Widely used cholesterol-lowering drugs, also known as statins, will have to carry safety warnings stating that they could cause memory loss and could increase blood sugar levels.
Following the recommendation of the US FDA, India has decided to use safety changes in the labels of statins. In his recent letter to the state licensing authorities, the Drug Controller-General of India has asked them to make sure that the safety changes are made in the labelling. The action was taken following the recommendation of the US FDA which had warned early this year that some statins could raise blood sugar levels and cause memory loss. Accordingly, the FDA had announced safety changes to the labelling for these drugs. The matter was considered by the New Drugs Advisory Committee which decided to implement the warnings in India too.
The labels have been revised to remove the need for routine periodic monitoring of liver enzymes in patients taking statins. According to the FDA recommendation, liver enzyme tests should be performed before stating statin therapy. “FDA has concluded that serious liver injury with statins is rare and unpredictable in individual patients and the routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing this rare side-effect,” the letter said.
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India votes against UNGA resolution
Yoshita Singh
United Nations, Nov. 20
India was among the 39 countries that voted against a UN General Assembly draft resolution which called for abolishing the death penalty, saying every nation had the “sovereign right” to determine its own legal system.
The non-binding resolution called for a moratorium on executions with a view to abolishing the death penalty.
It was adopted on Monday at the General Assembly’s Third Committee, which deals with social and humanitarian issues, after 110 nations voted in favour of the resolution while 36 abstained.
The draft resolution expresses its “deep concern about the continued application of the death penalty and calls on states to establish a moratorium on executions, with a view to abolishing the practice”.
— PTI