Fosamax Linked to Esophageal Cancer
Diane Wysowski of the FDA’s division of drug risk assessment says researchers should check into potential links between oral bisphosphonate drugs and cancer of the esophagus.
Merck’s oral osteoporosis drug Fosamax may carry a risk for esophageal cancer, Wysowski writes in a letter to January 1, 2009 New England Journal of Medicine.
Bisphosphonates are a class of drugs used against osteoporosis in post-menopausal women and in men and women who are taking cancer treatments that affect bone density. Patients on the oral form of these drugs are instructed to take them with water on an empty stomach and to stay sitting or standing upright for 30 minutes after swallowing the tablet.
Fosamax is now available as a generic for as low as $4 per month. Similar branded drugs are the widely advertised Boniva and Actonel.
As reported today by Reuters:
Wysowski said since the initial marketing of Fosamax, known generically as alendronate, in 1995, the FDA has received 23 reports in which patients developed esophageal tumors.
Typically, two years lapsed between the start of the drug and the development of esophageal cancer. Eight patients died, she reported.
In Europe and Japan, 21 cases involving Fosamax have been logged, with another six instances where Procter & Gamble’s Actonel or risedronate and Didronel or etidronate, and Roche’s Boniva (ibandronate) may have been involved. Six of those people died.
Esophagitis, which is an inflammation of the lining of the tube carrying food to the stomach, is already know to be a side effect of the drugs, which is why patients are instructed to remain upright for at least a half hour after taking them.
In addition, Wysowski said, doctors should avoid prescribing the drugs to people with Barrett’s esophagus, which is a change in the lining that leads to the stomach. It is often found in people with acid reflux disease and itself increases the risk of cancer.
Oral and intravenous bisphosphonates are also under scrutiny for causing necrosis of the jaw, and some evidence has suggested that Fosamax increases the risk of chronically irregular heartbeat (atrial fibrillation). A study published in Arch Intern Med. 2008;168[8]:826-831. from Group Health Cooperative and University of Washington raised the red flag over this. As Reuters notes, in November the FDA said clinical trial data showed no overall risk of heart rhythm problems in patients taking bisphosphonates.
01/01/2009 at 6:30 pm Permalink
I would like to suggest an alternative for men (and women) to consider instead of bisphosphonates: Strontium.
In the mid 1980s, a Prof. Skornya investigated the use of strontium (Sr) salts for protection of bone density. At that time, BMD testing was not as easy as it is today, but his results did indicate benefits.
I am not referring to radioactive strontium 89 used to treat bone mets (but don’t forget this sentence), nor am I referring to the radioactive Sr 90 formed during early atomic bomb detonations and ultimately found in milk. I am talking about plain ole Strontium 88, which is very similar to Calcium and, not surprisingly, also ends up in bones. One paragraph in the Skornya paper intrigued me: He tried to assess whether strontium (88) salts also had an effect on bone mets but was unable to draw any conclusion.
Fast forward to the current decade. A compound called strontium ranelate is being extensively studied in Europe and is reported to have significant bone density and fracture protection benefits in postmenopausal women. Side effects seem to be very limited. It has one other advantage: it was patentable while other strontium salts are “public domain”.
Papers on strontium ranelate again suggest that strontium affects osteoclasts (bone removal) and osteoblasts (bone building) in a [beneficial] manner similar to bisphosphonates (and Vitamin K2 – see LEF 01/09, p65). When strontium 89 chloride is used for bone metastases (for pain control, I believe), it is also believed to become part of the bone at the met sites.
Putting these ideas together, I decided to try readily available strontium citrate (over the counter!) for bone density–with the remote hope that it might also prevent bone mets. It appears to have worked for my bone density. At this point, without known bone mets, I can’t say if it has done anything in that area.
Few doctors know anything about strontium, even for bone density; their knowledge is limited to awareness of strontium 89 for pain alleviation. Dr. Strum and a few others are now mentioning otc, non-radioactive strontium salts as alternatives for bone density .
I am not recommending this; I am only suggesting you might want to investigate strontium. And, because the data are so limited, I would love to hear anything new you might uncover.