Reglan: JPML Hearing held in Louisville, KY

A motion to form an MDL, or Multidistrict Litigation, was argued yesterday before the JPML sitting in Louisville, Kentucky. There are at least 15 Reglan lawsuits pending in 11 different district courts throughout the United States.

Reglan is prescribed to treat gastrointestinal disorders like diabetic gastroparesis, GERD (gastroesphageal reflux and delayed gastrict emptying.

Request for Reglan lawsuit consolidation was opposed by the attorneys for companies involved in the litigation, including Wyeth, who manufactured the brand name Reglan products, and several manufacturers of generic versions, such as Baxter, Pliva, Barr, Duramed, Actavis, Teva and Scwarz Pharma.

Life Investors Insurance Class Action: Deadline Looms

Our firm is currently representing consumers who have cancer insurance policies with Life Investors Insurance Company of America as well as Transamerica.

Good and honest people bought cancer policies for a simple reason - To provide for a reimbursement amount of “actual charges” to be paid when incurred or billed. When claims were submitted, we believe that these two companies do not pay the “actual charges.” Instead, these insurers will pay a discounted amount for those same cancer treatments, contrary to the terms of the policy. We are pursuing individual cases.

Many people who bought a cancer insurance policy may have a received recently a class action notice in the case of Runyan v. Life Investors Insurance Company of America / Transamerica. The time period that applies to any policy bought during the years 2004 - 2006.

In our experience, the class action relief asked for is simply not an adequate remedy. As we see it, the Runyan class settlement is inadequate relief for policyholders.

We believe that “opting out” of the class action may be more appropriate to protect their individual rights. Alternatively, filing an objection to the class may be even more appropriate. We are currently evaluating both of these options for these policyowners, but we are nonetheless accepting cases for those who wish to either opt out or object to the class settlement in its entirety. The deadline to exclude yourself from this class is June 29, 2009.

The deadline to object to the settlement is June 29. 2009.

Tech: PDF For Lawyers

The site, that is. http://www.pdfforlawyers.com/ Is worth a look. Tips include: "Using Acrobat to put Exhibit stamps on digital documents." Also, learn how to OCR with the ScanSnap to create searchable PDF files at just the push of the “scan” button…


Worth your time. We use the Scansnap at work, and it's a must have.

Hydroxycut Lawsuit; Hypertensive retinopathy associated with Hydroxycut Usage

Here's a report on the use of performance-enhancing and weight-loss supplements is prevalent in the United States. The report notes that with new restrictions placed on such products, companies have been marketing caffeine-based ephedra-free herbal supplements.


The report notes, "less is known about the potential side effects of these products. We present the case of a 42-year-old, previously healthy man who developed malignant hypertension and hypertensive retinopathy while taking Hydroxycut, a caffeine-based ephedra-free supplement."

Find the abstract here.

Flomax and Cataracts

Men taking Flomax to treat an enlarged prostate face more than double the risk for serious complications should they need cataract surgery, a new Canadian study has found.

It's not the first time that Flomax (tamsulosin) has been linked to cataract complications. A study in 2005 found that men taking Flomax or other alpha-blockers before cataract surgery had complications during and immediately after the procedure. The U.S. Food and Drug Administration called for stronger warnings about the drug, and Boehringer Ingelheim Pharmaceuticals, which makes Flomax, sent warning letters to doctors about the potential problems.

In the new study, 7.5 percent of the men who had taken Flomax in the two weeks before cataract surgery had a serious complication, compared with 2.7 percent of those who had not taken the drug, for a 2.3 times greater risk.

Read more at this source, here.

Reglan: FDA Video from YouTube

Interesting that the FDA now uploads video to youtube.com

Hydroxycut Lawsuit Filed in Georgia State Court

Our office filed in Georgia State Court a lawsuit where a consumer claims she suffered an injury related to her use of Hydroxycut. The multi-count lawsuit claims, among other things, what most would expect: Negligence, Breach of Warranty, and other claims of wrongdoing.

We don't file class actions in my office, believing that the best way to seek some measure of justice for someone is to make a specific claim for each person in separate lawsuits. Other lawyers may go the class action route; it's just not for me.

I will post a few pages of the Complaint filed in the next day or so.

