Parker Waichman LLP

FDA Warns of Rare But Serious Acetaminophen Risk

On Thursday, the U.S. Food and Drug Administration (FDA) issued a warning to consumers of a link between the fever and pain reliever acetaminophen and rare but potentially fatal skin diseases. The FDA said it has identified evidence of a connection between acetaminophen — one of the most widely used medicines in the U.S. — […]

fda_warns_of_acetaminophen_riskOn Thursday, the U.S. Food and Drug Administration (FDA) issued a warning to consumers of a link between the fever and pain reliever acetaminophen and rare but potentially fatal skin diseases.

The FDA said it has identified evidence of a connection between acetaminophen — one of the most widely used medicines in the U.S. — and Stevens-Johnson Syndrome and toxic epidermal necrolysis (TEN), Law360 reports. Both diseases typically require hospitalization and can be fatal, according to the agency.

Although such reactions are rare, according to the FDA, acetaminophen users can develop rashes, blisters and, in the worst case, widespread damage to the surface of skin. Anyone taking acetaminophen who develops a rash or other skin reaction should stop taking the product immediately and seek medical attention right away. Problems usually begin with flu-like symptoms followed by skin manifestations.

Acetaminophen has long been a common active ingredient in both prescription and non-prescription medicines. Tylenol, the brand-name acetaminophen, is sold over the counter. Generic acetaminophen is widely available and acetaminophen is also commonly combined with other pain medications and is an ingredient in medicines to treat colds, coughs, allergy, headaches, and trouble sleeping.

“This new information is not intended to worry consumers or health care professionals, nor is it meant to encourage them to choose other medications,” said Dr. Sharon Hertz, deputy director of the FDA’s Division of Anesthesia, Analgesia and Addiction. But, Hertz stresses, “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.”

The FDA decided to add a skin-reaction warning to acetaminophen products after reviewing medical literature and its Adverse Event Reporting System database (FAERS). The FAERS search uncovered 107 skin disease cases from 1969 to 2012, resulting in 67 hospitalizations and 12 deaths. Most cases involved single-ingredient acetaminophen products and were categorized as either probable or possible cases associated with acetaminophen.

Other fever and pain medicines — like ibuprofen (Advil and Motrin) and naproxen  (Aleve and Midol Extended Relief) — already carry warnings about the risk of serious skin reactions, according to Law360.

 

 

 

 

 

 

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Positive: Professionalism , Quality , Responsiveness , Value They helped me throughout the whole process and they worked hard for me and got a generous settlement and have additional health coverage. They communicated with me and always replied to emails, texts and calls promptly. I highly recommend them!
Giovanna Losardo
3 years ago
5 Star Reviews 150
I speak with Joanne Stevens Nurse Consultant from Parker Waichman LLP she is a pleasure and very compasionate person. so far happy with the people and the firm..
Lona Frawley
5 years ago
5 Star Reviews 150
Michele Josama Has been an Amazing Help, I appreciate all she has done!! Her customers service is 100%.
Angee Hammond
4 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038