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Lawsuits, warnings from the U.S. Food and Drug Administration (FDA), and numerous studies have linked the osteoporosis drug Fosamax to severe side effects, including osteonecrosis of the jaw (ONJ) and femur fractures.
If you suffered these side effects while taking this drug, you should contact one of our defective drug attorneys about filing a Fosamax lawsuit. The purpose of a lawsuit is to try to obtain fair compensation for the effects of your injuries, including medical expenses, lost wages, and physical pain. We have the resources to conduct an in-depth investigation to help build a strong case in defense of your rights.
Your consultation with our attorneys is completely free and we do not charge legal fees unless our clients receive compensation at the end of the legal process.
FOSAMAX SIDE EFFECTS
Alendronate, known by the brand name Fosamax, is one of many drugs used to treat osteoporosis. This condition causes bones to become brittle due to a loss of tissue and is a threat for tens of millions of men and women who are 50 years old or older, according to statistics published by the International Osteoporosis Foundation.
Fosamax received FDA approval in 1995 and generated billions in revenue for manufacturer Merck & Co. Fosamax belongs to a class of drugs called bisphosphonates, which are designed to increase bone density by slowing the natural process of breaking down bone.
The problem with Fosamax is it has been linked to serious side effects, such as ONJ and femur fractures.
OSTEONECROSIS OF THE JAW
ONJ is a serious bone disease that causes part of the jaw bone to become exposed. This causes decreased blood flow to the area, weakening the bone and causing it to die. If this happens for longer than eight weeks, it may be diagnosed as ONJ.
This condition often occurs in people who are taking antiresorptive medications for the treatment of cancer or osteoporosis. Bisphosphonates like Fosamax may cause ONJ because they make it harder for bones to heal after they are damaged.
Many cases of ONJ occur after someone has dental work, such as having a tooth extracted, according to the American College of Rheumatology.
Another potential side effect of Fosamax is fractures of the femur, which is the bone in the thighs. Fosamax can increase the risk of fractures because it increases the bone’s mineral density. Increasing the density might sound like a good thing, but it actually does not make the bone stronger. Fosamax also inhibits the body from forming new bone.
Femur fractures are extremely dangerous because they can cause life-threatening complications, like blood clots, infections or pneumonia. Even if you do not suffer life-threatening complications, you could experience severe bruising, muscle spasms, numbness and swelling in the hip.
Our attorneys may be able to help you file a Fosamax lawsuit to try to obtain compensation for the injuries you have suffered.
FDA WARNINGS ABOUT FOSAMAX
The FDA has issued multiple warnings about potential side effects of taking Fosamax and other bisphosphonates.
WARNING ABOUT ONJ
In 2005, the FDA made an announcement that it was possible for bisphosphonates to cause ONJ. The announcement said the benefits outweighed the risks for patients who had suffered post-osteoporotic fractures. Not long after that, Merck added a warning about the risk of ONJ to the Fosamax label.
The Fosamax medication guide currently notes that the drug may cause severe jaw bone problems. Doctors should examine patients’ mouths before prescribing the drug. The medication guide also says patients should practice good mouth care when they are treated with Fosamax.
WARNING ABOUT FEMUR FRACTURES
On Oct. 13, 2010, the FDA released a drug safety communication about the risk of atypical fractures of the thigh in patients taking bisphosphonates for osteoporosis.
The communication warns about two types of atypical fractures: subtrochanteric and diaphyseal femur fractures. Subtrochanteric femur fractures are fractures of the bone right below the hip joint. Diaphyseal fractures are in the long part of the thigh bone.
The communication notes that these injuries represent fewer than one percent of hip and femur fractures. It is unclear if these fractures are caused by bisphosphonates, but many of them have been reported in patients who are taking these types of drugs.
The drug safety alert says atypical femur fractures could be related to long-term use of Fosamax or other bisphosphonates. The FDA updated the limitations of use statement on the labels of these types of drugs to say there is uncertainty about the length of time these medications should be taken to treat or prevent osteoporosis.
The FDA advised doctors to be aware of the risk of fractures and to discontinue these medications in patients who have evidence of a femoral fracture. Patients are advised to immediately talk to their health care provider about hip or thigh pain, as it could be evidence of a fracture.
The FDA decided to release this communication after reviewing all available data about femur fractures from bisphosphonates. This includes data from the American Society for Bone and Mineral Research Task Force about bisphosphonates and femur fractures.
