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.
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Perspective of a Legal Specialist in Whistleblower Law and Pharmaceutical Injury
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