A number of recent studies have reasserted the connection between serious side effects like osteonecrosis of the jaw, and the use of the bisphosphonate drug Fosamax. Fosamax, was originally approved by the Food and Drug Administration in 1995 to treat bone deterioration resulting from osteoporosis and other bone diseases. However, since 2001, a number of Fosamax consumers have reported the development of osteonecrosis of the jaw, or ONJ, a severe bone disease resulting in the damage or death of portions of the jaw bone. On the heels of a study published in the Journal of Oral and Maxillofacial Surgery, the FDA released a Fosamax warning to patients and health professionals regarding the drug’s potential connection to severe cases of osteonecrosis of the jaw.
Osteonecrosis of the jaw is a disfiguring and disabling condition in which the jaw bones suffer catastrophic damage or death through infection and rotting. Under normal circumstances, bone is constantly breaking down and rebuilding itself, replacing old bone with new in order to maintain the strength of our skeletons. In an individual with osteonecrosis of the jaw however, bone tissue breaks down faster than the body can repair it, causing major bone deterioration. Some of the main symptoms of osteonecrosis of the jaw include loose teeth, pain, swelling or infection of the gums or jaw, gum loss, drainage of jaw abscesses, and exposed bone through missing gum tissue.
One of the major causes of osteonecrosis of the jaw is the use of bisphosphonate medications like Fosamax, which can inhibit bone turnover and result in permanent bone decay and debilitating bone diseases. The only treatment options currently available to individuals suffering from osteonecrosis of the jaw is antibiotic therapy and surgery, which is extremely risky. Individuals who decide to undergo surgery will require the removal a large portion of the jaw bone, possibly leaving the patient unable even to chew solid foods. Antibiotics are also typically administered to ONJ victims during and after dental surgery in order to prevent infection.
Extensive research has indicated that while Fosamax may initially effectively prevent bone loss, over time it may inhibit the bone’s natural ability to protect itself from harm. So, by taking a medication like Fosamax to prevent bone loss, an individual may actually be gradually causing permanent bone damage and decay. The dangerous side effects associated with Fosamax have been apparent since 2001, but the FDA’s Fosamax warning wasn’t released to the public until 2004. Merck & Co., the manufacturing company responsible for Fosamax has been accused of intentionally concealing the dangers of the drug and for waiting too long to take action once the drug’s potential for harm was discovered. During this time, people may have continued to take Fosamax, unaware of the permanent harm they may have been subjecting themselves to at the hands of a reckless drug manufacturing company.
Before a drug can be approved by the FDA, it must participate in clinical trials performed by the drug manufacturing company in order to ensure its safety. Unfortunately, many manufacturing companies intentionally fail to notify the FDA of the most serious side effects associated with their drug, in order for it to be approved more quickly. This deceptive practice leaves countless consumers at risk for developing significantly harmful conditions like osteonecrosis of the jaw. These negligent pharmaceutical companies are responsible for the safety of their drug even after it enters the market; they should be held accountable for the injuries sustained by people who take the drug as well, especially if they have been misinformed of the drug’s harmful nature. Consumers assume that a drug is safe if it is approved by the FDA and made available to the public, and most people expect that, besides a few minor side effects, the drug will not cause them any harm. Unfortunately, the side effects associated with Fosamax are far beyond minor; they are significant and catastrophic.
Despite these dangers, Fosamax remains on the market today, and it is estimated that nearly ten million people have taken or are currently taking Fosamax, the most popular of the bisphosphonate medications. Individuals who have been injured as a result of taking Fosamax should consider how a Fosamax lawsuit can benefit them. A number of individuals have already filed lawsuits against Merck, accusing the company of being aware of the drug’s connection to osteonecrosis of the jaw and failing to alert the public. Victims of Fosamax injuries like osteonecrosis of the jaw are not at fault and may be entitled to reimbursement for their injuries. If you or a loved one has suffered from osteonecrosis of the jaw associated with the use of Fosamax, contact a Fosamax attorney for legal advice. Fosamax lawyers are experienced in defective drug litigation and can help you collect the compensation you deserve.