Navigation Links
American Heart Association comment: FDA announces safety changes on labeling for some statins

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
American Heart Association

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:
(Date:6/25/2016)... ... June 25, 2016 , ... First Choice Emergency ... named Dr. Sesan Ogunleye, as the Medical Director of its new Mesquite-Samuell Farm facility. ... Director of our new Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical Director ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van ... Wellness at Work award to iHire in recognition of their exemplary accomplishments in worksite ... 7th annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Those who have ... these feelings, many turn to unhealthy avenues, such as drug or alcohol abuse, as ... Michigan, has released tools for healthy coping following a traumatic event. , Trauma sufferers ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary Hypertension Association ... it will receive two significant new grants to support its work to advance ... 25th anniversary by recognizing patients, medical professionals and scientists for their work in ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San Diego, CA is excited ... To Recovery® program to drive cancer patients to and from their cancer treatments. ... highest quality of life and ongoing independence. Getting to and from medical treatments ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)...  Arkis BioSciences, a leading innovator in the ... cerebrospinal fluid treatments, today announced it has secured ... led by Innova Memphis, followed by Angel Capital ... Arkis, new financing will accelerate the commercialization of ... of its in-licensed Endexo® technology. ...
(Date:6/23/2016)... Research and Markets has announced ... Type (Organic Chemical (Sugar, Petrochemical, Glycerin), Inorganic Chemical), Functionality ... - Global Forecast to 2021" report to their ... global pharmaceutical excipients market is projected to reach USD ... in the forecast period 2016 to 2021. ...
(Date:6/23/2016)... , June 23, 2016 ... CAPR ), a biotechnology company focused on the ... announced that patient enrollment in its ongoing randomized ... has exceeded 50% of its 24-patient target. Capricor ... the third quarter of 2016, and to report ...
Breaking Medicine Technology: