Bad Weight Loss And Performance Dietary Supplements Recalled By FDA | Omudhome Ogbru, PharmD | RxEconsult
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The Hidden Danger In Dietary Supplements Category: Diet & Weight Loss by - November 23, 2013 | Views: 18094 | Likes: 4 | Comment: 0  

Bad dietary supplements

Dietary supplements are buyer beware products and some of them are over the counter poisons. These products are promoted as safe and natural alternatives to prescription medication for several types of conditions such as sexual dysfunction, high blood pressure, weight gain, and diabetes. They are sold over the counter at many food stores and on websites. They are far from effective and many of them are not safe. Most of them are also not natural since they contain lower quantities of active ingredients used in approved prescription drugs. 

Consumers are placed at risk because these highly active ingredients are not disclosed and they have the potential to interact with other medications and interfere with medical treatment. Essentially, these dietary supplements are really unapproved drugs that contain enough active ingredient to cause side effects and drug interactions but not enough to provide adequate benefit. Many dietary supplements have become a back door to sell unapproved drugs to unsuspecting consumers and this is a serious health hazard. Manufacturers of dietary supplements are avoiding the FDA drug approval process and cost of bringing a drug to market by classifying their drugs as dietary supplements.
 

Related: Dietary Supplement, Vitamin, or Quack


Recent Withdrawal of Supplements

Here are some recent recalls and of dietary supplements. If you are taking any of these supplements stop and seek proper treatment for your condition. 

The FDA is urging consumers to stop using Mass Destruction. Mass Destruction is sold as a dietary supplement for muscle growth. It has been linked with an incidence of liver failure requiring transplantation after one week of using Mass Destruction. Mass Destruction is manufactured for Blunt Force Nutrition and is sold on the internet, nutrition stores, and gyms. The FDA suspects that Mass Destruction may contain anabolic steroids and steroid -like compounds. 

P-Boost also sold as NatuRect is a dietary supplement used for enhancing male sexual function. On November 19, 2013, the FDA asked Tendex the manufacturer of both products to recall Lot#F51Q of P-Boost and NatuRect because they contain tadalafil which is the active ingredient in Cialis. Cialis is approved by the FDA for the treatment of erectile dysfunction (ED) and carries warnings about drug interactions with nitrates and reduction of blood pressure to dangerous levels. P-Boost and NatuRect are essentially unapproved drugs with undeclared active ingredients that can harm unsuspecting consumers. They did not carry warnings about drug interactions and effect on blood pressure.

A recall was also issued for RezzRx which contains undeclared hydroxylthiohomosildenafil and aminotadalafil and VitaliKOR Fast Acting which contains tadalafil and also vardenafil the active ingredient in Levitra. 

OxyElite Pro dietary supplements products were recalled on November 19, 2013, due to the risk of serious liver damage and liver failure from an ingredient called Aegeline. Aegiline is a synthesized version of a natural extract from the Bael tree. 

Adipotrim XT is marketed as a natural herb dietary supplement for weight loss. It was recalled by the FDA on November 14, 2013 because analysis showed that it contains fluoxetine, the same active ingredient in prescription drug Prozac used for treating depression, panic disorder, bulimia, and obsessive compulsive disorder. The manufacturer of Adipotrim did not disclose that it contained fluoxetine making it an unapproved drug. Fluoxetine has many serious side effects such as suicidal thinking, abnormal bleeding, and seizures as well as serious interactions with other medications that can lead to death. Adipotrim XT was sold directly to consumers through their website. 

On November 8, 2013, Vega recalled Vega One Nutritional Shakes and Sports Performance Protein products due to the presence of trace amounts of chloramphenicol, an antibiotic. 

These are just a few examples of recent recalls and they demonstrate the hidden dangers in the dietary supplement market. Unscrupulous manufacturers are selling active drugs that would otherwise require a prescription and supervision of a healthcare provider as over the counter food supplements without including proper warnings and disclosures. This a dangerous practice.

 
Next: FDA Regulation of Dietary Supplements
 
 

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