Case report of nonhealing gastric ulcer while taking Fosamax
If you ever wonder why medical care is so expensive, here is a great example to show you why. It really falls back to the old cliche, "When all else fails read the directions" that so many of us forget as we deal with a problem. See the article by Malnick SD and others, PMID: 12145563. More details on the article can be seen at Medscape. You will need to sign in to read the article, but there is no expense to do that.
First, here is what Merck says in their package insert and online prescribing information about Fosamax: "Physicians should therefore be alert to any signs or symptoms signaling a possible esophageal reaction and patients should be instructed to discontinue FOSAMAX and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn." Additionally, it says, "Because of possible irritant effects of FOSAMAX on the upper gastrointestinal mucosa and a potential for worsening of the underlying disease, caution should be used when FOSAMAX is given to patients with active upper gastrointestinal problems (such as dysphagia, esophageal diseases, gastritis, duodenitis, or ulcers)." Another statement in the the information is, "Physicians should instruct their patients to read the patient package insert before starting therapy with FOSAMAX and to reread it each time the prescription is renewed."
In this case report the 68-year-old woman reported with epigastric pain. She was taking multiple medications including both aspirin and 10-mg Fosamax. Rather than following the guidelines in the prescribing information, the authors did upper gastrointestinal endoscopy which showed a 1.5-cm ulcer. Subsequently several treatments were provided to the patient along with a total of at least six endoscopic procedures over a period of seven months. Finally, after the fifth endoscopy they withdrew the Fosamax which led to the healing of the ulcer.
As I've pointed out in multiple articles on this Website, the bisphosphonates in general, and Fosamax specifically, are capable of causing epigastric problems. However, in controlled clinical trials, there was no difference between controls and active participants as concerns epigastric discomfort. Still, the possibility of epigastric problems is real and can definitely occur, especially if patients don't follow recommendations for taking the medication. This involves taking it on an empty stomach with a full glass of water and remaining upright for at least one-half hour or until eating breakfast. Also, as noted in an update and the last newsletter, the risk of epigastric problems appears minimal on the once-weekly 70-mg dose of Fosamax.
So, I have several problems with this case report. First, I'm wondering why the investigators ignored the prescribing information and failed to stop the Fosamax immediately when the patient reported epigastric pain? If not immediately, why did they take five months and a total of five endoscopic examinations to stop the Fosamax? I don't know for sure when this woman's problems occurred. But, if they were after the the 70-mg once-weekly dose of Fosamax was approved, why wasn't she put on that since it assuredly had less incidence of epigastric problems? Also, I would argue with the title of the paper and with the conclusions of the authors as to the cause of the ulcer. They simply don't know if Fosamax caused ulcer. All they know is that, irrespective of whatever caused it, stopping the Fosamax resolved the problem. It is entirely possible that the ulcer existed before Fosamax was started, that the aspirin therapy, or simply bacteria caused it, but that it would not go away while the patient was still taking daily Fosamax. To prove that Fosamax caused the ulcer they would need to place the patient on Fosamax again and show that the ulcer reoccurred--which they didn't do.
The bottom line for readers is that, as I've said many times, it behooves you as patients to learn everything you can about your osteoporosis and its treatment so you can be an educated patient. There are times when you will need to provide guidance to and consult with your care provider. If you don't understand your problem and how to treat it, you can't be sure if it was diagnosed and treated correctly. If the woman in this case report was an educated patient, she would have stopped the Fosamax immediately on her own without even consulting with her physician. She would then tell the physician she had stopped so they could observe the results. If her symptoms didn't resolve within a few weeks, then a full diagnostic work up would have been warranted. When her symptoms stopped, then another form of therapy, such as Actonel once-weekly could have been tried.