Complain about a product or service

FDA Recommends No Change In Use Of Statins

Agency says little evidence of usage leading to ALS

October 1, 2008

• Researchers Suggest Fructose Link With High Blood Pressure • House Calls Dial Back Blood Pressure • Statins Could Prevent More Heart Attacks • High Blood Pressure Control More Elusive for Black Americans • Low Potassium May Equal High Sodium as Blood Pressure Risk • Grapes Might Help Manage Blood Pressure • Statins May Help Prevent Miscarriages • FDA Recommends No Change In Use Of Statins • Statins May Help Reduce Blood Pressure • New Guidelines for Stubborn High Blood Pressure • Study: New Blood Pressure Rx Has Fewer Side Effects • Weight Loss Found Effective in Reducing Blood Pressure • Blood Pressure Patients Ignore Recommended Diet • Study: Beetroot Juice Can Beat High Blood Pressure • How Much Sodium Is Too Much? It Depends • Blood Pressure: What You Don't Know Can Kill You • Diuretics May Be Best Blood Pressure Treatment • Researchers Find Gene Implicated in High Blood Pressure • FDA Approves New Beta Blocker • VA Study Finds Seasonal Differences in Blood Pressure • Heavy Drinking Linked To High Blood Pressure In Older Men • Yoga May Help Control Blood Pressure • High Blood Pressure Often Undiagnosed in Children, Teens • Small Amounts Of Exercise Can Lower Blood Pressure • Cocoa, Not Tea, Appears To Lower Blood Pressure • FDA Green Lights New Blood Pressure Drug • Researchers Find Chinese Herb Reduces Blood Pressure • Moderate Drinking May Be OK for Men with High Blood Pressure • High Blood Pressure Not Well Controlled Among Older Patients • Small Doses Of Exercise Can Lower Blood Pressure • Medical Experts Call for FDA Action on Salt --- • Health News

A Food and Drug Administration (FDA) analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as "Lou Gehrig's Disease."

The FDA analysis, undertaken after the agency received a higher than expected number of Adverse Event Reporting System reports of ALS in patients on statins, is based on data from 41 long-term controlled clinical trials. The results showed no increased incidence of the disease in patients treated with a statin compared with placebo.

Statins -- HMG-CoA-reductase inhibitors -- are the most commonly prescribed medications to treat elevated cholesterol levels in the United States. ALS is a fatal neurodegenerative condition with an overall annual incidence of 1 to 2 per 100,000 people in the general population. The incidence of ALS increases with age.

"Statins have also been shown to reduce the risk of heart disease in a wide variety of patients. Based on currently available information, health care professionals should not change their prescribing practices for statins and patients should not change their use of statins," the agency said.

During the course of the FDA's long-term placebo-controlled clinical trials, nine of about 64,000 patients treated with a statin and 10 of about 56,000 patients treated with placebo were diagnosed with ALS.

From these data, the incidence of ALS in patients treated with statins was 4.2 cases per 100,000 patient-years and the incidence of ALS in patients treated with placebo was 5.0 cases per 100,000 patient-years.

"While the FDA finds the lack of an increase in the incidence of amyotrophic lateral sclerosis in patients treated with statins in clinical trials reassuring, given the extensive use of this class of drugs and the serious nature of ALS, continued study of this issue is warranted," said Mark Avigan, M.D., director, Division of Pharmacovigilance I, Center for Drug Evaluation and Research, FDA.

The FDA is anticipating the completion of a case-control or epidemiological study of ALS and statin use that is being conducted by Dr. Lorene Nelson, Chief of the Division of Epidemiology, Stanford University School of Medicine, and colleagues at the Division of Research, Kaiser Permanente. Results from this study should be available within six to nine months.

FDA is examining the feasibility of conducting additional epidemiologic studies to examine the incidence and clinical course of ALS in patients taking statins.

Report Your Experience
If you've had a bad experience -- or a good one -- with a consumer product or service, we'd like to hear about it. All complaints are reviewed by class action attorneys and are considered for publication on our site. Knowledge is power! Help spread the word. File your consumer report now.

Follow us on Twitter.