FDA Warns Fosamax May Cause Bone Fractures

Fosamax and its class of osteoporosis drugs increases the chances of a bone fracture, according to a warning to doctors and patients released by the Food and Drug Administration (FDA) on Wednesday. The FDA has asked for a change in how the Warnings and Precautions section is labeled on all bisphosphonate products. Bisphosphonates are a class of drugs primarily used to treat the symptoms of osteoporosis, a bone disease that weakens the bone's density and can make it more likely to break. According to the FDA, this class of drugs must now be accompanied by a medication guide that alerts people taking the drug of its risks.

The FDA warning comes as the result of a rare type of bone fracture repeatedly occurring in patients receiving these drugs. Currently, many doctors believe that the risk of bone fracture are rare and more closely associated with patients who have long-term bisphosphonate use. "There is a dull aching thigh or groin pain that occurs weeks or months before the fracture occurs," Dr. Sandra Kweder, deputy director, Office of New Drugs in the FDA's Center for Drug Evaluation and Research. "It is predominantly in patients who have taken bisphosphonates for five years or more."

The changes to be made on the warning labels are will only occur on bisphosphonates that have been approved for osteoporosis treatment. These drugs include: Actonel, Actonel with Calcium, Atelvia, Boniva, Fosamax, Fosamax Plus D and all of their respective generic versions. Included in the changes of warning labels are the injectable osteoporosis drugs like Boniva and Reclast Reclast. Bisphosphonates that are labeled for use in the treatment of other diseases will not be affected.

The FDA first began studying the side-effects of bisphosphonate use and the frequency of the bone and femur fractures in March. The FDA was also made aware of and reviewed a report issued by the American Society for Bone Mineral Research Task Force. The report made a strong recommendation to add additional labeling, in addition to adding a system that would identify and track patients with femur and bone breaks.

Fosamax Side Effects

Drug manufacturer Merck & Co.'s bisphosphonate drug Fosamax and Fosamax D has been associated with numerous serious side effects. Patients using Fosamax can often suffer from a multitude of Fosamax side effects like gastrointestinal tract abnormalities, which can include:

• Abdominal cramping
• Diaherrhea
• Flatulence
• Obstipation
• Ulcers on the esophagus

The side effects that impact the GI are typically considered to be relatively mild. There are also a few general Fosamax side effects that may occur from long-term use of Fosamax:

• Problems with the eyes
• General pain of the joints, muscles or bones
• Skin rash (with potential of developing Stevens Johnson Syndrome)

Osteonecrosis of the Jaw and other Serious Fosamax Side Effects

While some of the side effects mentioned above can potentially become severe in nature, the most dangerous and serious Fosamax side effect is the manifestation of a bone disease known as osteonecrosis of the jaw (ONJ), or "dead jaw."

Osteonecrosis of the jaw is a kind of bone disease that is usually associated with the large joints of the body such as the ankles,hips, knees, or elbows. The manifestation of osteonecrosis is tied to the temporary or even sometimes permanent loss of blood to the bone tissue of the jaw, this leads to the death of the jaw bone tissue and the inevitible collapse of the bone. Currently there are an estimated 10,000 to 20,000 new cases of osteonecrosis discovered each year in just the United States alone, most of these cases are the result of some kind of bone injury like a dislocation or fracture.

Users of Fosamax are putting themselves at risk of suffering through the severe pain that is commonly associated with osteonecrosis of the jaw and the death of the jawbone tissue. The severe pain that is associated with osteonecrosis has been reported as being like the extreme level of pain often suffered by arthritics. Common symptoms of the onset of ONJ usually include localized pain of the jaw,numbness or altered sensation in the jaw area, loosening of the teeth, infections of soft tissue, and bone exposure inside the oral cavity.

People taking Fosamax that are displaying any these severe osteonecrosis symptoms should contact their doctor immediately. If ONJ goes undetected or untreated, it can typically lead to the bone tissue death and joint collapse within the jaw, an irreversible condition.

Fosamax Lawsuit

Due to the serious nature of some of these Fosamax side effects, Merck & Co. has once again become the target of numerous personal injury lawsuits filed by individuals who have been victimized by the bisphosphonate.

