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:5/9/2017)... , May 9, 2017 Zimmer Biomet Holdings, ... musculoskeletal healthcare, today announced it has earned a spot ... 2017" list. The Company was ranked among 500 U.S. ... Employers and Healthcare Equipment and Services. The ... on an anonymous, independent survey of over 30,000 employees ...
(Date:5/8/2017)... 2017 MACRA replaces the outdated sustainable ... service reimbursement. Black Book Research crowdsource-surveyed 8,845 physician practices ... The Market for MIPS Compliance Technology is Booming ... with 3 or more clinicians seek to buy Merit-Based ... the magnitude of the changes, the hunt is on ...
(Date:5/6/2017)... N.Y. , May 5, 2017  Hill-Rom Holdings, ... will add approximately 100,000 square feet to its Welch ... September 2016 its commitment to bring more than 100 ... , where Welch Allyn has maintained a significant presence ... help accommodate these new positions, a large portion of ...
Breaking Medicine Technology:
(Date:5/24/2017)... ... May 24, 2017 , ... Dr. Alan I. Benvenisty, ... in New York City. He is known for his distinguished expertise and experience in ... Dr. Benvenisty holds sub-specialty training in treating renovascular disease and aortic aneurysm . ...
(Date:5/24/2017)... ... May 24, 2017 , ... ... in Bayside, NY, who have now spent 10 years as clinical instructors for ... University (NYU) College of Dentistry. Through the program, private practitioners receive cutting-edge clinical ...
(Date:5/24/2017)... ... May 24, 2017 , ... STATEMENT OPPOSING PRESIDENT ... opposed to Donald Trump’s budget, “A New Foundation for American Greatness—President's Budget FY ... the poor, marginalizes underserved populations, undermines productivity, and destroys the social safety net ...
(Date:5/24/2017)... ... May 24, 2017 , ... ... female reproductive tract in which the endometrial lining of the uterus spreads ... and pain. Patients experiencing painful intercourse, painful periods, pelvic pain, or irregular ...
(Date:5/24/2017)... California (PRWEB) , ... May 24, 2017 , ... If you are thinking of a ... are interested in business architecture, October is the perfect time to visit. , Business Architecture ... an à la carte offering for individuals, as a 4-½ day package for individuals, and ...
Breaking Medicine News(10 mins):