Fosamax (alendronate) is a medication used to prevent and treat osteoporosis and other diseases that contribute to bone weakness. Fosamax acts to increase the density of bones. The medication was brought onto the market in 1995 and quickly became a popular prescription for many people at risk for losing bone density. Unfortunately, since then Fosamax has been found to have some very serious side effects, ranging from jaw necrosis to esophageal bleeding.
Merck, the drug company responsible for Fosamax, has been warned by the U.S. Food and Drug Administration (FDA), has been required to add more to the drug’s warning label, and has been the subject of lawsuits brought by patients who suffered the terrible side effects of the medication. If you have been a victim of Fosamax, you may have a case against Merck that could net you the compensation that would help mitigate your pain and losses.
What is Fosamax?
Fosamax is the brand name for the medication called alendronate. Merck’s patent on the drug ended in 2008, so it is now available both as the brand name medication and as a generic. Fosamax belongs to a class of drugs called bisphosphonate, medications used to prevent bone mass loss and to decrease the risk of bone fractures and breaks. Fosamax is prescribed more often than any other type of bisphosphonate.
Uses for Fosamax
The main use for Fosamax is to prevent osteoporosis in women going through or who have gone through menopause. Osteoporosis occurs when bones become weaker and more brittle. The result is that even the smallest stress on them can cause a fracture. The tissue that makes up bone is constantly breaking down and reforming. When the reforming process doesn’t keep up with the breaking down, the result is osteoporosis. Bone loss occurs in everyone as they age, but women during and after menopause are at the greatest risk for osteoporosis because of hormonal changes.
Men can also develop osteoporosis, and Fosamax is used as a treatment in these cases. Osteoporosis can also be triggered by certain medications, like corticosteroids. Men and women of any age taking these drugs may be given Fosamax to reverse or prevent osteoporosis. Fosamax can also be used to treat Paget’s disease, a condition in which the bones grow abnormally and become weak, soft, and deformed, and osteogenesis imperfecta, a rare congenital disease that causes bones to be brittle.
How it Works
Fosamax, like other bisphosphonates, works by preventing or slowing bone loss. In the process of bone destruction and regrowth, cells called osteoblasts create new bone tissue, while osteoclasts destroy older bone tissue. Bisphosphonates kill osteoclasts to inhibit the loss of bone tissue. Fosamax has a significantly stronger effect on this process than the earlier drugs in the bisphosphonate class.
The most common side effects of Fosamax are acid regurgitation, abdominal pain, diarrhea, nausea, constipation, dyspepsia, and musculoskeletal pain. Other possible side effects are flatulence, vomiting, esophageal ulcers, changes in the ability to taste food, dizziness, joint swelling, and headaches. Anyone experiencing any of these that are severe or do not go away after a day or two should see a doctor.
Potentially serious side effect that require immediate medical attention include chest pains, difficulty swallowing, heartburn, bloody vomit or stools, fever, rash, blistering skin, hives, face or mouth swelling, difficulty breathing, numbness in the jaw, loose teeth, swollen gums, eye pain, and a dull pain in the hips or thighs.
The FDA issued a special warning in 2008 regarding the possibility of musculoskeletal pain caused by Fosamax. The side effect was already listed on the warning label, but the FDA felt that the warning was not adequate and reported that the drug could cause severe and debilitating pain. This pain can occur right away after starting Fosamax, but also may not start until months or years after taking the drug long-term.
Several of the most serious problems with taking Fosamax over the long term were discovered after the drug was on the market. The FDA required that Merck change its labeling to include these as important warnings and precautions, separate from the more common side effects. One of these is the risk of femur fractures. Research and reporting from patients has found that unusual fractures of the femur are possible while taking Fosamax. The most common sign of such a fracture is an unexplained pain in the thigh, hip, or groin.
Esophageal problems are also possible and can be serious and uncomfortable. The esophagus is the tube that connects the stomach and the mouth. Someone taking Fosamax may experience bleeding, ulcers, irritation, and inflammation in the esophagus, which are characterized by pain, heartburn, chest pain, and difficulty swallowing.
Researchers have even found that long-term use of Fosamax can increase the risk of esophageal cancer. A study found that people taking Fosamax or other bisphosphonates were at a doubled risk of developing this rare and deadly cancer than people who had never taken the medications. This is only the most recent evidence. The FDA found a connection to esophageal cancer in a study that followed patients from 1995 to 2008.
Osteonecrosis of the Jaw
People taking Fosamax are also at an increased risk for osteonecrosis of the jaw, especially after dental work like having a tooth pulled. Osteonecrosis, or bone death, is a serious condition. It happens when the jaw bone doesn’t heal after some type of trauma, like a tooth extraction. The consequences are swelling, pain, exposed bone, and infection. This condition requires treatment or it will only get worse.
Merck received a warning letter from the FDA in 1997 for unfair and dishonest marketing practices regarding Fosamax. The letter stated that Merck had been overstating the benefits of the medications while downplaying the risks. It also accused the company of making false statements in advertising materials. This kind of information is important in lawsuits brought by patients who suffered some of the side effects without being adequately warned of the risks.
Fosamax and Osteopenia
Another issue with the marketing of Fosamax has been for the treatment of osteopenia. This is the normal thinning of bones as people age, which up until a decade or so ago was never treated. Merck created the Bone Measurement Institute to get more bone scanners in doctors’ offices. On the one hand, this was great for public health, allowing more people to have their bone density measured so that cases of osteoporosis could be caught early and treated.
On the other hand, the greater access to bone scanning meant that more women were diagnosed with osteopenia. Merck created a low dose version of Fosamax specifically for treating osteopenia. Many women were given the diagnosis and essentially scared into taking Fosamax. Merck’s sales increased, but many doctors and researchers dare not convinced that osteopenia needs to be treated or that the benefits outweigh the risks.
Lawsuits have been started against Merck because of the many serious possible side effects of Fosamax that have caused debilitating pain and injury in some patients. Lawsuits focusing on the femur fractures, esophageal problems, osteonecrosis of the jaw, and severe pain are ongoing for thousands of suffering patients. It remains to be seen whether any cases will arise over the prescribing of Fosamax for osteopenia. If it can be proven that the medication is not necessary and that Merck pushed for it in spite of the risks or the lack of need, lawsuits may be filed for those women who have suffered the consequences of using Fosamax.
If you have taken Fosamax and struggled with some of the side effects, you may have a case against Merck. You can take the advice of a lawyer to start a suit or join in on class action lawsuits against the drug maker. Settlements are likely and you could be a part of them.