Drug Injury Watch

Levaquin Federal Court Cases Already Have MDL; Now "Mass-Tort Treatment" Requested In New Jersey State Court

While Levaquin Is Just One Of Several  Antibiotics In Fluoroquinolone Class, All Of Which Have Been Linked To Tendon Ruptures, Levaquin Has Most Tendon Injury Lawsuits Filed To Date

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE:  For recent developments regarding personal injury lawsuits that involve Levaquin and tendon-related side effects, visit the Levaquin Information page over at our Drug Injury Law web site.   (7/30/09)

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In late August 2006 the consumer advocacy group Public Citizen filed a petition with the FDA requesting that the agency order certain drug companies to put a "black-box" warning about the risks of tendon rupture that have been associated with a class of antibiotics known as fluoroquinolones.  Some of these antibiotics are Ortho-McNeil's Levaquin as well as Bayer's Cipro and Avelox products.

In January 2008 Public Citizen filed a lawsuit intended to force the FDA to decide whether this stronger warning should be added to antibiotics such Levaquin as well as Cipro and Avelox.

On July 8, 2008 the FDA announced that a so-called "black-box" warning would be added to the package insert, or label, to strengthen existing warnings about the increased risk of developing tendinitis and tendon rupture associated with the following fluoroquinolones:

Ciprofloxacin (marketed as Cipro and generic ciprofloxacin)
Ciprofloxacin extended release (marketed as Cipro XR and Proquin XR)
Gemifloxacin (marketed as Factive)
Levofloxacin (marketed as Levaquin)
Moxifloxacin (marketed as Avelox)
Norfloxacin (marketed as Noroxin)
Ofloxacin (marketed as Floxin and generic ofloxacin)

While the tendon rupture and tendinitis side effects have been associated with all of these fluoroquinolone class antibiotics, Levaquin has drawn the most lawsuits, by far, to date.

All Levaquin tendon rupture lawsuits filed in federal court have been assigned to MDL No. 08-1943, which is presided over by the Honorable John R. Tunheim, in the District of Minnesota.  The first test case, or bellwether, trial for the Levaquin MDL is scheduled currently for August 2010.

More recently, there has been a request of so-called "mass-tort treatment" made for a growing number of Levaquin lawsuits filed in the New Jersey state court system.

From a May 13, 2009 Law.com article, "Levaquin Tendon Injury Mass Tort Treatment Sought for Suits Over Ortho-McNeil Antibiotic Levaquin":

Users of Levaquin, an antibiotic linked to muscle ailments, are asking the New Jersey Supreme Court to accord mass-tort treatment to their suits against the manufacturer, Johnson & Johnson subsidiary Ortho-McNeil Pharmaceutical Inc.

Acting Administrative Director of the Courts Glenn Grant made the application public in a notice to the Bar that solicits comments on or before June 5.

We expect that the New Jersey Levaquin litigation will be given the requested mass-tort designation and that the number of Levaquin lawsuits filed in New Jersey will increase -- especially if the New Jersey cases are assigned to Judge Carol Higbee in Atlantic County.  (As some will recall, Judge Higbee was in charge of the NJ Vioxx mass-tort litigation.)

We will continue to monitor developments concerning the Levaquin litigation, both in the federal court MDL and in the NJ state court system.

P.S.  On June 16, 2009, the New Jersey Supreme Court designated all pending and future Levaquin litigation in the New Jersey Superior Court as a mass tort and assigned it for centralized management to Judge Carol E. Higbee in Atlantic County.  (7/17/09)

FDA Investigating Obesity Drugs Xenical And Alli For Possible Link With Liver Damage

Agency Has Received Case Reports Of Hepatotoxicity For Orlistat, The Active Ingredient For Xenical And Alli

(Posted by Tom Lamb at DrugInjuryWatch.com)

There was only this brief mention in the Memorandum of Meeting Minutes for the FDA's April 16, 2009 Drug Safety Oversight Board Meeting:

The Drug Safety Oversight Board (DSB) discussed two topics: the product orlistat and the potential risk of hepatotoxicity and alcohol-based skin antiseptics and the risk of a fire in the operating room.

Now, about a month later, we have some additional information about the orlistat - hepatotoxicity part of that DSB April 2009 meeting.   

As background, the anti-obesity agent orlistat is the active ingredient in the prescription drug Xenical (Roche) and the over-the-counter drug Alli (GlaxoSmithKline).

