BOSTON(AP)
Two research reports suggest a possible link between two
bone-building drugs and irregular heart rhythms in a small number
of women who take the medicine.
The signs of a problem were more pronounced with Reclast, a drug
made by Novartis AG and given through a once-a-year, 15-minute
intravenous infusion. But there was a hint of similar trouble in a
few women who took the leading osteoporosis pill, Fosamax by Merck
& Co. The two drugs are in the same class.
The safety question caught researchers by surprise. While
uncertain how big a worry it might be, they agreed the overall risk
is small. Specialists said women at high risk for bone breaks _ the
main target of these osteoporosis drugs _ should keep taking them
as prescribed.
But several experts said they'd be cautious about those who
also are at risk for a condition called atrial fibrillation, an
irregular heart rhythm that can cause strokes.
The two separate reports published Thursday in The New England
Journal of Medicine point to elevated rates of serious episodes of
that heart condition in women who took Reclast and Fosamax.
"For the first time, there may be a side effect," said
a researcher involved in both studies, Dr. Steven Cummings of
California Pacific Medical Center Research Institute. Until now,
people have assumed Fosamax "was completely safe and could be
given to almost anybody."
Fosamax, the Merck brand name for alendronate, is now used by an
estimated 1.8 million American women. In a letter to the medical
journal, Cummings reported evidence of the heart problem found in a
recent review of a 1997 Merck-sponsored study of postmenopausal
women on Fosamax.
There appeared to be 50 percent more risk of the serious heart
rhythm in women who took the daily pill than among those who
didn't take it. About half of the 6,459 women took Fosamax, and
47 developed atrial fibrillation, compared to just 31 cases among
the other women.
However, the finding, while not statistically definitive for
Fosamax, worried some researchers because it is in line with the
results of a new study published in the same issue of the medical
journal.
This study of 7,736 postmenopausal women with bone-thinning
osteoporosis focuses on Reclast. Novartis recently won approval to
sell Reclast, known generically as zoledronic acid, for Paget's
disease, another bone condition. The company hopes to get an OK
later this year to sell it for osteoporosis use.
The new study, funded by Novartis, shows that Reclast works at
least as well as existing drugs in the same class, researchers say.
However, the risk of a serious case of irregular heart rhythm was
more than double that in the other patients _ 50 cases in the
drug-taking half, compared to 20 cases in the others.
Researchers cautioned about overestimating the importance of the
heart rhythm problem. The Reclast study showed little apparent
difference in overall cardiac deaths and the overall risk of the
rhythm condition remained small.
Doctors made available by Merck and Novartis said the side
effect could be a statistical fluke or just a product of aging.
They said earlier studies showed no sign of the possible side
effect.
For now, it's unknown if the possible risk applies to other
drugs in the class known as biphosphonates. Future studies are
expected to help clarify the risk.
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