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FDA to Restrict Acetaminophen in Pain Medications

January 13th, 2011

Acetaminophen—the active ingredient in Tylenol products—is a popular, over-the-counter pain reliever. Because it is so useful to treat many types of pain, it is often added to prescription narcotic pain medications.

Even though you can buy acetaminophen in any supermarket or pharmacy, it is actually a potent drug, capable of causing permanent liver damage if taken in high doses. Now, the U.S. Food and Drug Administration has taken new steps to reduce the severe liver injury. Specifically, the FDA has announce that is is:

  • asking all makers of prescription products that contain acetaminophen to limit the amount of the drug to 325 milligrams per tablet or capsule;
  • requiring a Boxed Warning on all prescription acetaminophen products, highlighings the potential risk for severe liver injury. (Boxed Warnings are FDA’s strongest warnings for prescription drug products, used for calling attention to serious or life-threatening risks.)

Acetaminophen (also called APAP) is used in many prescription products in combination with other drugs, usually opioids. The brand names of opioid+acetaminophen combinations include Tylenol with Codeine, Percocet (for oxycodone plus acetaminophen), Lortab and Vicodin (both include hydrocodone plus acetaminophen), and Ultracet (for tramadol plus acetaminophen).

If you take an opioid medication, the active ingredients are always listed on the prescription bottle, and will look something like this (example from Vicodin):  hydrocodone/APAP     10 mg/325 mg tabs. This means that each tablet contains 10 milligrams of hydrocodone and 325 milligrams of APAP, which is acetaminophen.

According to the FDA:

“Overdoses from prescription products containing acetaminophen account for nearly half of all cases of acetaminophen-related liver failure in the U.S., many of which result in liver transplant or death,” says Sandra Kweder, M.D., deputy director of FDA’s Office of New Drugs.

Most of the cases of severe liver injury occurred in patients who:

  • took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period
  • took more than one acetaminophen-containing product at the same time
  • drank alcohol while taking the drug

“There is no immediate danger to patients who take these combination pain medications and they should continue to take them as directed by their health care provider,” says Dr. Kweder. “The risk of liver injury primarily occurs when patients take multiple products containing acetaminophen at one time and exceed the current maximum dose of 4,000 milligrams within a 24-hour period.”

If you have any questions about the medications you are using, talk with your health care provider or pharmacist. Do not stop taking any prescription medication without first talking with your doctor. In addition, keep yourself safe and reduce the risk of side effects by following these tips:

  • take opioid/acetaminophen combination products only as prescribed by a health care professional
  • don’t take more of an acetaminophen-containing medicine than directed
  • carefully read all labels for prescription and over-the-counter (OTC) medicines, and ask the pharmacist if your prescription pain medicine contains acetaminophen
  • don’t take more than one product that contains acetaminophen at any given time
  • don’t take alcohol when taking acetaminophen
  • don’t take more acetaminophen than the maximum daily dose of 4,000 milligrams (4 grams)
  • don’t take acetaminophen-containing products if you have liver disease, unless approved by your doctor
  • if you take so much medication that you feel the need to calculate the total amount of acetaminophen you take each day, don’t try to do it yourself. Instead, talk to your health care professional about all of the medications—prescription and OTC—you are taking and which include acetaminophen

In addition, seek immediate medical help if you think you have taken more acetaminophen than directed, OR if you experience allergic reactions such as swelling of the face, mouth, and  throat; difficulty breathing; itching; or rash.

The FDA has provided consumer-friendly information about acetaminophen. Click here for a printable PDF document:  FDA’s New Steps Aimed at Cutting Risks from Acetaminophen

For a video by the FDA about this topic, click here: Prescription Acetaminophen/Opioid Combinations

If you have suffered injury from taking these or other medications, and you want to explore your legal options, please feel free to call the lawyers of HensonFuerst. If you have questions, HensonFuerst has answers.