Microsoft word - health update tainted weight loss products 23mar09.doc

Health Update
From: Hugh F. Stallworth, MD, MPH
Tainted Weight Loss Products
Monterey County Health Officials are alerting health care providers to the finding
of new undeclared drug ingredients in over the counter weight loss products
The U.S. Food and Drug Administration (FDA) has expanded, for the second time, the nationwide alert to consumers about tainted weight loss products containing undeclared, active pharmaceutical ingredients. Unfortunately, FDA cannot test and identify all weight loss products on the market that have potentially harmful contaminants in order to assure their safety. Enforcement actions and consumer advisories for unapproved products only cover a small fraction of the potentially hazardous weight loss products marketed to consumers on the internet and at some retail establishments. The FDA has identified additional weight loss products (Herbal Xenicol, Slimbionic, and Xsvelten) and new undeclared active pharmaceutical ingredients (fenproporex, fluoxetine, furosemide, and cetilistat). The current list now includes 72 products. (List on page two) The products, some of which are marketed as dietary supplements, are promoted and sold on various Web sites and in some retail stores and beauty salons. Some of the products claim to be “natural” or to contain only “herbal” ingredients, but actually contain potentially harmful ingredients not listed on the products' labels or in promotional advertisements. These products have not been approved by the FDA, are illegal, and include the following undeclared active pharmaceutical ingredients: The health risks posed by these products can be very serious and include high blood pressure, seizures, tachycardia (rapid heartbeat), palpitations, heart attack, and stroke. The specific side effects of each of the ingredients are included at the end of this Update. Any adverse events that may be related to the use of these products should be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787. Tainted Weight Loss Products – March 24, 2009 FDA List of Tainted Weight Loss Products
7 Diet Day/Night Formula Miaozi Slim Capsules * This product should not be confused with the line of meal replacement and related products that are marketed as conventional foods under the brand name “Slim-Fast®”. The manufacturer of Slim-Fast®, Unilever United States, Inc., maintains that the Slim Fast product which appears on this list is not in any way associated with, sponsored or approved by, or otherwise related in any way to the Slim-Fast® brand of meal replacement and related products. For up to date information on recalls of drugs and other medical products regulated by the U.S.
Food and Drug Administration sign up for email alerts at on the MedWatch website at
www.fda.gov/medwatch
Tainted Weight Loss Products – March 24, 2009 Specific ingredients and associated risks
Please refer to the Physicians’ Desk Reference for complete product information.
Bumetanide
Bumetanide is the active pharmaceutical ingredient in Bumex, a prescription diuretic. Bumex carries a Boxed Warning because the drug may lead to serious and significant fluid and electrolyte loss. Another potential risk associated with the use of bumetanide is elevation in uric acid concentrations. Consumers should not take bumetanide if they are allergic to sulfonamides. Significant drug interactions, such as taking bumetanide with digoxin and lithium, may lead to an increased risk of toxicity. Consumers may also be at an increased risk of hypotension (low blood pressure), fainting, and resultant injury if they have normal blood pressure or are already taking an antihypertensive medication. The risk of toxic reactions to the drug may be greater in elderly consumers or consumers with impaired kidney function. Cetilistat
Cetilistat is an experimental obesity drug and is currently the subject of clinical trials in the U.S., Japan, and Europe. Because cetilistat is in clinical trials, there is no safety or efficacy profile for this drug. Consumers in certain populations, however, could face serious health risks if taking cetilistat. For example, transplant patients taking anti-rejection drugs could suffer organ rejection. Cetilistat is also contraindicated with warfarin and levothyroxine as this could cause increased risk of bleeding and hypothyroidism. The majority of adverse events associated with ingestion of cetilistat are gastrointestinal in nature; e.g., fecal incontinence, rectal discharge, and defecation urgency. Because cetilistat decreases the absorption of fat, this may result in fatty or oily stool which could lead to malabsorption of nutrients and vitamin deficiency. Other adverse events include skin and subcutaneous tissue disorders. Cetilstat may reduce serum concentrations of vitamin E, vitamin D, and beta-carotene. Other safety concerns include the development of gallstones and kidney stones. Fenproporex
