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Once again, Worst Pills, Best Pills readers were warned about the dangers of a drug well before — in this case two and one-half years before — the government got around to a ban. In the August, 2001 issue of Worst Pills, Best Pills News, we wrote the following:
“On June 14, 2001, Health Canada, the Canadian equivalent of our Food and Drug Administration (FDA), advised Canadian citizens not to use products containing the herb Ephedra, either alone or in combination with caffeine and other...
Once again, Worst Pills, Best Pills readers were warned about the dangers of a drug well before — in this case two and one-half years before — the government got around to a ban. In the August, 2001 issue of Worst Pills, Best Pills News, we wrote the following:
“On June 14, 2001, Health Canada, the Canadian equivalent of our Food and Drug Administration (FDA), advised Canadian citizens not to use products containing the herb Ephedra, either alone or in combination with caffeine and other stimulants, for weight loss, body building or increased energy. The Canadian authorities are particularly concerned about products containing Ephedra or ephedrine, one of the active chemicals of natural Ephedra, in combination with caffeine and other stimulants.
Because of the stimulant properties of ephedrine, such as raising heart rate and blood pressure, it may cause serious possibly fatal adverse effects when combined with other stimulants. Ephedrine is chemically and pharmacologically similar to the amphetamines (“speed”-like drugs) and phenylpropanolamine, (PPA).
Ephedrine-containing products may list the following ingredients on their labels: ma huang, Chinese Ephedra, ma huang extract, Ephedra, Ephedra Sinica, Ephedra extract, Ephedra herb powder, Sida Cordifolia or epitonin. Sources of caffeine or other stimulants may include: green tea, guarana, yerba mate, cola nut and yohimbe.
Health Canada based its advisory on adverse reaction reports obtained from the FDA. The adverse reactions associated with the use of ephedrine reported to the FDA range from episodes of dizziness, tremors, headaches and heart rate irregularities to seizures, psychosis, heart attacks, and strokes.”
The next month, in September 2001, Public Citizen’s Health Research Group filed a formal petition with the FDA to ban the use of ephedra, arguing that the large number of deaths, heart attacks, strokes, heart arrhythmia cases, and episodes of hypertension reported to the FDA exceeded the sum for all other dietary supplements combined.
The following statement was issued by Health Research Group Director and Health Letter Editor Dr. Sidney Wolfe following the belated FDA decision, just announced on December 30th, to ban ephedra:
“Today’s announcement by the FDA, coming more than two years after our petition to the agency to ban ephedra, shows the dangerous cowardice of FDA Commissioner Mark McClellan and HHS Secretary Tommy Thompson in waiting until more than 155 reports of death in people using ephedra have been reported to the FDA instead of acting much earlier. All of the scientific evidence and legal authority to ban ephedra was in place at the time of our petition in September, 2001. One of the reasons all the major manufacturers have stopped selling ephedra is that the companies have become uninsurable because of massive losses in product liability cases. Several weeks ago, the last major manufacturer of ephedra dietary supplements — Metabolife — announced that it would no longer sell ephedra. From 81 reported deaths at the time of our petition, the FDA has waited until there are now 155 deaths and very little ephedra is being manufactured before announcing a ban. This is an inexcusable dereliction of responsibility by an agency of the Public Health Service that has acted more like an ephedra sales extension agency.”
