The acetaminophen drug is a widely used analgesic and antipyretic for the relief of headaches and in cold and flu. It has been taken by millions of people for decades.
However, 109 cases of Stevens-Johnson Syndrome were registered since 1969.
As an example, in November 2000 a 3 year old girl, Brianna Maya, took Children’s Motrin and Children’s Tylenol on the pediatrician’s advice and soon developed a severe skin reaction affecting her mucus membranes. During the last decade, she had repeated eye surgeries and infections and other severe pains. Because her vagina was affected, she will never be able to have normal sexual relations. A jury in Philadelphia ordered the drug manufacturer Johnson and Johnson’s McNeil Consumer Healthcare to pay the family $10 million for her injuries but this will not make her actual life easier.
The FDA will force the producers of drugs that contain acetaminophen to update their packages with a black box warnings to call attention to serious risks.
“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”, said Sharon Hertz, deputy director of the RDA’s Division of Anesthesia, Analgesia and Addiction.