Fosamax (alendronate) is used to treat patients who have an increased risk of osteoporosis and a severe bone loss disease called Paget’s disease of bone. Those who suffer bone loss from osteoporosis or from steroid use are considered to be ideal candidates for Fosamax, however Fosamax may cause severe side effects, including esophageal cancer, osteonecrosis of the jaw, and unusual bone fractures.
Drug manufacturer Merck has faced thousands of Fosamax lawsuits filed by people or loved ones of those who were injured after taking the medication. It is also alleged that thousands of patients taking Fosamax did not actually face serious bone conditions but were encouraged to use the drug as a preventative treatment which may have contributed to unnecessary harm for many patients.
What Is Fosamax?
Fosamax (alendronate sodium) is a prescription drug used to treat and prevent osteoporosis in adults. It was first introduced to the U.S. market in 1995 by the drug manufacturer Merck. Fosamax is a member of a class of medications called bisphosphonates which work to alter the cycle through which bone is formed and broken down within the body. Fosamax is made to slow a patient’s bone loss while simultaneously increasing the bone mass. This is thought to help prevent fractures and reverse bone loss.
Fosamax can be taken in a liquid or pill form and may be given weekly or as smaller daily doses. Because it may cause esophageal erosion and stomach problems, Fosamax has certain restrictions for use. It must be taken in the morning at least 30 minutes before eating or drinking anything other than water and patients must stand or sit upright for at least 30 minutes after taking Fosamax.
Fosamax FDA Warning
The U.S. Food and Drug Administration (FDA) has issued a series of Fosamax FDA warnings regarding the safety of the drug and other bisphosphonates. These warnings have also resulted in a number of changes to drug labeling and inclusion of new safety information or warnings about risks of the medication. Thousands of Fosamax lawsuits have been filed for similar reasons
Fosamax Side Effects
Side effects of Fosamax can range from moderate to severe. Patients taking Fosamax commonly experience stomach pains and irritation of the gastrointestinal lining, as well joint, muscle, and bone pains.
In 2010, the FDA released a Drug Safety Communication warning the public of the potential increased risk of sustaining fractures in the femur, or thigh bone, in bisphosphonate patients. These atypical fractures include diaphyseal fractures which occur along the long shaft of the bone and subtrochanteric fracture which occur immediately below the femur’s lesser trochanter, or just below the hip joint.
The safety warning issued by the FDA also required that prescribing information also include bone fracture information but did not affect bisphosphonate drugs used exclusively for treating Paget’s disease or cancer-induced high blood calcium.
Fosamax Bone Fractures
Though Fosamax is given to prevent bone loss and fractures, in some cases, Fosamax side effects may contribute to weakened and broken bones. Fosamax-related fractures may occur in the femur, which is one of the body’s strongest bones or may result from damage to the jawbone. These low-impact fractures have often occurred without extreme stress on the bone. The majority of Fosamax fractures occur in female patients and may occur during routine, non-stressful physical activities.
Fosamax Femur Fracture
Reports indicate that Fosamax femur fractures tend to occur spontaneously and may occur during low impact activity. Fosamax femur fractures typically occur in the long, middle section of the femur as well as the bone located below the hip’s joint. These areas are typically not associated with osteoporosis fractures but are unique to drug side effects. Furthermore, the femur is one of the strongest bones in the body, making Fosamax femur fractures more unusual.
In March 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation on bisphosphonate drugs like Fosamax and their association with femur fractures. The FDA investigation was fueled in part by research conducted by the American Society of Bone and Mineral Research. The research indicated that rare but serious Fosamax femur fractures are associated with long-term use. The study was also published in the Journal of Bone and Mineral Research.
The 2010 study examined 310 patients who suffered femur breaks. The results showed that 94 percent of these were caused by Fosamax or other bisphosphonate drugs. Furthermore, the Fosamax femur fractures occurred in patients who had been taking Fosamax for an average of five or more years. The study revealed that a main warning sign of a Fosamax femur fracture is persistent pain in the thigh or groin where the fracture will typically take place.
Theories for Fosamax Femur Fracture
The exact explanation for the incidence of Fosamax femur fractures is currently unknown. However, it is believed that Fosamax alters the natural process of bone remodeling in the body. Fosamax may harden the bone’s outer layer but as a result, the interior cells are prevented from being routinely replaced during the bone remodeling process. When small fractures occur, they accumulate and contribute to severe Fosamax femur fractures.
Some experts also theorize that while preventing bone loss, Fosamax may cause a condition referred to as “frozen bone.” Frozen bone essentially shuts down the body’s remodeling process of bone breakdown and regeneration. In theory, frozen bone can contribute to the clean fractures that many Fosamax patients experience.
Fosamax Femur Fracture Case Examples
Carol Ames of Pennsylvania reports that she was walking into her husband’s bedroom when her femur broke. Another Fosamax user reported that her femur broke during a commute to work when the subway train she was traveling in came to a routine stop. Sue Heller of Colorado broke both femur bones during her 10 years of Fosamax treatment. Sandy Potter of New York reported that her femur broke completely in half while jumping rope with neighborhood children.
Fosamax Osteonecrosis of the Jaw
Also called dead jaw syndrome, Osteonecrosis is a Fosamax side effect which may cause the jawbone to degrade and collapse. Severe injury can occur as a result of small cuts or wounds in the mouth such as those caused by dental work. A small opening in the tissue over the jaw can become severely infected. After the onset of infection, the jawbone’s blood flow may be cut off. This causes the gradual death of the bone. Some users have reported collapse after small breaks in the jawbone.
Fosamax Esophagus Side Effects
The esophagus is the tube that carries food, liquid, and saliva to the stomach after they are swallowed. Fosamax may cause inflammation and irritation of the esophagus which may result in serious damage, including development of bleeding esophageal ulcers.
In severe cases, Fosamax side effects include esophageal erosion and perforation of the esophagus. Merck, the manufacturer of Fosamax, recommends that users take Fosamax with a large glass of water. Users should also stand or sit upright for at least 30 minutes after Fosamax treatment to avoid esophageal Fosamax side effects.
In some cases, damage to the esophagus may result in development of esophageal cancer. The New England Journal of Medicine published a report in 2008 discussing this potential Fosamax side effect which, according to FDA reports, may have affected at least 23 Fosamax patients between the drug’s introduction in 1995 and report publication in 2008.
It is highly recommended that patients who suffer dysphagia or Barrett’s esophagus do not take Fosamax. Conditions such as these show an increased risk of esophageal cancer.
Other Fosamax Side Effects
Other Fosamax side effects include low blood calcium levels and musculoskeletal pain. Low blood calcium is also referred to as hypocalcemia. This Fosamax side effect is caused by the fact that bisphosphonates are designed to hinder the body’s natural bone breakdown. This means that a Fosamax patient receives less calcium deposited back into the blood stream. As a Fosamax side effect, the patient’s bones do not receive consistent calcium fortification.
Fosamax side effects from hypocalcemia include:
- Softened bones
- Foot and hand spasms
- Muscular cramps
- Abdominal cramps
- Muscular weakness
Many users also report Fosamax side effects such as musculoskeletal pain. Many patients experience this Fosamax side effect within days of beginning treatment. For many, the musculoskeletal pain subsides when treatment is discontinued. However, some patients continue to experience musculoskeletal pain even after Fosamax treatment.
Fosamax Drug Interactions
Fosamax is known to interact with certain medications. Those who take aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen may experience stomach irritation. Iron and magnesium supplements have been known to prevent Fosamax absorption into the body. Additionally, antacids can make Fosamax less effective.
Pharmaceutical giant, Merck, manufacturer of Fosamax has faced thousands of Fosamax lawsuits over the life of the drug.
Reports of injuries associated with Fosamax use began shortly after the drug was introduced, however once 2004 research proved the link between Fosamax and osteonecrosis of the jaw, lawsuits against Merck began to be filed. Injuries cited in Fosamax lawsuits have included fractures, esophagus issues, musculoskeletal pain, and osteonecrosis of the jaw.
In 2013, Merck offered $28 million to settle over 1,200 federal multidistrict litigation (MDL) Fosamax lawsuits consolidated in 2006 which cited osteonecrosis of the jaw (ONJ) drug injury caused by the medication. Another 300 femur fracture federal lawsuits have not yet been settled.
In state courts, a group of over 3,000 femur fracture lawsuits was consolidated into Multicounty litigation (MCL) in New Jersey in 2011 and has yet to be settled. A number of the included cases were dismissed and reinstated and though several bellwether trials have resulted in awards for the plaintiffs, no large settlements have been announced.
Nearly 400 Fosamax femur-fracture lawsuits were also filed in state courts California and though the first case was settled for Merck, most have yet to be decided.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.