Reno Article: Reglan (Georgia, Alabama)

"It's wonderful when prescription medications cure ailments, but what happens when they cause adverse medical side effects?" The article goes on to note:


"I'm angry because I appear to be suffering from permanent central nervous system damage associated with the prescribed drug Reglan (brand name for "metoclopramide"), prescribed over a year ago for a digestive disorder.

I received a letter dated April 30 from my GI's office noting the FDA has placed a "Black Box Warning" on Reglan, explaining, it's possibly linked "with the development of a condition known as "tardive dyskinesia," a permanent CNS condition that's untreatable.

TD is a disorder of the tongue, mouth and jaw, causing them to move uncontrollably in abnormal ways.

The drug can also cause face jerking or involuntary body movements, including:

"Repetitive movements of the extremities

"Lip smacking, pursing, puckering

"Grimacing

"Tongue protrusion

"Rapid eye movements

"Impaired movement of fingers

"The movements are pretty much constant, except during sleep," reported Dr. Jeff Bronstein in a Los Angeles Times article. He's with the UCLA David Gaffen School of Medicine.

If you have taken Reglan, or are taking it now, the FDA says it's time to call your physician, whether you are experiencing side effects or not."

Read the rest here.

David Hodge: $17 Million Dollar Verdict in AL on 5/13/09

A guy who I consider a friend is David Hodge, a Birmingham, Alabama lawyer. Not too excitable, loves Bama football, family man, dog man like me.

David went to Hale County, which is right here:





His firm's client was Chapman Logging. The case involved the sale of a defective logging skidder equipped with a Cummins engine. David's firm is found here pdkhlaw.com. A skidder looks like this:

Image via Wikipedia

I know what you're thinking: How in the world did the jury come back with that verdict? I'm thinking the same thing, but will have to hear more about it tomorrow. Well done. I will tell you this - if you run across David Hodge in any case, take a get ready pill.

That Pesky Drug known as Cheerios

Image via Wikipedia

Sometimes you just shake your head in amazement. This warning letter from the FDA to the CEO of General Mills (never mind that people are getting ill or dying from bad foods):

(FDA source)

Ken Powell
Chairman of the Board and CEO
General Mills
One General Mills Boulevard
Minneapolis, Minnesota 55426

Dear Mr. Powell:

The Food and Drug Administration (FDA) has reviewed the label and labeling of your Cheerios® Toasted Whole Grain Oat Cereal. FDA's review found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations (21 CFR). You can find copies of the Act and these regulations through links in FDA's home page at http://www.fda.gov.

Unapproved New Drug

Based on claims made on your product's label, we have determined that your Cheerios® Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug because the product is intended for use in the prevention, mitigation, and treatment of disease. Specifically, your Cheerios® product bears the following claims on its label:

• "you can Lower Your Cholesterol 4% in 6 weeks" "
• "Did you know that in just 6 weeks Cheerios can reduce bad cholesterol by an average of 4 percent? Cheerios is ... clinically proven to lower cholesterol. A clinical study showed that eating two 1 1/2 cup servings daily of Cheerios cereal reduced bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol."

These claims indicate that Cheerios® is intended for use in lowering cholesterol, and therefore in preventing, mitigating, and treating the disease hypercholesterolemia. Additionally, the claims indicate that Cheerios® is intended for use in the treatment, mitigation, and prevention of coronary heart disease through, lowering total and "bad" (LDL) cholesterol. Elevated levels of total and LDL cholesterol are a risk factor for coronary heart disease and can be a sign of coronary heart disease. Because of these intended uses, the product is a drug within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C. § 321 (g)P)(B)]. The product is also a new drug under section 201(p) of the Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease. Therefore,under section 505(a) of the Act [21 U.S.C. § 355(a)], it may not be legally marketed with the above claims in the United States without an approved new drug application.

If you can ...ummm ...stomach the rest of that letter, you are a better person than I.

Lawyer Etiquette: Is Your Blackberry Use Hurting your Reputation?

Image by Getty Images via Daylife

I attended a meeting of lawyers this month, and when about 5-6 of us were sitting together talking shop, one member of the group brought up a good subject. As we talked, that same person started typing away on his Blackberry. He was so distracted, he missed two questions posed to him. I was to be candid appalled. It was rude and insensitive. I didn't know this person very well, but I will remember him now for that mistake.

