To that end, the Pediatric Advisory Committee, working under the auspices of the US Food and Drug Administration (FDA), met on March 14 of this year and determined that “observational studies suggest that proton pump inhibitor therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine in patients who received multiple daily doses and long-term PPI therapy.”
Health Canada, the FDA counterpart governing drugs and medicinal issues north of the border, weighed in on PPI side effects in similar fashion. According to Marketwire (4/4/13), the Canadian health authority is concerned over the potential for a small increased risk for fractures of the hip, wrist or spine related to osteoporosis.
While various other issues could be at play and further enhance the risk, Health Canada nonetheless noted that patients who received multiple daily doses of PPI medications such as Nexium, and continued with such therapy for a year or longer, presented with an increased risk for Nexium hip fracture and other fractures.
Health Canada mandated a label update for all manufacturers of PPI medications, including Nexium, over Nexium side effects.
A continuing problem related to proton pump inhibitor side effects is the fact that for many sufferers of acid reflux and heartburn, the latter is a continuing problem beyond control through diet and exercise. Thus, the difficulty in giving up PPI therapy within a year when the condition continues to be a problem for the patient.
Some doctors, according to various reports, have prescribed PPIs for longer than a year, thereby increasing the Nexium fracture risk for their patients.
READ MORE NEXIUM USE AND INCREASED RISK FOR FRACTURE LEGAL NEWS
To that end, 42 lawsuits have been filed as of March 5, 2013, as part of the MDL consolidation by the US Judicial Panel on Multi-District Litigation (US District Court, Central District of California, MDL 2404).
Akin to that court action is the massive product liability lawsuit filed in California Southern District Court at the end of last year (12/31/12), alleging fractures and bone problems stemming from their use of Nexium. No fewer than 512 plaintiffs involved in the action allege bone problems associated with Nexium fracture risk (case no. 3:2012cv03083).