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    Ephedra - FDA seizes supplements - 6 December 2005

    FDA Press Release This listserv covers mainly Class I (life-threatening) recalls. A complete listing of recalls can be found in the FDA Enforcement Report at: http://www.fda.gov/opacom/Enforce.html FOR IMMEDIATE RELEASE P05-94 December 6, 2005 Media Inquiries: Catherine McDermott, 301-827-6242 Consumer Inquiries: 888-INFO-FDA FDA Acts to Seize Ephedra-Containing Dietary Supplements At the request of the U.S. Food and Drug Administration (FDA), the U.S. Attorney's Office for the Eastern District of Texas and the U.S. Attorney's Office for the District of Oregon filed Complaints for Forfeiture against Nature's Treat Energy Plus #1, a dietary supplement that contains ephedra, an herbal source of ephedrine...

    Trypan Blue withdrawal in US

    Custom-Rx Compounding Pharmacy Issues Nationwide Recall of Trypan Blue 0.06% Ophthalmic Solution Contact: Verne Betlach 612-866-2211 Richfield, MN -- August 26, 2005 -- Custom RX Compounding Pharmacy of Richfield, Minnesota, is initiating a nationwide recall of Trypan Blue 0.06% Ophthalmic Solution because it may be contaminated with Pseudomonas aeruginosa, a bacteria that, if applied to the eyes, might lead to serious injury, including possible blindness. Use of Trypan Blue which is being recalled should stop immediately. Trypan Blue was distributed to hospitals and clinics in MD, MN, IL, NE, ND, MI, DC, and PA. This product is intended for ophthalmic...

    Herbal fen-phen

    Cracking down on makers of "herbal fen-phen," the Food and Drug Administration warned consumers Thursday that some products sold as substitutes for recently banned diet drugs may be dangerous. The FDA wrote to a Pennsylvania company this week that its products violate federal law and may be seized as illegal drugs. The diet drugs fenfluramine and its close cousin Redux were banned in September after doctors discovered the medicines could damage dieters' heart valves. Since then, dieters have flocked to blends of dietary supplements that bear such names as Herbal Phen-Fen and Herbal Phen Fuel. There is no evidence that...

    Echinacea

    Aristolochia Traditional Chinese medicine used for thousands of years, but recently been mistaken for other herbs used in slimming and for skin conditions. Dangers: In 1993 blamed for renal failure in patients at an upmarket Belgian slimming clinic and again in in Britain in 1999. It is not available in the UK. Echinacea An immune booster, used for increasing resistence to infection particularly in those with chronic fatigue syndrom. Should not be used by anyone with an autoimmune disease such as rheumatoid arthritis or HIV. Should not be taken continuously. EPHEDRA A herb used in weight loss and for boosting...

    Aristolochia

    AN emergency ban has been imposed on the import, sale and supply of a herb used in traditional Chinese herbal medicines after two users in the UK suffered kidney failure. The Medicines Control Agency (MCA) imposed the immediate ban on Aristolochia on the advice of the Committee on Safety of Medicines. Aristolochia is a herb used in Chinese medicine to treat fluid retention and rheumatic symptoms. But research has found the herb to be toxic and associated with kidney damage. Aristolochia has been a prescrip-tion-only medicine since 1997, but can be easily confused with two other harmless Chinese herbs, Stephania...

    Cholestin

    The U.S. Food and Drug Administration has banned the sale of this popular dietary supplement for lowering cholesterol, saying the substance contains a powerful prescription drug. The action - the first of its kind by the agency - goes to the heart of a long-running debate over the boundary between drugs and dietary supplements, which get far less regulatory scrutiny and have become increasingly popular in recent years. The maker of Cholestin, Pharmanex Inc. of Simi Valley, Calif., advertised that the product lets users "lower your cholesterol without drugs" because it is derived from an extract of Chinese red rice...

    Tryptophan

    Detective work by epidemiologsts in Britain and the United States led the health department in London to impose a ban on a food supplement linked to at least 22 deaths in America. The supplement is tryptophan, an essential amino acid which has been sold by health food stores and chemist shops in tablet form as a folk remedy for insomnia, premenstrual tension, stress and depression. It is also an ingredient of prescription-only anti-depressants, which have been withdrawn by their manufacturers on government advice. Researchers in the United States have found that tryptophan as a supplement is closely connected to outbreaks...

    Lipokinetix

    FDA last week warned consumers to stop using the dietary supplement Lipokinetix immediately, saying it has been linked to liver failure and similar diseases in people between ages 20 and 32. The agency said it has received "multiple" adverse reports from people who consumed the weight-loss supplement. No apparent cause of liver disease was identified in these cases other than Lipokinetix consumption, FDA reported. In its warning statement, FDA named Syntrax Innovations Inc. as the supplement's marketer. But the company said it has not sold Lipokinetix for a year and accused FDA of having a vendetta against some supplements. "This...

    5-HTP

    Doctors at the Mayo Clinic have discovered that the popular over-the-counter dietary supplement 5-Hydroxy-L-Tryptophan (5-HTP) may have the same contaminant found in a similar supplement banned nearly a decade ago after being associated with a rare and occasionally deadly blood disease. So far, there are no known cases of anyone becoming ill from taking contaminated supplements, Mayo researchers said, but they're warning people to avoid taking high doses of it for fear of triggering an outbreak of a possible fatal illness. The contaminant is similar to one found in tainted batches of a related amino acid dietary supplement, L-tryptophan, which...

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