Fenproporex is a stimulant not approved for marketing in the United States. Fenproporex, an amphetamine derivative, is a schedule IV controlled substance and could show up positive for amphetamines in a urinalysis. Serious adverse effects of stimulants include headache, tachycardia, increased breathing rate, increased blood pressure, fever, sweating, diarrhea, constipation, blurred vision, impaired speech, dizziness, uncontrollable movements or shaking, insomnia, numbness, palpitations, arrhythmia and possible sudden death. Fluoxetine
Fluoxetine is the active pharmaceutical ingredient in Prozac, a prescription antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. Prozac carries a Boxed Warning because it and other antidepressants increase the risk of suicidal thinking and suicide in children, adolescents, and young adults. Additional potential risks from exposure to this drug include rashes, hives, and the potentially life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome, which is characterized by changes in mental status, pulse, blood pressure, body temperature, and muscle control. Fluoxetine is also associated with nausea, diarrhea, headache, insomnia and anxiety. Tainted Weight Loss Products – March 24, 2009 Furosemide
Furosemide is the active pharmaceutical ingredient in Lasix, a potent diuretic which is available only through prescription for use in the treatment of congestive heart failure, high blood pressure, and edema. It can cause profound dehydration and electrolyte imbalance, with loss of potassium, calcium, sodium, and magnesium. Patients allergic to sulfonamides may also be allergic to furosemide. Serious adverse effects from overdose may lead to dehydration, seizures, GI problems, kidney damage, lethargy, collapse, and coma. Phenolphthalein
Phenolphthalein was an ingredient in some Over-the-Counter laxative products until 1999 when the FDA reclassified the drug as “not generally recognized as safe and effective” after studies indicated that phenolphthalein presented a potential carcinogenic risk. Phenolphthalein has also been found to be genotoxic in that it can damage or cause mutations to DNA. Phenytoin
Phenytoin is the active pharmaceutical ingredient in Dilantin, an approved anti-seizure medication. Because there were trace amounts of this drug in some of these products, the risk was not assessed. However, these products could pose a risk to consumers who are allergic or hypersensitive to phenytoin. Rimonabant
Rimonabant is the active pharmaceutical ingredient in Zimulti which has not been approved in the
United States. In Europe the drug is known as Acomplia.
In June 2007, the FDA Endocrinologic and Metabolic Drugs Advisory Committee unanimously voted
not to recommend approval of the drug because of increased risk of neurological and psychiatric side
effects—seizures, depression, anxiety, insomnia, aggressiveness, and suicidal thoughts among
patients. In June of 2008, the Medicines and Healthcare Products Regulatory Agency of the United
Kingdom linked rimonabant to 5 deaths and 720 adverse reactions over the past two years. In October,
the European Medicines Agency recommended that marketing and sales of Accomplia be suspended
due to safety concerns.
Sibutramine
Sibutramine is a Schedule IV controlled substance and the active pharmaceutical ingredient in Meridia, an approved prescription drug to treat obesity. Some of the identified products recommend taking more than 3 times the recommended daily dosage of sibutramine. Because of this, even consumers without a history of health problems that take these high doses of sibutramine may suffer serious adverse effects if they take these products, such as increased blood pressure, tachycardia, palpitations, and seizure. Populations who would be at increased risk of serious adverse health effects from consuming a standard dose of sibutramine include: Tainted Weight Loss Products – March 24, 2009 • Patients with a history of hypertension, especially those with uncontrolled or poorly • Patients with a history of coronary artery disease, congestive heart failure, arrhythmias, • Patients with narrow angle glaucoma. • Patients with a history of seizure. • Patients predisposed to bleeding events and those taking concomitant medications known to affect hemostasis or platelet function. • Patients with severe hepatic dysfunction. • Patients concurrently taking the following medications:

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