FDA Tylenol Warning: 325 mg of Acetaminophen is No Longer Safe

Ohio Pharmaceutical Lawyer:  The U.S. Food and Drug Administration (FDA) Issues a Tylenol Warning for Overuse Injuries

A new Tylenol warning is raising doubts about the safety of the common drug. The FDA is reminding health care professionals to stop prescribing and pharmacists to stop dispensing prescription combination drug products that contain more than 325 milligrams (mg) of acetaminophen per tablet, capsule, or other dosage unit.

If a pharmacist receives a prescription for a combination product with more than 325 mg of acetaminophen per dosage unit, FDA recommends that they contact the prescriber to discuss a product with a lower dose of acetaminophen. These products are no longer considered safe by FDA and have been voluntarily withdrawn. The FDA Tylenol warning encouraged pharmacists to return them to the wholesaler or manufacturer.

Johnson & Johnson, the manufacturer of Tylenol, has a duty to protect American consumers. Every drug company must place safety before profit. If they fail to do so, and consumers are injured as a result, lawsuits may be the best way to recover damages.

Johnson & Johnson has seen a fair number of lawsuits in relation to Tylenol and Motrin. In 2005, the U.S. Food and Drug Administration instructed Johnson & Johnson to amend the warning labels on their products.

The FDA informed the public that acetaminophen is associated with Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP). An FDA senior official stated, “It is extremely important that people recognize and react quickly to the initial symptoms of these rare but serious, side effects, which are potentially fatal.”