Parker Waichman LLP Injury Alerts
WOLVES IN SHEEP'S CLOTHING - The Dangerous World of Unlicensed, Fake and "Copycat" Generic Drugs and Dietary SupplementsAug 1, 2002 PART I - INTRODUCTION
As our long-time subscribers are aware, we have written a number of comprehensive newsletters dealing with dangerous prescription drugs and questionable conduct on he part of the major pharmaceutical manufacturers. Although flawed governmental regulation, inadequate testing and poor monitoring and supervision make the world of prescription drugs a perilous one, there is, at least, a significant level of accountability that prevents the problems from spiraling out of control.
Unfortunately, there are threats to the public health which go largely unnoticed because the substances involved are either unregulated, unlicensed, marketed as "supplements" or vitamins, or sold to unsuspecting (and often uneducated) residents of poor or "ethnic" neighborhoods. Moreover, all of these "products" are touted as beneficial and risk free. In this two-part article, we will examine a number of seemingly harmless products that have largely eluded government control and supervision and continue to appear on store shelves as "wolves in sheep's clothing".
Part I deals with supplements and vitamins. Part II will discuss unlicensed, fake and "copycat" generic drugs, and prescription drugs that have turned up in herbal products.
Under federal law, no one has to prove that a dietary supplement is safe or works as claimed before placing it on the market. Unlike in many other countries, the FDA must prove a supplement is dangerous before it can halt its sale. Thus, many supplements strongly suspected of having dangerous side effects or causing severe reactions or injuries remain on the market while research and studies are conducted to actually prove the link. This process has been strongly criticized by any number of scientists, doctors and public "watchdog" organizations.
KAVA: The Food and Drug Administration (FDA) says kava-kava, an herbal supplement, has recently been associated with severe liver injury. The following are commonly used names for KAVA as it appears in different supplemental forms: ava, ava pepper, awa, intoxicating pepper, kava pepper, kava root, kawa, kawa-kawa, kew, raushpfeffer, sakau, tonga, wurzelstock and yagona.
Kava is extracted from the root of the shrub Piper methysticum, a member of the pepper family. While it was once primarily used for certain rituals in its native South Pacific, it has recently been found in products in both Europe and the United States and used for its purported medicinal effects as a sedative, muscle relaxant and diuretic. It has been used as a dietary supplement and promoted as a remedy for a variety of conditions such as stress, insomnia, epilepsy, psychosis, depression, migraines, colds, tuberculosis, rheumatism and premenstrual syndrome (PMS).
This "drug" has been used for over 3,000 years for various purposes. Recent events, however, indicate that there is cause for alarm. In the past two years, kava has been directly linked to several cases of liver toxicity. Most of these cases of lover damage occurred in Germany and Switzerland and thus the two countries are moving to ban the supplement. Of the twenty-five reported incidents, one person died and three people were forced to undergo liver transplants. "This kind of liver damage appears to be extremely rare," says FDA Supplement Chief, Dr. Christine Taylor. "But because it's severe liver damage, we felt consumers needed to be aware of it."
If kava-kava is indeed dangerous, it may only prove to be problematic for people who already have pre-existing liver damage of some kind. A regulated intake of small quantities of kava may not be harmful to an otherwise health person. Yet, if you are using kava-kava and detect any possible sign of liver failure, consult your physician immediately. Symptoms include jaundice (yellowing of the skin or whites of eyes), brown urine, nausea, vomiting, light-colored stools, unusual tiredness or weakness, stomach or abdominal pain, and loss of appetite. Consumers should report any adverse events associated with the use of kava-kava supplements to the FDA's MedWatch program by calling their toll free number (1-800-332-1088) or by contacting them on the Internet at http://www.fda.gov/medwatch. Despite the growing demand for a ban on products containing kava-kava, there is yet to be a market withdrawal. It is possible that, by the end of 2002, the herb will be banned in both Europe and the United States. Germany is the first country to appeal for a mandatory ban.
EPHEDRA: Ephedra is another supplement that has recently come under careful scrutiny by the FDA. Ephedra is a stimulant containing ephedrine; an herbal remedy used for weight loss, asthma, hay fever and allergies, the common cold, congestion and increased energy. Since this supplement is used in a variety of products, it poses a widespread risk to the general public. The FDA warns that there have been numerous complaints of adverse reactions including heart attack, stroke, tachycardia, paranoid psychosis, depression, convulsions, coma, fever, vomiting, palpitations, hypertension and respiratory depression.
