According to a Consumer Update released by the FDA on August 1, 2013, Tylenol and other medicines containing acetaminophen have been linked to Stevens Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN). These “are the two most serious skin reactions linked in rare cases to acetaminophen” and “they usually require hospitalization and can cause death.” These reactions begin with flu-like symptoms followed by a rash. In some cases, the rash can blister and cover large areas of the body causing scarring. Dr. Sharon Hertz, a deputy director at the FDA, stated that “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” (i).
The FDA reviewed its adverse events database and discovered that there had been 107 cases of SJS and TEN resulting in 67 hospitalizations and 12 deaths. Based on this evidence, the Agency is requiring all prescription medicines containing acetaminophen to add a warning about skin reactions on their labels. The Agency stated that it would work with over the counter manufacturers to get similar labels on their medicines. Accurate and uniform labeling is an important part of consumer safety but many people may not know which over the counter drugs contain acetaminophen because the name is often shortened as “APAP,” “acet,” “acetamin,” or “acetaminoph” (i).
Attorney Paul d’Oliveira stated, “Fortunately, the FDA is finally recognizing the danger of SJS and TEN among commonly used drugs like Tylenol. Unfortunately, it is alleged that some drug manufacturers do not warn about these risks on the labels of their medicines. For many years nobody questioned the safety of Tylenol but recent reports suggest that liver damage and SJS are real dangers. Our law firm is investigating the possible allegations of manufacturing defects, design defects, and failure to warn and working with lawyers who are litigating these cases.”
Side effects of Tylenol can be very serious in some cases. People who have suffered liver or SJS injuries may be entitled to compensation for medical bills, lost income, pain and suffering, scarring, disfigurement, loss of consortium, or wrongful death. d’Oliveira & Associates has been investigating the link between widely used medicines and hypersensitivity reactions like SJS and TEN. The law firm works with some of the more experienced Tylenol lawyers, who are handling these cases, and there is no legal fee until a settlement or award is obtained.
To contact the firm call 1-800-992-6878 or submit a contact form online.
- (i) FDA Consumer Update, August 1, 2013.