FDA Tylenol Warning: Prescription Drugs with Acetaminophen May Cause Liver Damage

A FDA Tylenol warning has been issued, asking doctors to stop prescribing high-dose acetaminophen prescription drugs. Taking too much acetaminophen may increase a person’s risks of liver damage.

The federal agency asked doctors to stop prescribing combination medications, such as oxycodone (Percocet), hydrocodone (Vicodin) and codeine (Tylenol with codeine), that contain more than 325 mg of acetaminophen per dose. It is not rare for patients to unknowingly take too much Tylenol by taking pain medications along with over-the-counter medications, which also contain the pain reliever.

The FDA warning only applies to prescription drugs. The federal agency plans to address limits for over-the-counter acetaminophen products at a later date.

In an effort to limit patients’ intake, in 2011, the FDA asked manufacturers to restrict the amount of acetaminophen in prescription combination drugs to 325 mg per pill. The restricted amount of the pain reliever took effect in January 2014. Some combination drugs with larger amounts of acetaminophen remain available to consumers because only half of the manufacturers agreed to the limit.

The FDA plans to begin withdrawing the approval of prescription combination drugs from manufacturers who fail to comply.

The risks of too much acetaminophen

According to medical professionals, too much acetaminophen can lead to liver damage or death. The FDA recommends that adults take no more than 4,000 milligrams of acetaminophen per day. Just one Extra Strength Tylenol, for example, contains 500 mg. The FDA warns patients to never take more of any medication that contains the pain reliever than prescribed. Consumers are at a greater risk of side effects if they drink alcohol while taking acetaminophen.

For years, the public has been aware of the risk of liver damage associated with long-term acetaminophen use. However, many are unaware of the risks of taking large doses during short periods of time. This is especially noteworthy for those who may be taking both acetaminophen-laden prescription and over-the-counter drugs, such as cold medicines and cough syrups.

Liver damage often can be misdiagnosed for other conditions, such as the flu, because initial symptoms may include loss of appetite, nausea and vomiting. More serious symptoms include abdominal pain, convulsions, jaundice and coma. Within days, liver damage can turn into liver failure.

Other side effects of acetaminophen may include serious skin reactions. Though rare, these conditions, which can cause blisters, rashes and skin reddening, can be deadly, according to the FDA.

Doctors have a duty to warn patients about excess acetaminophen

Doctors who prescribe combination drugs are urged to warn patients about the risks of mixing them with other medications that contain acetaminophen. Doctors and pharmaceutical companies may be opening themselves up to medical liability claims if they fail to warn patients about the dangers associated with higher doses of pain relievers and combining prescriptions with the over-the-counter medications.

The FDA encourages patients to check the labels of medications to see if the ingredients include acetaminophen, Tylenol or APAP, which is an abbreviation that pharmacists sometimes use for the drug.