The US FDA (Food and Drug Administration) plans to modify labelling on all statins to change the blanketed contraindication on the drugs in all pregnant patients. Statins, a group of lipid-lowering drugs, are used to help reduce illness and mortality of patients who are at a high risk of cardiovascular disease. In their announcement, the FDA explained that this update should assure clinicians that statins are safe to prescribe in patients who may become pregnant and that due to the benefits of statins, “contraindicating these drugs in all pregnant women is not appropriate”. By removing the previously broadly- worded contraindication, the update should give health care workers and their patients the opportunity to make tailored decisions about the benefits and risks on an individual patient level, particularly for patients with a higher risk of heart attack or stroke. Elaborating on this, the FDA explained that this encompasses patients with homozygous familial hypercholesterolemia and those who take statins for secondary prevention. Clinicians should also take into account ongoing therapeutic needs of individual patients with very high risk for cardiovascular events during pregnancy.

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