Fosamax and osteonecrosis of the jaw


Published on - It has been reported that a drug manufactured by Merck & Co. Inc., known for its brand name as Fosamax, may cause osteonecrosis of the jaw (ONJ) after prolonged use. Osteonecrosis means bone death. It originates from the Latin word "osteo" which means bone and "necrosis" which means death. Osteonecrosis happens when the blood supply to a bone is suspended. Commonly, it happens at the end part of the bone where blood supply is most at risk. Necrosis is also known as avascular meaning "without blood supply" and ischemic meaning "inadequate blood supply".

Published in: Health & Medicine
  • 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

    Paul J. Molinaro, M.D., J.D.
    Attorney at Law, Physician
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Fosamax and osteonecrosis of the jaw

  1. 1. As Published on the Fosamax Femur Fracture Lawsuit Website
  2. 2. It has been reported that a drugmanufactured by Merck & Co. Inc., known forits brand name as Fosamax, may causeosteonecrosis of the jaw (ONJ) after prolongeduse.
  3. 3. Osteonecrosis means bone death. It originatesfrom the Latin word "osteo" which means boneand "necrosis" which means death.Osteonecrosis happens when the blood supplyto a bone is suspended. Commonly, it happensat the end part of the bone where blood supplyis most at risk. Necrosis is also known asavascular meaning "without blood supply" andischemic meaning "inadequate blood supply".
  4. 4. When osteonecrosis of the jaw symptomsdevelop, it is often caused by some type ofinvasive dental procedure like tooth extraction,dental implant and bone surgery. These dentalprocesses may bare the jawbone and generatethe rise of ONJ symptoms. However, the linkbetween Fosamax and ONJ may be quite trickyas there are Fosamax users who are not takingthe drug religiously.
  5. 5. Gums and the surroundingsoft tissues may becomeinflamed and painful. One’steeth or tooth may becomeloose. The mandibular ormaxillary bone may beexposed through thelesions in the gingiva. Thepatient may feel the jawbecoming heavy andinsensible.
  6. 6. Bisphosphonate drugs likeFosamax have beenassociated with ONJ cases.Fosamax belongs to the classof drugs known asbisphosphonates. Thesefamily of drugs work bytrimming the old bone thatbreaks down. People sufferingfrom osteoporosis or at highrisk of developing the samemay take Fosamax oralendronate hydrochloride toprevent bone loss.
  7. 7. It is also used by people for the treatment ofPagets disease. Fosamax has been one of themost prescribed brands to treat osteoporosisin recent years. However, several complaintshave been raised due to the rapid increase ofthe occurrence of ONJ among users.ONJ incidence appears to be uncommon inpeople taking oral bisphosphonates such asFosamax, according to recent data. Thecausative link between bisphosphonate drugsand Fosamax has not been settled.
  8. 8. The principally reportedFosamax side effects such asfemur fracture andosteonecrosis of the jaw havenot been categorically provenand further studies are stillbeing made.Yet it have not stopped some people fromfiling for a Fosamax femur fracture lawsuit.Notwithstanding, the FDA has advised themanufacturers of all bisphosphonate drugs toinclude a warning in their labels about thedanger of osteonecrosis of the jaw, and Merckthe manufacturer of Fosamax did so last year.