Navigation Links
Bone Drugs Linked to Rare Fractures, FDA Warns
Date:10/13/2010

By Steven Reinberg
HealthDay Reporter

WEDNESDAY, Oct. 13 (HealthDay News) -- People taking drugs called bisphosphonates, such as Fosamax and Boniva, to prevent or treat osteoporosis may be at risk for a rare type of fracture of the thigh bone, U.S. health officials warned Wednesday.

Bisphosphonates work by inhibiting bone loss and have been shown to prevent fractures due to osteoporosis. Whether bisphosphonates are the cause of these rare thigh fractures isn't clear, but they have predominantly been reported in patients taking these drugs, according to the U.S. Food and Drug Administration (FDA).

"FDA is warning again about the possible risk of an uncommon form of fracture in patients who take bisphosphonates to treat or prevent osteoporosis," Rear Admiral Sandra Kweder, M.D., deputy director of CDC's Office of New Drugs, Center for Drug Evaluation and Research, said during an afternoon press conference Wednesday.

The warning will take the form of a label change and a medication guide that patients will receive with their prescription, she said.

One of the unusual features of these atypical thigh fractures, also called atypical femur fractures, is that they are often associated with little or no trauma, Kweder said.

"Patients taking bisphosphonates who have experienced an atypical fracture are younger than patients experiencing typical osteoporotic fractures," she said. "In some cases people have fractures of both femurs."

Such fractures occur in the bone just below the hip joint or in the long part of the thigh bone. Over half of the patients who have had these fractures said they had dull aching thigh or groin pain that started weeks or months before there was a complete fracture, Kweder said.

The optimal length of time to take bisphosphonates isn't known, but FDA officials think these fractures may be related to using these drugs for more than five years, Kweder said.

Last year more than 5 million prescriptions for bisphosphonates were filled in the United States, she noted.

The labeling changes will affect all bisphosphonates approved for osteoporosis, including oral bisphosphonates such as Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia, and generics and injectable bisphosphonates such as Reclast and Boniva.

However, labeling changes will not apply to bisphosphonates used for Paget's disease or cancer/hypercalcemia such as Didronel, Zometa, Skelid, and their generic versions, the agency said.

This warning comes after the agency announced in March that there was an ongoing safety review of bisphosphonates and their association with atypical femur fractures.

Since then, the FDA has reviewed all available information on this connection, including 310 cases of atypical thigh fractures. In that review, 94 percent of the patients had taken bisphosphonates, and most had been on the drugs for five years or more.

However, these fractures are so unusual that they make up less than 1 percent of all hip and thigh fractures.

Based on that review, the agency is changing the Warnings and Precautions label section of all bisphosphonate products for osteoporosis and requiring a medication guide that will caution patients of the possible increased risk of fracture.

The agency also recommends that doctors and other health care professionals be aware of the potential risk in patients taking these drugs and consider re-evaluating the need for continued use of these drugs for patients who have been taking them for more than five years.

The agency also recommends that physicians discontinue bisphosphonates if patients develop a femoral shaft fracture.

For patients currently taking bisphosphonates for osteoporosis, the FDA recommends not discontinuing them without talking to their doctor.

In addition, patients taking bisphosphonates should report any new thigh or groin pain to their doctor and be evaluated for a possible thigh fracture, the FDA advises.

More information

For more information on osteoporosis, visit the U.S. National Library of Medicine.

SOURCES: Oct. 13, 2010, teleconference with: RADM Sandra Kweder, M.D., deputy director, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Sexual issues a major concern for cancer patients taking new targeted drugs
2. Cancer-Fighting Bone Drugs Might Raise Stroke Risk
3. Taking Blood Pressure Drugs at Bedtime May Boost Effectiveness
4. Study details structure of potential target for HIV and cancer drugs
5. Heartburn Drugs, Plavix Seem Safe to Take Together
6. Better cholesterol drugs may follow Saint Louis University researchers breakthrough
7. Researchers find no difference in drugs for macular degeneration
8. Money, drugs and chicken feet? What consumers will do for social acceptance
9. Anemia Drugs Could Pose Threat to Some Kidney Patients
10. Expert Panel Links Popular Bone Drugs to Rare Fracture
11. Long-Term Use of Bone Drugs May Be Linked to Esophageal Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Bone Drugs Linked to Rare Fractures, FDA Warns
(Date:2/11/2016)... ... , ... Husted Kicking has completed its Third Annual Husted Kicking ... 7th, 2016 according to kicking coach Michael Husted. , “This event serves as an ... in Indianapolis,” says Husted. “The NFL uses a third party organization to select players ...
(Date:2/10/2016)... ... 2016 , ... President Obama’s budget proposal yesterday enables the ... services via telehealth, estimated to generate more than $160 million in savings over ... years. Although there is more to be done, this represents an important ...
(Date:2/10/2016)... ... February 10, 2016 , ... ... health care communications company offering education, research and medical media, has launched ... specialists working in infectious diseases. , As the all-inclusive resource for infectious ...
(Date:2/10/2016)... NASHVILLE, Tenn. (PRWEB) , ... February 10, 2016 ... ... by the American Academy of Emergency Medicine , an emergency medicine ... of practice management services . , The American Academy of Emergency Medicine, ...
(Date:2/10/2016)... , ... February 10, 2016 , ... ... announces that his office is now offering a variety of comprehensive procedures for ... enhancement, eyebrow lift, facial volume restoration, lip enhancement and nasal reshaping. , ...
Breaking Medicine News(10 mins):
(Date:2/10/2016)... Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA ... fourth quarter and full year ended December 31, 2015. ... was a transformational year for Vanda with the continued ... market approval of HETLIOZ for Non-24," said Mihael H. ... Fanapt to our U.S. product portfolio builds on this ...
(Date:2/10/2016)... -- --> --> ... Spectroscopy Market by Industry (Oil & Gas, Petrochemical, Pharmaceutical, Water ... & Mining, and Others), And Geography - Global Forecast ... expected to grow to USD 3.9 Billion by 2020, ... 2020. Browse 82 market data Tables and ...
(Date:2/10/2016)... Feb. 10, 2016  Resolve Therapeutics, LLC, a ... approaches to the treatment of lupus and Sjogrens ... multiple ascending dose study in patients with systemic ... --> --> ... ascending dose study of RSLV-132 in 32 subjects ...
Breaking Medicine Technology: