Fosamax 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 specifically 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 steroid use are ideal candidates for Fosamax.
Fosamax users have experienced severe side effects, including esophageal cancer, osteonecrosis of the jaw, and unusual bone fractures. It is also alleged that thousands of patients taking Fosamax do not actually face serious bone conditions, but are encouraged to use the drug as a preventative treatment. This is believed to contribute to unnecessary harm for a number of patients.
What Is Fosamax?
Fosamax (alendronate sodium) is a member of a medicine group called bisphosphonates. These drugs 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 believed to help prevent fractures.
Fosamax can be taken in a liquid or pill form. Depending on the specific treatment regimen of a patient, it can be taken weekly or daily. Fosamax has certain restrictions for use. Patients must stand or sit upright for at least 30 minutes after taking Fosamax. If the patient does not remain upright, serious complications in the esophagus or stomach can occur. Additionally, it should be taken in the morning at least 30 minutes before the patient eats breakfast or drinks anything other than plain water.
Fosamax FDA Warning
The high number of adverse event reports has caused the U.S. Food and Drug Administration (FDA) to release a series of Fosamax FDA warnings regarding the safety of the drug and other bisphosphonates. In many cases, the FDA has required that the drug’s safety label include warnings of these risks. As a result, a number of Fosamax patients have filed lawsuits against Merck, the manufacturer of the drug.
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. Patients may also experience 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 and subtrochanteric fractures. Diaphyseal fractures occur along the long shaft of the bone. Subtrochanteric fractures occur immediately below the femur’s lesser trochanter, or just below the hip joint.
Following the Fosamax FDA warning, manufacturing companies were required to add femur fracture information to bisphosphonate safety labels. However, the warning did not affect bisphosphonate drugs used exclusively for treating Paget’s disease or cancer-induced high blood calcium.
Fosamax Bone Fractures
Many find it surprising that Fosamax side effects may contribute to weakened and broken bones. A number of Fosamax patients have reported bone fractures as a Fosamax side effect. The most common Fosamax fracture occurs in the femur, which is one of the body’s strongest bones. These low-impact fractures have often occurred without extreme stress on the bone. The majority of Fosamax fractures occur in female patients.
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.
Osteonecrosis of the Jaw
Also called dead jaw syndrome, this Fosamax side effect can cause the jawbone to completely 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 Problems
A number of users reported Fosamax side effects such as inflammation and irritation of the esophagus. The esophagus is the tube-shaped organ that carries food, liquid, and saliva to the stomach after they are swallowed. Bleeding esophageal ulcers are also reported. In severe cases, Fosamax side effects include 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.
Recent studies are beginning to show esophageal cancer as a Fosamax side effect. The New England Journal of Medicine published a report in 2008 discussing this potential Fosamax side effect. Between the drug’s release in 1995 and May 2008, the FDA received esophageal cancer reports from 23 Fosamax patients. 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.
Fosamax Femur Fracture
Fosamax is a drug used to treat and prevent particular types of bone disease and bone loss. It is primarily used for patients suffering osteoporosis or a condition called Paget’s disease of bone. The active ingredient in Fosamax is alendronate, and it belongs to a drug class called bisphosphonates. Fosamax was launched in the U.S. market in 1995 by pharmaceutical giant Merck. When Fosamax was first introduced, it was regarded as the superior bone disease treatment.
While millions of Americans have been successfully treated with Fosamax, a number have experienced debilitating side effects. The FDA has received numerous reports of Fosamax femur fractures, or thigh bone fractures. Additionally, patients can develop osteonecrosis of the jaw. Osteonecrosis of the jaw is a condition during which the jawbone becomes weak and brittle, and can collapse completely. Many patients filed lawsuits against Merck for bone damage that occurred while taking Fosamax.
Fosamax Femur Fracture Research
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. One theory states that Fosamax may harden the bone’s outer layer. 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.
Another theory states that 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
A number of Fosamax femur fracture reports are surfacing. Many of these Fosamax femur fracture cases are initiated from low impact. This means that serious trauma to the femur is not necessary to cause a Fosamax femur fracture. Many reports indicate that the patient was engaging in routine, everyday activities when they sustained a Fosamax femur fracture.
Reports indicate that Fosamax femur fractures tend to occur spontaneously. Additionally, they are atypical to normal femur fractures. This can be seen by the fact that 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. Furthermore, the femur is one of the strongest bones in the body, making Fosamax femur fractures more unusual.
Among many others, the following women have sustained a Fosamax femur fracture:
- Carol Ames was simply walking in her home when she sustained a Fosamax femur fracture
- Sandy Potter was jumping rope with children in the neighborhood when her femur snapped in half
- Over the course of 10 years of treatment, Sue Heller sustained a Fosamax femur fracture in both femur bones
- An anonymous women sustained a Fosamax femur fracture when the subway train she was riding came to routine stop
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 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.
Once 2004 research proved the link between Fosamax and osteonecrosis of the jaw, lawsuits against Merck began. Lawsuits cover side effects such as bone fractures, esophagus issues, musculoskeletal pain, and osteonecrosis of the jaw. Plaintiffs are seeking compensation for medical bills, lost wages, and suffering endured from Fosamax side effects.
Fosamax patients have filed thousands of federal claims. These claims are grouped into a multi-district litigation (MDL). MDLs take place when several federal lawsuits across multiple districts are consolidated during the pre-trial phase of the lawsuit. Currently, Fosamax MDL cases are assigned to U.S. District Courts in New Jersey and New York. After the pre-trial phase is complete, the cases will be returned to their original districts.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.