Navigation Links
American Heart Association comment: FDA announces safety changes on labeling for some statins
Date:2/29/2012

The United States Food and Drug Administration (FDA) announced it is revising safety information on the labels of some statins (cholesterol lowering drugs).

Statins are a class of drugs that work in the liver to prevent the formation of cholesterol. They are most effective at lowering the LDL (bad) cholesterol, but also have modest effects on lowering triglycerides (blood fats) and raising HDL (good) cholesterol. High cholesterol is a risk factor for cardiovascular disease and stroke.

The FDA changes to the statin labels include:

  • Revising the drug labels to remove the need for routine periodic monitoring of liver enzymes in patients taking statins.
  • Including labeling information about some patients experiencing memory loss and confusion.
  • Warning healthcare professionals and patients of the potential risk of increased blood sugar levels and of being diagnosed with type 2 diabetes mellitus.

The announcement also alerts health care professionals to new recommendations in the lovastatin label, including drug interactions like those with drugs used to treat HIV (protease inhibitors).

"The FDA's announcement on the label changes does not question the benefit of statins to lowering cholesterol, but it does provide patients and healthcare providers the most current information about the safe use of statins," said Gordon F. Tomaselli, M.D., president of the American Heart Association.

"Not surprising, but important for practitioners with regard to routine liver function test screening, which is no longer recommended, but should be done at baseline and for symptoms. This will change practice although I will remain vigilant in people with prior history of liver disease, people who drink or who are taking multiple drugs metabolized by the liver. Also, the contraindications of use of in particular anti-HIV drugs with Mevacor (lovastatin) are important to reemphasize as is the known but infrequent increase in blood sugar in patients taking statins."

Tomaselli says "while we recommend healthy people focus on prevention using lifestyle changes rather than drug therapy whenever possible, for some people, lifestyle changes aren't enough. As with all therapies, the decision to use statins for primary or secondary prevention must include careful consideration of the risks and benefits, side-effects and cost. Working with your healthcare provider to be sure you're doing what you need to do to stay healthy is the best approach."


'/>"/>

Contact: Julie Del Barto
julie.delbarto@heart.org
214-706-1173
American Heart Association
Source:Eurekalert

Related medicine news :

1. The North American Menopause Society (NAMS) reassures many women
2. In Tougher Economy, Fewer Americans Get Colonoscopy
3. Colon Cancer Alliance and American College of Radiology demand Medicare cover virtual colonoscopy
4. Hispanic Americans Born Outside Country Have Fewer Strokes
5. Hepatitis C Now Kills More Americans Than HIV
6. American Society of Hematology statement on critical methotrexate drug shortage
7. Millions of Americans Have Untreated Hearing Loss: Study
8. More Than 4 Million Americans Have New Knee
9. 4.5 million Americans living with total knee replacement
10. More Americans Seeking Love Online: Study
11. Too Few Americans Getting Screened for Common Cancers: CDC
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/26/2017)... ... May 26, 2017 , ... ... year’s recipient of proceeds from its 14th Annual Clays for Kids fundraiser, to ... Road 30, Bennett, Colorado. , As part of BluSky’s partnership with The ...
(Date:5/26/2017)... ... ... Jack: Against All Odds”: the story of Coach Cactus Jack and the impact he ... creation of published author, Walter Hubbard, a retired wildlife and fisheries biologist and pharmacy ... Walter and Jane have three adult children and a granddaughter. Walter and ...
(Date:5/24/2017)... ... May 24, 2017 , ... Last month, representatives from ... employees, and town officials to celebrate the grand opening of the 87,000 square ... as part of its ongoing relationship with RWJBarnabas Health, New Jersey’s largest health ...
(Date:5/24/2017)... ... May 24, 2017 , ... Dr. Alan I. Benvenisty, MD is dual board ... He is known for his distinguished expertise and experience in the diagnosis and treatment ... training in treating renovascular disease and aortic aneurysm . He is known for ...
(Date:5/24/2017)... ... May 24, 2017 , ... ... management and interpretation, has received U.S. Food and Drug Administration (FDA) 510(k) ... web-based, scalable and secure cloud platform for medical image management. At the core ...
Breaking Medicine News(10 mins):
(Date:5/10/2017)... May 10, 2017 Global Health Intelligence ... Latin America , published its 2017 ranking of the ... based on extensive data analysis from GHI,s hospitals database ... database for the region. The GHI database covers 86% of ... more than 130 data points for each institution in key ...
(Date:5/9/2017)... 9, 2017 Zimmer Biomet Holdings, Inc. (NYSE ... today announced it has earned a spot on ... The Company was ranked among 500 U.S. employers as ... Healthcare Equipment and Services. The annual ... anonymous, independent survey of over 30,000 employees across 25 ...
(Date:5/8/2017)... YORK , May 8, 2017 ... the transition from fee for service reimbursement. Black Book ... 2017. 1.       The Market for MIPS ... 77% of physician practices with 3 or more ... Technology Solutions by Q4. "Given the magnitude of the ...
Breaking Medicine Technology: