Ennis & Ennis, P.A. Discusses FDA Staff Report
The FDA Staff Report for September 9, 2011 Advisory Committee Meeting Questions the Safety of Biphosphonate Drugs.
September 09, 2011 /24-7PressRelease/ -- While two U.S. Food and Drug Administration (FDA) advisory panels are scheduled to meet tomorrow to explore the benefits and risks associated with the use of Fosamax and other biphosphonate drugs, the FDA preliminarily released a staff report yesterday stating that most women who take the "bone-building" drugs can safely stop taking them after five years. Biphosphonate drugs include Fosamax, Actonel, Boniva and Reclast and are widely used to prevent hip and other bone fractures associated with osteoporosis. Ironically, though, these medications have also been linked to osteonecrosis of the jaw (death of the jaw bone) and atypical femur fractures (uncommon breaks of the thigh bone).
According to the FDA staff report, studies show the medications provide benefits in preventing osteoporosis fractures for the first three years of treatment, however there isn't any data indicating such benefits associated with taking the medication beyond five years. Furthermore, the data indicates that women who stop taking the medications after five years have similar levels of increased bone density and reduced fracture risk as those who continue taking them. So the FDA panels will consider whether some patients should take a "drug holiday" after using the medication for three to five years. This, too, will be subject to great debate because there is no substantial data available to make informed decisions regarding the initiation or duration of a drug holiday.
Merck, on the other hand, maintains, according to its Briefing Document, that a "drug holiday" may be considered after 5 years for patients who have previously received long-term treatment and are no longer considered to have a sufficiently high fracture risk. But this is a small group of patients compared to all of the users. So, Merck then reports that long-term treatment must be determined on a case-by-case basis. There is still a very large grey area due to lack of data. Attorney David Ennis reports "I'm hopeful that the FDA will come to a resolution with this issue and while it is too late for my clients, hopefully it will save many women from suffering these horrible injuries in the future."
Merck & Co., the manufacturer of Fosamax, has been the subject of hundreds of lawsuits alleging improper warning of these potential severe injuries, which may result from the taking of the medication.
Ennis & Ennis is offering free nationwide confidential consultations to all individuals that have used Fosamax by calling toll free at 1-800-856-6405 or by visiting http://www.ennislaw.com and completing an online case evaluation form.
Ennis & Ennis, P.A. is a nationwide law firm with offices in Ft. Lauderdale, Miami and Washington D.C. that concentrates its practice in mass torts and represents individuals against pharmaceutical companies as well as medical device makers. Ennis & Ennis, P.A. has been representing clients individually since 1986 and has recovered over $100 million in settlements for its clients.
Ennis & Ennis, P.A. is also investigating cases involving, Accutane, Actos, Avandia, Transvaginal Mesh Implants, Paxil, Zoloft, Prozac, Depuy Hip Recall, Zimmer Hip Recall, Yaz, Yasmin and Ocella Birth Control Pills.
Remember the law limits the time you can file a claim, so don't wait to explore your legal rights. Call toll free 1-800-856-6405 or visit http://www.ennislaw.com.
Media Contact:
Jami Angelini Haggerty
Ennis & Ennis, P.A.
(954) 543-4452
www.fosamax-lawyer.com
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