The FDA Recalls Hydroxycut
When there’s a substantial risk involved with taking a medication or supplement, the U.S. Food and Drug Administration (FDA) issues a recall to warn consumers to stop taking it.
This is exactly what happened on May 1, 2009, when the FDA learned that popular weight loss drug Hydroxycut could be linked to major medical problems. Hydroxycut manufacturer Iovate has agreed to a voluntary recall of 14 different Hydroxycut products, and the FDA is urging consumers to discontinue use of all other Hydroxycut supplements as well.
The May 1, 2009 recall of Hydroxycut came after the FDA received over 20 reports of medical complications directly relating to the supplement. The most serious and common Hydroxycut problems are associated with liver failure, and one death has already been reported after a patient took Hydroxycut. This liver damage, which may cause the patient to need a liver transplant, has affected patients who were taken the recommended dosage. Other serious medical conditions that have been reported and contributed to the FDA’s decision to recall Hydroxycut include seizures, muscle damage, heart disease, and kidney failure.
The FDA recommends that everyone taking Hydroxycut stops using the product, as even a lower dosage could lead to medical problems. The symptoms relating to serious conditions sometimes appear as soon as the patient begins taking Hydroxycut; other times, it is several months later or they even occur after the consumer stops taking the supplement.
Based on the information the FDA has received, it is impossible to tell which ingredient in the supplement or blend of ingredients causes the problems. The first liver-related problems were reported to the FDA many years ago, but at the time, it was thought that ephedra was the cause. Ephedra, however, was removed from Hydroxycut in 2004, and problems have since been reported. Because Hydroxycut is a supplement and not a drug, though, reporting on problems is not as highly regulated, and laws governing the product are different.
If you’ve experienced a problem due to taking Hydroxycut, you should see a doctor right away and also file a complaint with the FDA. It is important to also talk to a Hydroxycut lawyer to learn about your rights.
Recalls
On May 1, 2009, popular weight loss supplement Hydroxycut was recalled after being linked to a number of patients with liver problems and other medical concerns.
Hydroxycut is sold in the United States without ephedra, and it is designed to boost a patient’s metabolism while also reducing cravings for food. Doctors question the effectiveness of Hydroxycut, though some studies suggest that the supplement helps patients lose weight up to 4.5 faster than they would just through diet and exercise. In addition, Hydroxycut has been shown to be much more effective than a placebo.
The following 14 Hydroxycut products were involved in the recall:
- Hydroxycut Regular Rapid Release Caplets
- Hydroxycut Caffeine-Free Rapid Release Caplets
- Hydroxycut Hardcore Liquid Capsules
- Hydroxycut Max Liquid Capsules
- 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 is made by Iovate Health Sciences and is used by millions of people. Based on the number of people taking Hydroxycut versus the number of incidents, Iovate says that the drug is still safe and the recall is precautionary. However, the FDA says that because this is a supplement and not a drug, it is harder to track the number of people who fall ill after using it. Liver damage is the most common problem associated with Hydroxycut, but other health concerns that have been reported include seizures, heart disease, and rhabdomyolysis (a type of muscle damage). Those with liver damage often experience jaundice, brown urine, vomiting, fatigue, stomach pain, itching, and appetite changes.
Although the FDA urges consumers to stop using all Hydroxycut products, Iovate has only officially recalled the 14 listed above. Other Hydroxycut products and Hoodia products may also be unsafe. For more information about Hydroxycut, you should talk to your doctor, and if you feel you’ve been injured due to using this product, contact a Hydroxycut lawyer right away to learn more about your rights.
Hydroxycut Side Effects
Hydroxycut side effects range from mild to deadly.
Some Hydroxycut side effects disappear or diminish after you stop taking the diet drug while some side effects linger longer to require hospitalization or liver transplant surgery.
What are the Hydroxycut side effects?
Side effects of liver damage include: nausea, vomiting, diarrhea, dizziness, fatigue, sleepiness, weakness, abdominal pain, itching, and loss of appetite. Unfortunately, these side effects are general and can be overlooked in a liver damage diagnosis. You may also think that you’re getting the flu or having a bad day.
More serious Hydroxycut side effects are a tendency to bleed easily, blurred vision, swollen stomach, mental confusion, extreme fatigue, and coma.
