Mumbai: A cardiac risk associated with Pfizer Inc.’s newly launched kidney cancer drug Sutent may trigger a regulatory review of the product that was launched in January in India.
The India launch was based on global data on the drug’s performance and side effects, but a month after this, a small study in the US reported a disproportionately high number of heart failures among its users. The drug was launched in the US in Miami, Florida, on 20 March 2006.
The office of India’s drug regulator, the drug controller general of India (DCGI), is yet to call for a review of the drug, but experts here say that considering the high risk, reported as 15% in the study, the drug should be subjected to a risk-benefit analysis.
The country’s former drug controller general, M. Venkateswarlu, under whose reign this drug was approved in India, said: “In case of more adverse reports coming during post-marketing, the regulator would normally redo a risk-benefit analysis and the product will be recalled if the risks are higher than the benefit, and if it is the other way, the product may still be continued with caution.”
Pfizer, the world’s top research spender, said “cardiovascular events” have been observed with Sutent and are included in the approved product labelling with recommendations for monitoring in patients with cardiac risk factors.
A Pfizer spokesperson said nearly half the patients in the latest study had pre-existing hypertension, a cardiac risk factor. A history of congestive heart failure, coronary artery disease and low body mass index were factors that appeared to be associated with increased risk from the drug.
Sutent, also known by its chemical term sunitinib malate, is prescribed for patients with advanced kidney and stomach cancer.
The study by a team of US researchers, published in the first week of February, said seven of 48 patients who took the drug, or nearly 15%, developed heart failure. Adverse reaction in 8-15% of the patients is considered high in a normal drug risk-benefit analysis.
A senior official at India’s Central Drug Controls Standard Organization, who did not want to be identified, said: “The department has not heard any adverse instances from Pfizer and the department may act appropriately if there are any.”
The organization prescribes standards for drugs and cosmetics in the country.
Certain drugs are approved in India without clinical trials if they are of a life-saving nature and needs of patients are of an immediate nature. As a result, the adverse reactions of such drugs are not immediately known and approvals are based on global data available, Venkateswarlu said.
In May 2007, the US Food and Drug Administration, the country’s drug regulator, had approved safety labelling revisions to advise of cardiovascular and other risks associated with the drug; the agency is yet to respond to the recent study. Sutent was originally approved in January 2006.