BP drug recalled, docs say no adverse effects reported

The adverse effects of contaminated drugs are giddiness, nausea and fatigue which have to be notified to the treating doctor. Experts state that the reporting of adverse effects in India is restricted to only a few hospitals.

Valsartan, a drug prescribed for hypertension management, is being recalled off by the Food and Drug Administration in the United States for the chances of developing cancer. But cardiologists state that no adverse effects have been reported in India so far.

The adverse effects of contaminated drugs are giddiness, nausea and fatigue which have to be notified to the treating doctor. Dr P.L.N. Kaparthi, senior interventional cardiologist at Apollo Hospitals, explained, “Only a few batches of valsartan drug produced by Zhejing Huahai Pharmaceutical Company in China and Hetero Labs in India are being recalled. Valsartan is an important drug for hypertension management and patients must not stop taking this drug without consulting their doctor. There were no negative reports in India but if there are any symptoms of nausea, giddiness, fatigue, severe headache or confusion, people must consult their doctor.”.

The active pharmaceutical ingredient (API) is produced in China and there has been a contamination of N – nitrosodi-methylamine impurity which is a potential carcinogen. NMDA is also found in low levels in food products but the levels were found to be high in the API used for valsartan. Hence, the drug is being recalled from the scale in 20 countries.

Dr Anup Agarwal, senior consultant cardiologist, explained, “The efficacy of valsartan is not questioned here. It is the contamination in the manufacturing plant which is an issue. If 8,000 people take the highest dose of valsartan 320 mg for a period of four years, studies suggest one of them will have a trigger for cancer as per the estimation. Hence people must not panic. There are also alternatives available for valsartan and if they want to change the medication, patients must consult their doctor. There is a need for Indian drug control authorities to aggressively test the available drugs in the Indian market, which is wide and diverse, for impurity. There is a need to have our own Indian list of products which are being recalled. This will help doctors prescribe alternate combinations and also avoid those batches which have impurity.”

Experts state that the reporting of adverse effects in India is restricted to only a few hospitals. Hence, if there are no reported cases it does not mean that there will not be any.

Drug Control authorities must test the existing batches and check the contamination levels.