FDA LOWERS THE ACETAMINOPHEN DOSAGE LIMIT
& PROPOSES BLACK BOX WARNING

On January 13, 2011 the Food and Drug Administration (FDA) lowered the limit of acetaminophen allowed to be included in prescription drugs to only 325 milligrams per dose. The FDA also mandated an update to labels of all prescription combination acetaminophen products to warn of the potential risk for severe liver injury. There is a wide array of both prescription and over the counter drugs that include acetaminophen (see list of drugs at the bottom of this page) and prior to this new limit, many of the prescription medications had up to 750 milligrams of acetaminophen per dose. The FDA also now proposes inclusion of their most severe “Black Box” warning on all prescription products that contain acetaminophen.

Sandra Kweder, M.D., deputy director of the Office of New Drugs in FDA’s Center for Drug Evaluation and Research (CDER) said, “FDA is taking this action to make prescription combination pain medications containing acetaminophen safer for patients to use. Overdose from prescription combination products containing acetaminophen account for nearly half of all cases of acetaminophen-related liver failure in the United States; many of which result in liver transplant or death.”

TAKING MORE ACETAMINOPHEN THAN YOU KNOW. WHAT IS APAP?

“APAP” is an abbreviation for acetaminophen that many drug-makers use as shorthand in the list of ingredients on their drug packaging. Even if the prior dosage of acetaminophen had been an appropriate amount, it is not uncommon for users to accidentally exceed recommended dosage limits by taking more than one medication that includes acetaminophen at a time without realizing it because they do not recognize that “APAP” is, in fact, also acetaminophen! Some of the most popular drugs that use the abbreviation “APAP” are Percocet, Vicodin, and Tylenol with Codeine, among others.

WHAT IS ACETAMINOPHEN?

Acetaminophen was approved by the United States Food and Drug Administration (FDA) in 1951. Acetaminophen, known as Paracetamol internationally, is a pain reliever and fever reducer. Acetaminophen is most commonly sold under the brand Tylenol, but it is an ingredient in hundreds of brands both prescription and over the counter (OTC). It is frequently found in cold and flu medications. Acetaminophen has been linked to liver damage and failure.

ACETAMINOPHEN LIVER DAMAGE/FAILURE

While there are claims of Acetaminophen’s general safety at recommended doses, acute overdoses can cause potentially fatal liver damage. There is also a chance for some users that a normal dose can carry the same risk. The liver is responsible for metabolizing drugs, so once toxic levels of acetaminophen occur in the liver, the natural antioxidant defenses of the body are overwhelmed. When this happens, the liver is damaged by the buildup of dangerous toxins. Scientists at the University of North Carolina, Chapel Hill recently conducted a study, now published in the Journal of the American Medical Association, that showed that in some cases 44% of participants who took acetaminophen, either alone or in combination with another drug, over a two week time frame, showed abnormal elevations of a liver enzyme that is known to be a precursor to liver damage.

Paracetamol toxicity is the leading cause of liver failure. Acetaminophen is to blame for the majority of drug overdoses in the United States. More than 30,000 cases of Acetaminophen overdose are reported per year, according to the American Association of Poison Control Centers. Overdoses of Acetaminophen can lead to liver failure, which requires treatment or can necessitate a liver transplant. Liver failure that necessitates a liver transplant is particularly devastating. Thousands of people in the United States are currently waiting for livers. A liver transplant is also one of the most expensive procedures in modern medicine. If left untreated, liver failure can result in death.

So adverse were the potential health risks of Acetaminophen that even before the recent change in dosage to prescriptions drugs containing acetaminophen noted above, the FDA advisory committee recommended restrictions to lower the maximum dosage and put warnings on the labels of over the counter drugs containing Acetaminophen in 2009. The FDA’s concern is that the former recommended maximum dose was shown to produce alterations in hepatic (liver) function. Unfortunately the many manufactures of prescription drugs containing Acetaminophen have three years to alter the amount in their products, so there are still drugs on the market with suggested maximum doses at harmful levels and without proper labeling to explain the risks to consumers.

SYMPTOMS OF LIVER DAMAGE

One of the most dangerous aspects of liver failure is that sometimes its victims don’t have symptoms. For those who do experience symptoms, they most often begin with nausea and vomiting in the first 24 hours. In the next 12 to 24 hours (the latent phase), the patient may have a feeling of wellness. It’s after this time, approximately 48 and sometimes as much as 72 hours after the overdose, liver blood test begin to appear abnormal. Tests at this time should provide an accurate outlook on whether the patient will be able to undergo treatment or will need a liver transplant. Patients who don’t receive these tests could not be aware that they have experienced liver damage. Untreated liver damage can result in death, often within a few days of Acetaminophen overdose.

If you or someone you care about has been injured by a product with Acetaminophen (See comprehensive list below), contact the lawyers at The Oshman Firm for a free and confidential case evaluation. We will find answers, hold negligent companies responsible, and fight to get you the compensation you deserve.

About Ted Oshman

Ted Oshman has been with The Oshman Firm since 1988 serving clients for over 25 years. Learn more about Ted's background and featured practice areas here.

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