The U.S. Food and Drug Administration (FDA) 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.

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.

Serious Health Risks

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.
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.
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.
FDA urges consumers to stop using Hydroxycut products in order to avoid any undue risk, says Linda Katz, M.D., interim chief medical officer of FDA’s Center for Food Safety and Applied Nutrition. “Adverse events are rare, but exist,” Katz says. “Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products.

Recalled Products

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 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 these products 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 FDA’s MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.

Online: Medwatch Reporting
Regular Mail: Use FDA postage paid form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: 800-FDA-0178
Phone: 800-FDA-1088
FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects

While this is a small number of reports relative to the many millions of people who have used Hydroxycut products over the years, out of an abundance of caution and because consumer safety is our top priority, we are voluntarily recalling these Hydroxycut-branded products.

The information below answers questions consumers may have about the advisory, the recall, and Hydroxycut-branded products.

What is Hydroxycut?

Hydroxycut is the brand name of some of America’s top-selling weight loss products which are taken by millions of consumers each year. Hydroxycut products are made by Iovate Health Sciences, which has over 750 items sold in more than 70 countries around the world.

What steps do you take to ensure the safety of Hydroxycut-branded products?

We conduct internal analyses of individual ingredients, and undertake extensive medical, scientific and toxicological literature reviews on the safety of the ingredients during the development stage of each product. Additionally, 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.

What is an adverse event?

The term “adverse event” refers to any unexpected or unintended event that happens while an individual is taking a dietary supplement, whether or not the supplement caused the event. Even minor events can be considered adverse if they are unexpected or unintended.

Which products are covered by this advisory?

The following products are covered by the advisory:

* 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

Does the advisory say I should stop taking Hydroxycut-branded products?

Yes. The FDA’s advisory states that, “Consumers who have these products are urged to stop using them.”

What if I want to return my Hydroxycut product. How do I do that?

For product refunds, consumers are directed to return their product directly to the place of purchase.

FDA will also require that manufacturers develop and implement a Risk Evaluation and Mitigation Strategy [REMS], including a communication plan to provide more information regarding the risk for distant spread of botulinum toxin effects after local injection, as well as information to explain that botulinum toxin products cannot be interchanged. The REMS would also include a Medication Guide that explains the risks to patients, their families, and caregivers. FDA is requiring the manufacturers to submit safety data after multiple administrations of the product in a specified number of children and adults with spasticity to assess the signal of serious risk regarding distant spread of toxin effects.

FDA’s evaluation of the data continues to support the recommendations made in the 2008 Early Communication.

* Influend Cold and Cough, 24 Tablets, Product Code/ Lot # 800074
* Influend Severe Cold & Flu, 24 Tablets, Product Code/Lot# 800075
* Influend JR. Cold & Cough, 4 oz. bottle, Product Code/Lot# 800076
* Influend JR. Severe Cold & Flu, 4 oz. bottle, Product Code/Lot# 800077

While no illnesses have been reported to date, ION Labs, Inc. has ceased distribution of these products until further notice.

Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product. Please return the product for a full refund to the address below.

ION Labs, Inc.
115th Ave. N.
Clearwater, Fl. 33760

Any adverse events that may be related to the use of this product should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online at the MedWatch website at www.fda.gov/medwatch

Consumers who have questions about the above recall may contact ION Labs Customer Service at 1-877-990-4466 and ask for the Quality Director at Ext. (212). Hours of operation are M-F from 8 a.m. to 5 p.m. EDT.

Caraco Pharmaceutical Laboratories and FDA notified healthcare professionals of a consumer-level recall of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011.  The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin, a drug product used to treat heart failure and abnormal heart rhythms.

Increased Risk of Digoxin Toxicity

The drug has a narrow therapeutic index and the existence of higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of lack of efficacy potentially resulting in cardiac instability. Consumers with the recalled product should return these products to their pharmacy or place of purchase.

After a two-week trial in federal court in Miami, a jury found David Rothman, M.D., 66; Keith Russell, M.D., 65; Eda Marietta Milanes, 43; and Jorge Luis Pacheco, 50; guilty on all charged counts, including conspiracy to commit health care fraud and multiple counts of health care fraud for submitting claims to Medicare for unnecessary medications. U.S. District Judge Ursula Ungaro of the Southern District of Florida remanded the defendants into custody following the verdict.

According to evidence presented at trial, the defendants worked as doctors and medical assistants at two Miami clinics, Medcore Group LLC (Medcore) and M&P Group of South Florida Inc. (M&P Group), that purported to specialize in the treatment of human immunodeficiency virus (HIV). Evidence at trial established that Rothman was the medical director for both Medcore and M&P Group between May 2004 and January 2006. Russell took over as medical director at M&P Group after January 2006. Pacheco and Milanes worked as medical assistants for Russell at M&P Group.

