• Revenue Cycle Management
  • COVID-19
  • Reimbursement
  • Diabetes Awareness Month
  • Risk Management
  • Patient Retention
  • Staffing
  • Medical Economics® 100th Anniversary
  • Coding and documentation
  • Business of Endocrinology
  • Telehealth
  • Physicians Financial News
  • Cybersecurity
  • Cardiovascular Clinical Consult
  • Locum Tenens, brought to you by LocumLife®
  • Weight Management
  • Business of Women's Health
  • Practice Efficiency
  • Finance and Wealth
  • EHRs
  • Remote Patient Monitoring
  • Sponsored Webinars
  • Medical Technology
  • Billing and collections
  • Acute Pain Management
  • Exclusive Content
  • Value-based Care
  • Business of Pediatrics
  • Concierge Medicine 2.0 by Castle Connolly Private Health Partners
  • Practice Growth
  • Concierge Medicine
  • Business of Cardiology
  • Implementing the Topcon Ocular Telehealth Platform
  • Malpractice
  • Influenza
  • Sexual Health
  • Chronic Conditions
  • Technology
  • Legal and Policy
  • Money
  • Opinion
  • Vaccines
  • Practice Management
  • Patient Relations
  • Careers

FDA: Off-label use of malaria drug tied to side effects


The U.S. FDA has approved a REMS to educate practitioners and patients about potential for side effects associated with unapproved treatment quinine for prevention of nocturnal leg cramps.

FDA Drug Safety Communication. July 8, 2010. http://www.fda.gov

The U.S. Food and Drug Administration has approved a Risk Evaluation and Mitigation Strategy (REMS) to educate practitioners and patients about the potential for serious side effects associated with the unapproved treatment quinine (Qualaquin) for the prevention of nocturnal leg cramps. The FDA has approved quinine only for the treatment of uncomplicated malaria caused by the parasite Plasmodium falciparum; however, the majority of the drug's use in the United States is for the treatment or prevention of nocturnal leg cramps. According to FDA, the use of quinine may result in serious adverse events, including hematological reactions, which could cause permanent kidney damage, hospitalizations, and death.

Related Videos
© drsampsondavis.com
© drsampsondavis.com
Mike Bannon ©CSG Partners
Mike Bannon ©CSG Partners