Parker Waichman LLP Warns Against Long-Term Use of Fosamax, Other Bisphosphonates In Light of Limited Benefits, Risk of Atypical Thigh Fractures, Other Side Effects

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FDA Analysis Published in New England Journal of Medicine Finds Little, if any Benefit, from Bisphosphonates Beyond Five Years of Use.

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Considering all of the unknowns surrounding the long-term use of Fosamax and other bisphosphonates, women need to discuss the risk and benefits of these drugs with their doctors

Parker Waichman, a national law firm committed to protecting the legal rights of people injured by defective drugs, is urging women who use Fosamax and other bisphosphonates to treat osteoporosis to seek the advice of their doctor if they have been taking the drugs for five years or more. A recent analysis performed by the U.S. Food & Drug Administration (FDA) and published in the New England Journal of Medicine (NEJM) has found that taking bisphosphonates beyond five years offers few, if any, benefits to patients. [nejm.org/doi/full/10.1056/NEJMp1202619]

In addition to Fosamax, other bisphosphonates include Actonel (risedronate), Boniva (ibandronate), Atelvia (risedronate delayed release), Didronel (etidronate), and Skelid (tiludronate), and Reclast (zoledronic acid injection).

According to the NEJM report, the FDA's analysis involved a review of previously released studies that included more than 2,400 post-menopausal women. One of the studies involved Fosamax and continued for 10 years. The FDA’s analysis of that study revealed that 10.6 percent of those who received the drug suffered a fracture during the first three years of use, compared with 21 percent given a placebo. However, no benefit was seen in women who continued taking Fosamax beyond five years.

A second study reviewed by the FDA involved women treated with Reclast who were followed for six years. In that trial, 9.8 percent of women treated with Reclast suffered a fracture in the first three years of the study, compared with 20 percent of women who were taking a placebo. However, by 3 to 6 years of use the gap narrowed, with 8.6 percent of Reclast users experiencing fractures, compared with 12 percent in the placebo group.

The FDA analysis did not offer much in the way of guidance regarding long-term bisphosphonate use, saying treatment decisions should be based on an individual assessment of risks, benefits and preferences discussed between a patient and her doctor.

According to Parker Waichman LLP, the authors of the study point out that the long-term safety and effectiveness of bisphosphonates has come under scrutiny because of the occurrence of rare but serious side effects such as atypical femur (thigh bone) fractures, osteonecrosis of the jaw (ONJ), and esophageal cancer. The FDA ordered that warnings be added to the labels of Fosamax and other bisphosphonates regarding their risk of ONJ in July 2005. [merck.com/newsroom/news-release-archive/corporate/fosamax_statement.html]

In October 2010, the agency asked the manufacturers of bisphosphonates used to treat osteoporosis, including Fosamax and Boniva, to add information to the "Warnings and Precautions" section of the drugs’ labels describing the risk of atypical thigh fractures after a study linked long-term use of such drugs to this side effect. [fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm229171.htm]

The FDA is currently investigating a possible association between oral bisphosphonates and esophageal cancer. [http://www.fda.gov/Drugs/DrugSafety/ucm263320.htm

Considering the lack of evidence indicating that long-term use of bisphosphonates provides any benefits to patients, Parker Waichman LLP urges women who have been taking these drugs for five years or more to seek the advice of their physician.

"Considering all of the unknowns surrounding the long-term use of Fosamax and other bisphosphonates, women need to discuss the risk and benefits of these drugs with their doctors,” says Matthew McCauley who is the leading attorney in the bisphosphonate litigation group at Parker Waichman LLP. "From the FDA analysis, it certainly doesn't appear that there are any good reasons why most women taking bisphosphonates for osteoporosis or osteopenia should continue doing so after five years."

Parker Waichman LLP continues to offer free legal consultations to victims of bisphosphonate side effects. If you or a loved experienced an atypical femur fracture, ONJ, or any other side effect that could be associated with the use of Fosamax or another bisphosphonate, please contact their office by visiting the firm’s bisphosphonate side effects page at http://www.yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).

For more information regarding bisphosphonates side effect lawsuits and Parker Waichman LLP, please visit: http://www.yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).

Contact:
Parker Waichman LLP
Gary Falkowitz, Managing Attorney
(800) LAW-INFO
(800) 529-4636
http://www.yourlawyer.com

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Herb Waichman, Partner
Parker Waichman LLP
(800) 529-4636
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