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Copyright © 2013 Natural Standard (www.naturalstandard.com)
February 2012

Weight Loss Supplement May Contain Undeclared Drug

Healthy People Co. has voluntarily recalled some of its weight loss supplements after the U.S. Food and Drug Administration (FDA) found the undeclared drugs sibutramine and tadalafil in these products.

Sibutramine is a type of central nervous system (CNS) stimulant, also called psychomotor stimulants or uppers. CNS stimulants are a class of drugs that speed up physical and mental processes. They temporarily make a person feel more alert and improve mood.

Stimulants are typically used to treat medical conditions such as attention-deficit hyperactivity disorder (ADHD), attention-deficit disorder (ADD), fatigue and narcolepsy. Some stimulants have been used as appetite suppressants, although the safety of this use remains controversial. In general, stimulants cause limited weight loss because patients eventually develop tolerances to long-term treatment.

While sibutramine has been approved by the FDA to treat obesity, its use is regulated as a Schedule IV controlled substance due to its potential negative side effects. Sibutramine can cause increase blood pressure or pulse rate, which may cause significant risks to patients with heart disease, heart failure, abnormal heart beat rates, or stroke.

Furthermore, most CNS stimulants are highly addictive. Because stimulants are highly addictive and have euphoric effects on the brain, they are often abused and taken as recreational drugs. Long-term abuse of stimulants can cause changes in the brain and lead to serious health problems, including severe mental illness and memory loss.

Tadalafil (Cialis®) is one type of FDA-approved oral medications available to treat erectile dysfunction (ED) and female sexual arousal disorders. Like Viagra® and Levitra®, two other drugs used to treat ED, tadalafil is a type of chemical known as a phosphodiesterase-5 inhibitor (PDE-5). These drugs enhance the effects of nitric oxide, a chemical messenger that relaxes smooth muscles in the penis. This increases the amount of blood flowing into the penis and allows an erection in response to sexual arousal and stimulation. These medications do not automatically produce an erection. Instead they allow an erection to occur after physical and psychological stimulation and arousal. Many men experience improvement in erectile function after taking these medications regardless of the cause of their impotence.

Generally, these medications are absorbed and processed rapidly by the body and are usually taken 30 minutes to one hour before intercourse. Tadalafil (Cialis®) has been reported in clinical trials to stay in the body longer than the other drugs used to treat ED. It promotes erection within 30 minutes and enhances the ability to achieve erection for up to 36 hours.

Common side effects of phosphodiesterase inhibitors include headache, reddening of the face and neck (flushing), indigestion and nasal congestion. These drugs may also cause hypotension or low blood pressure. Tadalafil (Cialis®) may cause muscle aches and back pain, which usually go away on their own within 48 hours.

Medications prescribed for the treatment of erectile dysfunction may cause significant side effects when mixed with certain heart drugs called nitrates, including nitroglycerin (Nitrostat®, Nitro-Bid®), isosorbide mononitrate (Imdur®), and isosorbide dinitrate (Isordil®). Nitrates are often prescribed to reduce chest pain, dilate the blood vessels, and lower blood pressure. Because ED medications also reduce blood pressure, combining these two types of medication can cause a dangerous drop in blood pressure. Experts do not recommend taking medications such as tadalafil (Cialis®) if nitrates are used. If an individual has heart disease or has had a heart attack in recent months, he/she should check with a doctor before taking any of these drugs for erectile dysfunction. These medications should also not be used along with certain medications for high blood pressure called alpha blockers.

The particular products being recalled by Healthy People Co. include Mince Belle Dietary Supplement (Lots HPCMB/10-026, HPCMB/10-027, HPCMB/10-029, HPCMB/10-020, HPCMB/10-021 and UPC7503013203305), PERFECT Men Dietary Supplement (HPCPM/002 and UPC7503013203190), EVERLAX Dietary Supplement (HPCEX/074, HPCEX/076, HPCEX/072 and UPC7503013203046), EVER Slim Dietary Supplement (HPCES-079, HPCES-070, HPCES-071 and UPC7503013203053), Herbal Drink Acai-man Mangosteen Dietary Supplement (HPJAC/004 and UPC7503013203015), EVER SLIM Shake Mix Dietary Supplement Strawberry (HPESSF/168 and UPC7503013203084) and EVER SLIM Shake Mix Dietary Supplement Chocolate (HPESSC/061 and UPC7503013203077).

All of these products were sold at a Healthy People. Co. store located at 13105 Ramona Blvd. Ste F, Irwindale, CA, 91706. Anyone who has purchased these products is advised to return the unused items to the company for a full refund. Questions or concerns regarding the recall can be directed to Healthy People Co. at 626-939-4132 (Monday-Friday, 9am-5pm PST).

For more information about integrative therapies for weight loss, please visit Natural Standard's Comparative Effectiveness Database.

References

  1. Natural Standard: The Authority on Integrative Medicine. www.naturalstandard.com
  2. U.S. Food and Drug Administration (FDA). www.fda.gov
The information in this brief report is intended for informational purposes only, and is meant to help users better understand health concerns. This information should not be interpreted as specific medical advice. Users should consult with a qualified healthcare provider for specific questions regarding therapies, diagnosis and/or health conditions, prior to making therapeutic decisions. Copyright © 2013 Natural Standard Inc. Commercial distribution or reproduction prohibited.