The FDA gave us final word on its review of popular acid-reflux drugs: High doses or prolonged use may boost the risk of bone fractures, the agency says, advising doctors to consider lower doses and shorter-term therapy. According to the agency, the risks are greatest in patients older than 50.
"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," Dr. Joyce Korvick, an FDA deputy director for safety, says in a statement. "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 warning can't be good news to AstraZeneca (NYSE: AZN) (which makes Nexium), Pfizer (NYSE: PFE) (Protonix), or Takeda (Prevacid); these proton-pump inhibitor meds have been big sellers, especially the still-on-patent Nexium, which is the world's third-best-selling drug by revenue. (Protonix is still on-patent, too, but that's a more complicated story.) As a class, these drugs plus a few others accounted for $13.9 billion in sales last year, Bloomberg reports.
So what happens next? The drug's labeling will be revised to include the possibility of increased risk of fractures of the hip, wrist and spine. And we wait and see whether the possible risks affect sales.