PART III OF III -FDA ALERT ON DANGERS OF WEIGHT LOSS PRODUCTS

The agency advises consumers to discontinue use of these supplements and then to consult their healthcare provider.

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 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 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 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.

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 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 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 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 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:
• Patients with a history of hypertension, especially those with uncontrolled or poorly controlled hypertension.
• Patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
• 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:
o Sumatriptan
o Dihydroergotamine
o Dextromethorphan
o Meperidine,
o Pentazocine
o Fentanyl
o Lithium
o Tryptophan
o MAO inhibitors




Please remember, as with all our articles we provide information, not medical advice.
For any treatment of your own medical condition you must visit your local doctor, with or without our article[s]. These articles are not to be taken as individual medical advice.

* Tune in tomorrow for WHY IS THE MEDITERRANEAN DIET AN ADVANTAGE IN LONGEVITY?

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