Health Professionals

An Analysis of the 22 Deaths Reported to FDA as Possibly Linked to the Consumption of Dietary Supplements Containing Ephedrine Alkaloids

Issue: Whether dietary supplements containing ephedrine alkaloids played a causative role in any of the 22 deaths reported in adverse event reports (AERs) to the Food and Drug Administration (FDA).

Findings: The 22 AERs do not show any consistency of clinical or pathologic features nor do they show that exposure to ephedrine alkaloids was a contributing or causative factor in any of the deaths.

Methodology: Dr. Grover M. Hutchins, member of the Ephedra Education Council (EEC) Expert Panel, reviewed the 22 AERs to determine whether the consumption of ephedrine alkaloids may have played a causative role in any of the deaths. (Dr. Hutchins' detailed analysis of the deaths appears in his EEC statement.) In conducting his review, Dr. Hutchins looked for the most likely cause or a likely differential diagnosis of the cause of the individual's event. He used his training and experience in correlating clinical and pathologic information derived from autopsies to develop his opinions on causation relating to the AERs.

In examining the likelihood of any causative role of ephedrine alkaloids in the deaths, Dr. Hutchins considered the 22 AER deaths as a whole to see whether there was a likely and consistent pathogenic process that could account for the events. For example, there are a number of conditions where exposure to an environmental or chemical agent may lead to well-characterized pathologies, including asbestos, tobacco smoke, coal dust, and fenfluramine. In reviewing the 22 AERs, Dr. Hutchins was seeking evidence for the existence of a similar coherent pathogenetic explanation for the deaths.

It should be noted that of the 22 AERs, six were only one to two pages long. In addition, autopsies were performed in only 13 of the cases, not performed in seven, and it is unknown whether they were performed in two. Twelve cases were known to have been exposed to ephedrine alkaloids; it is not known whether the remaining 10 were exposed. Toxicology reports were completed in 14 of the cases, with only four of the cases testing positive for ephedrine alkaloids.

Analysis: Dr. Hutchins determined upon his review of the 22 AERs that:

• Four of the deaths are entirely attributable to a structural abnormality of the heart that had arisen during the formation of the heart.
• Three of the deaths were the consequence of attempts at rapid weight loss by extreme fasting and exercise (e.g., exercise wearing a rubber suit and sweat suit which led to hyperthermia).
• Three of the deaths were explained by coronary artery atherosclerosis.
• Two of the deaths occurred in persons found to have myocarditis, or inflammation of the muscular walls of the heart.
• Two of the deaths were caused by dissections of the aorta.
• Four of the deaths were the result of cerebral vascular disease.
• Two of the deaths were miscellaneous events, including the death of a 5-day-old infant from necrotizing enterocolitis and the death of a female after a short course of flu-like illness, possibly related to pulmonary or cardiac disease.
• Two AERs had no explanation for death, which is consistent with general experience in death investigation.

Conclusion: The available evidence indicates that exposure to ephedrine alkaloids was not a contributing or causative factor in any of the 22 reported deaths.

Dr. Hutchins concluded that the 22 AERs he reviewed do not show any consistency of clinical or pathologic features or show that exposure to ephedrine alkaloids was a contributing or causative factor in the deaths. Dr.ÝHutchins stated that in only the two unexplained deaths could ephedrine alkaloids be a speculative explanation for the deaths. However, Dr. Hutchins noted that the occurrence of two unexplained deaths from a total of 22 unexpected deaths is consistent with general experience in death investigation.

Back to top