How Dangerous are Fosamax, Actonel and other Bisphosphonates?

Recent media reports have indicated that a class of drugs that includes Fosamax and Actonel have been associated with osteonecrosis of the jaw (ONJ), also called “jaw death”. Patients are scared and lawyers and lining up to represent clients in a class-action lawsuit. Meanwhile, most serious researchers are calling “Hold on” and saying that the fear is quite overblown. This is an attempt to present some basic facts about bisphosphonates, particularly Fosamax, and osteonecrosis. I have no ties to drug companies, lawyers or patients. I have no opinion about the class-action lawsuit against Merck, maker of Fosamax. This appears to be a serious problem that warrants study, but that the hype is wildly overblown given the small number of cases of ONJ tied to Fosamax (most cases concern intravenous bisphosphonates like Zometa and Aredia). I have seen how a shattered hip can shatter a life in an elderly person. Persons who suffer from serious osteoporosis should consult with their physician before stopping treatment of any drug. Obviously, if you think you've suffered osteonecrosis of the jaw (ONJ) while on Fosamax, you may want to find a lawyer specializing in the Fosamax case. That's certainly your prerogative. However, and most importantly, I am not a physician or a lawyer, so this page is not meant to be medical or legal advice, just a quick assembly of facts and links that may help others sort out their questions regarding Fosamax in particular and bisphosphonates in general. If you know a good source of information to add to the list of sources, drop me a line at .

Fosamax questions and answers

What are bisphosphonates?

Bisphosphonates are used to prevent bone loss in cancer patients taking other drugs that would cause bones loss, to treat bone pain associated with cancer treatment, and to treat osteoporosis sufferers to help them maintain bone mass.

Which commercial drugs are involved?

The most common drugs are oral drugs used to treat osteoporosis in post-menopausal women. These drugs go by brand names like Fosamax, Actonel and Boniva and generic names like alendronate, ibandronate and risedronate.

Intravenous bisphosphonates taken intravenously in much higher doses to treat cancer patients include brand-name drugs such as Zometa and Aredia and go by generic names such as pamidronate and zoledronic acid (zolendronate).

What problems are associated with bisphosphonates?

There are a number of minor symptomatic problems associated with bisphosphonates, but the main fear concerns “osteonecrosis”, that is “bone death” of the jaw. Minor issues include stomach upset and discomfort in the digestive tract in general.

How dangerous are bisphosphonates? Is the lawsuit justified?

These are still open questions, though the Food and Drug Administration does require that bisphosphonate labeling make note of the link between the drugs and osteonecrosis. Current research (as of June 2006) shows that 94% of published cases, concern patients taking nitrogen-containing intravenous bisphosphonates to treat multiple myeloma and metastatic carcinoma to the skeleton. Furthermore, a full 60% of cases affect patients who had recently had dental surgery[1]. The actual risk to cancer patients taking the drugs appears to be relatively high: between one and ten percent of cancer patients taking intravenous bisphosphonates will have an incidence of osteonecrosis of the jaw. According to the New York Times, “Among people with osteoporosis, only 15 cases of the new ailment have been reported in the medical literature.” [2]

Drug companies have recognized the risk and Novartis started labeling their drugs even before the FDA required them to do so, but of course would like to see patients continue taking their drugs, believing that the benefits outweigh the risks. Most neutral researchers seem to believe that it is still too early to make a definitive determination, but many are skeptical of putting osteoporosis patients on bisphosphonates for the rest of their lives. At the same time, there are no good alternatives at present for cancer patients who, without bisphosphonates may face great pain and crippling bone loss.