I went searching on the web for a quick list of suggestions that I lawyers could read to help them when using a Blackberry, since at least 50% of its users forget basic courtesies:

From the Legalease Blog:


1. If you are attending an event, meal, meeting or presentation, turn off your electronic devices. If you put MUST keep them on, turn them to silent or vibrate, do not place them on the table so that the vibration disturbs those around you;

2. If you are awaiting an important call or email, consider not attending the event so that you can attend to your important business;

3. If it is imperative that you attend the event, be sure that you keep your focus or attention on the event. Advise your companions at the outset that you are waiting for an urgent call, and sit near the door. Leave the room or the table discreetly if you absolutely MUST check your email or voice mail or return a call or email;

4. Remember that those around you are forming an impression of you AT ALL TIMES; if you are with a client and are checking your BlackBerry, reading emails, surfing the web, the client is going to think that you don't care about them and that they are not important to you;

5. Be aware that if you are replying to important emails while at dinner, a networking event or another meeting, you are not presenting your best self either at the event or in the email. Not only are you unable to devote your complete attention to the event and the people you are with, but you are also unable to devote your full attention to the email message. You may be making a poor impression on two groups of people at the same time.

6. Even if your device is under the table or you think you are being discreet others in the room are well aware of what you are doing. Regardless of what you think, you are NOT getting away with it!

7. The smaller the meeting, the more noticeable your behavior. But even in large meetings, be mindful of those around you, since they will certainly be aware of your behavior, so if your boss or an important client or colleague is sitting near you, refrain from checking your BlackBerry. And if the presenter, meeting facilitator or your boss is standing, seated on a dais or is behind you, they will be aware of your behavior even in a large room.

8. Reconsider your definition of what is an 'urgent' matter and what can wait. Think about your priorities, not just in the short term (answering this email immediately as opposed to 10 minutes from now), but also in the long term (if the client thinks I'm rude, I may lose the account).

There's more at the link above.

Take heed, lawyers!

Autism: Are Children able to "Recover?"

A close friend has a child with autism, and the frustrations, worries and concerns are etched on his face when we get together. I could never imagine what he and his family must address each day.

From several sources, including Yahoo, this article:

"Leo Lytel was diagnosed with autism as a toddler. But by age 9 he had overcome the disorder. His progress is part of a growing body of research that suggests at least 10 percent of children with autism can "recover" from it — most of them after undergoing years of intensive behavioral therapy.

Skeptics question the phenomenon, but University of Connecticut psychology professor Deborah Fein is among those convinced it's real.

She presented research this week at an autism conference in Chicago that included 20 children who, according to rigorous analysis, got a correct diagnosis but years later were no longer considered autistic.

Among them was Leo, a boy in Washington, D.C., who once made no eye contact, who echoed words said to him and often spun around in circles — all classic autism symptoms. Now he is an articulate, social third-grader. His mother, Jayne Lytel, says his teachers call Leo a leader.

The study, funded by the National Institute of Mental Health, involves children ages 9 to 18.

Autism researcher Geraldine Dawson, chief science officer of the advocacy group Autism Speaks, called Fein's research a breakthrough."

Read the rest here.

Hydroxycut: UPC Codes Released today (Georgia, Alabama, Florida)

Here's news on the Universal Product Codes related to the Hydroxycut products:

Iovate Health Sciences U.S.A., Inc. Adds Hydroxycut-Branded Product Universal Product Codes to its Voluntary Nationwide Recall

Contact:
Jamie Moss
201-493-1027

FOR IMMEDIATE RELEASE -- (May 7, 2009) -- Iovate Health Sciences USA, Inc. of Blasdell, New York and Ontario, Canada announced today that it is adding Universal Product Codes (UPCs) with respect to the Hydroxycut-branded products sold in the United States and subject to the voluntary recall. These additions all involve additional packages and sizes of products previously referenced.

The UPC numbers being added to the May 1 list are as follows:

631656800265 Hydroxycut Hardcore 8 fl. oz. Grape Explosion
631656800210 Hydroxycut Hardcore 8 fl. oz. Triple Wildberry
631656001501 Hydroxycut 280ct-3 Pak Kit *Discontinued*
631656001563 Hydroxycut 280ct-6 Pak Kit *Discontinued*
631656000658 Hydroxycut 100ct-6 month supply (7 bottles+ 4 free) Kit
631656600896 Hydroxycut 2x60ct Club Pack US Kit
631656000672 Hydroxycut 100ct-1 month supply (1 bottle+1 free) Kit *Discontinued*
631656874693 Hydroxycut 58 cap 12-pack Target US Kit *Discontinued*
631656000665 Hydroxycut 100ct-3 month supply (4 bottles+2 free) Kit *Discontinued*
631656002362 Hydroxycut Sachet Twin Pack US Kit
631656860498 Hydroxycut Instant Weight Loss Shot 12 x 2oz - Wild berry US Kit
631656660623 Hydroxycut Hardcore Shredded Stack Kit120ct
631656500585 Hydroxycut 60 Rapid Release Caplets



