Ephedrine Legal Advice

In addition to Ephedra, many other herbal and other botanical ingredients of dietary supplements can be potentially dangerous.

A. Chaparral (Larrea tridentata)

Chaparral, commonly called the creosote bush, is a desert shrub with a long history of use as a traditional medicine by Native Americans. Chaparral is marketed as a tea, as well as in tablet, capsule, and concentrated extract form, and has been promoted as a natural antioxidant "blood purifier," cancer cure, and acne treatment. At least six cases (five in the United States and one in Canada) of acute non-viral hepatitis (rapidly developing liver damage) have been associated with the consumption of chaparral as a dietary supplement. Additional cases have been reported and are under investigation. In the majority of the cases reported thus far, the injury to the liver resolves over time, after discontinuation of the product. In at least two patients, however, there is evidence that chaparral consumption caused irreversible liver damage. One patient suffered terminal liver failure requiring liver transplant.

Most of these cases are associated with the consumption of single ingredient chaparral capsules or tablets; however, a few of the more recent cases appear to be associated with consumption of multi-ingredient products (capsules, tablets or teas) that contain chaparral as one ingredient. Chemical analyses have identified no contaminants in the products associated with the cases of hepatitis. Products from at least four different distributors and from at least two different sources have been implicated thus far.

After the FDA's health warning, many distributors of chaparral products voluntarily removed the products from the market in December of 1992. Some chaparral products remain on the market, however, and other distributors who removed their products from the market are seeking to clarify the status of these products.

B. Comfrey (Symphytum officinale (common comfrey), S. asperum (prickly comfrey), S. X uplandicum (Russian comfrey))

Preparations of comfrey, a fast-growing leafy plant, are widely sold in the United States as teas, tablets, capsules, tinctures, medicinal poultices, and lotions. Since 1985, at least seven cases of hepatic veno-occlusive disease--obstruction of blood flow from the liver with potential scarring (cirrhosis)--including one death, have been associated with the use of commercially available oral comfrey products.

Comfrey, like a number of other plants (e.g., Senecio species), contains pyrrolizidine alkaloids. The toxicity of pyrrolizidine alkaloids to humans is well-documented. Hepatic veno-occlusive disease following ingestion of pyrrolizidine alkaloid-containing products, has been documented repeatedly throughout the world. Hepatic veno-occlusive disease is usually acute and may result in fatal liver failure. In less severe cases, liver disease may progress to a subacute form. Even after apparent recovery, chronic liver disease, including cirrhosis, has been noted. Individuals who ingest small amounts of pyrrolizidine alkaloids for a prolonged period may also be at risk for development of hepatic cirrhosis. The diagnosis of pyrrolizidine alkaloid-induced hepatic veno-occlusive disease is complex, and the condition is probably underdiagnosed.

The degree of injury caused by pyrrolizidine alkaloid-containing plants, like comfrey, is probably influenced by such factors as the age of the user, body mass, gender, and hepatic function, as well the total cumulative dose ingested and the type of exposure (i.e., whether exposure was as to leaves or roots, infusions or capsules). Infants in general appear to be particularly susceptible to adverse effects of exposure to pyrrolizidine alkaloids; there are reports of infants developing hepatic veno-occlusive disease following acute exposure of less than one week. Transplacental pyrrolizidine poisoning has been suggested by the occurrence of hepatic disease in the newborn infant of a woman who consumed herbal tea during pregnancy.

Although liver damage is the major documented form of injury to humans from pyrrolizidine alkaloid-containing herbals, animal studies suggest that their toxicity is much broader. Animals exposed to pyrrolizidine alkaloids have developed a wide range of pulmonary, kidney and gastro-intestinal pathologies. Pyrrolizidine alkaloid-containing plants, including comfrey, have also been shown to cause cancer in laboratory animals.

Four countries (the United Kingdom, Australia, Canada, and Germany) have recently restricted the availability of products containing comfrey, and other countries permit use of comfrey only under a physician's prescription.

C. Yohimbe (Pausinystalia yohimbe)

Yohimbe is a tree bark containing a variety of pharmacologically active chemicals. It is marketed in a number of products for body building and "enchanced male performance." Serious adverse effects, including renal failure, seizures and death, have been reported to FDA with products containing yohimbe and are currently under investigation.

The major identified alkaloid in yohimbe is yohimbine, a chemical that causes vasodilation, thereby lowering blood pressure. Yohimbine is also a prescription drug in the United States. Side effects are well recognized and may include central nervous system stimulation that causes anxiety attacks.

At high doses, yohimbine is a monoamine oxidase (MAO) inhibitor. MAO inhibitors can cause serious adverse effects when taken concomitantly with tyramine-containing foods (e.g., liver, cheeses, red wine) or with over-the-counter (OTC) products containing phenylpropanolamine, such as nasal decongestants and diet aids. Individuals taking yohimbe should be warned to rigorously avoid these foods and OTC products because of the increased likelihood of adverse effects.

Yohimbe should also be avoided by individuals with hypotension (low blood pressure), diabetes, and heart, liver or kidney disease. Symptoms of overdosage include weakness and nervous stimulation followed by paralysis, fatigue, stomach disorders, and ultimately death.

D. Lobelia (Lobelia inflata)

Lobelia, also known as Indian tobacco, contains pyridine-derived alkaloids, primarily lobeline. These alkaloids have pharmacological actions similar to, although less potent than, nicotine. There have been several reported cases of adverse reactions associated with consumption of dietary supplements containing lobelia.

