AstraZeneca: FDA orders safety label changes in statins

The U.S. Food and Drug Administration (FDA) requests several cholesterol-lowering drugs called statins to contain warnings that they may raise blood sugar levels or cause short term cognitive side effects such as memory loss of confusion. AstraZeneca’s (LSE: AZN, OMXS: AZN, NYSE: AZN) blockbuster Crestor (rosuvastatin)for the treatment of dyslipidaemia is a member of the statin class of drugs. It is supposed to work by lowering LDL-C (‘bad’ cholesterol) and raises HDL-C (‘good’ cholesterol).

On the other hand FDA is saying there is no longer a need for routine monitoring of liver enzymes as liver damage stemming from the use of these drugs is rare and unpredictable. The agency now asks liver enzyme tests to be done before starting statin therapy.

There has been a hot debate on the merits of the entire class of drugs with some claiming their benefits are small while others naturally disagree. Several of the medicines gross billions and thus are integral for several large pharmaceutical companies.