In May 2012, the New England Journal of Medicine published a report where the FDA reiterated its concerns about ONJ and femoral fractures from taking medications like Fosamax.
The report also said women who do not have osteoporosis do not seem to get many benefits from taking the drugs for more than five years. The authors of the report said, given the concerns about side effects, patients should be able to stop taking the drugs after five years, particularly if they have a low risk of fractures.
STUDIES ON RISKS OF FOSAMAX
Research has consistently shown a link between taking Fosamax for osteoporosis and side effects like ONJ and femur fractures.
In 2014, the Journal of Oral and Maxillofacial Surgery published a study about the link between ONJ and bisphosphonates in Sweden. Researchers found the incidence of ONJ in patients taking bisphosphonates was 100 times greater than in patients who were not taking these medications. However, the incidence of ONJ was once every 62 years.
In 2008, Harvard health Publishing released an article about research on the link between taking Fosamax and suffering femur fractures.
The article says doctors at New York’s Hospital for Special Surgery were able to identify 70 patients who suffered low-energy fractures between 2002 and 2007 – 25 had been taking Fosamax. Doctors also found 19 of the 25 were patients who had been taking the drug the longest. On average, these 19 had been taking the drug for seven years. Doctors reached the conclusion that a significant risk factor for low-energy femur fractures is Fosamax use.
Another study from 2016 from Indiana University revealed that one-third of women who are prescribed bisphosphonates like Fosamax have an elevated risk of bone fracture. The study relied on research from the Regenstrief Institute-Merck on 7,435 women age 50 or older taking these medications for at least two years between 2000 and 2012.
Thousands of lawsuits have been filed against Merck by people who suffered ONJ or femur fractures while taking Fosamax.
By 2006, so many Fosamax lawsuits had been filed over ONJ that the U.S. Judicial Panel on Multidistrict Litigation decided to consolidate many of them into one legal action, called a multidistrict litigation (MDL). An MDL is put under the supervision of one judge to help streamline the legal process when many cases have similar allegations.
Once an MDL is created, the judge selects some lawsuits as bellwether cases, or test cases. The purpose of a bellwether case is to help show both parties how trials are likely to go. If the victims prevail in multiple bellwether trials, the product manufacturer is likely to attempt to settle the rest of the cases.
One of the first bellwether cases from the Fosamax MDL was a lawsuit filed by Florida woman who took Fosamax from 1997 to 2006. The jury awarded her $8 million for damages caused by ONJ. However, the judge said this award was excessive and gave the victim the option of a retrial or settlement of $1.5 million. The victim decided to accept the $1.5 million settlement.
There were four other bellwether cases that went to trial in this MDL. Three were decided in favor of Merck, while the fifth trial resulted in a $285,000 verdict for the victim. The victim was diagnosed with ONJ after having a tooth extracted in 2006. She took Fosamax from 2000 to 2006.
The jury in this trail ruled Merck failed to warn the woman about the risk of developing ONJ while taking Fosamax.
In 2013, Merck proposed a $27.7 million settlement of 1,140 Fosamax lawsuits alleging the drug caused ONJ. The victims accepted the settlement, resolving many of the cases about ONJ. There is currently only one pending lawsuit in the MDL, according to the U.S. Judicial Panel on Multidistrict Litigation.
FOSAMAX LAWSUITS ABOUT FEMUR FRACTURES
There is also an MDL for Fosamax lawsuits regarding fractures of the femur. This MDL is in a district court in New Jersey and has 561 pending cases as of Feb. 2018.
These lawsuits claim Merck concealed the risks of Fosamax, grossly exaggerated the chances of the drug reducing fractures and over-promoted the drug for non-approved, off-label uses.
As of March 2018, there have been no settlements of any Fosamax cases concerning femur fractures. There are also no trials scheduled for any of these cases.
CONTACT OUR ATTORNEYS TODAY ABOUT FILING A FOSAMAX LAWSUIT
If you suffered severe side effects while taking Fosamax, you may be able to file a lawsuit to pursue compensation for the damages you have suffered. Compensation cannot change what happened, but it can help as you attempt to move forward with your life.
The attorneys at our firm understand the devastation from a defective drug and that is why we are committed to fighting for all the compensation you deserve.
Your consultation with our attorneys is free and you will not be charged legal fees unless you receive compensation.