FDA Urges Doctors To Stop Prescribing Combination Drugs Containing More Than 325mg Acetaminophen
January 15, 2014

FDA Urges Doctors To Stop Prescribing Combination Drugs Containing More Than 325mg Acetaminophen

Brett Smith for redOrbit.com - Your Universe Online

Citing the potential risk for liver damage, the Food and Drug Administration (FDA) has asked doctors to stop prescribing combination medications containing over 325 milligrams of acetaminophen. The move comes after the federal regulator issued a similar request in 2011 to companies manufacturing these combination medications.

"There are no available data to show that taking more than 325 milligrams of acetaminophen per dosage unit provides additional benefit that outweighs the added risks for liver injury," the FDA said in a statement released on Tuesday.

Acetaminophen is a pain and fever reliever that can be found in both prescription and over-the-counter (OTC) remedies. In prescription drugs, the ones affected by Tuesday’s announcement, acetaminophen is commonly combined with opioids such as codeine, oxycodone and hydrocodone. OTC products containing acetaminophen are not affected by the new FDA announcement, but the agency signaled that it may further regulate them in the future.

"Many consumers are often unaware that many products (both prescription and OTC) contain acetaminophen, making it easy to accidentally take too much," the FDA said.

According to the National Institutes of Health, acetaminophen overdose, which can lead to liver failure or death, is one of the most common types of poisoning worldwide. The FDA has set the maximum daily dose for the drug at 4,000 milligrams. A typical OTC medication may contain 500 milligrams.

Incidental liver damage due to acetaminophen typically included people who took over the prescribed amount, those who took multiple acetaminophen products at once, and those who consumed alcohol while taking acetaminophen medications, the FDA said.

In 2011, the FDA requested manufacturers to start limiting the quantity of acetaminophen in combination drugs to 325 milligrams per dose by January 2014. Approximately half of manufacturers complied with the request, according to a CNN report.

“FDA is taking this action to make prescription combination pain medications containing acetaminophen safer for patients to use,” said Dr. Sandra Kweder, a deputy director in the FDA’s Center for Drug Evaluation and Research (CDER), at the time. “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."

With Tuesday’s announcement, the FDA said it would begin the process of taking back approval of prescription combination drugs with amounts of acetaminophen above 325 milligrams.

In August, Johnson & Johnson announced bottles containing its OTC acetaminophen medication Tylenol would have a new warning label on its caps which reads: “Contains acetaminophen. Always read the label.”

“With more than 600 (over the counter) and prescription medications containing acetaminophen on the market, this is an important step because it will help remind consumers to always read the label,” Johnson & Johnson said in a statement about the new caps.

The company has also addressed liver damage as a result of Tylenol use in the past. In 1994, a warning was added to bottles that warned about combining Tylenol and alcohol. In 1998, a warning to not “exceed recommended dose” was added. In 2004, a specific warning about liver damage was added.