New arthritis drug linked to SJS, TEN
May 3rd, 2010 by Jennifer Walker-Journey
A newly approved drug for the treatment of arthritis in patients at risk of developing NSAID-associated gastric ulcers has been linked to a rare but serious hypersensitivity disorder known as Stevens Johnson Syndrome (SJS).
VIMOVO (naproxen and esomeprazole magnesium) delayed-release tablets by AstraZeneca and POZEN, has been approved by the Food and Drug Administration (FDA) for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. The medication is also designed to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated ulcers. The fixed dose of the pain-relieving non-steroidal anti-inflammatory (NSAID) drug combined with an immediate-release esomeprazole, a proton pump inhibitor, was shown in clinical studies to result in fewer endoscopic gastric ulcers compared to patients receiving enteric-coated naproxen.
The drug offers an alternative treatment to the estimated 27 million Americans are affected by osteoarthritis, which is the most common form of arthritis. While most sufferers treat their symptoms with NSAIDs, half of the chronic NSAID users are at risk of gastrointestinal ulcers.
However, VIMOVO is not without its side effects. Serious skin adverse reactions such as exfoliative dermatitis, SJS and the most severe form of SJS, toxic epidermal necrolysis (TEN), which can be fatal, can occur without warning. Patients taking VIMOVO should stop taking the medication at the first appearance of skin rash or any other sign of hypersensitivity.
Other, more commonly observed adverse events associated with VIMOVO include erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal pain and nausea.