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:5/5/2016)... ... May 05, 2016 , ... TIME for Kids and The ZAC Foundation – ... partnership to reach nearly 1 million children with important water safety messages before summer ... leading cause of accidental death in children one to 6 years of age. ...
(Date:5/5/2016)... ... May 05, 2016 , ... The 2016 Nike Soccer ... Pittman, along with his university coaching staff. Together they bring their winning Vandals coaching ... run for youth players ages 5-13, and high school players. Session dates are as ...
(Date:5/5/2016)... ... 05, 2016 , ... United Collection Bureau, Inc. (UCB) announces Sarah Clark as ... years of experience within the healthcare revenue cycle industry. With a primary focus of ... Patient Financial Services at Spectrum Health. While at Spectrum Health, Clark helped Spectrum achieve ...
(Date:5/5/2016)... ... 2016 , ... T.E.N., a technology and information security executive ... the 2016 ISE® Central Executive Forum and Awards Gala at the Sheraton Downtown ... of HMS, was selected as the Information Security Executive® of the Year Award ...
(Date:5/5/2016)... ... 2016 , ... ACLS Certification Institute, a leading provider of ... giving participants incentive for spreading the word about the Institute’s certification and recertification ... share resources with their friends and colleagues,” said Vonda Andrews, ACLS Certification Institute ...
Breaking Medicine News(10 mins):
(Date:5/3/2016)... with watching a film or TV show in high definition, you may not be familiar ... Ampronix  is a renowned authorized reseller of the medical industry,s top brands as well as ... ... ... Although initially ...
(Date:5/3/2016)... DUBLIN , May 3, 2016 ... to pay $55 million to a woman who says ... State court awarded Gloria Ristesund $5 million ...      (Logo: http://photos.prnewswire.com/prnh/20160330/349511LOGO ) , ... of accusations against the company. In February, the same ...
(Date:5/3/2016)... JERUSALEM , May 3, 2016 ... (TASE: INTP), a clinical-stage biopharmaceutical company, today announced the ... Clinical and Regulatory Affairs. "Ms. Strauss-Levy has ... affairs, and has established an outstanding track record, having ... development and regulatory approval processes in the ...
Breaking Medicine Technology: