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:6/23/2016)... DUBLIN , June 23, 2016 ... "Global MEMS Devices Medical Market Analysis 2016 - Forecast to ... The report contains up to date financial ... reliable analysis. Assessment of major trends with potential impact on ... dive analysis of market segmentation which comprises of sub markets, ...
(Date:6/23/2016)... , June 23, 2016 Research ... Pharma News Issue 52" report to their offering. ... in influenza treatment creates a favourable commercial environment for MedImmune ... growing patient base that will serve to drive considerable growth ... vaccine would serve to cap sales considerably, but development is ...
(Date:6/23/2016)... , , , WHEN: ... , , , , LOCATION: , , , Online, with ... , EXPERT PANELISTS:  , , , Frost & Sullivan,s Global Vice ... Senior Industry Analyst, Divyaa Ravishankar and Unmesh Lal, Program Manager , ... industry is witnessing an exceptional era. Several new demand spaces, such ...
Breaking Medicine Technology:
(Date:6/25/2016)... FL (PRWEB) , ... June 25, 2016 , ... The temporary closing of Bruton Memorial ... Plant City Observer , brings up a new, often overlooked aspect of head lice: the ... closing for fumigation is not a common occurrence, but a necessary one in the event ...
(Date:6/25/2016)... , ... June 25, 2016 , ... First Choice ... States, named Dr. Sesan Ogunleye, as the Medical Director of its new Mesquite-Samuell Farm ... Medical Director of our new Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical ...
(Date:6/25/2016)... , ... June 25, 2016 , ... ... and non-athletes recover from injury. Recently, he has implemented orthobiologic procedures as a ... area —Johnson is one of the first doctors to perform the treatment. Orthobiologics ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits of moderation, ... the latter, setting the bar too high can result in disappointment, perhaps even self-loathing. ... toward their goal. , Research from PsychTests.com reveals that behind the ...
(Date:6/24/2016)... ... , ... Those who have experienced traumatic events may suffer from a complex ... as drug or alcohol abuse, as a coping mechanism. To avoid this pain and ... a traumatic event. , Trauma sufferers tend to feel a range of emotions, from ...
Breaking Medicine News(10 mins):