Fosamax, a prescription medication used to treat and prevent the bone loss of osteoporosis, is associated with a number of side effects, some of them severe and damaging. Made by Merck, Fosamax first came on the market in 1995. Although it has been popular in people susceptible to bone density loss, this medication has also been associated with some serious and troubling side effects, including bone fractures, jaw bone loss, and debilitating pain.
Merck has also been accused of unethical marketing practices, pushing Fosamax for patients who may not need it and boosting the benefits of the drug while downplaying the very serious risks. If you took Fosamax and experienced any of these, you may be like others who have filed lawsuits against Merck. The company has been shown to engage in questionable marketing practices, and this means that plaintiffs in lawsuits may have strong cases to make against it.
Fosamax and Bone Density
Loss of density in bone tissue happens to some extent in all people as they age. Osteoporosis occurs when that bone loss is more than normal, when bones become unnaturally weak and brittle and susceptible to breaks and fractures. Women going through menopause or already post-menopausal are at the greatest risk for osteoporosis, and it is this population that is most often prescribed Fosamax.
The generic name for the drug is alendronate, a type of medication belonging to the class called bisphosphonate. These are drugs that are used to build bone density, to prevent bone loss, and to prevent breaks and fractures. Among bisphosphonate drugs, Fosamax has been the most popular and the biggest seller. Although older women are the most common patients using Fosamax, men may also experience osteoporosis and use this medication. It can also be used to treat a rare condition called Paget’s disease, characterized by brittle, weak bones.
Typical Fosamax Side Effects
Most commonly, Fosamax causes mild side effects like abdominal pain, diarrhea, constipation, nausea, dyspepsia, acid regurgitation, and pain. Less common are swollen joints, dizziness, flatulence, vomiting, the inability to taste food, headaches, and esophageal ulcers. Most side effects of Fosamax are not concerning and should disappear or lessen within a few days of starting the medication.
The kind of pain that Fosamax may cause as a side effect is musculoskeletal. The U.S. Food and Drug Administration (FDA) issued a warning about it in 2008, stating that the current label for the drug did not emphasize this particular side effect enough. The agency stated that the pain caused by the drug has the potential to become debilitating.
Bone Fractures
In addition to the more common and less serious side effects of Fosamax, there are also some serious ones. These are the risks that Merck has been accused of downplaying in its advertising and promotions of the drug. One such serious risk seems counterintuitive for an osteoporosis drug, but Fosamax has been found to increase the risk of certain types of bone fractures.
In particular, reports indicate that people on Fosamax are susceptible to fractures of the femur, the thighbone. The fractures tend to occur randomly, while walking or even just while standing. The risk is greatest for patients taking the drug for five years or longer. Since the discovery of this side effect, the FDA has required that the labeling be updated to warn patients of the risk.
The evidence that Fosamax contributes to femur fractures comes from research, including the FDA’s own investigations. One study of 20 patients with femur fractures found that 19 of them had been using Fosamax for years. The FDA’s study found that 94 percent of 310 people with femur fractures were on Fosamax for five years or more. The explanation for how it could be triggering fractures is that the drug block’s the body’s natural way of repairing and regenerating bone tissue.
Esophageal Side Effects
Another serious potential side effect of Fosamax is damage to the esophagus, the tube that connects the mouth and stomach. Fosamax has been connected with ulcers in the esophagus, bleeding, inflammation, and irritation. These types of damage to the tissue causes pain, difficulty swallowing, and heartburn. There is even evidence that over the long-term, Fosamax use can lead to esophageal cancer. One study found that the risk was doubled for people using a bisphosphonate drug compared to people who had never used one.
Osteonecrosis of the Jaw
Osteonecrosis means bone tissue death, and dead jaw syndrome refers to this phenomenon when it occurs in the jaw bone. Studies and reports indicate that people using Fosamax are at a greater risk for osteonecrosis of the jaw, especially after having dental work done. The condition usually begins after something like having a tooth pulled. The area doesn’t fully heal, an infection sets in, gum tissue starts to erode, and the bone of the jaw becomes exposed and starts to decay. The result is that the teeth start to fall out and the bone simply crumbles.
Dead jaw syndrome can be devastating because once the warning signs are detected it is usually too late to save at least part of the jaw bone. These patients then must have prosthetic devices installed to restore shape and function to the jaw. The result is painful and debilitating. As with femur fractures, it is thought that the fact that Fosamax stops natural bone regrowth is what leads to the osteonecrosis.
The FDA has warned Merck about how it promotes Fosamax. The company has been found to be unethical in how it has pushed the drug, including to people who may not have needed it. The company has also been shown to downplay the serious potential Fosamax side effects that have caused so many people pain and suffering. For these reasons a number of lawsuits have been started against the company by people hoping to get compensation for what they suffered. If you suffered some of the side effects of Fosamax, you may want to speak to a lawyer to find out what you can do to get compensation.
Sources
- https://www.nlm.nih.gov/medlineplus/druginfo/meds/a601011.html
- http://www.npr.org/2009/12/21/121609815/how-a-bone-disease-grew-to-fit-the-prescription
- http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm124165.htm
- http://www.fda.gov/downloads/Drugs/.../UCM170602.pdf
- https://www.merck.com/product/usa/pi_circulars/f/fosamax/fosamax_pi.pdf
- http://www.nejm.org/doi/full/10.1056/NEJMc0808738
- http://www.webmd.com/osteoporosis/news/20090101/fosamax-higher-risk-of-jawbone-death