On May 1, 2009, the FDA issued an advisory which states that, “Although the liver damage appears to be relatively rare, FDA believes consumers should not be exposed to unnecessary risk.” The number of adverse event reports described by the FDA is small relative to the many millions of people who have used Hydroxycut products over the 7 years referenced by the FDA.

Iovate’s own assessment of the potential risk associated with the use of these products differs from that expressed by the Agency. Every product marketed by Iovate is evaluated during its development for the safety of its individual ingredients. Additionally, independent third-party experts from the leading independent scientific firm specializing in ingredient assessment, toxicology and product safety for the nutritional and pharmaceutical industry review the safety of Iovate’s ingredients and formulas before products are introduced in the marketplace. Only after this external review is completed does Iovate release a formula.

Source here.

FDA: Testosterone Gel Puts Children at Risk

From various sources, including the AP:

The FDA issued a statement that adults using prescription testosterone gel should be cautious and avoid its contact with children to avoid causing serious side effects. This week a black box warning was added to several products, AndroGel and Testim.

AndroGel is approved to be applied to the abdomen and shoulders and arms, while Testim can only be applied to the arms and shoulders. An FDA rep. has informed that in a few reports people had applied the product to their chest and then held their children without wearing shirts.

As of December 2008, the agency had received eight cases of secondary exposure to the products in children ranging in age from nine months to five years. Other reports have since come in, the FDA said. In most cases the side effects in children regressed after they weren't exposed to the product, but in a few instances enlarged genitalia didn't fully return to age-appropriate size and bone age remained modestly greater than the child's chronological age. Source here.

Certain Epilepsy Drugs Get a Suicide Warning

the FDA has approved new labels for epilepsy drugs that include warnings about an increased risk of suicidal thoughts and behaviors associated with the medicines.

The labeling for the epilepsy drugs Topamax, Lamictal, Tegretol and Trileptal come after the FDA ordered the drugs' labels be updated with warnings about suicidal risks with the medications.

In December, the FDA issued a public-health advisory about the drugs, saying a review of clinical studies showed there was one additional case of suicidal thoughts or behaviors for every 500 patients treated with an anti-epileptic drugs compared with a placebo, or fake pill.

Source here.

Botox Warnings

Allergan Inc.will work with the Food and Drug Administration to appropriately update labeling for its Botox and Botox cosmetic products.

"We are pleased that the FDA has emphasized that the dosing units are different between the products," Chairman and Chief Executive David Pyott said on the earnings call, adding he was happy with Botox's first-quarter sales, which declined 5.8%.

Last week the FDA said it was strengthening warnings on Allergan's Botox and similar products about the possibility of life-threatening breathing and swallowing problems.

Link here.

Hydroxycut Recall: TV Report (Georgia, Alabama, Florida)

Image by size8jeans via Flickr

From NBC and Tom Costello and NBC: The government issued an urgent warning to immediately stop using the dieting supplement after reports surfaced of liver damage and at least one death. FDA's limited ability to oversee is discussed. Report notes that 114 million people use OTC supplements.

Hydroxycut Lawsuit from 2003

Found this from 2003, a press release from the then Missouri A.G.:


Attorney General Jay Nixon today filed a lawsuit in St. Louis against the maker of Hydroxycut, marketed to consumers as a safe and tested over-the-counter way to lose bodyfat rapidly. Hydroxycut is sold in several retail store chains, through television ads and on several Web sites.

Nixon said manufacturer MuscleTech Research and Development Inc., based in Mississauga, Ontario, did not disclose safety risks associated with Hydroxycut containing ephedra, and that claims that Hydroxycut was "clinically proven" to be a "fat-burner" were false.

"MuscleTech's own consultants had serious concerns about the safety of Hydroxycut, but the company continued to market the product," Nixon said. "The disclaimers and warnings on the bottle label are so small as to be useless to many consumers, so they would not be able to read that the disclaimers would preclude use of Hydroxycut by most of the adult population of the United States, including anyone who drinks coffee or cola containing caffeine."

