Key words       "Have good reason."

"They often are used without a clear or justified indication for the
treatment."

Bill
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Study Links Heartburn Drugs, Broken Hip

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By CARLA K. JOHNSON Associated Press Writer

December 26,2006 | CHICAGO -- Taking such popular heartburn drugs as
Nexium, Prevacid or Prilosec for a year or more can raise the risk of a
broken hip markedly in people over 50, a large study in Britain found.

The study raises questions about the safety of some of the most widely
used and heavily promoted prescription drugs on the market, taken by
millions of people.

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.

Hip fractures in the elderly often lead to life-threatening
complications. As a result, doctors should make sure patients have good
reason to stay on heartburn drugs long term, said study co-author Dr.
Yu-Xiao Yang of the University of Pennsylvania School of Medicine.

"The general perception is they are relatively harmless," Yang said.
"They often are used without a clear or justified indication for the
treatment."

Some people find relief from heartburn with over-the-counter antacids
such as Tums, Rolaids and Maalox. But for others, those medicines do not
work well. Moreover, heartburn can be more than a source of discomfort.
People with chronic heartburn can develop painful ulcers in the
esophagus, and in rare cases, some can end up with damage that can lead
to esophageal cancer.

Dr. Sandra Dial of McGill University in Montreal, who was not involved
in the study but has done similar research, said patients should discuss
the risks and benefits with their doctors and taper off their use of
these medicines if they can.

Nexium, Prevacid and Prilosec are members of a class of drugs known as
proton pump inhibitors. The study found a similar but smaller risk of
hip fractures for another class of acid-fighting drugs called H2
blockers. Those drugs include Tagamet and Pepcid.

The study, published in Wednesday's Journal of the American Medical
Association, looked at medical records of more than 145,000 patients in
England, where a large electronic database of records is available for
research. 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 biggest risk was seen in people who took high doses of the drugs for
more than a year. That group had a 2 1/2 times greater risk of hip
fractures than nonusers.

Yang said that for every 1,262 elderly patients treated with the drugs
for more than a year, there would be one additional hip fracture a year
attributable to the drugs. For every 336 elderly patients treated for
more than a year with high doses, there would be one extra hip fracture
a year attributable to the drugs.

Dr. Doug Levine of AstraZeneca PLC, which makes Nexium and Prilosec,
said the study does not prove that proton pump inhibitors cause hip
fractures. It merely suggests a potential association, he said. Doctors
need to monitor their patients for proper dosage and watch how long they
take the drugs, Levine said.

Julia Ellwanger, a spokeswoman for TAP Pharmaceutical Products Inc.,
which markets Prevacid, said proton pump inhibitors' safety has been
well-established by rigorous studies, and the new study does not prove
or disprove a connection to hip fractures.

Dr. Alan Buchman of Northwestern University, who was not involved in the
research, said the study should not change medical practice, since
doctors already should be monitoring the bone density of elderly people
taking the drugs and recommending calcium-rich diets to all patients.

"Most people are not taking enough calcium to start with," he said. He
also wondered if a similar result would have been found in a sunny
climate, because vitamin D from sunshine helps with calcium absorption.

Also, Buchman said it not known whether the acid-fighting drugs prevent
esophageal cancer. He said the risk of esophageal cancer has been
exaggerated in the marketing of these drugs.

"I think the risk has been overplayed and scared the community," Buchman
said.

Heartburn medicines are heavily are advertised in "Ask your doctor about
..." commercials in this country, particularly during the evening news.

Nexium is the third biggest selling drug in the world, behind the
cholesterol medicine Lipitor and blood thinner Plavix, with global sales
totaling $5.7 billion last year, according to IMS Health, which tracks
drug sales.

Yang and his co-authors disclosed in the paper that they have worked as
consultants and received speaking fees from companies making
acid-fighting drugs. The study was funded by the National Institutes of
Health and the American Gastroenterological Association/GlaxoSmithKline
Glaxo Institute for Digestive Health.

Men in the study had a higher drug-associated risk of hip fracture than
women, possibly because women may be more aware of osteoporosis and may
get more calcium in their diets, Yang said. He plans more research on
whether calcium-rich diets or calcium supplements can prevent the
problem.

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