One of the owners of the clinics, Tony Marrero, testified at trial that the clinics were established for the sole purpose of defrauding Medicare. Marrero testified that the scheme was to submit claims for medically unnecessary HIV infusion and injection treatments. Evidence at trial showed that Medcore and M&P Group billed Medicare for $5,300,186 and were paid $2,511,387 during two years of operations. Marrero testified that the unnecessary medicines were not administered to patients, and that the clinics were only operated to create the appearance of legitimacy. Marrero stated that he had an arrangement with a pharmaceutical wholesale company, Lifecare Medical, to buy invoices showing the purchase of large amounts of medications, when only minor amounts were actually bought. Marrero; his wife, Belkis Marrero; his brother-in-law, Orlando Pascual; the owner of Lifecare Medical, Harold Sio; a patient recruiter and clinic employee, Alberto R. Gonzalez; and a medical assistant at Medcore, Luz Borrego; each previously pleaded guilty in connection with this scheme.

Borrego testified that she manipulated the patients’ blood samples at Medcore to ensure that lab results would appear to support the Medicare claims. Borrego stated that she would not give the medications ordered by Rothman because she knew the medications could harm the patients.

Trial testimony established that every patient who went to Medcore and M&P Group was paid a cash kickback of up to $200 per visit. The scheme relied upon 20 patients during the two-year period at both clinics. Four patients testified that they took kickbacks and never received any medication at the clinics. One patient testified that he used his payments from the clinics to support his cocaine addiction. Another patient testified that he did not have HIV, even though the clinics’ documents showed he was being infused with medication to treat HIV.

Evidence introduced at trial documented that Rothman worked at other Miami-area infusion clinics, which billed Medicare for more than $60 million between 2004 and the end of 2005. Trial evidence also established that Russell worked at Tendercare Medical Center (Tendercare), another fraudulent infusion clinic, with Pacheco and Milanes at the same time as M&P Group. Further, two of the patients who testified at trial received kickbacks from both Tendercare and M&P Group.

According to evidence presented at trial, Milanes was paid extra by Marrero at M&P Group to manipulate blood samples to justify the false claims. Pacheco worked directly for Marrero to determine what drugs would be falsely billed to Medicare through M&P Group. Trial testimony established that Pacheco was a physician in Cuba prior to coming to the United States.

On March 14, 2009, while trial was ongoing, Pacheco attempted to flee the United States, according to evidence presented in court. He was apprehended heading south on Krome Avenue in Miami-Dade County with $12,600 in cash and a false Florida driver’s license in the name of Jose Luis Falcon. Evidence presented to the court proved that prior to being apprehended, Pacheco cut off his ankle monitor in violation of the terms of his pre-trial release. Documents seized from Pacheco at the time of his apprehension contained multiple contacts in the Dominican Republic. According to evidence presented at court, Pacheco stated to officers that he was “going fishing.” Judge Ungaro revoked his bond and remanded him into custody for the remainder of the trial.

“The jury’s verdict shows that medical professionals, trusted to provide necessary care and medicine to their legitimate patients, can and will be held accountable when they defraud the Medicare program,” said Acting Assistant Attorney General Rita M. Glavin of the Criminal Division. “The Department of Justice will continue our vigorous pursuit of those who steal from Medicare for their own personal benefit.”

“The Medicare program relies on physicians to be the first line of defense against fraud,” said Bernardo Rodriguez, Acting Special Agent-in-Charge of the Miami Office of Inspector General, Department of Health and Human Services. “As in this case, when doctors shirk that responsibility and steal from Medicare, we have to prosecute them to the fullest extent of the law.”

This case was investigated by the FBI and the Department of Health and Human Services (HHS), Office of Inspector General, Office of Investigations. The Homestead, Fla., Police Department, along with the FBI and HHS, were critical in the apprehension of Pacheco during his attempted flight during trial.

Pacheco and Milanes were remanded into custody following the verdicts. Rothman and Russell were required to post bond and are under house arrest until sentencing. Rothman faces a maximum of 50 years in prison. Russell, Milanes and Pacheco each face a maximum of 30 years in prison. Sentencing for all defendants has been scheduled for June 26, 2009.

The case was prosecuted by Deputy Chief Kirk Ogrosky, Assistant Chief John S. (Jay) Darden and Trial Attorney Charles D. Reed of the Criminal Division’s Fraud Section, with the investigative assistance of HHS and the FBI. The case was brought as part of the Medicare Fraud Strike Force (MFSF), supervised by the Criminal Division’s Fraud Section and U.S. Attorney Acosta of the Southern District of Florida. Since the inception of MFSF operations, federal prosecutors have indicted 106 cases with 192 defendants in both Los Angeles and Miami. Collectively, these defendants fraudulently billed the Medicare program for more than half a billion dollars.

