Actonel

What is Actonel?

Actonel (risedronate) is a prescription medication used in the treatment of osteoporosis for postmenopausal women, Paget’s disease, osteoporosis, and osteoporosis from glucocorticoid treatment. Actonel reduces the incidence of bone fractures from osteoporosis by increasing bone mass. Actonel is an anti-resorptive agent which alters the formation and breakdown cycles of bone tissue. Actonel prevents bones from breaking because it slows down the loss of bone tissue while increasing the amount of bone mass.

The U.S. Food and Drug Administration (FDA) urged caution about long-term usage of Actonel for the treatment of osteoporosis and other bone weakening conditions. Actonel and similar drugs were linked to rare fractures, cancer, and other side effects.

Actonel was approved in 1998 and was initially manufactured by consumer products giant, Procter & Gamble but is now manufactured by Allergan. Both companies have faced numerous Actonel lawsuits filed by people who experienced bone fractures, cancer, or other complications after using Actonel.

Actonel Side Effects

Actonel is a member of the bisphosphonate group of medications which carry a number of typical side effects. While some of these side effects are mild-to-moderate and will go away with time, others are more severe or serious and may be life-threatening. Some of the most severe Actonel side effects are bone fractures from continued use, esophageal erosion, bladder cancer, and osteonecrosis of the jaw (ONJ).

As a result of these Actonel side effects, the U.S Food and Drug Administration (FDA) reviewed and issued a warning in regard to future use of Actonel. The FDA warning was issued to both doctors and patients indicating that the medication may not be safe if used longer than five years.

Common Actonel Side Effects

Actonel side effects can include serious health issues such as problems with the esophagus, low calcium in blood, jawbone necrosis, and unusual fractures of the femur (thigh bone). These effects can range from mild to severe.

The most common side effects of Actonel may include:

• Heartburn
• Indigestion
• Diarrhea
• Stomach pain
• Back pain
• Joint pain
• Muscle pain

To help reduce the chance for esophageal irritation, patients are instructed to take Actonel first thing in the morning before anything else is consumed. The medication should be swallowed with a full glass of water and the patient is instructed to avoid laying down or eating for at least 30 minutes after the medication has been taken.

Esophagus Side Effects

The esophagus is the tube that carries food and liquid to the stomach.

Actonel may cause direct irritation of the esophagus and result in side effects such as:

• Irritation
• Inflammation
• Ulcers
• Heartburn
• Difficulty or painful swallowing

In severe cases, Actonel may result in esophageal erosion which over time, may increase the risk of esophageal cancer. Side effects that are severe or sudden, suddenly become worse or result in coughing up blood should be treated immediately.

In 2011, the FDA issued an advisory based on data from published studies about whether bisphosphonates like Actonel are associated with heightened risk of developing esophageal cancer. In one study they reviewed, it was noted by researchers that there was a double in the risk of developing esophageal cancer if the patients had received 10 or more prescriptions of bisphosphonates or if the patients were prescribed to the medications for over 3 years.

Low Blood Calcium

Actonel may decrease the calcium level in the bloodstream.

This may result in side effects that affect the muscles or nerves including:

• Nausea
• Fatigue
• Spasms
• Twitching
• Cramps
• Tingling
• Numbness

A doctor may advise or prescribe calcium and vitamin D to help rebalance blood calcium levels.

Osteonecrosis of the Jaw

Actonel has been shown to increase the risk of Osteonecrosis of the jaw (ONJ). ONJ is a potentially severe condition in which the jawbone either begins to decay or has become decayed and may be referred to as “dead jaw syndrome”.

ONJ often occurs after dental work has been performed which may have resulted in small cuts or wounds in the mouth. Afterward, the area may be slow to heal or might not heal properly, causing blood flow to the jawbone to be restricted and resulting in gradual death of the bone. Careful dental hygiene is essential when taking Actonel.

Symptoms of Actonel osteonecrosis of the jaw include:

• Pain
• Inflammation of the soft tissue
• Secondary infection or drainage

Patients may develop Actonel osteonecrosis of the jaw after as little as 12 months of taking Actonel and respective bisphosphonate drugs. The longer the drug is taken, the higher the chance of developing osteonecrosis of the jaw. The majority of Actonel osteonecrosis of the jaw cases occur in patients who received treatment for longer than 5 years.

The Actonel osteonecrosis of the jaw risk is higher in patients who receive bisphosphonate as a treatment for cancer. It is estimated that dosages of Actonel and other bisphosphonates can be as much as 10 times higher when used to treat cancer. Additionally, cancer patients often receive the drug intravenously as often as every month. Osteoporosis patients may only receive one IV dose per year.

Atypical Thigh Bone Fractures

Though Actonel is given to prevent bone fractures, it may contribute to unusual breakage of the femur, or thigh bone, from minor stress. These types of fractures have often occurred while patients were walking normally, under low-stress conditions.

Fractures typically occur in the long section of the leg bone or in the area of the femur just below the hip joint. They are not the type of fractures commonly associated with osteoporosis but are a unique drug side effect.

The bone fracture side effect risk may occur as part of the way Actonel and other bisphosphonates work. The primary effect from the medication is through slowing down the process of “bone remodeling” which repairs small cracks in the bone structure. Over time, the small breaks become numerous from everyday activity and causes bone structure to become brittle.

In March 2010, the U.S. Food and Drug Administration (FDA) investigated bisphosphonate drugs like Actonel after research conducted by the American Society of Bone and Mineral Research showed that rare but serious femur fractures are associated with long-term use of bisphosphonates.

The 2010 study published in the Journal of Bone and Mineral Research showed that 94 percent of femur fractures examined were caused by bisphosphonate medications, most of whom had taken the medication for five or more years. The research indicated that a warning sign of femur fracture related to Actonel or bisphosphonate use is persistent pain in thigh or groin.

Research has indicated that these types of bone fractures are usually rare. However, a study assessing the risk of atypical femur fractures showed an increased rate based on the duration of treatment from Actonel. The rates increased from 2 to 78 out of 100,000 per year between two and six years of treatment using Actonel.

Actonel Lawsuits

Healthcare giant Procter & Gamble has faced a number of Actonel lawsuits filed by people who may have experienced injury after taking the medication. Actonel is now manufactured by Allergan, who may also be facing a number of lawsuits for drug injuries including esophageal cancer, osteonecrosis of the jaw, bone fractures and other serious side effects. No group consolidations or settlements for Actonel lawsuits have been announced.

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