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FDA Presses Doctors to Limit Prescribed Amounts of Acetaminophen

Destiny Baker3 years ago

The U.S. Food and Drug Administration is advising physicians and healthcare professionals to stop prescribing combination drugs with more than 325 milligrams of acetaminophen per dose.

Acetaminophen Linked to Liver Damage

“There are no available data to show that taking more than 325 mg of acetaminophen per dosage unit provides additional benefit that outweighs the added risks of liver injury.” – FDA statement as published by FOX News

Acetaminophen is a compound commonly found in combination painkillers including Tylenol and Panadol. These drugs are often prescribed to consumers to treat post-operative pain, toothaches and acute injuries.

FOX News reports that in 2011, amid reports of serious side effects including sever liver damage, the FDA asked manufacturers to limit the amount of acetaminophen in combination drugs to no more than 325 mg per tablet or capsule by January 14, 2014. While most manufacturers have complied, many combination drugs which contain more than 325 mg of acetaminophen per single dosage unit remain on the market.

As such, the agency is now urging that doctors and healthcare professionals no longer prescribe combination drugs with more than 325 milligrams of acetaminophen per tablet or capsule. The agency believes such steps will reduce inadvertent acetaminophen overdose, which can result in liver failure, liver transplant and death.

Other Acetaminophen Side Effects

Beyond liver damage, large doses of acetaminophen can result in a number of other adverse events including:

  • Arrhythmia
  • Toxicity
  • Cardiac Arrest
  • Respiratory Arrest
  • Myocardial Infarction
  • Hypotension

In August, the FDA announced that it would require Tylenol and similar painkillers to include an updated warning label informing consumers of a potentially fatal skin rash called Stevens – Johnson syndrome.

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