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FDA: High Doses of Acetaminophen May Cause Liver Damage

January 14, 2014 – The U.S. Food & Drug Administration (FDA) issued a press release today warning against the use of prescription drug combinations that contain more than 325 milligrams of acetaminophen per dose. The administration believes that limiting the amount of acetaminophen will reduce the risk of severe liver injury from accidental overdose, which can cause liver failure, the need for a liver transplant, or death. Symptoms of acetaminophen liver damage may include a swollen abdomen, discolored skin and eyes (jaundice), changes in urine color, irritated skin, and nausea.

Free Acetaminophen Lawsuit Evaluation: If you or a loved one developed liver damage or liver failure after taking acetaminophen, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of acetaminophen and we can help.

How Can Acetaminophen Cause Liver Damage?

Cases of acetaminophen liver damage have occurred in patients who:

  • consumed more than the prescribed dose of acetaminophen in a 24-hour period;
  • used more than 1 acetaminophen-containing drug simultaneously; or
  • drank alcohol while using acetaminophen.

Accidental acetaminophen overdoses account for nearly 50% of all cases of acetaminophen-related liver failure in the U.S., some of which result in the need for a liver transplant procedure and even death. Acetaminophen is also commonly used as an over-the-counter pain reliever and fever reducer, and is often combined with other ingredients, such as cough and cold medications. Consumers are often unaware of how many products contain acetaminophen, making it easy to accidentally overdose.

January 2011: FDA Advises Acetaminophen Manufacturers to Lower Doses

In January 2011, the FDA requested that manufacturers of prescription acetaminophen-containing drugs limit the amount of the ingredient to no more than 325 mg per dose by January 14, 2014. The agency requested this action to protect users from liver damage that can result from consuming too much acetaminophen. These medications combine acetaminophen with another pain reliever ingredient (most often an opioid), and these products are commonly prescribed for pain from serious injuries, post-operative pain, or pain following dental work.

To date, more than half of manufacturers have complied with the FDA’s request. However, some combination drug products containing more than 325 mg of acetaminophen per dose are still available on the market. In the future, the administration intends to institute proceedings to withdraw approval for prescription combination drugs that contain over 325 mg of acetaminophen per dose that still remain on the market.

Recommendation on Acetaminophen Dosages

FDA is advising healthcare providers to consider prescribing drug combinations that contain 325 mg or less of acetaminophen per dose. The administration is also recommending that when a pharmacist receives a prescription for a combination drug with over 325 mg of acetaminophen per dose that they contact the prescriber to discuss lower dose alternatives. If appropriate, a 2 tablet or 2 capsule dose may still be prescribed to the patient. When determining individual dosages, healthcare providers should always take into consideration the doses of both the acetaminophen and opioid components of the drug combination before prescribing.

Do I Have an Acetaminophen Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Acetaminophen Lawsuits. We are handling individual litigation nationwide and currently accepting new Acetaminophen liver damage and liver failure cases in all 50 states.

Free Acetaminophen Lawsuit Evaluation: If you or a loved one developed liver damage or liver failure after taking acetaminophen, you should contact our law firm immediately. You may be entitled to compensation by filing an Acetaminophen Suit and we can help.

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