WASHINGTON, DC – US Food and Drug Administration (FDA) officials warned osteoporosis patients Wednesday that a popular class of osteoporosis drugs known as biophosphonates may increase the risk of a rare type of thigh fracture. According to the FDA, over 5 million people filled prescriptions last year for biophosphonates, the most popular of which include Fosamax (made by Merck), Boniva (Roche), Reclast (Novartis), and Actonel (Warner Chilcott). Fosamax has already been linked to osteonecrosis of the jaw (ONJ), along with other biophosphonates, prompting Fosamax lawsuits over ONJ.
Biophosphonates are a “mainstay of osteoporosis management,” according to Deputy Director Dr. Sandra Kweder of the FDA’s Office of New Drugs, who also advised patients not to be “fearful of their medicine.” The drugs are still considered effective in helping to prevent the wrist, hip, and spine fractures common among osteoporosis patients. Of course, no medicine can completely eliminate the risk of broken bones for those with osteoporosis, a progressive disease that causes the loss of bone mass and is most common in postmenopausal women.
Biophosphonate (Fosamax) Prescription Drug Injury
The type of prescription drug injury warned about by the FDA is quite rare, accounting for less than 1% of hip and femur fractures, which the FDA does not consider serious enough to merit a full defective drug recall. However, this warning—issued along with a requirement that biophosphonates be dispensed with an explanation of their risks—is important for osteoporosis patients because the type of femur fracture involved can possibly be prevented. Most patients who suffered the thigh fracture complained of aches and dull pains in the area for months before the fracture occurred, often without a specific injury or trauma involved. The FDA urged anyone taking biophosphonates like Fosamax and Boniva who experiences thigh aches and pains to contact their doctor to attempt to prevent the thigh fracture.
The National Osteoporosis Foundation believes there is not significant evidence that biophosphonates continue to be effective after 5-7 years of treatment and believes thigh fracture rates may be increasing after the drugs stop working. If the biophosphonate prescription drug injuries may be occurring when taking the drugs is no longer necessary, doctors who prescribe biophosphonates for patients who are not benefitting from the drugs may potentially be vulnerable to medical malpractice lawsuits in Alabama and other states.
If you or a loved one has suffered an unexplained thigh fracture after taking Fosamax, Boniva, or another osteoporosis drug in the Mobile, Alabama area, please contact the prescription drug injury attorneys of Long & Long to find out you may be eligible for defective drug injury compensation.