Fosamax

What Is Fosamax?

Fosamax (alendronate sodium) is a prescription drug used to treat and prevent osteoporosis in adults. Fosamax can be taken in a liquid or pill form and may be given weekly or in 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.

What Type of Medication Is Fosamax?

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 bone mass. This is thought to help prevent fractures and reverse bone loss.

Who Manufactures Fosamax?

Fosamax was first introduced to the U.S. market in 1995 by the drug manufacturer New Jersey-based, Merck & Co. While the company is now separate, it was once the American branch of a German company founded in 1668 called Merck Group. Merck & Co. was established in 1891 and was expropriated by the Trading with the Enemy Act of 1917 during World War I. Merck Group did buy back the company in 1919 at an auction after the war ended, but Merck & Co. remained a separate company rather than re-integrating with Merck Group.

What Is Fosamax Prescribed to Treat?

Fosamax is typically prescribed to treat osteoporosis and Paget’s disease, both of which impact the strength of the bones. People with either condition may experience a higher risk of bone fractures.

What Is Osteoporosis?

Osteoporosis is a health condition in which bones become brittle and weak. Someone with osteoporosis is at greater risk of bone fractures and can experience them with even the slightest action, such as coughing or even bending over. Over a human lifetime, bone material is in a constant cycle of being created and then replaced. When we’re younger, the bone creation process is much faster than the loss of older bone. This reaches its peak usually in the 30s and slows down after that. Osteoporosis occurs when bone mass is lost because the process of creating new bone isn’t fast enough to keep up with the speed at which bone is lost.

What Are the Symptoms of Osteoporosis?

In the earlier stages of the disease, there may be no symptoms at all.

In later stages, the following symptoms may occur:

• Stooped posture
• Loss of height
• Bones breaking more easily
• Back pain
• Fractured vertebrae
• Collapsed vertebrae

What Are the Risk Factors for Osteoporosis?

How much bone density you had in your 20s and 30s, when the creation of new bone material was at its peak, may determine whether you’ll get osteoporosis. Some people will lose bone mass over time but won’t experience osteoporosis because they had higher levels of bone mass when they were younger. Others don’t have high bone density in youth and may be more susceptible to osteoporosis when they get older.

Other factors that can increase the risk of osteoporosis can be divided into a few different categories.

Hormones:

• Lower sex hormones
• Too many thyroid hormones
• Overactive parathyroid gland
• Overactive adrenal gland

Dietary Factors:

• Eating disorders
• Gastrointestinal surgery
• Low calcium

Lifestyle Choices:

• Smoking
• Drinking excessively
• Being sedentary

Certain medications for:

• Seizures
• Transplant rejection
• Cancer
• Gastric reflux
• Certain types of steroid medications

Osteoporosis is also associated with certain medical conditions, such as:

• Rheumatoid arthritis
• Multiple myeloma
• Kidney disease
• Liver disease
• Cancer
• Celiac disease
• Inflammatory bowel disease

Other risk factors:

• Older age
• Caucasian or Asian descent
• Being female
• Smaller body size
• Family history

What Complications Can Arise from Osteoporosis?

Treatment for Osteoporosis is essential to reduce risk of complications like easily fractured bones. Spine and hip fractures are the most serious and can happen in osteoporosis patients even if they haven’t fallen.

Can Osteoporosis Be Prevented?

While it may not be possible to completely prevent osteoporosis, due to risk factors outside of your control, there are some steps that you can take to minimize the risk. Eating healthy foods, particularly those with calcium and vitamin D, reducing alcohol intake, and maintaining a good exercise regime can help.

What Is Paget’s Disease?

Like osteoporosis, Paget’s disease is a bone disease that affects the body’s normal process of recycling old bone tissue and replacing it with new bone material. Conversely to osteoporosis, Paget’s disease results in new bone being created too quickly. This can, over time, cause the bones to become misshapen and fragile and, in particular, impacts the skull, spine, pelvis, and legs most frequently. 

What Are the Symptoms of Paget’s Disease?

Many people who suffer from Paget’s disease may experience no symptoms at all. Others may experience bone pain, particularly in the areas affected. For those who do experience symptoms, they may differ depending on where in the body the disease is most active. In some people, Paget’s disease may impact only one or two areas of the body while in others, the effects of the disease are more widespread.

The areas affected by Paget’s disease may include:

• Skull:
  • Hearing loss
  • Headache
• Spine:
  • Pain in an arm or leg
  • Numbness in an arm or leg
  • Tingling in an arm or leg
• Pelvis:
  • Hip pain
• Legs:
  • Bowleggedness
  • Osteoarthritis in the knees
  • Osteoarthritis in the hips

What Causes Paget’s Disease?

While the exact cause of Paget’s disease isn’t known, it’s suspected that a combination of genetics and environmental factors may increase the risk of developing the disease.

These risk factors include:

• Older age
• Being male
• Family history
• National origin, in particular:
  • England
  • Scotland
  • Greece
  • Central Europe
  • Countries settled by immigrants from these places

What Complications Can Arise From Paget’s Disease?

The following complications may occur in those who have Paget’s disease:

• Bone fractures
• Bone deformities
• Osteoarthritis
• Bone cancer
• Heart disease
• Neurological problems

How Does Fosamax Work?

Fosamax treats osteoporosis and Paget’s disease by inhibiting the osteoclasts, which are the bone cells responsible for breaking down older bone material. This helps to strengthen the bones by slowing the rate at which the older bone is broken down and reabsorbed.

Can Fosamax Interact With Other Drugs?

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 are known to prevent Fosamax absorption into the body. Additionally, antacids may also make Fosamax less effective.

What Are the Side Effects of Taking Fosamax?

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 as 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 fractures, 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.

What Is the FDA’s Fosamax 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 the inclusion of new safety information or warnings about the risks of the medication. Thousands of Fosamax lawsuits have been filed for similar reasons.

What Are Fosamax’s Links to Bone Fractures?

Though Fosamax is given to prevent bone loss and fractures, in some cases, Fosamax’s 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.

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.

Where Can Fosamax Cause Fractures?

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.

Has the FDA Linked Fosamax to Femur Fractures?

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.

What Did the FDA Study Find Regarding Fosamax’s Links to Femur Breaks?

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.

Why Does Fosamax Cause Femur Fractures?

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.

What Is Frozen Bone?

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.

What Are Fosamax’s Links to Osteonecrosis of the Jaw?

Also called dead jaw syndrome, osteonecrosis is a Fosamax side effect that 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 people have reported collapse after small breaks in the jawbone.

How Can Fosamax Affect the Esophagus?

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, such as 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.

What Are Fosamax’s Links to Esophageal Cancer?

In some cases, damage to the esophagus may result in the development of esophageal cancer. The New England Journal of Medicine published a report in 2008 discussing potential Fosamax esophageal side effects which, according to FDA reports, may have affected at least 23 Fosamax patients between the drug’s introduction in 1995 and the report’s publication in 2008.

It is highly recommended that patients who suffer from dysphagia or Barrett’s esophagus do not take Fosamax. Conditions such as these show an increased risk of esophageal cancer.

What Are the Symptoms of Esophageal Cancer?

The symptoms of esophageal cancer may include:

• Unintentional weight loss
• Difficulty swallowing
• Hoarseness
• Coughing
• Indigestion
• Heartburn
• Chest pain
• Chest pressure
• A burning feeling in the chest

What Are Fosamax’s Links to Hypocalcemia?

Other Fosamax side effects may include low blood calcium levels and musculoskeletal pain. Low blood calcium is also referred to as hypocalcemia. This Fosamax side effect may be caused by bisphosphonates ability to to hinder the body’s natural bone breakdown. This means that a Fosamax patient receives less calcium deposited back into the bloodstream. As a Fosamax side effect, the patient’s bones do not receive consistent calcium fortification.

What Are the Symptoms of Hypocalcemia?

The symptoms of low blood calcium can include:

• Nausea
• Fatigue
• Softened bones
• Foot and hand spasms
• Muscular cramps
• Abdominal cramps
• Muscular weakness

What Are Fosamax’s Links to Musculoskeletal Pain?

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.

Why Are People Filing Fosamax Lawsuits?

Pharmaceutical giant, Merck, manufacturer of Fosamax has faced thousands of Fosamax lawsuits over the life of the drug. The plaintiffs have claimed that the company failed to adequately warn them of the risks of taking Fosamax.

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.

What Fosamax Lawsuit Settlements Have There Been?

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.

Thousands more cases had been filed in state courts that were consolidated together into a multidistrict litigation (MDL). In 2013, Merck succeeded in getting those cases dismissed on the grounds that the company had attempted to add a warning label to Fosamax, but that warning had been rejected by the FDA. This ruling was overturned in 2017 by the 3rd U.S. Circuit Court of Appeals, which determined that a jury needed to decide whether in this case federal law would trump state law. In 2019, the U.S. Supreme Court ordered that the issue be reconsidered, stating that the federal vs state law question was indeed one for a judge, not a jury. In 2022, 500 of these cases were dismissed.

What Fosamax Lawsuits Are There?

As of February 25, 2022, Merck was still facing thousands of product liability lawsuits at both the state and federal levels. These cases have not yet been decided.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.