The arthritis medication Arthotec has been linked to a life-threatening drug reaction called Stevens Johnson Syndrome, putting drug maker Pfizer in the hot seat for failure to warn.

Stevens Johnson Syndrome is an autoimmune disorder. More specifically, it’s a hypersensitivity disorder. With initial flu-like symptoms, SJS symptoms range from mild skin and mucous membrane lesions to skin death. It usually occurs in response to medication or infection.

Rare but Dangerous

According to eHealthMe, which looks at pharmaceutical information via FDA and social media sites, of the 5,530 people reviewed who take Arthrotec, six have reported Stevens Johnson Syndrome, or less than one percent.

Stevens Johnson Syndrome is rare. It’s estimated that only 300 cases of Stevens Johnson Syndrome are diagnosed in the United States annually. But for those few sufferers, it is dangerous. If misdiagnosed or left untreated, it can develop into Toxic Epidermal Necrolysis (skin death).

Due to the infrequency of occurrence, few companies think to share the threat of it. As SJS attacks the mucous membranes, if the label carries the warning, it’s listed under “Skin Reactions.”

Arthrotec Uses

Arthrotec is a prescription non-steroidal anti-inflammatory drug (NSAID) for arthritis sufferers. Produced by Pfizer, it’s actually a combination of two NSAIDs: diclofenac and misoprostol.

Diclofenac is similar to ibuprofen (think Advil), and misoprostol is a synthetic prostaglandin that stimulates secretion of mucus in the GI tract, protecting the lining of the stomach from acid. Together they are meant to provide relief for arthritis pain and inflammation while avoiding stomach ulcers and stomach issues commonly associated with NSAID use. However, the risk for autoimmune reactions from NSAIDs is still there.

What is Stevens Johnson Syndrome?

Stevens Johnson Syndrome is a specific type of allergic reaction. Expressing initially as a rash, with brightly colored skin lesions, SJS cell death causes the epidermis to separate from the dermis. It also attacks the mucous membranes, like the eyes and mouth. Victims can suffer not only permanent scarring, but also eye complications like severe conjunctivitis, corneal blisters and holes, and vision loss. If not treated, it can lead to toxic epidermal necrolysis (TEN).

Almost any drug can cause SJS, and NSAIDs are frequently on the list. Often preceded by a viral infection, and accompanying flu-like symptoms, the allergic reaction may not occur until 7-14 days after first using the medication.

As extreme medical conditions, SJS and TEN are treated with the utmost urgency when diagnosed. Treatments focus on controlling symptoms and minimizing complications. Stevens Johnson Syndrome treatment usually occurs in a hospital’s burn ward, and is of utmost importance as both SJS and TEN can be fatal. Recovery can take several weeks to several months, leading to large medical bills for victims.

Many victims of SJS have sued Pfizer and other drug makers for failing to warn about the risk of developing Stevens Johnson Syndrome from medication. SJS lawsuits seek to hold the manufacturers responsible for negligent marketing and labeling practices, and seek compensation for hospital bills, pain and suffering, and more.