FOSAMAX, ZOMETA, AND BISPHOSPHONATES INFORMATION
The Nations Law Firm represents people who have been injured by dangerous medications, such as Fosamax and Zometa. If you or someone you know has used Fosamax, Zometa or other bone density drugs and has suffered from osteonecrosis of the jaw (ONJ) or other serious side effects, please contact our offices for a free consultation with one of our pharmaceutical attorneys.
BISPHOSPHONATE ISSUES
- Bisphosphonates are drugs commonly used in the treatment of osteoporosis and cancer.
- Osteonecrosis of the jaw (ONJ) has been associated with the use of bisphosphonates.
- Symptoms of ONJ include jaw pain, toothache, exposed bone, swelling and loosening of the teeth, altered sensation and recurrent soft-tissue infection.
- ONJ frequently results in chronic pain and disfigurement, and is difficult to treat.
- Having dental work done while using bisphosphonates increases the chance of getting ONJ.
- Since 2001, more than 2,400 people taking bisphosphonates have reported ONJ.
- Warnings about the link between bisphosphonates and osteonecrosis of the jaw were issued in 2004.
Fosamax and Zometa are included in a category of drugs called bisphosphonates. These drugs, used for cancer and osteoporosis, have been linked to spontaneous occurrences of a serious and disabling condition called osteonecrosis of the jaw, also known as jaw bone death.
If you or someone you know has used Fosamax, Zometa or other bisphosphonate drugs and has suffered from osteonecrosis of the jaw (ONJ) or other serious side effects, please contact our offices for a free case evaluation.
WHAT ARE BISPHOSPHONATES?
Bisphosphonates are drugs used to treat and prevent bone loss. Since 1995, they have been commonly prescribed for the prevention and treatment of osteoporosis in post-menopausal women. For the past 15 years, they have been widely used in the management of advanced cancers that have metastacized to the bone.
The following medications are bisphosphonates:
- Fosamax (Alendronate Sodium)
- Zometa (Zoledronate)
- Didronel (Etidronate)
- Aredia (Pamidronate)
- Actonel (Risedronate)
- Boniva (Ibandronate)
- Skelid (Tiludronate)
RISKS AND INJURIES
Osteonecrosis of the jaw (ONJ), also known as dead jaw or jaw bone death, is a serious and disabling complication that has been associated with the use of bisphosphonates. Symptoms of ONJ include jaw pain, toothache, exposed bone, swelling and loosening of the teeth, altered sensation and recurrent soft-tissue infection. The condition results in chronic pain and disfigurement and is resistant to treatment.
Since 2001, more than 2,400 people taking bisphosphonates have reported jaw bone death. Most of these people were taking the stronger IV form of the drug. An additional 120 people who took the milder pill form reported severe bone, muscle or joint pain leaving them bed-ridden or in need of crutches, walkers or wheelchairs. These findings were published in the Journal of Oral and Maxillofacial Surgery. The majority of the reported cases were in cancer patients who underwent dental procedures, such as tooth extractions, while receiving bisphosphonate therapy. Patients are now being advised to avoid invasive dental procedures during bisphosphonate therapy. Although the majority of ONJ cases involved dental procedures, some of them did not.
The risk factors for developing osteonecrosis of the jaw (ONJ) include the following:
- Taking bisphosphonates, especially in IV form
- History of cancer, osteoporosis or Paget’s disease
- Concomitant therapies (e.g. chemotherapy, radiotherapy, corticosteroids)
- Co-morbid conditions (e.g. anemia, coagulopathies, infection, pre-existing oral disease)
- Invasive dental procedures (e.g. tooth extraction or dental implants)
THE DRUG COMPANIES
In September 2004, Novartis Oncology updated the labels on their two bisphosphonate drugs - Aredia Injection and Zometa Injection to include a warning about osteonecrosis of the jaw. The FDA and Novartis issued warnings and “Dear Healthcare Provider” letters were sent on September 24, 2004.
But, for many people, these warnings came too late. According to the numerous lawsuits on file, the drug companies knew about the risks of ONJ long before they issued any warnings. Yet they made a conscious decision to conceal this information from consumers in order to protect their profits.
LEGAL RECOURSE
Our law firm represents people across the country who have been injured by Fosamax, Zometa and other bisphosphonate medications. Pharmaceutical companies owe a moral and legal responsibility to the public to ensure that the medications they manufacture and market are not unreasonably dangerous and to ensure that the consumer is made aware of the risks associated with the medication. The business of pharmaceuticals in the United States is highly competitive and is worth billions of dollars. Unfortunately, some pharmaceutical companies are hastily introducing and marketing new drugs prematurely and without adequate warnings, resulting in tragic losses that could have been avoided.
In an effort to efficiently manage the high number of individual lawsuits filed against the drug companies, multi-district litigations (MDLs) have been created. Under this procedure, the individual cases are transferred into one court where all pre-trial proceedings take place.
Zometa and Aredia MDL
Status: Active since 4-18-06
In Re: Aredia and Zometa Products Liability Litigation
MDL No. 1760. United States District Court for the Middle District of Tennessee
Fosamax MDL
Status: Active since 8-16-06
In Re: Fosamax Products Liability Litigation
MDL No. 1789. United States District Court for the Southern District of New York
If you or someone you know has used Fosamax, Zometa or other bisphosphonate drugs and has suffered from osteonecrosis of the jaw (ONJ) or other serious side effects, please contact our offices for a free case evaluation.
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