subject: Fda Attaches New Warning About Fosamax [print this page] In October 2010, the FDA issued a safety announcement regarding the risk of atypical fractures of the thigh, known as subtrochanteric and diaphyseal femur fractures, in patients who take bisphosphonates for osteoporosis, warning patients to be alert of an dull or aching pain in their hip or thigh and advising healthcare professionals to be alert to the increased risk of uncommon femoral shaft fractures.
An FDA staff report noted that bisphosphonate drugs have no significant benefits beyond five years of use, which is the same period at which their risks increase dramatically, but the FDA advisory panels reviewing Fosamax have only recommended stronger warning labels, and have not recommended limiting Fosamax use to the first few years of treatment. Thus, Fosamax continues to be prescribed to patients who may actually be hurt, rather than helped, by the drug.
There have been some rare cases in where Fosamax has been known to cause a condition called osteonecrosis of the jaw. This is an often serious and possibly disfiguring, problem in which the bone of the jaw dies. Most of the time there there are symptoms (such as pain, infection, or loosening of the teeth), but sometimes there are no symptoms until a person notices exposed bone. This problem is most common when Fosamax is given by IV, but is still possible when the medication is taken orally.Patients who have had recent dental work such as tooth extractions seems to be at a higher risk.Good dental care of mouth and teeth combined with frequent dentist visits is advised for those patients at risk for ONJ.
There have been several reports of unusual broken thigh bones in people taking Fosamax. At this time no real link can be made to Fosamax since these fractures could be due to other medications or the osteoporosis. Many of these fractures were not caused by trauma or injury. Those who have unexplained groin or thigh pain, should see their doctor as soon as possible as these are sometimes signs of thigh fractures
Millions of people are prescribed Fosamax each year.During 2005 alone there were 22.5 million prescriptions for Fosamax, and each one could potentially cause harmful side effects to the patient it was prescribed to. Fosamax Litigation has also risen recently because of those affected by the side effects of the drug.
