Learn More About Fosamax Claims
Fosamax (generic name alendronate) is a drug designed to slow bone loss and increase overall bone density. It was approved by the Food and Drug Administration (FDA) in 1995, as a treatment for osteoporosis and Paget's disease (Paget's disease is a chronic bone disorder which can lead to arthritis, deformity and fractures. It is also known as osteitis deformans.)
Fosamax is manufactured by Merck & Co. and classified among a group of medicines known as bisphosphonates. Other bisphosphonate brand names are: Aredia, Zometa, Boniva and Actonel. Recipients for these medicines are most often postmenopausal woman, men with osteoporosis, steroid users, chemotherapy patients or Paget’s disease patients. Bisphosphonates may also be prescribed for purposes other than those listed.
The FDA says that Fosamax was the most commonly dispensed bisphosphonate in America from 2001-2004. In 2004, the total number of Fosamax prescriptions exceeded 22-million.
According to some legal experts, Merck has downplayed the dangerous side effects of Fosamax, namely its link to osteonecrosis of the jaw (ONJ) -- or dead jaw -- which is a rare bone disease in which the jaw bone deteriorates and dies. If you have developed ONJ as a result of Fosamax usage, contact a Fosamax lawyer, personal injury attorney, or pharmaceutical attorney.
Since 2001, more than 2,400 patients have reportedly been diagnosed with ONJ after taking Fosamax or one of the other bisphosphonate medications. Most of these were patients who were taking the drug intravenously. However, even patients on the pill were not immune. Many people taking Fosamax orally became bedridden or found themselves needing walkers, crutches or wheelchairs as a result of their debilitating pain.
In September 24, 2004 -- after establishing the link between ONJ and bisphosphonates -- the FDA issued an alert to warn of the risks. This resulted in an additional warning on the Fosamax label in 2005.
It is alleged that: 1/ Fosamax has shown a higher incidence of ONJ than other bisphosphonates, and 2/ Merck failed to update its Fosamax warning label promptly enough, thereby subjecting millions of users to unnecessary health risks during the lag time. This failure to notify users of the inherent risks could give you an opportunity to receive financial retribution for the damages done to you from Fosamax. A qualified personal injury attorney, pharmaceutical lawyer, or Fosamax attorney can help sort through the legal paperwork.
While both men and women may be prescribed bisphosphonates, over 36 million women take the medication to prevent or slow osteoporosis following menopause -- and that number is said to be increasing.
In the past, women relied on hormone replacement therapy (HRT) to keep their bones healthy after menopause. But following studies which linked estrogen with the increased risk of heart disease and breast cancer, more women turned to Fosamax and other bisphosphonates at younger ages. It is these women who are now at an increased risk of ONJ because they will be on the drug for a longer time.
According to the New England Journal of Medicine, Fosamax has also been linked to irregular heartbeats or atrial fibrillation. The other less severe drug side effects of Fosamax include: heartburn, abdominal pain, irritation of the esophagus, headache, jaw pain, pain in muscles and joints, constipation, diarrhea, flatulence, difficulty swallowing and allergic reactions.
Fosamax should not be taken by pregnant women or persons with severe kidney problems, heartburn or inflammation of the esophagus. It should not be taken at the same time with parathyroid hormone. In order to build or maintain bone density, Fosamax and parathyroid hormone can be taken at alternate times – such as one for the first year followed by the second for the next year. If your doctor failed to take this into account in prescribing Fosamax, a medical malpractice lawyer will be of assistance.
The long-term effect of taking bisphosphonates such as Fosamax is not known.
Who Can Sue
Legal experts say that by September, 2008, over 340 Fosamax lawsuits had been filed against Merck.
If you or a loved one has been injured due to Fosamax or another bisphosphonate drug, contact a personal injury attorney, Fosamax lawyer, or pharmaceutical attorney to see if you are eligible to receive a financial settlement.
In some states, patients who are injured by unsafe medicines are entitled to recovery for ‘loss of enjoyment of life’ in addition to their lost wages, medical expenses and pain and suffering. A pharmaceutical lawyer or personal injury attorney can explain the process needed to seek reimbursement.
In April, 2006, a class action lawsuit was filed against the manufacturer of Fosamax. A qualified pharmaceutical attorney who is skilled in drug effects law can review the facts of your case and quickly advise you as to whether you would be better off joining with others in an existing class action or filing your own individual lawsuit. If you have experience adverse effects after using Fosamax, contact a pharmaceutical lawyer, Fosamax attorney, or personal injury lawyer for legal consultation.
Merck has defended Fosamax, saying that the clinical evidence shows no rise in fractures. Nevertheless, as of Sept. 30, 2008, Merck had reportedly set aside $48 million in Fosamax litigation reserve funds. This is a significantly lower figure than the billion dollar-plus litigation reserve it set aside for its Vioxx lawsuits.
Vioxx and Fosamax were Merck's two best selling drugs. In 2003, the last year Vioxx was manufactured, it generated $2.5 billion in sales. In 2005, Fosamax sales totaled $3.2-billion.
Directions for using Fosamax state that it must be taken first thing in the morning -- at least 30 minutes before eating or drinking -- along with a full glass of plain water. No other medicines may be taken with it.
For 30 minutes after taking a Fosamax tablet, the patient may not lie down or even slightly recline. If a person cannot stand or sit upright for 30 minutes, they may not take Fosamax.
Fosamax side effects are said to be uncommon if taken as directed.
Serious problems with bone healing, particularly after dental surgery, have been found in some people taking bisphosphonates. If a person is on Fosamax and needs dental surgery, they must first consult with their doctor.
Do not take Fosamax late in the day if you miss your dose in the morning. If you are taking Fosamax, you should also take calcium and vitamin D supplements.
Because calcium supplements may interfere with the body's ability to absorb bisphosphonates they should not be taken in the morning along with the Fosamax.
Studies show that in people with osteoporosis, Fosamax lowered the risk of fractures of the vertebrae by 50% and other bone fractures by 30% to 49%. A study of postmenopausal women who took Fosamax for 10 years reported increased bone density and effective prevention of fractures. Bone density again decreased when Fosamax use was stopped.
A study by the Women’s Health Initiative showed that taking Fosamax with hormone therapy (HRT) resulted in increased bone mass as compared to taking Fosamax or estrogen alone. But because HTH puts a woman at risk for certain diseases, experts recommend that only women with a significant risk for osteoporosis use long-term HRT.
In men, Fosamax increased bone density in the spine and hips and helped to prevent spinal fractures and decreases in height.
A pharmaceutical attorney, personal injury lawyer, or drug effects lawyer will be able to help pursue retribution for damages.
Lawsuits have already been filed against Merck & Co. for injuries caused by Fosamax. The Fosamax drug side effect that has been at the center of most of the legal action is osteonecrosis of the jaw (ONJ), or ‘dead jaw.’
A 57 year-old Pensacola, Fl., woman claimed that her six year use of Fosamax -- prescribed to treat her osteoporosis -- resulted in "significant bone loss in her jaw" as well as tooth rot. Her attorney was quoted as seeking "seven figures" in this personal injury claim.
There is also a class action lawsuit pending against Merck on behalf of the hundreds of Fosamax patients who developed ONJ. It is expected that Merck will offer some kind of financial compensation to the claimants, however, a settlement agreement has not yet been reached.
Our experienced Fosamax Litigation Attorneys can help you figure out who is liable for your injuries and seek financial assistance in your recovery.
Fosamax, Merck's other drug problem
Information on Bisphosphonates