Signs of Liver Damage
Though more revealing Hydroxycut side effects includes pale stools and brown urine which could be a symptom of jaundice. Stools that are pale or clay-or putty-colored may result from problems in the bile track. The liver releases bile salts into the stool, giving it a normal brown color. You may have clay-colored stools if you have a liver infection or if the flow of bile out of the liver is blocked. Bile is a thick fluid released by the liver and stored in the gallbladder. Bile helps break down fats into fatty acids.
Jaundice or yellow skin accompanies clay-colored stools due to build up of the bile chemicals in the body. Jaundice is a yellow color in the skin, the mucous membranes, or the eyes. The yellow pigment is from bilirubin, a byproduct of old red blood cells. As with a bruise, you may have noticed that the skin went through a series of color changes as it healed. When you saw yellow in the bruise, you were seeing bilirubin. If there are too many red blood cells retiring for an overloaded or damaged liver, yellow pigment builds up in the body – and jaundice results.
Hydroxycut side effects have caused hepatitis – an extension of liver damage.
A 20-year-old male victim who used Hydroxycut fat burner for bodybuilding died from necrosis of the large and small intestines. Necrosis is death of body tissue that happens when there is not enough blood to the tissue, whether from chemicals, radiation, and injury. Necrosis is not reversible.
Life threatening Hydroxycut side effects include arrhythmia or irregular heartbeat, heart attack, seizures, stroke, and rhabdomyolysis.
Arrhythmia refers to any change from the normal heart sequence whether too fast, too slow, or too erratic. When the heart fails to beat properly, it can’t pump blood effectively. When the heart doesn’t pump blood effectively, the lungs, brain, and all other organs don’t work properly which may result in damage or shutting down.
Another frightening side effect of Hydroxycut, the allegedly fat-burning diet drug is rhabdomyolysis, a skeletal muscle disorder leading to kidney damage. Rhabdomyolysis is often caused by excessive muscle exercise, electric shock, heat stroke, hypothyroidism, and some drugs.
Some of the most common symptoms of rhabdomyolysis are dark, red, or cola colored urine; muscle tenderness, weakness of the affected muscle, general weakness, muscle stiffness or aching, seizures, joint pain, and fatigue. If not treated properly, rhabdomyolysis may cause life-threatening complications. Rhabdomyolysis can cause acute kidney failure and heart attack.
Absolutely no one should suffer life threatening side effects, the need for a liver transplant, insurmountable medical bills, and/or wrongful death because of a diet drug.
Liver Failure
The recent Hydroxycut recall by manufacturer Iovate Health Sciences and the U.S. Food and Drug Administration (FDA) have affected millions of users across the country.
The supplement, which is used to boost energy and help with weight loss, has been associated with over 20 cases of severe health problems, one of which resulted in death. The most serious medical condition associated with Hydroxycut is liver failure.
The liver is necessary for survival, and some of its main functions are detoxification and production of chemicals needed for digestion. When the liver shuts down, one of the most common symptoms is jaundice, which causes the skin and whites of the eyes to turn yellow. At this level of liver failure, the urine also turns brown.
As the liver just starts to become damaged, patients may experience other symptoms, including vomiting and nausea, fatigue, weakness, stomach pain, loss of appetite, unusual stools, and itching. Some patients experience these symptoms right away, while others don’t experience the symptoms until after they’ve experienced prolonged use of Hydroxycut. In addition, some people who take Hydroxycut and later stop taking the supplement could develop liver failure after they aren’t taking the product any longer.
Iovate, the company that makes and promotes Hydroxycut, has said that the risk involved with this supplement is very low and the supplement is safe for the vast majority of the millions of people who have been taking it. However, one person has already died due to Hydroxycut causing liver failure and a number of other people may need liver transplants.
If you are currently using Hydroxycut or have used it in the past, your best course of action is to talk to your doctor to ensure that you don’t have any major liver problems. Patients who’ve been hurt after using Hydroxycut should also talk to a Hydroxycut lawyer to learn about your rights.
Liver Transplant Surgery Needed in Some Hydroxycut Cases
Hydroxycut products have been found to be damaging to the liver. While the percentage of people with liver disease from Hydroxycut is small the product is recalled due to the possible severity of the damage.
If you have used Hydroxycut products in the past and have experienced liver problems as a result you should seek advice about how to proceed.