"The use of dietary supplements does pose a health risk to some people," says Dr. Neal Benowitz, Professor of Medicine and Chief of Clinical Pharmacology at the University of California, San Francisco. "Just because it's natural, doesn't mean it's safe." As of April 2001, the FDA had received 1,200 reports of health problems associated with ephedra including 60 deaths. While ephedra has been known to affect even health people, individuals with high blood pressure, heart problems, diabetes, or a history of seizure or stroke run a greater risk of developing health complications as a result of using this supplement. The most dangerous products are those that are designed for weight-loss and bodybuilding. These products can contain unsafe amounts of ephedra supplement whereas most decongestants use the prescribed amount. The maximum allowable dosage is 8 mg. Ephedra/ephedrine per single dose or 32 mg per day.
MA HUANG: Ma huang, an herbal form of ephedrine, has also been linked to serious health conditions such as heart attack, stroke, and sudden death. It has been used in Chinese medicine for more than 5,000 years but now, it can be found in weight-loss and energy enhancement supplements. In a recent study conducted by the FDA, 926 incidents of poisoning related to ma huang were discovered. Doctors and other health professionals all over the country are currently advocating the adoption of new regulations for dietary supplements. If this were the case, these herbal supplements would be reviewed before being put out into the market and thus the associated health risks would be eliminated.
GINKGO BILOBA: Ginkgo biloba is possibly one of the most widely "hyped" herbal supplements in America. Marketed for its ability to help prevent memory loss, ginkgo biloba is used primarily by men and women over fifty. Recently, however, the herb has been found ineffective when used by elderly people, and may even cause epileptic seizures in those consumers who already exhibit signs of dementia. It is important to state, however, that while ginkgo has been known to have certain harmful side effects such as gastrointestinal complications, blood pressure problems and allergic reactions, the associated with seizures is still unproven.
Researchers claim that using ginkgo may really lead to deterioration rather than an improvement in health. Consumers are therefore urged to find alternate herbal supplements and consult a doctor to make sure that ginkgo biloba is not found within the product.
ARISTOLCHIC ACID: Aristolchic acid, or aristolchia, is the most common name for the supplement but there are also many alternative names such as Asarum, Bragantia, Stephania, Clematis, Akebia, Cocculus, Diploclisia, Menispernum, Sinomenium, Mu tong, Fang ji, Guang fang ji, Fang Chi and Kan-Mokutusu. Products containing this extremely toxic supplement were sold as "traditional medicines", dietary supplements and are even used to treat certain skin diseases such as eczema.
Aristolchic acid is considered to be a potent carcinogen and nephrotoxin and has been proven to cause kidney damage and cancers in multiple patients. Seventy cases of kidney failure were reported in Belgium in 1993 and, in 1999, two more cases of kidney failure associated with this supplement prompted an emergency ban in Britain. In the United States, aristolchia was found in numerous batches of products distributed by Jade Pharmacy under the names Meridian Circulation and Quell Fire. Anyone who has taken or is currently taking these products should consult a physician immediately. For more information, call East Earth Herb at 1-800-827-4372.
VITAMINS A and B: We all assume that vitamins are not dangerous and that they actually improve our overall health. When vitamins take the form of supplements, however, they can possibly be ingested in much higher quantities than the recommended levels. To much Vitamin A or B, as found in supplements, may have harmful effects on consumers
While Vitamin A can improve bone growth and allow for health skin, elderly women with high intakes of Vitamin A have an increased risk of hip fractures. Those who suspect they are taking more than a safe amount of Vitamin A should consult a physician.
In addition, large quantities of Vitamin B supplements may be harmful even to the average user. Vitamin B dietary supplements have become more popular since the FDA allowed manufacturers to tout recent findings that Vitamin B helps reduce the risk of vascular disease. "There may be good medical reasons for exceeding [safe] levels, but there may also be significant side effects," says Dr. Tod Cooperman, President of ConsumerLab.com. "People interested in using high doses of B vitamins should consult with a health care professional." Dr. Cooperman also noted that 40% of the products evaluated exceeded the safe tolerance levels for Vitamin B and that some of the products contained "more than 10 times the upper limit."
The findings with respect to the potential problems raised by elevated intake of Vitamins A and B suggest that vitamin supplements may benefit from stricter government regulations, as would the entire dietary supplement industry.
For further information regarding the rights you or your loved one may have with respect to this matter contact PARKER & WAICHMAN immediately by calling 1-800-YOURLAWYER or visiting http://www.yourlawyer.com.