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Ephedra

Public Health Officials Caution against Ephedra Use

The use of herb Ephedra has assumed renewed attention after the death of Baltimore Orioles pitcher Steve Bechler in February 2003. As per Joshua Perper, M.D., chief medical examiner in Broward County, Fla, Bechler died from multiple organ failure due to heat stroke, and a dietary supplement containing Ephedra was a contributing factor.

Sporting bodies such as National Football League, the National Collegiate Athletic Association, and the International Olympic Committee have already banned the use of herb Ephedra, and immediately after the death of Bechler’s at age 23, minor league baseball also banned its use.

In the recent past, Health officials cautioned American consumers about the use of Ephedra-containing products, especially if strenuous exercise is involved, or in combination with other stimulants such as caffeine. Essentially Ephedra is a stimulant much like adrenaline; it may have serious effects on the nervous system and heart.

Ephedra is a substance found naturally and is derived from ma huang, a Chinese herbal medicine. This is being promoted to help in weight-loss program, to increase athletic performance and to enhance energy. A chemical called ephedrine is the main active ingredient of Ephedra.

Being an herb Ephedra, it is taken as a dietary supplement regulated under the Dietary Supplement Health and Education Act of 1994. As per this law, the FDA does not review dietary supplements for safety and effectiveness before they are marketed. This law allows the FDA to stop the sale of any dietary supplement in case it presents a significant or unreasonable risk of injury.

However, synthetic ephedrine is regulated as a drug. Ephedrine-containing products which are to be consumed orally can be sold over the counter (OTC) and do not need any pre market approval, till they confirm to the final monograph for OTC drug products which are utilized in temporary asthma relief. The formulation, use, and labeling of OTC drug products are covered under the final monographs. Prescribed medicines containing ephedrine, for the use other than those covered under the final monograph; require a pre market review for safety and effectiveness.

The prescription drugs and OTC drugs may contain synthetic ephedrine, which are taken orally for the temporary relief of shortness of breath, chest tightness, and wheezing due to bronchial asthma. This medicine can also be used for a topical nasal decongestant (nose drops, sprays, or jelly) for temporary relief of nasal congestion due to colds, hay fever, sinusitis, or other upper respiratory allergies. This medicine, as a regulated drug product contains mandatory warnings labeled on it. This medicine is also not allowed to be consumed in combination with caffeine and with other medicines which may react. Under FDA regulations, the controlled availability of synthetic ephedrine drug has not been connected with same kind of adverse effects as associated with dietary supplements containing Ephedra.

There are some still concerns about the OTC availability. According to Barbara Michal, a paralegal in San Bernardino, Calif, she is very much concerned that ma huang, Ephedra, and ephedrine are available OTC still; let it be in any form. These forms may be herbal form in dietary supplements or as synthetic ephedrine in drugs. She has also formed a nonprofit group called Halt Ephedrine Abuse Today (HEAT) after she lost her son, Christopher at the age of 24 in 1997 due to sudden cardiac arrest, which was caused by the overdose of ephedrine.

She further adds that she received a call from Nicole, Christopher’s wife, mentioning that he collapsed. The only information given by the medical team was that he was down for about 10 minutes and the team is working on him. It took me around three hours of drive to get there without really knowing that my son was no more.

As per Michal her son was using taking one of the OTC drug having synthetic ephedrine at different times: maximum strength Efedrin and Mini Two Way Action, formerly called Mini Thins. Further she adds that these drugs are marketed as asthma aids, but she observed that people have bought them from gas stations, truck stops, convenience stores and liquor stores, and used them as stimulants. Her son also took them just casually and had no idea of the risks. Of course he was taking coffee and not mountain dew. I have come to later that caffeine makes ephedrine even more dangerous.

About new actions announced by HHS
In February 2003, a study sponsored by federal government was carried out by the experts at the RAND and examined the information on the products containing the herb Ephedra and the drug ephedrine. This study was done on about 1500 adverse effects reported related to Ephedra and were voluntarily reported to the FDA, and also about 125 reports connected with products containing synthetic Ephedra.

The conclusion of this study was that the Ephedra is connected to the dangers of side effects which may include heart palpitations, psychiatric and upper gastrointestinal effects, and symptoms of hyperactivity such as tremor and insomnia, especially when taken with other stimulants.
As per the RAND’s review of some 150000 additional reports submitted by Metabolife International in summer 2002, revealed two deaths, four heart attacks, nine strokes, one seizure, and five psychiatric cases involving Ephedra, in which no other contributing factors were identified. RAND labeled these cases as “sentinel events”, because this indicates a safety concern and does not conform that these events are effect of Ephedra. These results also indicated that the Ephedra is helpful up to some extent in loosing weight and very remote evidence of its effect on performance enhancement in certain physical activities.

The Department of Health and Human Services and the FDA, in February 2003, decided to take some actions for the protection of the Americans from potentially serious risks of diet supplements which contain Ephedra. Some of the decisions are listed below.

  • Taking public opinion about the new information on the health risks connected with the diet supplements containing ephedrine alkaloids. In this way an up-to-date public record can be established in support of latest restrictions on products which contain ephedrine alkaloids.
  • Taking public opinion about the current available information and medical literature is completely giving significant or unreasonable risk of illness or injury, which can be caused by diet supplements containing Ephedra. A rule known as Dietary Supplements Containing Ephedrine Alkaloids was reopened by FDA in 1997 in taking public opinion. As per the rule such products need a warning and also restrictions on dosage. General Accounting Office showed some concerns about the information used for putting dosage limits, because of this FDA withdraw some part of this 1997 rule.
  • Taking public opinion about warning mandatory labels on any Ephedra products which are still available in the market. These warning label should contain warnings about serious effects of the drug, which may include heart attack, seizure, stroke, and death, and further cautions that the risk can increase with dose, with strenuous exercise, and when used with other stimulants, such as caffeine. This label also clearly warns that who should not use the drug such as women who are pregnant or breast-feeding. This label also contains information about other conditions such as diabetes and the use of certain medications that rule out the use of products containing Ephedra.
  • Taking appropriate action against the Ephedra products making any false claims regarding increase in sports performance. Two dozen warning letters have been issued by FDA to the firms marketing dietary supplements that contain ephedrine alkaloids. The letter clearly make out that the claims made by the product on the on the structure and function of the human body should be true and should not be misleading. This letter also very clearly make out that the companies should not claim their product’s ability to treat a disease or condition, such as obesity. As per the Federal Food, Drug, and Cosmetic Act, diet supplements which also claim to cure diseases should be taken as new drug and subject to prompt regulatory actions, including injunctions against firms and seizures of their products.