Free Newsletter
FEATURES >> The most interesting logos in Pharma
FDA reviewing bone meds' fracture risk
In the wake of two new studies suggesting a link between bisphosphonates and a certain type of bone breakage, the FDA says it's in the midst of reviewing the drugs' safety. So far, the agency hasn't found "a clear connection" between the meds--including Merck's Fosamax; Sanofi-Aventis and Procter & Gamble's Actonel; and Roche and GlaxoSmithKline's Boniva--and the risk of subtrochanteric femur fractures.
The agency says it requested data from drugmakers in 2008 after reports of femur fractures in women using bisphosphonates. The update on this review comes after researchers presented two studies at the American Academy of Orthopaedic Surgeons' annual confab, one of which showed that prolonged therapy with the drugs may create bone that's more susceptible to fractures. The other showed that bone tissue among bisphosphonate patients was less heterogeneous than among women not using the drugs, which might affect bone quality.
Though the data it has reviewed hasn't turned up a clear link, the FDA says it's going to continue reviewing Fosamax and its ilk, seeking help from outside experts. In the meantime, it advises patients to stay on the meds, but to alert their doctors if they get new pain in the hip or thigh.
- see the FDA announcement
- read the Wall Street Journal story
- get more from Reuters
Related Articles:
Study: Bisphosphonates may cut breast cancer risk
Bisphosphonates may weaken bones
Comments
I took Boniva for approx. three years. May I suggest you go to ask a patient.com to view testimony of the consequences as well as many other users of this product and Fosomax.
The Fosamax (Alendronate) study done for FDA approval failed to show any benefit for the majority of the worried well, which is the osteopenia group defined as T score greater than -2.5. This Osteopenia Group actually had higher fracture rates than placebo. This was published by Cummings in JAMA in 1998.
Bisphosphonate drugs like Fosamax have severe adverse side effects of jaw necrosis (OJN), spontaneous mid-femur fracture, heart rhythm disturbances, and severe bone and joint pain.
The spontaneous mid femur fractures are especially troubling, since these are spontaneous fractures without any trauma. Subtrochanteric fractures are pathological fractures, indicating the underlying bone matrix is abnormal. This anormal weakening and brittleness is directly caused by the bisphosphonate drug.
Bottom Line: These are BAD drugs that actually make the bones weaker not stronger, and they should be banned by the FDA . However, knowing the FDA which is in the pocket of the drug companies, no action will be taken until many more women victims suffer from these drugs, and many more cases work their way through drug litigation court.
For More: http://www.drdach.com/Fosamax_Fractures.html
jeffrey dach md
Post new comment
Paid Research Reports
- Cloud Computing Adoption In The APAC Life Sciences Industry
- Pharmaceutical Licensing Overview
- Stakeholder Opinions: Vaccines in emerging markets (Latin America) - Opportunities in Brazil, Mexico and Argentina
- Pharmaceutical Key Trends 2010
- Commercial Insight: Top 20 Oncology Therapy Brands in Australia
- The Specialty Pharma Market Outlook: Key players, new company growth models and emerging opportunities
SHARE
WITH: