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Actonel is a medication that is intended to treat osteoporosis. It is similar to Boniva and Fosamax and it is a nitrogenous bisphosphonate. Actonel is supposed to slow down the process of bone breakdown in patients with osteoporosis. Like all of the nitrogenous bisphosphonate drugs, those who have been prescribed this medication have reported that they have suffered a rare type of fracture in their femur. This is backed up by several published studies. As a result, Procter & Gamble Pharmaceuticals and Warner Chilcott Pharmaceuticals have faced numerous lawsuits. In addition, there is litigation about Fosamax that has made its way all the way to the United States Supreme Court. If you or a loved one has been prescribed Actonel and have suffered an atypical femur fracture, you should immediately contact an actonel lawsuit lawyer to discuss the facts of your case.

What is Osteoporosis?

The natural process of bones is that they continuously break down over time. However, bones also will regenerate, leading to a constant amount of bone in the body. Osteoporosis is what happens when the body either loses too much bone or the bone does not regenerate. This conditions leads to either an outright loss of bone or bone density. As a result, bones tend to become more brittle. Those who suffer from osteoporosis may have a degeneration of their posture or their bones may become more brittle and susceptible to fracture.

Osteoporosis is a common condition. Approximately 54 million Americans suffer from it and it becomes more likely as a person ages. Women are nearly twice as likely as men to suffer from osteoporosis. There are nearly two million bone fractures every year as a result of the condition. The economic costs of osteoporosis are large, nearing $20 billion each year.

What is Actonel and How Does it Work?

Actonel is one of a class of nitrogenous bisphosphonates. The medication was developed by Sanofi-Aventis and Procter & Gamble. In 2009, Warner Chilcott Pharmaceuticals bought the patent for the drug. After the patent expired, numerous drug makers launched generic versions of the medication.  Actonel originally had a dominant position in the market for drugs to treat osteoporosis. However, the loss of the patent as well as other classes of newer drugs have combined to reduce the sales. Nevertheless, the sales of the drug still exceeded $150 million in 2014.

In bone resorption, osteoclasts break down the tissue in bones. This results in the minerals in the bone being released into the bloodstream. The most prevalent of these minerals is calcium. Medications that have bisphosphonates limit the resorption of bone. They have an affinity to bind to calcium, helping them stay in the bone. They are then ingested by osteoclasts and work to inhibit enzymes that are found in the osteoclasts. This helps prevent the osteoclasts from breaking down the bone.

Actonel can be used to treat not only osteoporosis, but also a number of different conditions that impact bone density. Conditions such as multiple myeloma, avascular necrosis and Paget’s disease can lead to bone loss. Actonel works against these conditions in the same manner that it can treat osteoporosis.

Side Effects of Actonel | actonel lawsuit

The standard side effects of Actonel include upset stomach, muscle pain and joint pain. However, there are other more severe side effects that have caused drastic consequences for those who have suffered them. As stated above, Actonel does aim to reduce the activity of the osteoclasts. However, at the same time, it also increases the bone mineralization, which can make the bones more brittle, even if they have a higher density.  While Actonel does attempt to reduce the breakdown and regeneration of bones, it can also have negative consequences for the patient. The limitation of this process may weaken the existing bone, making the patient more susceptible to fractures.

Specifically, with regard to Actonel and the other bisphosphonates, patients have reported suffering spontaneous fractures. The most prevalent type of fractures that has been reported is that of the femur bone. The location of the fracture is just below the hip joint, which is a rare type of break.

In the wake of numerous reports of these types of fractures, the FDA issued an announcement in March 2010 that stated that it was reviewing reports of a connection between the drug and femur fractures and was undertaking more study. At the time, it stated that it did not have enough evidence of a connection.  However, the FDA convened a task force to study the issue further. Shortly thereafter, the results of the study were published, and they stated that there was evidence of a connection between bisphosphonates and this specific type of femur fracture.  As a result, the FDA added information about the possibility of a femoral fracture to the warning label for the drug. It also required a Medication Guide for all bisphosphonates.

There is another side effect from the drug that also resulted in FDA action. Specifically, the jaw bone is weakened and disintegrates in response to the medication.  There are then holes where the jawbone is missing and the patient develops open sores. This will result in the need for significant dental surgery.  In addition, the FDA has also issued a safety advisory warning of a possible link between bisphosphonates and esophageal cancer.

Lawsuits Against Procter & Gamble and Warner Chilcott Pharmaceuticals

There have been hundreds of lawsuits filed against the manufacturers of these drugs involving femoral fractures sustained by those who have been taking the drug. These lawsuits have alleged that the product is both defectively designed and that the manufacturer failed to warn plaintiffs of the dangers associated with both femoral fractures and osteonecrosis of the jaw.  Warner Chilcott is no stranger to litigation involving Actonel. It settled with the U.S. Government for $125 when it was charged with paying physicians kickbacks to prescribe the medication.

Merck’s Fosamax, which is of the same class as Actonel, has also seen its fair share of litigation for similar side effects. There have been several verdicts against Merck’s for similar issues as have been associated with Actonel.  In addition, Merck had settled some of the claims. There is currently a case pending in front of the United States Supreme Court. Merck had supplied information to the FDA about femoral fractures and proposed warning language. The FDA took issue with the proposed warning language and the sides had some back-and-forth about the right language for the warning label. The plaintiffs were injured after Merck alerted the FDA, but before warning language was agreed upon.

There may still be more Actonel lawsuits filed against the drug makers. The drug has a long life in the body which can be as long as ten years. As such, potential plaintiffs may still be experiencing the side effects from this drug that they were prescribed before the FDA warning. They would then have the period of the statute of limitations to file suit after they sustained their injury.

If you have taken Actonel and have suffered any one of these side effects, you should immediately contact a Actonel lawsuit attorney to discuss whether you have a viable legal claims against the manufacturers of this drug. You may be entitled to financial compensation for the harm that you have suffered. As with any personal injury case, you would hire the  Femur fracture lawsuit lawyer on a contingency basis. In other words, you owe the Actonel lawsuit attorney nothing unless you are able to recover some sort of compensation, whether it be a settlement or a jury verdict.

Sources:

https://www.nof.org/patients/what-is-osteoporosis/