Warning on painkillers


FDA signals a red light vs. high-dose acetaminophen

The United States Food and Drug Administration will now take full action against the prescription of painkillers that contain high levels of acetaminophen due to the increasing reports of liver damage.

Painkillers and other over-the-counter medicines used for acute injuries, operations, and dental procedures are said to contain acetaminophen. The FDA said that it will now strictly implement the withdrawal of prescription painkillers that contain more than 325 milligrams of acetaminophen.

The agency said that accidental overdoses from using painkillers with acetaminophen have resulted in cases of liver failure.

It can also be noted that in most cases of severe liver injury, patients who took more than the prescribed dose with the acetaminophen in a day had also taken more than one acetaminophen-containing product simultaneously or while drinking alcohol.

Dr. Sandra Kweder, deputy director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, said in 2011 that there is no danger to patients when taking these combination medications provided that they will not take multiple products with acetaminophen at a time and exceed the maximum dose of 4,000 milligrams within a day.

The agency asked drug makers in 2011 to stop making painkillers that have more than 325 milligrams of acetaminophen per dose, wherein more than half of them have already complied today.

Kweder added that FDA is also taking a leap in its overall strategy to alleviate the threat of liver damage because of too much painkiller intake.

However, Kweder still underscored that acetaminophen is a safe product as long as it is taken as per instruction.

The FDA also added that many patients are not aware that the drug they’re taking contains acetaminophen or not even warned to avoid other products with high levels of acetaminophen.

The advised patients to read carefully the labels for prescription and OTC medication and see if it contains acetam