FDA warns of fractures with osteoporosis drugs

Oct 13, 2010 By MATTHEW PERRONE , AP Business Writer

(AP) -- Government health officials warned doctors and patients Wednesday about an increased risk of thigh fractures with a widely used group of bone-strengthening drugs.

The said patients taking bisphosphonate drugs such as Fosamax and Boniva appear more likely to suffer a rare type of fracture of the femur. The fractures occurred just below the hip joint and make up less than 1 percent of all femur fractures.

"We know from clinical trials that these drugs do prevent the common osteoporosis fractures," said Dr. Sandra Kweder, FDA's deputy director for new drugs. "The fractures we're talking about today are very unusual and rare."

In more than half the cases reported to the FDA, patients experienced pain or aching of the groin before the fracture.

It's unclear whether the drugs directly trigger the problem, but the FDA said it is updating the drugs' labels about the potential risk.

work by slowing the loss of that lead to . in that class include Merck & Co.'s Fosamax and Roche's Boniva, as well as Procter & Gamble Co.'s Actonel, Warner Chilcott's Atelvia and Novartis' Reclast.

More than 5 million prescriptions for the drugs were written last year, according to the FDA. The drug is mainly prescribed to women after menopause.

The FDA says patients should continue taking the treatments unless directed to stop by their doctor.

The fractures were publicized in a report last month from the American Society of Bone and Mineral Research, which suggests several explanations for the fractures. One is that the slowdown in cell turnover seen with bisphosphonates could lead to weaker bones in some cases.

The FDA said the fractures "may be related to the use of bisphosphonates for longer than five years." In reviewing reports of , FDA officials said they found patients who had been taking the drugs up to 15 years.

There are no guidelines for how long patients should take the drugs.

Explore further: FDA approves vaccine to block meningitis strain (Update)

5 /5 (1 vote)
add to favorites email to friend print save as pdf

Related Stories

Popular osteoporosis drugs triple risk of bone necrosis

Jan 15, 2008

A University of British Columbia and Vancouver Coastal Health Research Institute study has found that a popular class of osteoporosis drugs nearly triples the risk of developing bone necrosis, a condition that can lead to ...

Once-a-year drug reduces fractures from osteoporosis

May 02, 2007

A treatment for osteoporosis delivered once a year is as effective as current monthly or weekly osteoporosis regimens at reducing the incidence of bone fractures, according to a new study led by a UCSF research team.

Recommended for you

A new tool in drug overdose prevention

12 hours ago

The Center for Disease Control reported earlier this month that the heroin overdose death rate across 28 states it surveyed doubled between 2010 and 2012. This sharp increase and the chilling statistics that say more than 11 ...

Nasal spray treats heroin overdose

Oct 28, 2014

"Every year, drug overdoses are responsible for roughly 1000 ambulance calls in Oslo," says Arne Skulberg, an anaesthesiologist, a PhD candidate at NTNU and the 2014 winner of Norway's Researcher Grand Prix ...

User comments : 0

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.