Acetaminophen warning by FDA for prescription and non-prescription drugs like Tylenol, Midol, Sudafed, Benadryl (Video)

An acetaminophen warning was released by the FDA because the pain-killing medication has been linked to three skin diseases, two of them potentially fatal.

Acetaminophen is the most common drug ingredient in America and can be found in more than 600 different over-the-counter and prescription medicines which include Tylenol, Midol, Benadryl, Nyquil, Sudafed, Robitussin, Vicks, and other products which are used as pain relievers, fever reducers, sleep aids as well as cough, cold, and allergy medicines.

Due to the FDA’s recent acetaminophen warning, consumers are advised to check any medication label for acetaminophen. On prescription labels, acetaminophen is sometimes listed as “APAP,” “acetam,” or other shortened versions of the word.

“The FDA discovered the risk of skin diseases while reviewing adverse events reported in its database between 1969 and 2012, during which 107 cases of significant skin reactions were reported, 67 people were hospitalized and 12 people died.”

The first and less serious skin disease that can be caused by acetaminophen is acute generalized exanthematous pustulosis (AGEP). Symptoms of AGEP include uncommon skin eruptions with rapid appearance of areas of red skin studded with small pustules (small blisters filled with white/yellow fluid). AGEP typically starts as a rash on the face or in the armpits and groin and then becomes more widespread. AGEP may be accompanied by fever and malaise, but generally the patient is not particularly unwell. The rash may last for one to two weeks and then the skin peels off as it resolves.

The second and third more serious skin conditions that can be caused by acetaminophen is Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN), which require hospitalization since they can be fatal.

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are severe cutaneous hypersensitivity reactions to drugs like sulfa drugs, antiepileptics, antibiotics, and now acetaminophen.

According to The Merck Manual, one to three weeks after beginning to take an offending drug like acetaminophen, a person might develop malaise, fever, headache, cough, and conjunctivitis. “Macules, often in a target configuration, then appear suddenly, usually on the face, neck, and upper trunk. These macules simultaneously appear elsewhere on the body, coalesce into large flaccid bullae, and slough over a period of 1 to 3 days. Nails and eyebrows may be lost along with epithelium.”

“Severe TEN is similar to extensive burns; patients are acutely ill, may be unable to eat or open their eyes, and suffer massive fluid and electrolyte losses. They are at high risk of infection, multiorgan failure, and death. … Prognosis depends on how early the disorders are diagnosed and treated. Mortality can be as high as 7.5% in children and 20 to 25% in adults.”

The FDA’s acetaminophen warning should encourage people to read medication labels, medication descriptions, and to keep an eye out for any side effects while taking medication.