risk for complications and overdose when mixed with Tylenol, making lower dosages more of a concern. Recommended dosages for Tylenol are two tablets for adults every four to six hours, or as needed. The loose “as needed” interpretation is subjective. A couple of doses over when mixed with other drugs, has the potential to cause serious harm.

The FDA reports more than 500 deaths per year from acetaminophen overdose and more than 56,000 emergency room visits. With this level of preventable deaths, consumers used to taking pills to reduce pain associated with minor body aches and tension will need to pay closer attention for safety and personal health.

The FDA recommendation has caught the attention of advocacy groups serving as watchdogs and a protective arm for consumers. Acetaminophen Awareness Coalition reports, “Acetaminophen is also an extremely popular over-the-counter drug. Both Tylenol and generic versions are used to treat pain and fevers, and they are also combined with cough and cold medicines.” Common over-the-counter medicines containing the drug that people take to self-medicate a headache or cough when they are not ill enough to see a doctor can become potentially harmful when mixed with other medications. These medications can be purchased at a drugstore without a prescription.

The FDA recommendation comes at a crucial time. It is cold and flu season and many people are seeking relief from their symptoms with over-the counter medicines. With the FDA connecting links of liver failure to high dosages of acetaminophen, consumers will be able to make better informed decisions.

By C. Imani Williams



Los Angeles Times