The FDA is requiring that additional information be provided by several pharmaceutical companies about the risk of bone fractures from Nexium, Prilosec, Prevacid and other heart burn medications.
In a drug safety communication released on May 25, the FDA announced that all proton pump inhibitors (PPIs) will now include a warning that they may increase the risk of fracturing bones in the hip, wrist, and spine. The labeling change came after FDA drug safety reviewers looked at a number of epidemiological studies into PPI bone fracture risks.
One such study, published earlier this month in the Archives of Internal Medicine, found that women who took PPIs were 25% more likely to suffer a Prilosec or Nexium bone fracture over an 8-year period than women who did not. The new labeling changes will indicate that the fracture risks appear to be linked to long-term use. FDA officials say that although the studies have looked at people who used the drug for more than a year, the drug facts section of the labels will indicate the possibility of risk after 14 days of continuous use.
Drugs that will be affected by the labeling changes include the prescription drugs Nexium, Prilosec, Zegerid, Prevacid, Protonix, Aciphex and Vimovo. The labeling changes will also be applied to over-the-counter drugs including Prilosec OTC, Zegerid OTC, and Prevacid 24HR.
"Epidemiology studies suggest a possible increased risk of bone fractures with the use of proton pump inhibitors for one year or longer, or at high doses," said Dr. Joyce Korvick, FDA's Division of Gastroenterology Products deputy director for safety. "Because these products are used by a great number of people, it's important for the public to be aware of this possible increased risk and, when prescribing proton pump inhibitors, health care professionals should consider whether a lower dose or shorter duration of therapy would adequately treat the patient's condition."
The prescription drugs pull in about $14 billion in U.S. sales each year, and many are prescribed for indigestion and heart burn, although with the exception of Prilosec, they are only approved for treatment of ulcers, acid reflux disease and erosive esophagitis. There were about 119 million prescriptions for proton pump inhibitors in the U.S. last year. Some medical experts estimate that as many as 69% of proton pump inhibitor prescriptions were written for "off-label" uses, which have not been approved as safe and effective by the FDA.