Nexium – its effective marketing directly to consumers reminds Americans it is the “little purple pill” designed to treat acid reflux disease. Nexium, manufactured by AstraZeneca, is a proton pump inhibitor (PPI) prescribed to treat heartburn, acid-reflux, and inflammation of the esophagus.
But plaintiffs allege that Nexium may cause a variety of bone ailments —in particular, osteoporosis, loss of bone density, and bone fractures— and that AstraZeneca failed to adequately warn of these potential adverse side effects.
At least 42 lawsuits have been consolidated in California’s Central District MDL No. 2404.
AstraZeneca LP argues that because the injuries are so varied that the cases should not be consolidated into multidistrict litigation. The company points out that some plaintiffs argue they suffered cardiovascular problems while others claim Nexium caused bones to weaken and led to broken hips or wrist.
Nexium is prescribed to treat heartburn by stopping the release of acid and inflammation of the esophagus. Approved by the Food and Drug Administration (FDA) to treat gastroesophageal reflux disease (GERD), the lawsuits claim that AstraZeneca failed to label the drug correctly to notify users it could affect bone density.
Nexium, also known as (esomeprazole magnesium) can be used for up to six months to reduce stomach ulcers or stomach infections. For children Nexium can be used for up to eight weeks to treat GERD. Besides an increased risk of bone fractures, side effects include an infection with Clostridium difficile, a bacterium. As a result elderly adults are prescribed PPIs for short-term only.
Long-term use of PPIs can inhibit the absorption of some nutrients such as calcium, vitamin b12 and magnesium, according to a story in the New York Times. In one case a woman who had taken PPIs on and off for more than a decade fainted and was diagnosed with anemia because of being malnourished.
Included in this MDL are companies such as Takeda Pharmaceuticals America, Inc. and Johnson & Johnson which also make heartburn medications.
An August 2007 FDA review of safety data suggested an elevated risk for heart problems for PPIs including Prilosec and Nexium. The FDA reviewed data from two studies and determined long-term use of omeprazole (Prilosec and generics) or esomeprazole (Nexium generic name) is not associated with an increased risk of heart problems including sudden death, heart failure and heart attack. By December, the agency said these data do not support the increased risk.
GERD affects as many as 25 percent of Americans and treatments include Prilosec, Prevacid and Nexium. These blockbuster drugs amount to nearly $14 billion in sales in 2010 and more than 100 million prescriptions.