Hydroxycut One of Many Potentially Dangerous Supplements

Hydroxycut, voluntarily recalled from the marketplace on Friday, is just one of literally thousands of fat burning, weight loss, muscle producing diet supplements manufactured by an unregulated, multi-million dollar supplement industry. You only need visit a fitness store like GNC or a local gym to find a multitude of products that promise weight loss or muscle mass without supporting those claims through scientific fact or FDA oversight.
While the FDA has its hands full with the job it presently has, we need federal oversight of this industry before consumers are seriously and permanently injured.

FDA and Hydroxycut

While complaints about the dangers of the dietary supplement Hydroxycut have been around for years, the FDA never issued a consumer warning about the weight loss drug until yesterday. According to the FDA, the complaints were infrequent and were not definitively linked to liver damage or other health concern.
Unfortunately for consumers, diet supplements and weight loss pills and formulas are not regulated by the FDA. Unlike prescription drugs, these products don’t have to be evaluated or approved by the FDA prior to market launch. As a result, they are marketed as “all natural” and “healthy” even though there is no scientific evidence to support such claims. Additionally, people are often mislead to believe that a product marketed as “natural” is automatically safe. This is patently false. Many natural products are toxic and can cause serious harm to the human body and its internal organs.
In prior doses, Hydroxycut even contained the banned Ephedra. In fact, Ephedra was part of the chemical ingredients that comprised Hydroxycut until 2004 when it was removed.
The FDA is still evaluating what chemical, herb, or natural extract has caused the liver toxicity. In fact, it may be a combination of ingredients that have caused liver injury. Furthermore, the FDA does not know if its a problem with dosage, chemical ingredients, or the length of time that one is exposed to Hydroxycut. These answers should be forthcoming in the next weeks or months as the federal agency studies the weight loss formula. In the meantime, if you’ve used Hydroxycut stop using it immediately. If you show signs of liver disease such as jaundice, brownish urine, or light-colored stools, contact your healthcare professional.

Hydroxycut Lawsuit Weight Loss Drug Recall

A class action lawsuit will most likely be the result of today’s recall of the popular diet drug Hydroxycut. The fat burner has been highly and aggressively touted on television, radio, and the Internet for years. Many people who have tried to lose weight as well as health and fitness disciples have taken the drug in order to sculpt their bodies or lose weight.
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However, like Fen-phen and Ephedra, Hydroxycut has serious health consequences. Fen-phen caused cardiac problems including primary pulmonary hypertension. Hydroxycut has been linked to liver toxicity. Our firm has already been contacted by consumers who’ve been advised by their healthcare professionals that they have liver problems.
Diet drugs such as Hydroxycut are marketed as quick fixes and miracle drugs but they are not regulated or approved by the FDA. This lack of regulation has led to needless suffering for those who’ve taken these harmful drugs.
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Hydroxycut Recall Lawsuit Attorney

FOR IMMEDIATE RELEASE
Recall attorney Saunders & Walker with FDA Warns Consumers to Stop Using Hydroxycut Products recall
Dietary Supplements Linked to One Death; Pose Risk of Liver Injury and will likely result in lawsxuits
The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market.
The FDA and lawyers 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.
Liver injury, although rare, was reported by patients at the doses of Hydroxycut recommended on the bottle. Symptoms of liver injury include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite.
“The FDA urges consumers to discontinue use of Hydroxycut products in order to avoid any undue risk. Adverse events are rare, but exist. Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products,” said Linda Katz, M.D., interim chief medical officer of the FDA’s Center for Food Safety and Applied Nutrition.
Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names. The list of products being recalled by Iovate currently includes:
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
Although the FDA has not received reports of serious liver-related adverse reactions for all Hydroxycut products, Iovate has agreed to recall all the products listed above. Hydroxycut Cleanse and Hoodia products are not affected by the recall. Consumers who have any of the products involved in the recall are advised to stop using them and to return them to the place of purchase. 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.
Health care professionals and consumers are encouraged to report serious adverse events (side effects) or product quality problems with the use of these products to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.

Pat Buchanan’s World: Bed Bugs Tied to Illegal Immigration

I was watching MSNBC’s Hardball with Chris Matthews the other night and happened to catch conservative political commentator Pat Buchanan discuss the issue of swine flu. During his commentary, Buchanan linked swine flu with illegal immigration noting that the first cases of swine flu originated in Mexico. If you think that may be a stretch, wait for his next comment. Buchanan also attributed the growing problems with bed bugs on illegal immigration! I haven’t seen that the mainstream media or the blogosphere caught the comment but he actually argued for the connection.
Bed bugs have re-surfaced in this country as a result of a dearth of effective agents to kill the pesky insects. In addition, the bed bugs multiply rapidly and can go undetected until they start feeding on the blood of human beings. None of this has anything to do with the immigration issue. Bed bugs aren’t even restricted to the warmer weather climes of the border states. Bed bug problems have been noted in Chicago, New York, Boston and other northeastern cities.
As an attorney who handles bed bug cases, I thought it was suprising, almost comical to have Pat Buchanan trying to blame bed bugs on immigration.

Drug and Medical Device Manufacturers May Receive More Inspections from FDA

A bill introduced by Senators Chuck Grassley and Edward Kennedy would provide more funding for inspections of manufacturing plants that produce medical devices and pharmaceutical drugs. The proposal would give the FDA broad new powers in detaining questionable drugs or medical devices, allow the federal agency to issue subpoenas, and collect inspection fees from the company they are investigating.
The legislation comes in response to the contaminated Chines heparin as well as problems with manufacturing processes in medical device plants that make Stryker hip implants and Zimmer Durom Cup him implants.
While Congress has complained that the FDA has done a poor, ineffective job at regulating and inspecting medical devices and pharmaceutical drugs, the agency has argued that it is woefully understaffed and underfunded to complete the consumer safety tasks the federal government demands of the agency. This bill is widely seen as a corrective measure that would give the FDA the money and regulatory power to ensure better adherence to safety guidelines for both drugs and medical devices.