Depending on the dose, lobeline can cause either autonomic nervous system stimulation or depression. At low doses, it produces bronchial dilation and increased respiratory rate. Higher doses result in respiratory depression, as well as sweating, rapid heart rate, hypotension, and even coma and death.

As little as 50 milligrams of dried herb or a single milliliter of lobelia tincture has caused these reactions.

Because of its similarity to nicotine, lobelia may be dangerous to susceptible populations, including children, pregnant women, and individuals with cardiac disease. Lobelia is nevertheless found in dietary supplement products that are marketed for use by children and infants, pregnant women, and smokers.

E. Germander (Teucrium genus)

Germander is the common name for a group of plants that are contained in medicinal teas, elixirs and capsules or tablets, either singly or in combination with other herbs, and marketed for the treatment of obesity and to facilitate weight loss.

Since 1986, at least 27 cases of acute nonviral hepatitis (liver disease), including one death, have been associated with the use of commercially available germander products in France. These cases show a clear temporal relationship between ingestion of germander and onset of hepatitis, as well as the resolution of symptoms when the use of germander was stopped. In 12 cases, re-administration of germander was followed by prompt recurrence of hepatitis. Recovery occurred gradually in most cases, approximately two to six months after withdrawal of germander. Analyses of these cases does not indicate a strong relationship between the dosage or duration of ingestion and the occurrence of hepatitis.

Although the constituent in germander responsible for its hepatic toxicity has not been identified, germander contains several chemicals, including polyphenols, tannins, diterpenoids, and flavonoids.

On the basis of the 27 French hepatitis cases, the French Ministry of Health has forbidden the use of germander in drugs. Its use has been restricted in other countries as well.

F. Willow Bark (Salix species)

Willow bark has long been used for its analgesic (pain killing), antirheumatic, and antipyretic (fever-reducing) properties. Willow bark is widely promoted as an "aspirin-free" analgesic, including in dietary supplement products for children. Because it shares the same chemical properties and the same adverse effects as aspirin, this claim is highly misleading. The "aspirin-free" claim is particularly dangerous on products marketed, without warning labels, for use by children and other aspirin-sensitive individuals.

The pharmacologically active component in willow bark is "salicin," a compound that is converted to salicylic acid by the body after ingestion. Both willow bark and aspirin are salicylates, a class of compounds that work by virtue of their salicylic acid content. Aspirin (acetylsalicylic acid) is also converted to salicylic acid after ingestion.

All salicylates share substantially the same side effects. The major adverse effects include irritation of the gastric mucosa (a particular hazard to individuals with ulcer disease), adverse effects when used during pregnancy (including stillbirth, bleeding, prolonged gestation and labor, and low-birth-weight infants), stroke, and adverse effects in children with fever and dehydration. Children with influenza or chickenpox should avoid salicylates because their use, even in small doses, is associated with development of Reye syndrome, which is characterized by severe, sometimes fatal, liver injury. Salicylate intoxication (headache, dizziness, ringing in ears, difficulty hearing, dimness of vision, confusion, lassitude, drowsiness, sweating, hyperventilation, nausea, vomiting, and central nervous system disturbances in severe cases) may occur as the result of over-medication, or kidney or liver insufficiency. Hypersensitivity, manifested by itching, broncho-spasm and localized swelling (which may be life-threatening), can occur with very small doses of salicylates, and may occur even in those without a prior history of sensitivity to salicylates. Approximately 5 percent of the population is hypersensitive to salicylates.

G. Jin Bu Huan

Jin Bu Huan is a Chinese herbal product whose label claims that it is good for "insomnia due to pain," ulcer, "stomachic neuralgia", pain in shrunken womb after childbirth, nervous insomnia, spasmodic cough, and etc. Jin Bu Huan has been recently reported to be responsible for the poisoning of at least three young children (ages 13 months to 2 years), who accidentally ingested this product. The children were hospitalized with rapid-onset, life-threatening bradycardia (very low heart rate), and central nervous system and respiratory depression. One child required intubation (assisted breathing). All three utlimately recovered following intensive medical care.

Although the product label identifies the plant source for Jin Bu Huan as Polygala chinensis, this appears to be incorrect since preliminary analyses indicate the presence of tetrahydropalmatine (THP), a chemical not found in Polygala. THP is found, however, in high concentrations in plants of certain Stephania species. In animals, exposure to THP results in sedation, analgesia, and neuromuscular blockade (paralysis). The symptoms of the three children are consistent with these effects.

An additional case of THP toxicity, reported in the Netherlands, appears to be associated with the same product, and is being investigated.

H. Herbal products containing Stephania and Magnolia species

A Chinese herbal preparation containing Stephania and Magnolia species that was sold as a weight-loss treatment in Belgium has been implicated recently as a cause of severe kidney injury in at least 48 women. These cases were only discovered by diligent investigations by physicians treating two young women who presented with similar cases of rapidly progressing kidney disease that required renal dialysis. Once it was determined that both these women had used the herbal diet treatment, further investigation of kidney dialysis centers in Belgium found a total of 48 individuals with kidney injury who had used the herbal product.

At the time that a report of these adverse effects was published in February 1993, 18 of the 48 women had terminal kidney failure that required either kidney transplantation or life-long renal dialysis.

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