Quantcast
35.7 C
United States of America
Friday, July 30, 2021

FDA to Cut Broadly Worded Statin Pregnancy Contraindication

Must read

FDA to Cut Broadly Worded Statin Pregnancy Contraindication

The US Food and Drug Administration (FDA) aims to update the labeling on all statins to remove the drugs’ blanket contraindication in all pregnant patients, the agency has announced. The change should reinforce for both physicians and patients that statin use in women with unrecognized pregnancy is unlikely to be harmful, it said.

“Because the benefits of statins may include prevention of serious or potentially fatal events in a small group of very high-risk pregnant patients, contraindicating these drugs in all pregnant women is not appropriate.”

The revision should emphasize for clinicians “that statins are safe to prescribe in patients who can become pregnant and help them reassure patients with unintended statin exposure in early pregnancy” the FDA explained.

- Advertisement -

Removal of the broadly worded contraindication should “enable health care professionals and patients to make individual decisions about benefit and risk, especially for those at very high risk of heart attack or stroke.” That includes women with homozygous familial hypercholesterolemia and those who are prescribed statins for secondary prevention, the agency said.

Clinicians “should discontinue statin therapy in most pregnant patients, or they can consider the ongoing therapeutic needs of the individual patient, particularly those at very high risk for cardiovascular events during pregnancy. Because of the chronic nature of cardiovascular disease, treatment of hyperlipidemia is not generally necessary during pregnancy.”

Follow Steve Stiles on Twitter: @SteveStiles2. For more from theheart.org, follow us on Twitter and Facebook.

Read more
This post originally posted here Medscape Medical News

- Advertisement -
FDA to Cut Broadly Worded Statin Pregnancy Contraindication
Newslanes Mediahttps://newslanes.com
Newslanes.com is the leading e-news platform for the latest breaking news of world today. The news repository targets everyone after factual and well-researched information from a dedicated global team of news reporters and editors.
- Advertisement -

More articles

LEAVE A REPLY

Please enter your comment!
Please enter your name here

This site uses Akismet to reduce spam. Learn how your comment data is processed.

- Advertisement -

Latest article