Medical Device Company Gets FDA Warning Letter

St. Jude Medical Inc. has received a warning letter from the FDA regarding its manufacturing practices at its Minnesota plant. The plant makes medical devices designed to correct atrial fibrillation disorders.
In its letter, the FDA made mention of St. Jude Medical’s Safire ablation catheter which is designed to disengage electrical signals that cause atrial fibrillation. The warning letter was issued as a result of a December FDA inspection of the Minnesota facility. Such a warning letter can result in the termination of production of the medical device in question if the company does not correct the problems cited in the warning letter.
Other medical device companies such as Stryker Corporation, Boston Scientific, and Johnson & Johnson have received similar warning letters in the recent past concerning other medical device products.

Sex Abuse Rocks Paraguayan President

The president of Paraguay Fernando Lugo was a Catholic bishop prior to his resignation in 2004 in order to run for the presidency of Paraguay. In the last few weeks, Lugo admitted fathering one child while he was a bishop. Now it seems that Lugo fathered more than one child while a Catholic bishop. A former episcopal colleague of his, Most Rev. Rogelio Livieres, spoke out yesterday. Bishop Livieres spoke to the media and revealed that when Lugo was confronted with two complaints of sexual activity in 2004, he didn’t deny the accusations. In fact, Lugo stated that at least in one instance the child was most likely his.
If you think this is bad, wait, it gets worse. The women who are now accusing the former bishop of fathering their children were minors at the time. According to Bishop Livieres, two of the women wrote letters in 2004 to the Vatican informing them of their allegations. Livieres claims “everyone” knew about Lugo’s sexual activity with the minors but it was covered up so as not to hinder his presidential chances.
So, once again, the church knew about sexual abuse and covered it up. It covered up this behavior by a bishop who was preying on poor women who looked to him for guidance, spiritual assistance, and fatherly love. Instead, he abused his authority and role as a bishop to sexually prey on these young women. When notified of the bishop’s behavior, the Vatican officials turned a blind eye to it. I guess they didn’t want to create scandal!

Bed Bugs More than a Nuisance

Infestations of bed bugs are causing quite a stir not only locally but in our nation’s capital. Last week, the EPA convened its first ever Bed Bug Summit to address the growing problem. These stubbon insects are found in homes, hotels, motels, college dorms, hospitals, and nursing homes. The recent growth in bed bugs complaints can be directly related to the decrase in effective agents on the market to remove the pesky creatures. After the effective chemical agent DDT (Dichloro-Diphenyl-Trichloroethane) was banned in 1972, the bed bugs became increasingly difficult to kill. The lack of effective agents coupled with the rapid pace at which bed bugs multiply has lead to what some have called a dire situation.
While there have been no known diseases spread by bed bug bites, I know, as a bed bug lawyer, the harm and discomfort these insects can cause. Some of my clients have permanent scars from their bed bug infestations. Others continue to experience “phantom itching” even after the bed bugs have been eradicated.
A common bed bug myth is that they are only found in unsanitary places. However, the truth isn’t so simple. Let me give an example. Suppose you and your family travel on vacation. You arrive at your hotel and you put your suitcase on one of the beds in your hotel room. Eager to unpack and start your vacation, you open the suitcase on the bed and unpack your clothes. If that bed is infested with bed bugs, chances are very good that you’ll be carrying these insects home with you. Now, you’re bringing them into your home. A simple remedy would be to inspect the beds in your hotel BEFORE placing your belongings on the bed. If you see brownish-reddish stains on the sheets or more likely the mattress, bed bugs are present.
Bed bugs are a nasty problem that cause pain and discomfort. From all I’ve read, the EPA Summit posed more questions than it actually answered. We don’t seem near a solution to this insect problem.

The Week That Was

In the past week, we’ve seen many news stories that affect us us one way or another. Some of the stories have a direct impact on us while others have a slightly less impact or one that will be subtle at best. Some of those news stories include:
Archbishop Timothy Dolan becomes the Archbishop of New York: Dolan’s appointment to the nation’s most prestigious See is a statement about how the Vatican views the church in the US. Dolan, a charismatic figure who holds a graduate degree in history, has been viewed by many as a conservative who holds fast to the Vatican line. Most importantly, he’s brushed off the sexual abuse scandal through charm and a relatively successful public relations campaign in Milwaukee. Unfortunately, there is little hope he’ll do anything differently in New York. He will in all likelihood support the Lopez bill before the NY State Legislature which will do little to help survivors of sexual abuse.
FDA Clamps Down on Medical Device Companies-this news is a long time in coming. For years now, the medical device manufacturers have made millions promoting device products that received scant attention from the FDA due to a loophole that allowed them to avoid rigorous clinical trials. The new FDA announcement will hopefully force them to comply with existing laws that compel them to demonstrate their device’s effectiveness and safety before they are marketed to the public.
Gadolinium Lawsuit Settlement– Bayer AG has settled a few of the lawsuits linked to Nehprogenic Systemic Fibrosis. These and other consumer justice lawsuits are an important check on the power and influence of pharmaceutical companies that market products that are dangerous and potentially lethal to the consumer.