As for the lawyers... As with so many such issues, the problem is likely being blown out of proportion with worried patients and lawyers lining up to sue the drug makers and would portray the drugs as highly dangerous. Many of these lawyers are playing fast and loose with the facts to make their class action lawsuit seem more worthy. Notably, they often say that over 1000 cases of “jaw death” due to bisphosphonates like Fosamax have been documented. However, as we have seen, the vast majority of these cases were due to high doses of intravenous bisphosphonates taken for cancer, not due to oral bisphosphonates like Fosamax taken in relatively low doses for osteoporosis. Again, I am not a physican or a doctor, but if it weren't for the huge money on the table, lawyers would probably behave more like scientists and wait for a bit more data before rushing in.  However, the nature of a class-action lawsuit is that clients typically receive relatively small settlements (like the 12 cents I received when my credit card company lost a class-action suit), but the lawyers who can line up thousands of clients rake in a nice sum.

Are there alternative treatments for osteoporosis?

For a brief and understandable rundown of treatment options for osteoporosis, see the Medications page of the National Osteoporosis Foundation.

When was the association between bisphosphonates and osteonecrosis noticed?

Novartis, maker of Zometa and Aredia says they got their first patient report in December 2002. In 2003, Dr. Robert Marx of the University of Miami reported in a letter to The Journal of Oral Maxillofacial Surgery of "a growing epidemic" of osteonecrosis and reported on 36 patients.[2]

What precautions should patients take?

It seems that the main issue is infection of the affected area. Therefore, it is important to treat any potential sites of infection before beginning a course of bisphosphonates. That means, for example, making sure that oral surgery patients are fully healed and risk of infection brought down to a very low level before beginning to take bisphosphonates, particularly nitrogen-containing intravenous bisphosphonates.

What are the symptoms of osteonecrosis in the jaw?

ONJ usually presents itself as a wound in the mouth, usually in the jaw (mandible), that exposes bone. Attempts to scrape the bone and fix the dead bone often make it worse.

What is the preferred treatment for osteonecrosis of the jaw?

According to the leading meta-study on the subject,“Conservative débridement of necrotic bone, pain control, infection management, use of antimicrobial oral rinses, and withdrawal of bisphosphonates are preferable to aggressive surgical measures for treating this condition.” [1

What is multiple myeloma?

Multiple myeloma is a cancer formed by malignant plasma cells. Normal plasma cells are an important component of the immune system, but sometimes these cells grow out of control and form tumors. When these tumors are spread throughout the bone marrow, it is referred to as multiple myeloma. Myeloma is difficult to detect early and typically first manifests itself as bone pain, low counts of red cells, white cells and platelets in the blood, nervous system problems (pain, numbness), kidney problems, high blood calcium, and infection (myeloma sufferers are 15 times more likely to get infections). [5,3]

Why are bisphosphonates used on myeloma patients?

Bisphosphonates treat the symptoms rather than the causes of myeloma. One serious side effect of myeloma is bone loss that can lead to fractures. Bisphosphonates slow this process.

What is metastatic carcinoma of the skeleton? Essentially, this just means a bone cancer that has spread from another organ, such as breast cancer that has spread to the bones. With respect to bisphosphonates, the reasons for using bisphosphonates and the associated risks are similar to that for myeloma.

What should be done?

This might seem a little off the topic, but first, whether affected or not, you should refuse to support any political candidate for national government who does not support a plan to get universal health care to those who need it. Many such suits that essentially cover the costs of treatment would simply go away if the costs of treatment were already covered. Beyond that, you should obviously see your doctor and consult with her before stopping treatment for osteoporosis. If you have suffered from osteonecrosis of the jaw, aka jaw death, caused by Actonel or Fosamax, you may also wish to consult a lawyer to help recoup some of your costs.

Sources and Links

  1. "Systematic Review: Bisphosphonates and Osteonecrosis of the Jaws," by Sook-Bin Woo, John W Hellstein, John R Kalmar, Annals of Internal Medicine, May 16, 2006 (vol. 144:10), pp. 753-761.
  2. Drug for Bones Is Newly Linked to Jaw Disease, Gina Kolata, New York Times, June 2, 2006.
  3. Myeloma Bone Disease, Multiple Myeloma Research Foundation.
  4. National Cancer Institute - Bone Cancer: Questions and Answers
  5. What Is Multiple Myeloma?, by the American Cancer Society.

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