Hyderabad: For the third time this year, the medicine valsartan is being recalled by the US Food and Drug Administration (FDA). This time, the recall is from an Indian company. The FDA has recalled the combination medicines of amlodipine, valsartan and hydrochlorothiazide manufactured by Teva Pharmaceuticals.
The combination medicine is used for treating blood pressure. The earlier recall of valsartan was in September where it was found that it contained N-nitroso-diethylamine, a chemical classified as a human carcinogen.
N-nitroso-diethylaimine is a naturally occurring chemical in some foods and is found in drinking water. It is also one of the pollutants in the air due to industrial processes.
The FDA suspects that the tablet Irbesartan is contaminated and has recalled the products.
In July, the FDA had traced the N-nitroso-dimethylamine contamination of valsartan back to its active pharmaceutical ingredients. This contamination was found to originate in the manufacturing processes of Chinese pharmaceutical firms, and their use was stopped.
India imports a lot of active pharmaceutical ingredients from China. After the FDA’s July alert, the active pharmaceuticals import of valsartan into India was stopped. Valsartan is commonly prescribed to treat high blood pressure in India. Cardiologists state that it is an important drug and people must not stop taking it without speaking to their doctors.
Dr K.K. Aggarwal, a senior cardiologist, said, “The adverse effects of the contaminated drug are giddiness, nausea, fatigue. If these symptoms are noticed, the patients must immediately notify their treating doctor. Do not change the medication without consulting your doctor.”
Cardiologists have been asked to check with their patients and report the adverse effects if any to the drug controller or the hospital committee. But so far, there have not been any reports.
A senior pharmacist on condition of anonymity said the adverse effects of the drugs are to be dealt with by the pharmaco-vigilance cell or the adverse effects committee in hospitals.
“But these are not there. The doctors do not report any symptoms as that system has not been inculcated. It is a process where the adverse effects have to be noted and then followed up. This is the work of pharmacists but they are not notified hence it is not recorded.”