The lawsuit claims that in order to obtain the research results it sought, MuscleTech would replace research subjects who had to drop out of the company's studies because they could no longer tolerate the Hydroxycut or because it became too dangerous for them to continue. In at least one study, Nixon said, those dropouts were concealed and not treated as an adverse effect of Hydroxycut. In another study cited in the lawsuit, one subject was rushed to the hospital due to a serious change in heartbeat. This incident was not treated as an adverse reaction in the final study.

From the Complaint:

JEREMIAH W. (JAY) NIXON,
Attorney General of the State of Missouri
Plaintiff

Vs

MUSCLETECH RESEARCH &
DEVELOPMENT, INC.,
Defendant.


1. Defendant MuscleTech Research and Development, Inc. (“MuscleTech”) has made and sold purported weight loss products under the name “Hydroxycut” containing ephedra alkaloids. Such products continue to be sold at least at the retail level. The product is not “clinically proven” to be a “fat-burner,” as MuscleTech claims. MuscleTech’s own study showed that Hydroxycut has no efficacy as compared to placebo with the possible exception of an appetite-suppressing effect. Moreover, the serious adverse health risks of Hydroxycut with ephedra – including death – were not adequately described or disclosed in marketing and labeling of the product. This conduct violated the Missouri Merchandising
Practices Act.

16. MuscleTech used deception, misrepresentation, unfair practice and/or the concealment, suppression, or omission of material fact in connection with the sale and advertisement of MuscleTech in regard to Hydroxycut’s safety – or lack of safety – including but not limited to the following:

a. MuscleTech’s web site and advertisements [b]did not adequately disclose safety risks associated with Hydroxycut.[b/] Some advertisements or material supplied by MuscleTech to magazine publishers specifically stated that Hydroxycut is effective in reducing bodyfat “without any unwanted side effects,” that it is “extremely safe” and that “studies” have shown the herbal equivalents to ephedrine and caffeine to be “very safe,” that potential users can be “reassured” that Hydroxycut is “safe,” and that even prescription drugs do not yield as much fat loss as the ingredients in Hydroxycut “with as little negative side effects.”

iii. In at least one instance, a subject was rushed to a hospital for atrial fibrillation, which is a precursor to ventricular fibrillation (a lethal arrythmia that results in sudden cardiac death). The study of which he was a subject did not treat this event as an adverse event for purposes of its statistical analysis.


However, the results of MuscleTech’s studies regarding safety did not accurately indicate the safety risks for most consumers of Hydroxycut because MuscleTech carefully screened all study subjects for health risks. This screening meant that there was no testing done on persons with physical and health characteristics of many consumers purchasing Hydroxycut over the counter (such as high blood pressure), making the results of such studies misleading for those consumers. Moreover, even after this screening was performed, MuscleTech’s studies were still tainted in at least the following respects:

c. MuscleTech has not disclosed in any of its marketing or advertising materials that its own consultants believe there are serious concerns as to the safety of Hydroxycut. At least one person whom MuscleTech hired as an expert in litigation stated under oath that he believes people should not take products with ephedra and caffeine, such as Hydroxycut, and that he cautions people not to take these “drugs.” Both he and another expert hired by MuscleTech testified separately that they would not recommend Hydroxycut to anyone.

17. a) Another study commissioned by MuscleTech showed that the subjects using a “new and improved” version of Hydroxycut showed no statistically significant weight loss that was greater than the placebo group, and even lost less weight than the placebo group. MuscleTech misrepresented the true results of this study by having one of its marketing persons submit a letter to the researcher suggesting that the researcher attribute the study’s result to the horrific events of 9-11-01. The researcher complied, without explaining why the events of 9-11-01 would affect the placebo group differently.

b) b. MuscleTech ran advertisements using deceptive “before” and “after” pictures. The pictures are deceptive in that, among other things:

i. The pictures use different lighting to convey an artificial fattening and slimming effect.

ii. The models in the pictures use different poses to convey an artificial fattening and slimming effect.

iii. The pictures and the accompanying copy do not fully disclose the extent of weight loss and muscle toning activities used by the models in conjunction with the use of Hydroxycut.

iv. MuscleTech has used one picture (in multiple advertisements) showing a “before” photograph of a woman with a much larger abdomen than in the after picture. A copy of one such advertisement is attached as Exhibit B. [b]The advertisements identify the woman as Marla Duncan and tout that she lost 35 pounds. At least some advertisements did not indicate that the “before” picture reflected post-pregnancy weight. Nor did the advertisements state that Marla Duncan has been a swimsuit and fitness model since at least 1983 (when she was 19 years old), has appeared on more than 100 magazine covers, and was Miss Fitness USA in 1990.

