In an article printed this week,British Medical Journal has raised questions about the safety of a class of new-age drugs touted not only as a wonder cure for type 2 diabetes but also hailed for its possible potential as a weight loss agent. The BMJ article talks about heightened risk of pancreatic cancer in mice models and hints that companies marketing the drugs may not be telling doctors the whole truth about it.
Coming after an announcement in March that the US Food and Drug Administration is evaluating unpublished data that suggest an increased risk of pancreatitis or inflammation of the pancreas,and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with drugs called incretin mimetics Januvia by Merck is the best known in its class in India the BMJ article,doctors here say,is creating waves. Merck says in absence of any compelling evidence on the contrary,it stands by the drugs safety profile.
An independent analysis of health insurance data published in February found that people taking exenatide and sitagliptin were at twice the risk for acute pancreatitis compared with people taking other antidiabetic drugs… the absolute risk 0.6 per cent. And in April an analysis of data from the US Food and Drug Administrations adverse event reporting system showed an increase in reports for pancreatitis and pancreatic cancer in people taking incretin mimetics compared with those taking other antidiabetic drugs, reads the article.
Drugs in the incretin mimetic class include exenatide (Byetta,Bydureon),liraglutide (Victoza),sitagliptin (Januvia,Janumet,Janumet XR,Juvisync),saxagliptin (Onglyza,Kombiglyze XR),alogliptin (Nesina,Kazano,Oseni),linagliptin (Tradjenta,Jentadueto). They work by mimicking the incretin hormones to stimulate the release of insulin in response to a meal. They are used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. Many of these drugs come with a warning of possible risk of pancreatitis,but the spectre of pancreatic cancer raised by the article that may have been kept away from doctors and patients is disturbing,says Dr Amrish Mithal,chairman of the department of endocrinology and diabetes at Medanta – the Medicity. This class of drugs has changed diabetes management. That there is a mild risk of pancreatitis is well known and we take precautions while prescribing even though it has never been proved in large clinical trials. The reports of pancreatic cancer are disturbing and even more so are the claims made in the article that companies may be hiding data, he said.
Dr Anoop Misra chairman,department of diabetes and metabolic diseases,Fortis Hospitals,however,points out that all the quoted data is in animals and nothing has been proven yet.
In an e-mailed response,Merck,which markets sitagliptin in India as Januvia,said: Nothing is more important to us than the safety of our medicines and the people who take them… The weight of all available evidence supports the current safety profile of sitagliptin,and we find no compelling evidence of a causal relationship between sitagliptin and pancreatitis or pancreatic cancer.