Prilosec, Nexium, Other Heartburn Drugs to Undergo Safety Review Following Hip Fracture ReportsDec 11, 2007 | Parker Waichman LLP
Prilosec, Nexium and other proton pump inhibitors could increase the risk of patients’ suffering hip fractures, prompting the Food & Drug Administration (FDA) to initiate a safety review of the popular heartburn medications. At the same time, the FDA said that a just concluded review of Prilosec and Nexium did not find that the drugs put people at a higher risk of heart problems.
Prilosec and Nexium belong to a class of drugs called proton pump inhibitors. These medications provide a pronounced and long-lasting reduction of gastric acid production that relieves symptoms of severe heartburn, GERD, ulcers and other stomach ailments. In addition to AstraZeneca’s Nexium and Prilosec, other proton pump inhibitors include Wyeth's Protonix and Eisai Inc's Aciphex. Nexium, with sales of more than $5 billion last year, is AstraZeneca’s best selling medication, and was the world’s second best selling drug in 2006. Prilosec and Nexium are sold as prescription medications by AstraZeneca, while an over-the-counter version of Prilosec is sold by Proctor & Gamble.
In 2006, a British study found that taking Nexium, Prilosec and other proton pump inhibitors for a year or more raised the risk of a broken hip significantly in people over 50. The study, published in the December 2006 “Journal of the American Medical Association”, looked at medical records of more than 145,000 patients in England, where the average age of the patients was 77. The patients who used proton pump inhibitors for more than a year had a 44 percent higher risk of hip fracture than nonusers. The longer the patients took the drugs, the higher their risk. The researchers speculated that when the drugs reduce acid in the stomach, they also make it more difficult for the body to absorb bone-building calcium. That can lead to weaker bones and fractures.
At a briefing of reporters yesterday, the FDA said that it would begin a safety review of proton pump inhibitors to assess the hip fracture risk associated with these drugs. "Internally we've looked at the issue and we've asked the sponsors to send additional information and analysis," Joyce Orrick, deputy director in the gastroenterology unit at the FDA said during the briefing.
At the same briefing, the FDA said that a separate safety review of Nexium and Prilosec had not found that the medications increased patients’ risk of heart problems. The heart issue had been raised earlier this year after two small studies suggested a greater risk of heart attacks, heart failure and heart-related sudden death from the drugs than from a common surgery to remedy severe reflux disease. After reviewing that research, the FDA discovered more patients getting the drugs already had a history of heart attacks, skewing the results of both studies. The FDA also said that it looked at 14 studies of Prilosec, the older of the two drugs, and was not able to conclude that there was an increased heart attack risk with the drug.