The FDA will convene two advisory panels this week to determine the long-term risks of so-called “bone drugs” like Fosamax, Boniva, and Actonel. This drug family, called “biophosphonates,” is often used to treat osteoporosis and pre-osteoporosis conditions in women. However, recent studies have shown increased risk of certain bone-related complications in women taking these drugs, prompting medical experts to suggest the possibility of women taking a “drug holiday” during their therapeutic treatment. Such a holiday might allow serum drug levels to diminish to safer ranges and possibly stave off or eliminate entirely the risk of bone defects.
The advisory boards will consider evidence gathered by research teams and other organizations and try to determine if the drugs are safe for use beyond the currently established three to five year window currently adhered to. Exploration from a medical and scientific standpoint is needed to complement the anecdotal evidence being gathered by law firms who handle drug cases like this.
“Our law firm has been investigating Fosamax side effect claims since 2004 and unfortunately for our clients, this meeting has come a little too late.”
That was attorney David Ennis. Many attorneys and law firms specialize in representing people who have taken medications to cure an ailment and have actually been afflicted with even worse consequences due to drug interactions, unsafe processing of the drug, insufficient testing, or a number of other reasons. Some of these issues, if they affect a large enough number of drug units, can result in a drug recall. Enough affected victims can band together into a class-action lawsuit and seek compensation on a larger scale. Support from a governmental body like the FDA would go a long way towards securing that kind of judgement (should one prove necessary).
Fosamax and other bone drugs came to market over 15 years ago. They’ve been used to treat postmenopausal osteoporosis and osteopenia, but have drawn attention for increased rates of osteonecrosis of the jaw (sometimes called “jaw death”) and also increased rates of broken femurs (the thigh bone). Any bone-related issue connected to a drug that is designed to remedy bone loss, etc. is a huge red flag, especially because postmenopausal women are already at increased risk of fractures and bone-related injuries.
One main reason why these issues may be coming to light now is the lack of prior long-term study. The drugs were initially approved with a three to five year window in mind, but according to Dr. Susan Ott, a bone specialist at the University of Washington:
“In my opinion, after five years, in most cases, it ought to be stopped. The longest anybody could have taken this drug is 15 years now. It’s an ongoing experiment, and there are a few million women in this country who are participating in it.”
According to her, there are no proven benefits and the possibility of increased health risks after more than five years. Sadly for many men and women affected in cases like this all over the country and the world, there is often not enough time to exhaustively study many drugs before they are released. The public at large become the test subjects, and by the time a drug recall is initialized, it can often be too late.
