Fosamax, Actonel and Boniva May Cause Femur Fractures and Esophageal Cancer

Two FDA committees on Sept. 9 recommended that labels for bisphosphonate drugs be changed due to the risk of fractures.

In a 17-6 vote, the committees said the FDA should clarify how long patients should take the drugs, which are prescribed to treat osteoporosis.  The committees were the Reproductive Health and the Drug Safety and Management advisory committees.
The drugs, sold as Fosamax, Actonel and Boniva, have previously been linked to osteonecrosis of the jaw (ONJ), a condition in which new jaw bone fails to grow and the jaw "dies." More recently, studies have linked the drugs to fractures of the femur and to esophageal cancer.

Litigation of claims for ONJ has been ongoing in a multidistrict litigation in the U.S. District Court for the Southern District of New York and in the Atlantic City Superior Court in New Jersey. An MDL for cases alleging femur fractures was recently created in the District of New Jersey.

If you or someone you know took either Fosamax, Actonel and Boniva and either suffered a femur fracture or have been diagnosed with esophageal cancer, please call Claudine Homolash at (215) 790-7379 or email chomolash@sheller.com

Use Of Avastin or Sutent and I.V. Bisphosphonates May Increase Osteonecrosis of Jaw (ONJ) Risk

MHRA Warns UK Doctors To Monitor Cancer Patients For ONJ Where There Is Concomitant Use Of These Drugs - Pfizer Sends "Dear Doctor" Letter in the UK but Not to Doctors in the U.S.

On November 30, 2010, the Medicines and Healthcare products Regulatory Agency (MHRA) issued two new safety warnings to doctors and other healthcare providers in the UK concerning the cancer drugs Avastin and Sutent.

The first item, "Avastin (bevacizumab) Cases of osteonecrosis of the jaw in patients with cancer treated with bevacizumab and concomitant or previous use of bisphosphonates", simply identified the nature of this emerging drug safety issue:

Cases of osteonecrosis of the jaw (ONJ) have been reported in cancer patients in association with Avastin treatment, the majority of whom had received prior or concomitant treatment with i.v. bisphosphonates.

Avastin treatment may be an additional risk factor for the development of osteonecrosis of the jaw....

Avastin is from the drug company Roche.

The second item, "Sutent (sunitinib) Cases of osteonecrosis of the jaw in patients with cancer treated with sunitinib and concomitant or previous use of bisphosphonates", included a so-called "Dear Doctor" letter from Pfizer with some more information about the extent of this problem, at least as it regards Sutent:

From 26 January 2006 (International Birth Date [IBD]) through 31 January 2010, the worldwide estimated exposure to Sutent is 101400 including post-marketing and clinical trials worldwide.

Overall, a total of 27 cases of ONJ have been reported as of 31 January 2010....

To date, Pfizer has only issued a Dear Doctor Letter in the UK even though Sutent is also sold in the U.S.

If you have suffered an injury related to Avastin or Sutent and have questions regarding your legal rights, please call me.

Claudine Homolash, Esquire
(215) 790-7379
Sheller, P.C.