Arthrotec, a drug used to treat osteoarthritis and rheumatoid arthritis, has been associated with a potentially fatal allergic drug reaction known as Stevens Johnson Syndrome, which can cause death in 5-15% of cases.
Manufactured and marketed by Pfizer, Arthrotec features a combination of two drugs: diclofenac and misoprostol. Diclofenac is an NSAID (non-steroidal anti-inflammatory), which is effective in reducing pain and inflammation. However, it can also lead to stomach issues. Misoprostol is added to reduce stomach acid to protect the stomach from any potential harm from the NSAID diclofenac.
Like many prescription drugs, Arthrotec can have mild to moderate side effects such as insomnia, dry mouth, dizziness and upset stomach. However, the potential for a reaction such as Stevens Johnson Syndrome is not included in the product labeling for the drug and plaintiffs have filed lawsuits against Pfizer for failing to adequate warn patients of this danger.
Stevens Johnson Syndrome first presents with symptoms that can mimic a cold or flu, including a sore throat, fever, chills, muscle aches, weakness and pain. Next, a rash made of red or purple blisters appears on the body or in the mucous membranes, including the nose, mouth and genital area. As the rash spreads, tissue dies and flakes off. In more severe cases, large areas of skin can slough off, leaving a patient vulnerable to life-threatening infections.
Treatment for Stevens Johnson Syndrome is typically hospitalization as it is considered to be a medical emergency. The drug must be discontinued and the patient is treated with supportive measures to control pain and avoid infection. There is no cure.
The mortality rate for Stevens Johnson Syndrome is 5-15%. If a more serious form of Stevens Johnson Syndrome known as Toxic Epidermal Necrolysis develops, the mortality rate jumps to 25-40%.
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