About Liver Disease
Liver disease is characterized by a breakdown in the function of the liver. The liver is the largest solid organ in the body and is responsible for many important functions. The liver provides detoxification ridding the body of many harmful toxins. The liver makes proteins that actually contribute to maintaining the proper amount of blood in the body as well as assisting in clotting. The liver stores and processes fats that are used by the body for energy. One of the most important functions of the liver is to secrete bile that helps the intestines absorb vitamins.
People cannot survive without a functioning liver. When the liver is damaged it can no longer properly perform these functions. In the case of damage caused by Hydroxycut some of the harm may be reversed when product use is promptly halted. Severe acute liver damage cannot be corrected and survival is dependant on a liver transplant.
Liver Translants
Liver transplant surgery is quite a complex operation. The liver is a solid organ as well as a gland so liver transplant surgery is considered organ transplant surgery. As soon as it is known that a liver transplant is necessary the patient goes on a waiting list. The liver must be a proper match for the recipient. It may take days, weeks or even months to locate a liver suitable for transplant. The patient needs to be prepared and ready to go to surgery at a moment’s notice when a matching liver is located.
Liver transplant surgery is considered major surgery and you will likely have a team of surgeons who will perform the operation. The surgeon opens the abdomen and first removes the old liver. The liver is connected via various major blood vessels and bile ducts that are left intact for reconnection to the new liver. The patient will likely have a drainage tube inserted that is used to drain bile from the body during the procedure. The new liver is then placed in the body and reconnected to each of the blood vessels and bile duct.
Kidney Damage
Hydroxycut diet pill supplement does more than help you lose weight. Hydroxycut has many quality of life diminishing side effects including kidney damage.
Kidney damage occurs which the kidneys fail to function adequately causing kidney failure or renal failure. Symptoms of kidney disease can vary from person to person. Often people with kidney disease won’t notice any symptoms until it’s too late. When the kidneys fail to function, waste products accumulate in the blood and the body.
The Hydroxycut side effects coincide with the symptoms of kidney damage. Such symptoms are feeling tired and weak, memory problems, difficulty concentrating, dizziness, difficulty sleeping, loss of appetite or a constant bad taste in your mouth.
As kidney damage worsens, kidney failure is next. Symptoms of kidney failure are vomiting and diarrhea, dehydration, nausea, foamy urine, dark colored urine, blood in urine, difficulty urinating.
When a buildup of phosphates in the blood occur, diseased kidneys cannot filter – symptoms such as itching, muscle cramps, abnormal heart rhythms, swelling of the limbs, and shortness of breath. Some of which are side effects of Hydroxycut too.
Causes of kidney disease are diabetes mellitus uncontrolled hypertension, and the overuse of common drugs like aspirin, ibuprofen, cocaine, and acetaminophen. Can we add Hydroxycut diet and energy supplements to the list?
FAQ
Q. Why are these products being recalled?
A. Hydroxycut products have been associated with potential risk of severe liver injury. The FDA has received 23 reports of liver problems in people who used Hydroxycut, some of whom needed liver transplants, and one death has been reported. FDA has learned of several other serious problems that some Hydroxycut users have had, including seizures; rhabdomyolysis (a type of muscle damage that can lead to other serious problems, such as kidney failure); and cardiovascular problems, ranging in severity from irregular heart beat to heart attack.
Q. What is Hydroxycut?
A. Hydroxycut products contain a variety of ingredients, including herbal extracts, chemicals and metals.
Q. How can I find out if other Hydroxycut products are being added to the recall?
A. FDA will provide additional information in future Consumer Alerts, which will be posted on the FDA web site at FDA.gov
Q. Can Hydroxycut make me sick?
A. Although the serious liver problems experienced by some people after taking Hydroxycut appear to be rare, anyone taking Hydroxycut products could be at risk. For this reason, FDA recommends that all people stop using Hydroxycut weight loss products.
Q. Are some people at higher risk than others?
A. There is not sufficient medical evidence at this time to make a definitive statement on the risk of one segment of the population over another. It is, however, important to note that even people who had no preexisting medical conditions have needed liver transplants after taking Hydroxycut.
