Earlier this month, a closely-watched trial over the osteoporosis drug Fosamax ended in mistrial, to the frustration of nearly everyone involved. The trial was marked by great tension, with a deadlocked jury, reports of threats of physical violence, and a judge-ordered cooling-down period.
What could cause such intense drama? Well, this was just one of approximately 900 state and federal cases pending against Fosamax, alleging that that medication causes osteonecrosis of the jaw (the death of jawbone tissue). In large part, the tension in the Manhattan courtroom was that this trial “the first” was supposed to be an indicator of how these hundreds of similar cases might proceed. The other major factor is that it is notoriously difficult to “prove” drug-related injuries, and this difficulty was definitely shown in the frustration and tension among jury members.
Millions of women have taken Fosamax (alendronate), a Merck drug that was approved in 1995 to treat osteoporosis associated with menopause, and in 1997 to prevent osteoporosis itself. Until the recent introduction of some competing medications, it was one of the most popular drugs in the U.S. It is still prescribed millions of times per year to women suffering from bone loss.
In short, Merck’s defense on this topic is that there is no definitive evidence that Fosamax causes the death of jaw tissue, while plaintiffs and their lawyers insist that Merck overpromoted Fosamax without warning doctors about the potential for jaw injury. Obviously, no conclusions were reached.
Of course, this is of great interest to women who may have taken, or are considering taking, Fosamax. Only your doctor can decide what is the right choice for you, but we thought we would enumerate the other medications available for treating osteoporosis for those doing research on Fosamax alternatives. One very important thing to be aware of it is that Fosamax is not the only osteoporosis drug in this class (the bisphosphonates), which all have a similar mode of action. Fosamax is being talked about most in the media, but all are associated with some amount of risk of damaging the jaw.
If you do choose to take a bisphophonate, know these facts:
- A high proportion of jaw injuries occur following high-dose intravenous administration, so that is a particularly risky way to take the medication.
- As many as 60% of the cases are preceded by a dental surgical procedure involving the jaw. In short, women who are expecting major dental work should consider delaying treatment with Fosamax, Boniva, Actonel or similar drugs until after their dental surgery.
Here are the main alternatives on the market for Fosamax:
- Actonel (risedronate) is a bisphosphonate manufactured and marketed by Procter & Gamble and Sanofi-Aventis. It belongs to the same family of drugs as Fosamax, and may be associated with the same jaw side effects.
- Boniva (ibandronate) is also a bisphosphonate, manufactured and marketed by GlaxoSmithKline and Roche Laboratories. It is a competitor to Fosamax, and may also affect the jaw tissue.
- Evista (raloxifene) is NOT a bisphosphonate , but rather an oral selective estrogen receptor modulator from Eli Lilly and Company that affects bones through estrogen. Evista may be an interesting alternative for women concerned about their jaw health or planning oral surgery.
Also this month, The Wall Street Journal published an article called “From the Osteoporosis Front, Updates on Potential New Drugs“. These are the up-and-comers in clinical trials and going before the FDA. The story covers the latest news about Wyeth’s Viviant, Pfizer’s Fablyn, Amgen’s denosumab, and other upcoming treatments for osteoporosis.
If you are interested in following the Fosamax case that ended in a mistrial, it is expected to be re-tried in the spring. The name of the case is “In re Fosamax Products Liability Litigation, U.S. District Court, Southern District of New York (Manhattan), No. 06-1789.”200