Hydroxycut and FDA Response
A chain of dietary supplements for weight loss are sold under the brand name Hydroxycut. The U S Food and Drug Administration (FDA), on May 1 2009, issued a warning after the drug was found responsible for liver damage. The manufacturers reformulated and sold Hydroxycut with some different ingredients.
The use of Hydroxycut caused a death and reportedly 23 serious health problems ranging from jaundice to liver damage. The indication can be of potential liver injury which may, in serious cases, require liver transplant. One death is reported to the FDA due to liver failure. It is rare but the issue being raised is the death occurred due to the dosage recommended on the bottle. Yellowing of the skin or whites of the eyes known as jaundice, nausea, stomach or abdominal pain, vomiting, light-colored stools, weakness, itching, excessive fatigue and loss of appetite are some of the symptoms of the liver injury. It can also cause seizures and cardiovascular disorders. Kidney failure can occur as it damages skeletal muscle, the process of damaging known as rhabdomyolysis in which damaged muscle cells are released in blood, which can damage the kidneys.
It led FDA to warn people against using Hydroxycut products. As per analysis of the researchers in a study reported by the American Journal of Gastroenterology, 17 cases of liver damage had not yet appeared in the medical literature,. Eight cases were studied by the authors and nine had been reported to the FDA. Certain factors like patients’ risk factors for liver disease and the timing of the Hydroxycut use were kept in mind while investigating. There was more than 95% chance that the weight-loss aid was to blame for eight of the liver-damage cases revealed the researchers. Some industry sources believed that the FDA withdrawal was given unnecessary hype by the media, hence defended the safety of Hydroxycut.
Under Iovate and MuscleTech brand names, Hydroxycut products are sold as dietary supplements that can prove helpful in weight loss. Some people put forward the query that despite having money to publish long term safety studies on the final products of the Hydroxycut, Iovate did not do so. Due to its association with large number of severe liver injuries, Hydroxycut products are recalled from the market to which Iovate responded in agreement.
Iovate has agreed to recall all the products FDA warned against, however, all Hydroxycut products are not reported to have serious liver-related adverse reactions. Hydroxycut Regular Rapid Release Caplets, Hydroxycut Caffeine-Free Rapid Release Caplets, Hydroxycut Hardcore Liquid Caplets, Hydroxycut Max Liquid Caplets, Hydroxycut Regular Drink Packets, Hydroxycut Caffeine-Free Drink Packets, Hydroxycut Hardcore Drink Packets (Ignition Stix), Hydroxycut Max Drink Packets, Hydroxycut Liquid Shots, Hydroxycut Hardcore RTDs (Ready-to-Drink), Hydroxycut Max Aqua Shed, Hydroxycut 24, Hydroxycut Carb Control, Hydroxycut Natural are all recalled. Customers are directed to stop usage of these drugs. They can also return them to the place of purchase.
The editors of the nutrition trade journal Nutrition Business Journal deem the measures of making the manufacturers, who promote themselves as research-oriented, realize the reality of the matter useful. They believe that if this recall will remind and encourage the manufacturers of the weight loss supplements to care about the safety of their products the same way they care about their profit and expansion of business then this recall is a good step.