Regulators in the USA have issued a warning that proton pump inhibitors such as AstraZeneca’s Nexium and Pfizer’s Protonix can increase the risk of fractures if used for a year or more.

The US Food and Drug Administration has changed the labels on PPIs, to include the possible increased risk of fractures of the hip, wrist and spine with high doses or long-term use of the drugs. They are used to treat gastroesophageal reflux disease, stomach and small intestine ulcers, and inflammation of the esophagus, as well as over-the-counter treatments for frequent heartburn.

The FDA noted that drugs which will be affected by the label change include Protonix (pantoprazole), Nexium (esomeprazole) and AstraZeneca’s older treatment Prilosec (omeprazole), as well as Takeda’s Dexilant (dexlansoprazole) and Prevacid (lansoprazole), plus Johnson & Johnson’s Aciphex (rabeprazole).

Joyce Korvick, deputy director for safety at the FDA’s Division of Gastroenterology Products, said that “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”. She added that doctors should consider “whether a lower dose or shorter duration of therapy would adequately treat the patient's condition”.

PPIs are indeed big-sellers for young and old; earlier this week, according to a eport published by pharmacy benefit manager Medco, during 2001-9, the number of children on the drugs, which are also sometimes prescribed for colic in infants - increased 147%. IMS figures for 2009 showed that sales of PPIs fell 2% to $13.6 billion, but they became the second top-selling class of medications in the USA, moving ahead of lipid regulators and coming in behind antipsychotics.