Hydroxycut News Part 2/Background

Herbs that have been associated with liver disease include:

- Black Cohosh

• Buckthorn (Rhamnus cathartica).

- Callilepsis laureola ( Impila)

- Cascara Sagrada

- Celandine ( also known as greater celandine) (Chelidonium majus)

• Chaparral (also known as creosote bush or greasewood) (Larrea taridentata).

• Comfrey and other herbs containing pyrrolizidine alkaloids (heliotropium, senecio, crotalaria, symphytum)

- Doxidan ( Danthron 1,8-hydroxyanthroquinone and dioctyl calcium sulfosuccinate)

• Germander (Teucrium chamaedrys).

- Green tea leaf

• Groundsel (Senecio vulgaris).

- Impila root

• Jin Bu Huan.

- Kava ( also known as kava kava or Piper methysticum)

- Kombucha

• Lobelia (Lobelia inflata).

• Ma huang (ephedra).

• Mate (also known as paraquay tea) (Ilex paraguariensis).

• Mistletoe (Viscum album).

• Nutmeg (Myristica fragrans).

• Pau d’arco (La pachol).

• Pennyroyal (Mentha pulegium).

• Poke root (Phytolacca americana).

• Ragwort (Senecio jacoboea).

• Sarsparilla (Smilax species).

• Sassafras (Sassafras albidum).

• Saw palmetto – the main ingredient of the herbal preparation known as “Prostata”.

• Senna (Casio acutifolia).

• Skullcap (Scutellaria laterifolia).

- Soy phytoestrogen

• Sweet clover (Melilotus officinalis).

• Tansy (Tanacetum vulgare).

• T’u-san-chi.

• Valerian (Valeriana offinalis).

• Woodruff (Galium odorata).













Found this article posted a while back by a "doctor" who commented on Hydroxycut:

"Hydroxycut made headlines for over a controversial compound that it contained called Ephedra. This compound is banned by FDA. Now you can get a Ephedra-free product that claims to increase your metabolism and energy while suppressing your appetite, therefore cutting caloric intake and hence causing weight loss. Claims made by there manufacturers are pretty bold. They say that Hydroxycut can decrease body fat by 8%, and increase norinephrine by 40%. Among the most important ingredients in this product are:

Hydroxagen™: This is a compound which has been shown to decrease the activity of the enzyme which is responsible for the conversion of excess carbohydrates into fat. This subsequently makes it extremely effective for low fat diets. There may some added advantage of it curbing hunger and cravings.

Guarana Extract: Guarana, is the herbal form of caffeine and this has been shown to stimulate fat stores and resulting in fat being utilized as energy. Caffeine also facilitates the effectiveness of ephedrine, thus making it a more potent.

L-Carnitine: This is an amino acid that has been reported to carry fats to the interior of cells where it can be metabolized as energy. The addition of L-carnitine is an absolute necessity to get fat burning.

Chromium Picolinate: It has been shown that dosages of chromium as that contained in Hydroxycut can cause fat reduction and increases in muscle tone.



It should be understood that many people do experience side effects with these “stimulating” medications. Some say that feel anxious, others complain of increased libido. If you have heart condition, hyperthyroidism etc you should stay clear from this product (see all contraindications before starting)."

Source here.



Firm handling it is: www.bunchandjames.com/hydroxycut/

FDA Recalls Hydroxycut

Government health officials are announcing the recall of popular weight loss pill Hydroxycut, after reports of liver damage and other health problems.

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 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



Food and Drug Administration officials said Friday the manufacturer of Hydroxycut has launched a nationwide recall of the dietary supplement, used by people trying to shed pounds and by body builders to sharpen their muscles.

Hydroxycut is advertised as made from natural ingredients. It accounts for about 90 percent of the market for weight loss supplements, with sales of about 1 million bottles a year.

Dietary supplements are not as tightly regulated by the government as medications. Manufacturers don't need FDA approval ahead of time before marketing their products.

Sources include: AP and FDA.