What exactly is a "black box" warning? Simply put, it's the strongest warning that the U.S. Food and Drug Administration (FDA) can require on a drug's packaging. The FDA requires the black box warning when studies suggest a drug can cause a serious or life-threatening side effect. The text of the warning is set apart from other information in a black box, so that doctors, pharmacists, and patients can easily see it. What did the FDA advisory panel recommend? The FDA itself hasn't made a decision about acetaminophen, but an FDA advisory panel has made 10 recommendations concerning the drug. Among those recommendations, the panel voted to remove acetaminophen-containing painkillers such as Vicodin, Tylenol 3, and Percocet from the nation's formularies. It also voted in favor of removing all acetaminophen-containing prescription drugs from the market. But the panel voted to keep over-the-counter (OTC) pills that combine acetaminophen and other ingredients, su...
The FDA has issued a warning that on rare occasions acetaminophen may cause a serious skin rash that can be life-threatening. Acetaminophen is an ingredient in a number of opioid pain medications. Some of the best-known examples include Percocet, Vicodin and Lortab. Following is the FDA's Consumer Update.
Acetaminophen, a fever and pain reliever that is one of the most widely used medicines in the U.S., can cause rare but serious skin reactions, warns the Food and Drug Administration (FDA).
Although rare, possible reactions to acetaminophen include three serious skin diseases whose symptoms can include rash, blisters and, in the worst case, widespread damage to the surface of skin.
If you are taking acetaminophen and develop a rash or other skin reaction, stop taking the product immediately and seek medical attention right away.
Used for decades by millions of people, acetaminophen is the generic name of a common active ingredient included in numerous pres...
Alternative Names Tylenol # 3 overdose; Phenaphen with codeine overdose; Tylenol with codeine overdose Symptoms Airways and lungs
Breathing shallow Breathing slow and labored Respiratory arrest Eyes, ears, nose, and throat
Pinpoint pupils Heart and blood vessels
Low blood pressure Nervous system
Coma Convulsions Drowsiness Stupor (lack of alertness) Skin
Bluish skin (fingernails and lips) Cold, clammy skin Heavy sweating Stomach and gastrointestinal system
Nausea and vomiting Spasms of the stomach and intestines Vomiting Liver failure Urinary system
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