On April 10, 2006, a lawsuit was filed against Merck, the manufacturer of the bone density increaser drug, Fosamax. The lawsuit claims that Fosamax, rather than increasing bone density and strengthening bones, has actually caused, in some cases, a deterioration of the jaw bone. This condition is known as osteonecrosis of the jaw. If you or a loved one is or has ever taken Fosamax, the user may be entitled to settlement.
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Fosamax (Alendronate) was released in 1996 with its main function to increase bone density. The drug falls in a category of nitrogenous bisphosphonates. Other similar drugs in this category are used for treatments such as chemotherapy. Fosamax, when prescribed, is typically taken early in the morning, on an empty stomach, and the user must be sure not to lie down or eat anything else, including other medications, for 30 minutes.
Fosamax, as a prescription drug, can only be taken when prescribed by a licensed physician, and is then supposed to be taken only in the amount and frequency instructed by the prescribing doctor in California. Before Fosamax is prescribed, the user is warned about a number of potential side effects, including chest pain, difficulty or pain when swallowing, pain under the ribs or in the back, jaw pain, numbness or swelling of the jaw, heartburn, joint pain, or headaches. The user may even be told that “similar drugs” are believed to have caused breakdown of the jaw bone, or Osteonecrosis.
In 2002, the Women’s Health Initiative discovered that estrogen therapy, previously the primary treatment and prevention option for osteoporosis, had serious cancer risks. Directly as a result of this research, sales of drugs like Fosamax skyrocketed, and in early 2006 it was reported that nearly ten million (10,000,000) Americans were taking Fosamax. At this time, Merck was bringing in more than three billion dollars ($3,244,000,000) annually from Fosamax sales, making the bone density increasing drug their second biggest seller.
Fosamax is most often prescribed to patients suffering from post menopausal osteoporosis, steroid induced osteoporosis, or Paget’s disease. While it may have other uses as well, these are the primary intended uses as described by the manufacturer. These three conditions are similar in that they all result in low bone density from similar causes.
Normal, healthy bones are continually being broken down, recycled, and rebuilt. This is because bone, if simply built and left, will become brittle after only a few years. Your body understands that, and works very hard to combat brittle bones. However, in each of these conditions (two forms of osteoporosis and Paget’s disease), there is a problem with the recycling of the bones.
In osteoporosis, it is the rebuilding side of the cycle that is damaged. For various reasons, the rebuilding of bone matrix has been slowed down or stopped altogether. The bone is continuing, however, to be broken down at the normal rate, however, and this means the bone is continually being weakened, and becomes prone to fracture. Osteoporosis can affect any bone in the body, but common bones of most concern are the spine and hip, especially since fractures to these bones are especially dangerous and debilitating.
In Paget’s disease, however, it is the breakdown side of the cycle that has been affected. For reasons still unknown, the bone is being broken down faster than is normal, and in order to rebuild as fast as the bone is being broken down, the bone that is rebuilt is typically softer, more porous, and also has a greater volume of blood vessels. It is also possible that excess bone may be formed, and this may cause pain and increased risk of fracture. Paget’s disease can affect any bone in the body, but most commonly affects the skull, spine, pelvis, thigh (femur), and shin (tibia).
Fosamax was designed with the idea of reducing the risk of serious injury due to osteoporosis and Paget’s disease. In cases of osteoporosis, Fosamax works to slow the process of bone breakdown, allowing the body more time to rebuild strong, normal bone. It also actually helps to increase bone mass itself, therefore reversing the process of osteoporosis. In Paget’s disease, Fosamax slows down bone resorption, thus giving the body the time it needs to build healthy, non-porous bone.
Merck & Co., still facing over 9,000 lawsuits over its painkiller, Vioxx, is now being sued for misrepresenting the safety of the bone density increaser, Fosamax. Attorneys involved in the lawsuit allege that Fosamax is a defective drug, causing more harm than good. The lawsuit states that Merck & Co. intentionally concealed information of the dangers of Fosamax from the public, and also that the drug company refused to comply with an FDA request in August of 2004 to place specific additional warnings on all Fosamax labels.
In 1996, shortly after Fosamax was approved by the FDA for treatment of osteoporosis in post menopausal women, Merck & Co. launched an aggressive marketing campaign for the new drug. Many orthopedists claim that the marketing campaign, which was aimed at women aged between 40 and 50, may have overemphasized the risk of hip fracture as a scare tactic, and may have promoted Fosamax prescriptions to women who did not need the drug, and were not at a great risk of developing osteoporosis any time in the near future. While aggressive marketing is not illegal, it did draw a large amount of undue attention to Merck’s new drug, and this may have been one factor leading to such a large lawsuit.
Studies in the past six years have suggested that Fosamax may have some connection with new instances of osteonecrosis of the jaw bone. In fact, a study released in April 2006 stated that nearly 2,500 users of Fosamax have developed osteonecrosis of the jaw, 120 others suffered incapacitating pain to joints, bones, or muscles, and that 1,100 new cases of osteonecrosis directly related to Fosamax use were discovered in the preceding six month period.
Other studies also suggest that while Fosamax does, in fact, increase bone density, it does nothing to reduce the risk of fractures. Some studies have even suggested that long term use of Fosamax may make bones more brittle and more likely to fracture. That Fosamax has not been proven to produce any benefit to its users is why the lawsuit alleges that the drug causes more harm than benefit.
In August 2004, the FDA issued a request that Merck & Co. alter the warning label on Fosamax labeling to include more aggressive warnings of the risks of osteonecrosis due to regular Fosamax use. Lawyers in the suit allege that Merck & Co. has not complied with this request. Fosamax attorneys, however, say that the request to change labeling was received in January 2005, and that by July 2005 all labeling had been changed in cooperation with the FDA’s request.
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