The cancer and liver toxicity risks of Bristol-Myers Squibb Co. (BMY) and AstraZeneca Plc (AZN)’s diabetes medicine may outweigh any benefit the drug has on the heart, U.S. regulators said.
The pill, potentially the second to reach the market in a new class of diabetes drugs, has cardiovascular benefit including lower blood pressure and weight loss. Food and Drug Administration staff members were wary that the heart benefits were enough to balance an increased risk of bladder cancer and indications of liver damage, according to a report posted today ahead of a Dec. 12 meeting of advisers to the agency.
The FDA rejected dapagliflozin in January 2012 after a previous advisory panel raised concern about the potential association with cancer. Today’s report cited trials showing increased liver enzymes that indicate damage to the organ of those who took the diabetes pill and an increased potential for heart attack and stroke soon after starting treatment, though FDA staff said there is a long-term cardiovascular benefit.
“As a result of these updated analyses the agency could not conclude with any level of confidence that the purported CV-benefit associated with dapagliflozin use outweighed the observed imbalance in specific malignancies or potential liver toxicity risks,” Jean-Marc Guettier, director of the FDA’s endocrinology product division, wrote in today’s report.
The FDA is scheduled to decide whether to approve the diabetes treatment by Jan. 11. The agency approved Johnson & Johnson (JNJ)’s Invokana in March for Type 2 diabetes that was the first in a class of therapies like dapagliflozin called SGLT2s, which expel sugar in the urine after the kidneys filter it from the blood. New Brunswick, New Jersey-based J&J must study the effects of the pill on the heart while its on the market.
Graham
1 comment:
It has occurred to me recently that no Dr has ever discussed the risks of any form of medication for diabetes with me. In fact when questioned they usually try to reassure me that they are very safe,Sometimes this is because they don't know and sometimes it is well- meant but it is only by persistence -and often prior knowledge I can get any sense.
I can never forget that when financial incentives were offered to put T2s onto insulin the Practice DSN assured me that it didn't have a downside although a Dr had already told me that insulin was not a good idea for me -it had health implications.
Neither can I forget refusing pioglitazone on the grounds that rosiglitazone had caused my macular oedema. I had no access to information at the surgery but it just seemed obvious to me. The nurse ranted at me but when I checked later the NHS own leaflet on macular oedema stated on the first page that pioglitazone should not be given where macular oedema was present as it would make the condition worse and lead quickly to blindness.
Looking at these new drugs it certainly seems to be the case that patients should be made aware of the risks.
That obviously won't happen though they will be told that a drug will protect against cardiovascular problems but not that there is a higher risk of bladder or liver cancer before the cardiovascular benefits can take effect.
Once the drugs are out there and the Nurse Practitioners are prescribing them willy nilly it will be too late.
I don't know about DUK's 15 checks which I always think fairly meaningless as the support doesn't exist and isn't likely to i the near future there needs to be some urgent discussion on patient consent and information at primary care level.
Kath
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