Lawyers are working on class action lawsuits against the pharmaceutical companies selling Fosamax, Actonel, Boniva, Atelvia, and Reclast--and other versions, including generics, of these "bisphosphates."
(I found this FDA news release from Oct. 13, 2010.)
A lot of us have been alerting women for YEARS not to take these. My understanding is that they do an unnatural thing. To increase bone density, they stop dead bone cells from sloughing off the way nature designed them to do--the natural process. So the dead cells stay in there to increase bone density--certainly not the natural, healthy way to increase bone density. (Diane Petoskey, nutritionist, called this “mushy bones”. )
My business colleague was prescribed one of these products and instead of taking it, continued to take all the good SHAKLEE basics, and increased OsteoMatrix and exercise (to let the bone know the body is active and needs stronger bones). Her bone density increased in a short time, impressing the doctor.
FDA NEWS RELEASE
For Immediate Release: Oct. 13, 2010
Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA: Possible increased risk of thigh bone fracture with bisphosphonates
For Immediate Release: Oct. 13, 2010
Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA: Possible increased risk of thigh bone fracture with bisphosphonates
Labeling change adds warning about possible risks of long-term use of osteoporosis drugs
The U.S. Food and Drug Administration today warned patients and health care providers about the possible risk of atypical thigh bone (femoral) fracture in patients who take bisphosphonates, a class of drugs used to prevent and treat osteoporosis. A labeling change and Medication Guide will reflect this risk.
Bisphosphonates inhibit the loss of bone mass in people with osteoporosis. Bisphosphonates have been shown to reduce the rate of osteoporotic fractures -- fractures that can result in pain, hospitalization, and surgery-- in people with osteoporosis. While it is not clear whether bisphosphonates are the cause, atypical femur fractures, a rare but serious type of thigh bone fracture, have been predominantly reported in patients taking bisphosphonates. The optimal duration of bisphosphonate use for osteoporosis is unknown, and the FDA is highlighting this uncertainty because these fractures may be related to use of bisphosphonates for longer than five years.
The labeling changes and Medication Guide will affect only those bisphosphonates approved for osteoporosis, including oral bisphosphonates such as Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia, and their generic products, as well as injectable bisphosphonates such as Reclast and Boniva.
Labeling changes and the Medication Guide will not apply to bisphosphonates used for Paget’s disease or cancer/hypercalcemia such as Didronel, Zometa, Skelid, and their generic products.
“The FDA is continuing to evaluate data about the safety and effectiveness of bisphosphonates when used long-term for osteoporosis treatment,” said RADM Sandra Kweder, M.D., deputy director, Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. "In the interim, it’s important for patients and health care professionals to have all the safety information available when determining the best course of treatment for osteoporosis.”
Today’s warning follows a March 10, 2010, Drug Safety Communication announcing the FDA’s ongoing safety review of bisphosphonate use and the occurrence of atypical femur fractures. The FDA has since reviewed all available data on bisphosphonate use, including data summarized in the American Society for Bone Mineral Research Task Force report. The report recommended additional product labeling, better identification and tracking of patients experiencing these breaks, and more research to determine whether and how these drugs cause the serious but uncommon fractures.
Based on the FDA’s review, the Warnings and Precautions section of all bisphosphonate products for osteoporosis will be revised, and the FDA will require the inclusion of a Medication Guide to better inform patients of the possible increased fracture risk.
The FDA recommends that health care professionals be aware of the possible risk in patients taking bisphosphonates and consider periodic reevaluation of the need for continued bisphosphonate therapy for patients who have been on bisphosphonates for longer than five years.
Patients taking bisphosphonates for osteoporosis should not stop using their medication unless told to do so by their health care professional. Those taking bisphosphonates also should report any new thigh or groin pain to their health care provider and be evaluated for a possible femur fracture. Patients and health care professionals should report side effects with the use of bisphosphonates to the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling (800) 332-1088.
For more information:
FDA Drug Safety CommunicationConsumer Update: Possible Fracture Risk With Osteoporosis DrugsLetters to Sponsor/Applicants Requesting Labeling Changes
Fosamax lawsuit/side effects
Fosamax is Merck's $3 billion per year osteoporosis drug that's drawing fresh controversy with a court battle over an unusual side effect.
According to the Associated Press (AP), a lawsuit filed in Florida claims that Merck has been negligent by attempting to downplay one of the drug's side effects.
A New England Journal of Medicine report linked Fosamax (and other drugs in a class of pharmaceuticals known as bisphosphonates) with ocular inflammation. When untreated, this condition causes blurred vision, swelling and even blindness.
The Florida lawsuit highlights another unusual bisphosphonate side effect: osteonecrosis of the jaw; also known as "jaw necrosis" or "jaw death," prompted by a loss of blood supply to the jawbone. The suit has been filed on behalf of 250 Fosamax users who developed this condition.
The AP article notes that Merck representatives responded to the suit by stating that no cases of osteonecrosis of the jaw were reported among more than 17,000 subjects in clinical trials. Nevertheless, in January 2005 the FDA directed Merck to update the Fosamax label with a warning about the side effect. The company complied later in the year, but the lawsuit claims that the warning is not sufficient.
According to the Fosamax web site, other side effects include inflammation and ulceration of the esophagus, painful swallowing, stomach pain, indigestion and nausea.
Source: Health Sciences Institute, May 3, 2006
