Intended to prevent and treat certain types of bone loss and bone disease in adults, Fosamax has been linked to a rare jawbone disorder, esophageal cancer, chronic irregular heartbeat and unusual bone fractures, among other side effects.
Introduced in 1995, this drug was hailed as the superior treatment for the some 40 million Americans who have or are at risk for osteoporosis and Paget’s disease of bone, which causes severe bone loss. Fosamax (alendronate) belongs to a drug class called bisphosphonates, which are supposed to boost bone density by slowing the body’s natural process of bone breakdown. But researchers have now found that this drug actually causes bones to weaken and crumble.
Worse yet, some claim that Fosamax has been prescribed to thousands of people who don’t need it. Early on, the drug’s manufacturer, Merck, opened its nonprofit Bone Research Institute as an opportunity to broaden the drug’s reach. With it, the company was not only able to reach the osteoporosis market, but also convinced medical professionals that osteopenia needed treatment as well. Before Fosamax, osteopenia, which is a slight thinning of the bones, was rarely diagnosed or treated. Today, treatment for osteopenia patients remains controversial.
Over the years, Merck has been rebuked several times by the U.S. Food and Drug Administration (FDA) for falsely advertising the Fosamax’s benefits. Within years of Fosamax entering the market, patients started reporting a host of medical problems associated with it. The FDA required Merck to add more and more warning labels as research unfolded.
Alendronate, the active ingredient in Fosamax, is mainly used to prevent and treat osteoporosis, a condition that leads to reduced bone density. Osteoporosis is often seen in women after menopause, older men and adults who are taking corticosteroids. Fosamax is also used to treat Paget’s disease of bone, a chronic disorder that can result in enlarged and misshapen bones.
Fosamax, which comes in a pill and liquid form, can be taken once a week or once daily, depending on the treatment. There is a narrow set of parameters under which it should be taken: at least a half-hour before eating breakfast with only water; no lying down for at least 30 minutes after taking the pill; no eating, drinking or taking any other medications within 30 minutes of taking it.
The drug also comes in a combo pill with vitamin D, called Fosamax Plus D.
Fosamax is known to interact with several common medications. Some make the drug less effective, while others can increase the risk of side effects.
- Aspirin and NSAIDs drugs (ibuprofen, naproxen and anaprox): causes increased stomach irritation.
- Iron supplements and magnesium products: prevents Fosamax absorption.
- Antacids: makes Fosamax less effective.
Fosamax is known to cause irritation to the gastrointestinal lining and may worsen underlying diseases, including Barrett’s esophagus, dysphagia and gastritis. Also, post-marketing studies have shown that the drug can lead to incapacitating bone, joint and muscle pains. Patients who cannot sit or stand for 30 minutes should not take Fosamax. Also, patients with esophagus abnormalities or hypocalcaemia — which is low calcium — should not take the drug.
FDA Recalls and Warnings
Since Fosamax was released, medical professional have been scrutinizing the problems associated with the drug. The FDA first stepped in about a year after the drug hit the market, sending Merck a warning letter for “overstating the benefits of Fosamax while minimizing the risks associated with the drug.”
Within several years, women started reporting thighbone breaks and jawbone death, although the FDA continually overlooked the problems. It wasn’t until 2004 that the FDA found that long-term Fosamax use was conclusively linked to osteonecrosis of the jaw, which causes the jawbone to deteriorate. Then, in 2008, the FDA warned that bisphosphonates were also linked to debilitating bone, muscle and joint pain.
By 2009, a study in the New England Journal of Medicine linked long-term Fosamax use to esophageal cancer. In 2010, the FDA required that Fosamax and other drugs in its class include warning labels about the increase risk of thighbone fractures. In 2011, the FDA added a new warning label to the drug that states that the optimal duration of Fosamax use has not been determined. An FDA advisory committee wants the agency to limit the amount of time a patient uses the drug, but the group can’t agree on the time limit.
In addition, medical researchers are making clear connections between Fosamax and irregular heartbeat and painful eye disorders that cause inflammation and distorted vision.
Fosamax Femur Fractures
For patients taking this drug, some of the more surprising side effects are random bone breaks. Researchers linked the drug to low-energy fractures, which means they happen after some kind of low-impact repetitive force. But for some Fosamax patients, these fractures — also called stress fractures — occurred even without a fall. Women have reported turning their bodies the wrong way, coming to a short stop in the car or simply walking and suffering a broken femur.
Researchers are still trying to determine the cause of the fractures. Some say that alendronate slows the development of new collagen, a naturally occurring protein that is found in abundance in bones. Others say the drug kills the cells that remove old bone and doesn’t make room for new bone growth, which causes the bone to become brittle. Still others say it’s because the slower bone turnover causes brittle bones.
Osteonecrosis of the Jaw
Even more alarming to many patients is the link between Fosamax and a severe bone disease that causes the jawbone to die. Also called Dead Jaw Syndrome, osteonecrosis of the jaw begins after dental work or other minor trauma, and causes the bone to be exposed. Soon the area becomes infected, the overlying tissue erodes and the blood flow to the jawbone stops. This causes tiny breaks that can lead to the whole jawbone collapsing.
While scientists are still trying to determine the link between this painful and disfiguring disease and Fosamax, many doctors urge patients to undergo dental surgeries prior to starting Fosamax treatment.
Cases Against Fosamax Increase
Court cases against Merck began in 2004 once research proved that Fosamax causes osteonecrosis of the jaw. Patients with side effects such as femur fractures, Dead Jaw Syndrome, esophagus problems and musculoskeletal pain have filed lawsuits against Merck. Thousands of patients have filed in a multidistrict litigation (MDL) in New York and New Jersey. With MDL cases, pre-trial proceedings are heard together; however, each case has a separate trial.