Q. I’ve been taking Hydroxycut. Should I stop?
A. Yes. FDA recommends that all people stop using Hydroxycut weight loss products.
Q. If I just cut back my dose of Hydroxycut, will that reduce the risk that it could make me sick?
A. No. The amount of Hydroxycut that could cause illness is unknown. Liver injury occurred even when patients said they had taken the doses of Hydroxycut recommended on the bottle.
Q. What are the symptoms I should watch for if I have taken Hydroxycut?
A. Symptoms of serious liver disease include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms of liver disease might include nausea, vomiting, light-colored stools, unusual tiredness, weakness, stomach or abdominal pain, itching, or loss of appetite.
Q. If I were going to have symptoms, how soon would they appear?
A. Symptoms could have occurred while you were taking Hydroxycut, or they could occur up to several months after you stopped taking it.
Q. What should I do if I develop these symptoms?
A. If you have the symptoms above or develop any other new symptoms after taking Hydroxycut, see your health care provider as soon as possible.
Q. I thought ephedra was banned. Does Hydroxycut contain ephedra, and could that be what caused the illnesses linked to Hydroxycut?
A. The company that makes Hydroxycut states that the current formula does not contain ephedra and that ephedra was removed from Hydroxycut products in 2004. The serious problems that have been occurring do not appear to be due to ephedra.
Q. Are any of the ingredients in Hydroxycut known to cause illness?
A. Based on the information that is available, FDA can’t determine exactly which ingredient or blends of ingredients in Hydroxycut may be associated with liver injury, or what other factors may affect the risks associated with Hydroxycut. These other factors may include, for example, pre-existing medical conditions, length of time Hydroxycut has been used, or use of both Hydroxycut and other dietary supplements or drugs.
Q. I thought Hydroxycut contains natural ingredients. Doesn’t that make it safe?
No. “Natural” ingredients don’t necessarily mean that a product is safe. Many substances that come from nature can be toxic.
Q. I still have some Hydroxycut. What should I do with it?
A. You should dispose of any Hydroxycut that you have.
Q. I read that potential problems with Hydroxycut were first reported seven years ago. Why has it taken FDA so long to notify the public?
A. Because liver-related problems associated with Hydroxycut were reported infrequently, several years elapsed before a clear relationship between Hydroxycut and liver disease became discernible. Now that the relationship has been established, FDA is notifying the public and health care providers. In addition, until 2004, Hydroxycut contained ephedra, which subsequently has been removed. It was thought that ephedra may have caused the liver-related problems, but following its removal from the Hydroxycut products, reports of illness continued.
Q. How can I lose weight safely?
A. The safest way to lose weight is to develop a weight-loss plan with your health care provider. To find out more about safe weight loss, visit the following web site offered by the National Institutes of Health:win.niddk.nih.gov.
Hiring a Lawyer for your Hydroxycut Case
On May 1, 2009, 14 different kinds of Hydroxycut were recalled. The United States Food and Drug Administration is also encouraging users to stop taking other forms of Hydroxycut, and more recalls may happen in the future.
If you believe that you’ve been hurt due to using this weight loss supplement, you should hire a Hydroxycut lawyer to find out more about your rights – but how do you find the Hydroxycutattorney that is best for your case?
First, it is important to look at the lawyer’s experience with recalls and pharmaceutical cases. Whenever a drug is recalled like Hydroxycut was, lawyers across the country try to jump on board, hoping for a slice of the pie. No one has Hydroxycut experience, since the case is brand new, but the best lawyers will be those that have dealt with drug recalls in the past.
Contact Our Hydroxycut Recall Lawyers Today »
With so many people seeking help from lawyers about Hydroxycut right now, it is also important to look for a lawyer that has time for your case. Hydroxycut lawyers that are too busy may dismiss your needs or lump you in with others who were taking Hydroxycut, but who may be dealing with a completely different situation. A good Hydroxycut attorney will care about your specific case.
Another aspect of hiring a lawyer that you should keep in mind if you are dealing with a Hydroxycut case is location. Hydroxycut is most commonly associated with liver problems, and if this is affecting you, you’ll need serious medical care over the next several months. A Hydroxycut lawyer that lives far away from your home and hospital may not be the best choice.
Lastly, when hiring a Hydroxycut attorney, make sure that you feel comfortable with the lawyer and his staff. You’ll need to share very personal information about your weight loss attempts with Hydroxycut and your current medical condition. If you don’t feel comfortable with your lawyer, your Hydroxycut case will only suffer.