Navigation Links
Victims of Abnormal Bone Fractures Await Action as FDA Lingers on Edge of Tightening Fosamax Regulations
Date:2/23/2012

NEW YORK, Feb. 23, 2012 /PRNewswire/ -- Doctors and other healthcare professionals have grown increasingly concerned about the regulation paradigm the Food & Drug Administration is taking with regard to Fosamax - a widely used osteoporosis drug, as evidence of its link to abnormal bone fractures.

The FDA has so far resisted adding labeling requirements to Fosamax's packaging that would warn against prolonged use. Such labels are necessary in light of the dangers long-term use of the drug poses to patients with already weak bones, according to leading medical experts.

Multiple clinical studies have linked Fosamax and femur fractures. The drug, which is supposed to strengthen bones by inhibiting a process called resorption, may actually lead to the severe, irregular fractures some patients have reported.

Dozens of women have reported experiencing these Fosamax femur fractures in accidents where they experienced very minimal impacts, the jolt of walking down steps or a bumpy car ride in some cases being enough to cause severe transverse femur fractures. 

An FDA panel convened in September to discuss heightening regulations on the drug, but no action has been taken since.

According to Merck, the drug's manufacturer, Fosamax underwent the customary clinical trials that demonstrate a product's safety for use. These trials lasted for only three to five years, however, while many patients who suffered these unique Fosamax bone fractures had taken the drug for six years or more.

The lawyers of thousands of patients who suffered Fosamax femur fractures say that the lack of labeling regarding this five-year window is central to their clients' Fosamax lawsuits. According to legal experts, drug companies like Merck have a duty to warn patients about the risks their products pose.

Standard Fosamax labeling does not contraindicate use of the drug beyond any particular number of years.

One option that some healthcare professionals have recommended to the FDA is requiring "drug holidays," periods of time away from a drug to lower the risk of side effects.

However, the FDA has not implemented any such precautions. No upcoming action regarding Fosamax labeling has been announced by the agency.

Meanwhile thousands of patients already harmed by the drug continue to file Fosamax lawsuits against Merck.

Contact:
Weitz & Luxenberg P.C.
Bert Phillips, 1-212-558-5840

This press release was issued through eReleases(R).  For more information, visit eReleases Press Release Distribution at http://www.ereleases.com.

 


'/>"/>
SOURCE Weitz & Luxenberg P.C.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Philips Launches HeartStart FR3 Automated External Defibrillator for Professional Responders Treating Victims of Sudden Cardiac Arrest
2. Sanofi Pasteur Donates Tdap Vaccine to Aid Storm Victims
3. Amgen Donates $1 Million to Help Japanese Disaster Victims
4. Sutter Health Network Donates $150,000 to Aid Victims of San Bruno Fire
5. Heritage Provider Network, Dr. Richard Merkin, Comes to the Aid of Chilean Earthquake Victims
6. PointCare Donates Diagnostic Tests to Haitian Clinics to Ensure Resumption of Critical HIV/AIDS Patient Care and Bolster Emergency Medical Treatment for Earthquake Victims
7. First Choice ER to Donate Over $15,000 in Medical Supplies to Haitian Earthquake Victims
8. Medco Partners with AmeriCares to Rush Donated Medicines to Help Victims of the Haiti Earthquake
9. FDA Approves Xarelto to Prevent Stroke in People With Common Type of Abnormal Heart Rhythm
10. ProUroCare Medical Completes Multiple Site Clinical Study for Imaging Prostate Abnormalities
11. Blood Testing Identifies Abnormal Cells Up to Six Years Prior to Leukemia Diagnosis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/23/2016)... ALBANY, New York , May 23, 2016 /PRNewswire/ ... new market report titled, " Exocrine Pancreatic Insufficiency Market ... Forecast 2013 - 2023 ." According to the report, ... at a CAGR of 8.3% from 2015 to 2023 ... pancreatic insufficiency (EPI) is a condition characterized by the ...
(Date:5/23/2016)... May 23, 2016 Clarifying Vision ... and Monitoring, and Vision Care What can ... are going to grow at the fastest rates? This ... 2026, assessing data, trends, opportunities and prospects. ... graphs. Discover the most lucrative areas in the industry ...
(Date:5/23/2016)... JERUSALEM , May 23, 2016 ... DNA for detection of multiple diseases; ,Technology to be ... Yissum Research Development Company of the ... entered into a research agreement with Aurum Ventures MKI, the ... the development of a new diagnostic approach for early ...
Breaking Medicine Technology:
(Date:5/25/2016)... ... May 25, 2016 , ... The World Molecular Imaging ... Molecular Imaging.” The focus of ADDMI-IG will be geared towards how using molecular ... issues. Through ADDMI-IG WMIS will provide a platform for productive discussions about the ...
(Date:5/25/2016)... ... 2016 , ... DKT International, one of the largest private ... to release their 2015 global impact data. In 2015, DKT served over 30 ... and 3.8 million unsafe abortions across 21 countries worldwide. , “We are ...
(Date:5/25/2016)... (PRWEB) , ... May 25, 2016 , ... ... solutions to industries ranging from medical and pharmaceutical, to food and HVAC facilities. ... well as on-site training. , For medical applications, Afrimesure offers a variety ...
(Date:5/25/2016)... ... , ... Casa Velas, an adults-only boutique hotel in Puerto Vallarta, Mexico, introduces ... wellness suites . The two 1,350 sq. ft. suites which debuted in late ... insuite amenities, from a custom soap selection and in-suite exercise kit to a personal ...
(Date:5/25/2016)... CA (PRWEB) , ... May 25, 2016 , ... The ... of Nursing and Health Professions. She will lead a team of more than 100 ... Baker will begin her role as dean in late August. , Baker comes to ...
Breaking Medicine News(10 mins):