If you or a loved one has been severely injured as a result of using a bisphosphonate drug like Fosamax, you may be eligible to receive compensation for your pain and suffering. Merck & Co. are currently facing a multitude of personal injury liabilities that are related to side effects that resulted from the use of Fosamax.

Fosamax Lawsuit Update

Fosamax Lawsuit News Update

In 2005 popular osteoporosis drug Fosamax, was linked to severe musculoskeletal pain (bone, joint and muscle pain), as well as a painful bone disease called ONJ, also known as "fossy jaw". The Journal of Oral and Maxillofacial Surgeons published an article exploring the association between people who were taking Fosamax and Osteonecrosis of the Jaw, which caused the FDA to examine the safety of Fosamax and other drugs in its class. Merck, the company that manufactures Fosamax, received a notice on January 31, 2005, from the FDA requesting the company to update the label for Fosamax and to include notices regarding the jawbone tissue disease. The revised labels weren't made available until July 2005.

The US Food and Drug Administration warned on January 7, 2008, that Fosamax had been linked to severe and sometimes incapacitating joint, muscle and bone pain. The agency advised doctors and patients that they be aware of this possible side effect, and to discontinue Fosamax if it should occur.

About FosamaxFosamax (Generic Name: Alendronate Sodium), manufactured and distributed by Merck, gained FDA approval in 1995. Fosamax Plus D (Generic Name: Alendronate Sodium Cholecalciferol) contains the additive Vitamin D. Fosamax is usually prescribed for the treatment of osteoporosis and Paget's disease. Fosamax is a type of drug known as bisphosphonates. Persons using Fosamax or other bisphosphonate medications should try to avoid tooth extractions and other major dental work while prescribed the drugs.

About BisphosphonatesBisphosphonate medications are commonly taken in tablet form for the prevention and treatment of osteoporosis in post-menopausal women. More powerful forms of bisphosphonate drugs are administered in the management of cancers that have metastasized to the bones. When bisphosphonates are prescribed in cancer chemotherapy, the drugs are given in higher doses and intravenously for a longer period of time.

More About Osteonecrosis of the Jaw (ONJ)"Fossy jaw" is a disease in which the bone tissue of the jaw fails to heal after a minor trauma such as a tooth removal, causing the bone to be exposed. The exposed boneexposure can lead to fracturing and infection and often requires surgery or long-term antibiotic therapy to get rid of the dead bone tissue. The prevention and early treatment of people given Fosamax or other bisphosphonates is very important in preserving the jawbone. Signs of "jaw death" may include: the swelling of the gums, jaw or facial pain, loose teeth, excessive drainage, exposed jaw bone, facial numbness, or a feeling of heaviness in the jaw. The development of Osteonecrosis of the jaw is preceeded by the loss of blood being supplied to the jaw. Fosamax reduces the activity of the cells that cause bone loss, which is supposed to lower the fast rate of bone loss in women after menopause. Sadly, this exact drug mechanism may be what causes osteonecrosis of the jawbone.


Fosamax and Extreme Musculoskeletal PainThe severe musculoskeletal pain commonly associated with Fosamax can occur within days, months, or years after starting treatment with the drug, according to the 2008 Food and Drug Administration Fosamax health alert. While some patients that have obtained complete relief of symptoms after discontinuing Fosamax, others have reported that the pain has continued.

While severe musculoskeletal pain was already included in the prescription information for Fosamax, the FDA stated that the direct link between Fosamax and extreme musculoskeletal pain could be ignored by health care providers, resulting in impairment, prolonged pain, delayed diagnosis and possibly needing treatment with pain medication. The FDA has recommended that healthcare professionals be mindful that the administering of of Fosamax may be responsible for extreme musculoskeletal pain in individuals who have these symptoms. If individuals taking Fosamax do experience this extreme musculoskeletal pain, the Food and Drug Administration advises that their healthcare professionals,healthcare providers,doctors consider permanently discontinuing taking the drug.

If you or a loved one has been severely injured as a result of Fosamax, you may be eligible to receive compensation for your pain and suffering. Merck & Co. are currently facing  hundreds of personal injury lawsuits that are related to side effects that resulted from the use of Fosamax.