Hydroxycut Recall after FDA Warning to Stop Using the Diet Pill
Following the death of a 19-year-old male and 23 reports of liver damage, the FDA has stepped in to warn consumers to discontinue use of the popular diet pill Hydroxycut. Hydroxycut manufacturer Iovate Health Sciences has agreed to recall 14 products from the market as “an abundance of caution.”
From the FDA press release — The FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to the FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.
The teen’s death happened in 2007, and was only reported to the FDA in March 2009. Dr. Linda Katz of the FDA’s food and nutrition division said it has taken so long to bring this to the public’s attention because the cases were rare and the FDA has no authority over supplements (a government report in March 2009 called for higher supervision of supplements by the FDA). “Part of the problem is that the FDA looks at dietary supplements from a post-market perspective, and an isolated incident is often difficult to follow,” she said.
The FDA does not regulate supplements with the same authority it does pharmaceuticals. Producers do not have to have an FDA approval nor inspection of the products for safety or efficacy before being sold to consumers. “You really have to be careful about dietary supplements, especially weight-loss pills,” said Ano Lobb, who has studied Hydroxycut for Consumer Reports. “People believe that the FDA has verified that these products are at least safe and effective, and that’s really not the case. When you see fantastic claims — that’s generally what they are.”
The FDA does monitor aftermarket reports for health problems related to these supplements. A similar warning in 2004 regarding ephedra forced the government to enact a ban on the supplement ingredient following reports of heart attack and stroke.
This list of Hydroxycut products being recalled include:
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
Hydroxycut Cleanse and Hoodia products are not affected by the recall.
“The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. The products contain a variety of ingredients and herbal extracts,” per the FDA press release.
Chantix has become the leading prescription to help smokers kick the habit. Pfizer, Manufacturer of Chantix, has reported skyrocketing sales since its introduction in 2006. Sales totaled $101 million in 2006, $883 million in 2007, and $846 in 2008. It’s dominant in its market, with a reported 90% market share.
Chantix is unique because it not only reduces the urge to smoke, it actually blocks the brain’s nicotine receptors. This means if the smoker lapses and lights up, it won’t satisfy the nicotine craving. Chantix can be taken up to 12 weeks, by which time the smoker should have lost any urge to smoke. By design, Chantix users experience the similar symptoms of quitting smoking cold turkey. Many patients experience mood swings, depression, and even thoughts of suicide. Pfizer has stated these side effects are a result of nicotine withdrawal, and not the drug itself. Other’s believe there is a link to Chantix and the psychological side effects.
Since Chantix was approved just a little more than three years ago in May of 2006, considerable controversy has mounted. Within months of its approval, the FDA issued public warnings about the increasing likelihood of Chantix being associated with serious changes in patients' behavior including agitation, hostility, depression, suicidal thoughts, and reports of attempted and completed suicide. In many cases, the problems began shortly after starting the medication and ended when the mediation was stopped. In 2007, the FDA released an alert to doctors to look for unusual behavior. This came shortly after the musician Carter Albrect was shot and killed. Those close to him cited his use of Chantix and atypical behavior leading up to his death.
The FDA issued a Public Health Advisory on February 1, 2008, to alert patients, doctors, and caregivers to important new safety warnings on the drug label relating to suicidal behavior and several other neuropsychiatic symptoms. Also, in 2008, the FAA banned the use of Chantix by pilots and co-pilots, citing possible psychological side effects. Also in 2008, the Department of Veterans Affairs made headline news by issuing Chantix to soldiers with post-traumatic stress disorder. Earlier this year Health Canada (Canada’s Public Health Department) revised the warnings of Chantix after receiving over 800 reports of adverse psychological side effects. Most recently, the FDA has (finally) required Pfizer to place new warnings in the form of a Boxed Warning – the strongest warning possible – highlighting the risks concerning Chantix and a link to changes in behavior, hostility, agitation, depressed mood, suicidal thoughts and behavior, and attempted suicide. The FDA has instructed doctors to have their patients cease use immediately if they experience any of these side effects.
With hundreds of suicides reportedly linked to Chantix, and thousands more attempted suicides, Pfizer has gone far too long downplaying the psychological side effects as simply nicotine withdrawal.
There are other side afects thay don't want anyone to know about such as stomac bleeding and paine from long term use..
If you know of any other's please let me know so I may warn other's