Safety

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Safety

The FDA has received more than 16,000 reports of adverse health effects and recognizes 155 reported deaths from the use of ephedra-containing products. These adverse effects on which the FDA based the ban of ephedra include:

  • nausea and vomiting
  • psychiatric disturbances (agitation & anxiety)
  • high blood pressure
  • irregular heartbeat
  • seizures [rare]
  • heart attack [rare]
  • heart failure [rare]
  • cardiomyopathy [rare]
  • stroke [rare]
  • death [rare]

In February 2003, the RAND corporation published the report, "Ephedra and Ephedrine for Weight Loss and Athletic Performance Enhancement:  Clinical Efficacy and Side Effects," as commissioned by the US Department of Health and Human Services in June 2002. This report was reprinted as a review in the Journal of American Medical Association (JAMA) in March 2003. In regard to safety, the report concluded that ephedra is associated with a higher risk of mild to moderate side effects such as heart palpitations, psychiatric symptoms (eg. euphoria, agitation, depressed mood), upper gastrointestinal effects (eg. nausea, heartburn), and symptoms of autonomic hyperactivity (eg. tremor, sweating, insomnia), especially when combined with other stimulants. The review of 16,000 adverse events associated with ephedra also revealed 2 deaths, 4 heart attacks, 9 strokes, and 5 psychiatric cases, in which no other contributing factors were identified ("sentinel events").

Also, in February 2003, the Annals of Internal Medicine revealed that although ephedra-containing products consititute less than 1% of all dietary supplement sales, these products are responsible for 64% of adverse effects associated with dietary supplements.

In the journal Neurology, a study was published in the January 2003 issue, stating the rate of hemorrhagic (bleeding) strokes was statistically significantly higher among ephedra users than non-users. This conclusion was based on a dose above 32 milligrams a day. Many ephedra-containing supplement manufacturers recommend that users take up to 100 milligrams daily.

The Ephedra Working Group presented their report to the National Advisory Council for Complementary and Alternative Medicine on February 26, 2003. Their report was based on the RAND review and new publications since the preparation of that review. The following is a synopsis of the report in regard to the safety of ephedra:

  • From the RAND report, the data on safety of ephedra were inconclusive. It could not be demonstrated that ephedra is safe, nor could it be demonstrated that it is not safe.
  • The data from randomized trials were sufficient to indicate that the use of ephedrine or ephedrine with caffeine is associated with 2-3 times the risk of nausea, vomiting, psychiatric symptoms such as anxiety and change in mood, autonomic hyperactivity, and palpitations.
  • Information on serious but rare events was available only from sporadic adverse event reports. It was important to note the limitations of these data in that they cannot demonstrate causality.
  • An analytic epidemiologic study design, such as a case-control study, was suggested to more rigorously evaluate whether consumption of ephedra is causally related to the serious but rare adverse events.
     
  • Consumer warnings were issued by the National Institutes of Health (click here for link to those warnings)

The FDA finalized the ban on ephedra-containing products Friday, February 6th, 2004, and after a 60-day phase-in period, all sales of such products were ceased on April 12th, 2004.