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October 18, 2010

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Paul J. Molinaro, M.D.,J.D.

The prescription drug Fosamax (the generic is alendronate sodium) is a medication which has been prescribed to hundreds of thousands of postmenopausal women to treat osteoporosis and help increase bone mass thereby reducing the chance of spinal or non-spinal fractures. Fosamax has also been prescribed to increase bone mass in men with osteoporosis. Brand name Fosamax is manufactured in the United States by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. In about 2008-2009, Fosamax became widely available in its generic form (alendronate sodium).

Side effects of Fosamax may include the following:
1. Esophagus problems including irritation, inflammation, or ulcers
2. Low blood calcium levels (hypocalcemia) which may lead to muscle spasms, twitches, or cramps as well as numbness or tingling in the face, fingers, toes, and around the mouth
3. Severe jaw bone problems (osteonecrosis of the jaw often abbreviated as “ONJ”)
4. Bone, joint, or muscle pain
5. Unusual femur (thigh bone) fractures

ABC News ran a story on May 10, 2012 about the dangers of “bone drugs” stating, “In a report published in the New England Journal of Medicine on Wednesday, the U.S. Food and Drug Administration raised concerns about the potential for some serious side effects in women taking bone-building drugs called bisphosphonates, specifically Fosamax, Actonel and Reclast. The published findings are not new. In 2011, the agency voiced concerns that taking the drugs long-term may actually make bones weaker and increase the risk of rare but serious side effects such as atypical fractures of the thigh bone, esophageal cancer and osteonecrosis of the jaw, a rare but painful condition in which the jaw bone crumbles. To investigate, the FDA reviewed data from women who had taken the drugs for six to 10 years.” Underscoring just how commonly these medications are prescribed, ABC News commented, “According to the FDA, doctors wrote more than 150 million prescriptions for bisphosphonates between 2005 and 2009.”

At the end of 2013, Merck settled with about 1,200 plaintiffs alleging that Fosamax caused them to suffer osteonecrosis of the jaw (“ONJ”). ONJ is a rare condition in which the patient suffers degeneration and deterioration of the jaw and often necessitates surgical repair with bone grafting. This recent settlement requires a total of about $27.7 million to be paid by Merck. Before anyone feels bad for Merck, he or she should also know that some researchers estimate that Merck “earned” about $3 billion (with a “b”) in 2007 from Fosamax. There are still many unsettled suits.

While alendronate sodium does have some appropriate indications, there are serious side effects which can occur. Most of the lawsuits focus on one of two harms – femur fractures or osteonecrosis of the jaw. Each is treated differently by many of the lawyers handling these cases. If someone has taken brand name Fosamax and suffered either of these harms, he or she should immediately consult with his or her physician and then consult with an attorney who is experienced in handling such a matter.

Paul J. Molinaro, M.D., J.D.
Attorney at Law, Physician
Fransen & Molinaro, LLP
4160 Temescal Canyon Road, Suite 306
Corona, CA 92883
(951)520-9684
www.fransenandmolinaro.com / www.888MDJDLAW.com

"When you need a lawyer, call the Doctor... Call Paul J. Molinaro, M.D., J.D... Call (888)MDJDLAW."

* This post and all others I make on Internet are for informational purposes only. None of the information or materials I post are legal (or medical) advice. Nothing I post as comments, answers, or other communications should be taken as legal advice for any individual case or situation. This information is not intended to create, and receipt or viewing of this information does not constitute, an attorney-client relationship. While I try to be accurate, I do not guarantee accuracy.

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I'm just glad that by treating children I don't have to worry about bisphosphonates. I have enough headaches already.

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Very informative article especially for those who are not yet aware of what's going on with bisphpshonate drugs. Moreover, one of these these drugs, Fosamax to be exact, is the subject of a number of Fosamax lawsuits filed by patronizers who are allegedly harmed by the use of it over a long course.

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What would be the most likely health outcomes if people were scared off taking their bisphosphonates by overhyped media reports? Funny that you should ask, because a study of this has already been done in Australia where medical and prescription drug records are available to researchers owing to governmental benefits programs. According to Sambook et al 2010, adverse media reports on the side effects and risks for bisphosphonates appearing in Australia last year probably resulted in the ensuing nine months in 70 more hip fractures, 60 more other fractures (largely vertebral) and 14 more deaths, than would have occurred if the patients had simply stuck to taking them.

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