Employers are under strict guidelines in regulating exposure to this exhaust, but not all employers are doing what they can to reduce exposure. The poor economy has lead employers to cuts back on the repair and replacement of outdated ventilation systems.

In the Urgent Device Correction letter, Baxter notified customers about failure codes in COLLEAGUE pumps that may cause them to alarm and stop infusing while delivering critical medication and fluids to patients. The letter also includes information warning of the possibility of the device overheating resulting in smoke and fire if improperly cleaned and/or if there is compromised battery harness insulation. Additionally, Baxter notified customers about a high occurrence of damaged battery messages related to the use of the pump as a battery-operated device. The letter reminds customers that safe and effective use of COLLEAGUE pumps is dependent on specific battery care practices as described in the operator’s manual. There have been serious injuries and/or deaths associated with failures identified in this letter.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

This study is the first to document the widespread presence of both formaldehyde and 1,4-dioxane in children’s bath products. Many products contained both formaldehyde and 1,4-dioxane, including Johnson’s Baby Shampoo and Sesame Street Bubble Bath.

Formaldehyde and 1,4-dioxane are known to cause cancer in animals and are listed as probable human carcinogens by the EPA. Formaldehyde can also trigger skin rashes in some children.

“Given the recent data showing that formaldehyde and the formaldehyde-releasing preservative, quaternium-15, are significant sensitizers and causal agents of contact dermatitis in children, it would be prudent to have these removed from children’s products,” said Sharon Jacob, M.D., assistant professor of medicine and pediatrics at the University of California San Diego and contact dermatitis specialist at Rady Children’s Hospital.

The Consumer Product Safety Commission says that “the presence of 1,4-dioxane, even as a trace contaminant, is cause for concern.”

Contrary to industry statements, no regulatory standards limit formaldehyde or 1,4-dioxane in personal care products sold in the U.S. Formaldehyde is banned from personal care products in Japan and Sweden. The EU bans 1,4-dioxane from personal care products and has recalled products found to contain the chemical.

There are signs the U.S. is gearing to catch up. Key Congressional leaders point to the findings of this report as further evidence of the need for action. “When products for babies are labeled ‘gentle’ and ‘pure,’ parents expect that they are just that,” said Sen. Diane Feinstein (D-Calif.). “To think that cancer-causing chemicals are contaminating baby shampoos and lotions is horrifying. I intend to soon introduce legislation requiring greater oversight of our cosmetics industry. We need to ensure that the chemicals that are used in our everyday products are safe.”

Rep. Jan Schakowsky (D-Ill.) said, “The fact that we are bathing our kids in products contaminated with carcinogens shows how woefully out of date our cosmetics laws are and how urgently they need to be updated. The science has moved forward, now the FDA needs to catch up and be given the authority to protect the health of Americans.”

Rep. Ed Markey (D-Mass.) commented that “Formaldehyde and 1,4-dioxane are better suited for the chem lab, not a child’s bathtub. This important report shows that ‘No More Tears’ can trigger toxic fears, and it provides another reason why these and other cosmetic products must be further regulated. “

For the study, the Campaign commissioned an independent laboratory to test 48 top-selling children’s products for 1,4-dioxane; 28 of those products were also tested for formaldehyde. Findings include:

• 61 percent of products contained both formaldehyde and 1,4-dioxane, including Johnson’s Baby Shampoo, Sesame Street Bubble Bath, Grins & Giggles Milk & Honey Baby Wash and Huggies Naturally Refreshing Cucumber & Green Tea Baby Wash.
• 82 percent contained formaldehyde at levels from 54 to 610 parts per million. Baby Magic Baby Lotion had the highest levels.
• 67 percent contained 1,4-dioxane at levels from 0.27 to 35 ppm. American Girl shower products had the highest levels.

“There no reason why manufacturers can’t remove hazardous chemicals from products being applied to babies’ bodies daily,” said Jeanne Rizzo, R.N., president of the Breast Cancer Fund. “We need to protect children from these repeated, unnecessary exposures.”

“Products made in the U.S. and marketed for children should not contain chemicals linked to cancer,” said Jane Houlihan, vice president for research at Environmental Working Group and creator of the Skin Deep cosmetic safety database. “Congress needs to protect the most vulnerable members of our society by ensuring that the personal care products we use every day are free from harmful chemicals.”

FDA has evaluated the composition of available patches to determine which of them contain metal components and to assure that this information is included in their labeling. Based on current information from this evaluation, FDA is working with the manufacturers of the following patches to update the labeling to include adequate warnings to patients about the risk of burns to the skin if the patch is worn during an MRI scan. It should be noted that some of the drugs listed may have a generic equivalent and more than one size and strength of patch. See the Public Health Advisory for a listing of patches. FDA will update this posting as information becomes available.