Overview

On May 1st 2009 Iovate Health Sciences voluntarily recalled all Hydroxycut products after the Food and Drug Administration (FDA) identified a number of serious health factors caused by the use of Hydroxycut products. The FDA had received, as of May 24th 2009, 23 separate complaints associated with this product ranging from jaundice and liver transplant to death. There has yet to be a press release by the FDA commenting on which ingredients, dosages or other health risks are possibly associated with the different Hydroxycut products.

Iovate Health Sciences claim that their analysis of Hydroxycut was significantly different to the FDA’s and that their analysis yielded minimal health risks and Iovate Health Sciences say that the number of adverse health effects are next to none when taking into account the number of products sold (more then 9 million units sold in 2008).

What Happened

Currently the major health problems that have been associated with the use of Hydroxycut have been focused around, but not limited to, the liver. In mild cases the users have been diagnosed with jaundice. Jaundice is most easily identified by the skin and eyes turning a yellowish color and is caused by the livers inability to metabolize and create bilirbin which helps in breaking down dying red blood cells. In severe cases users have be diagnosed with rhabdomyolysis which is a rapid breakdown of muscle tissue that specify attacks the liver and kidneys and can lead to sudden death. The symptoms to this are pain, tenderness, weakness, swelling of the muscles, nausea, vomiting, confusion, black urine and in the end cardiac arrest. Rhabdomyolysis is caused by extreme levels of creatine kinase levels and in the case of a 27-year-old German Army officer his creatine kinase levels were 3,000 times the normal healthy limit. Other side effects that have been recorded are seizures, irregular hear beats and kidney failure.

Two class action lawsuits have been filed since the recall of Hydroxycut on May 1st, one filed by Canada and the other Tennessee. Both accuse Iovate Health Sciences of failing to warn users of the potential dangers associated with the drug and the lack of precautions to protect Hydroxycut users.

My Personal Opinion on the Recall

In my opinion these two lawsuits are going to lead to stricter FDA and government regulations on dietary and other natural supplements in the future. In the United States the only act that has any sort of regulatory action against over-the-counter dietary supplements is the Dietary Supplement Health and Education Act (DSHEA) which was implemented in 1994. This act states that it is the responsibility of the manufacturer to make certain that their drugs are safe for the end consumer. Technically the company is required to use adequate evidence ensuring that the product is not going to be harmful to users, but the company is not required to disclose any evidence to the FDA unless the product uses a brand new dietary ingredient. Outside of the United States many countries do not regulate dietary supplements or other natural products so consumers are exposed to many outrageous product claims that have no clinical testing or proof.

I foresee that the FDA will be implementing an amendment to the current DSHEA requiring a disclosure of approved clinical test and risk analysis and also requiring more warning information for consumers. Enacting this would give the FDA the ability to see what is in dietary supplements and the health risks associated with the product as well as giving the FDA the power to shut down products that are more likely to cause harm to end users. This also will give the consumers more information so that they have the responsibility and ability to know what they are putting into their own bodies as well as the risks associated with the specific product.

From what I have seen in the past five years, more and more dietary supplements, and other “lose weight fast” products, have been released all claiming that if you take this little pill the pounds of fat will just melt away in a very short time. These products do seem very attractive to our society which strives and pushes people to be skinny, and millions of people turn to dietary supplements every year to achieve their weight goals. The problem is that most people do not need to take a pill to lose weight they just need to exercise and eat healthy, but because dietary supplements appear to be the easy way out; many people put their health in jeopardy.

I have seen many friends use dietary supplements, the majority have taken Hydroxycut, who are by no means over weight but they just wanted to shed a few quick pounds before spring break. I know that very few if any of these individuals read any of the supplemental material included with the product of their choice that explains the health risks and proper dosage. If the end consumers do not lookout for their own health it is up to the FDA to enforce more scrupulous regulations on dietary products in an attempt to minimize health factors associated with these products. Bottom line though it is the responsibility of the consumer to know what they are putting into their bodies and the risks associated. Though it is unfortunate that people have been harmed by this event it will result in more government regulation and hopefully more knowledgeable users of these products.

Disclaimer:

All opinions voiced are that of the writer and are not affiliated with this website. It is also the opinion of the writer that no dietary supplements should be taken unless prescribed by a doctor.

Sources:

http://en.wikipedia.org/wiki/Rhabdomyolysis
cnn.com
nyt.com

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Last Updated on Wednesday, 08 July 2009 10:24

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