MHRA Warns UK Doctors To Monitor Cancer Patients For ONJ Where There Is Concomitant Use Of These Drugs
(Posted by Tom Lamb at DrugInjuryWatch.com)
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....
We will watch to see whether there is a similar drug safety warning about Avastin and/or Sutent forthcoming from the FDA as well as whether any Dear Doctor letters are sent out in the U.S. by Roche or Pfizer.
P.S. "Bevacizumab [Avastin] and sunitinib [Sutent]: risk of osteonecrosis of the jaw" (January 2011, MHRA's Drug Safety Update newsletter)
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