Reporter Sue Sutter, in her May 21, 2009 article "US FDA examining reports of liver damage with orlistat", published online by Scrip News (subscription required; free trial available), takes us forward from there:

"Orlistat was discussed in the context of both non-prescription and prescription versions and the potential risk of hepatotoxicity based on several postmarketing reports," the FDA told Scrip.

The agency said it was still reviewing the case reports to determine the extent of orlistat's contribution, if any, to the development of liver damage. The FDA declined to provide the number of postmarketing reports it has received and said any action would depend upon results of its ongoing analysis....

Roche said more than 35 million patients have been exposed to orlistat therapy, and obesity is a high risk factor for hepatic injury. "The available information – postmarketing spontaneous reports, clinical trial data and published literature as well as epidemiology data for drug-induced liver disease – does not suggest that orlistat is causally related to hepatic events."

The current package insert, or label, for Xenical (accessed 5/22/09) mentions rare reports of hepatic, or liver, injury.

Previously, the anti-obesity agent orlistat had been under scrutiny at the FDA for concerns about rectal bleeding.  See: Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between April - June 2008

If you are aware of any cases of drug-induced hepatitis, liver injury, or liver failure involving the use of Xenical or Alli, please let us know by submitting a Comment, below, or you can send me a private email.

P.S.  On August 24, 2009 the FDA issued its "Early Communication about an Ongoing Safety Review Orlistat (marketed as Alli and Xenical)".  (8/25/09)

Birth Control Pill YAZ Is Subject Of Ongoing Safety Study Regarding Cardiovascular Side Effects

A Comparison Of This "Fourth Generation" DRSP / EE Pill To Other Established Oral Contraceptives For Incidence Of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Heart Attack (MI), And Stroke (CVA)

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE:  FDA Drug Safety Communication: Safety Review of possible increased risk of blood clots with birth control pills containing drospirenone  [May 31, 2011]

... The European Medicines Agency (EMA) announced on May 27, 2011, that it is updating the product information on oral contraceptives containing drospirenone and ethinyl estradiol regarding the risk of venous thromboembolism after review of all available data, including the same newly published data FDA is reviewing.

The FDA is currently evaluating the conflicting results from these studies and will look at all currently available information to fully assess the risks and benefits of drospirenone-containing birth control pills. FDA will continue to communicate any new safety information to the public as it becomes available.

(6/2/11) 

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UPDATE: November 2009 status "snapshot" of ongoing YAZ safety study called "International Active Surveillance Study of Women Taking Oral Contraceptives (INAS-OC Study)".
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YAZ (3 mg drospirenone/20 mcg ethinyl estradiol) is an oral contraceptive (OC) which is the first pill to combine 20 mcg of ethinyl estradiol (EE) with the so-called "fourth generation" progestin drospirenone (DRSP).  YAZ was approved by the FDA in March 2006.

A company press release, "FDA Approves YAZ(R), The First Oral Contraceptive To Offer Drospirenone In A 24-Day, Active-Pill Regimen", issued at the time of FDA approval, can be read so as to suggest that the list of possible serious side effects of YAZ about which women should be most concerned does not include any cardiovascular side effects:

YAZ contains 3 mg of the progestin drospirenone that has antimineralocorticoid activity, including the potential for hyperkalemia in high-risk patients, comparable to a 25-mg dose of spironolactone. YAZ should not be used in patients with conditions that predispose to hyperkalemia (i.e., renal insufficiency, hepatic dysfunction, or adrenal insufficiency). Women receiving daily, long-term treatment for chronic conditions or diseases with medications that may increase serum potassium should have their serum potassium levels checked during the first treatment cycle. Medications that may increase serum potassium include ACE inhibitors, angiotensin-ll receptor antagonists, potassium-sparing diuretics, potassium supplementation medications, aldosterone antagonists and NSAIDs.

In fact, the current YAZ package insert, or label (accessed 5/18/09), includes this same text in bolded font, while the warning about cardiovascular side effects like deep vein thrombosis (DVT), pulmonary embolism (PE), heart attack, and stroke is not bolded for emphasis.

Seemingly, however, the FDA has had some concerns about an association between YAZ and DVT, PE, heart attack, and stroke, as seen below.

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YAZ / Yasmin / Ocella / Beyaz / Safyral
Free Case Evaluation
Strictly Confidential, No Obligation.

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A study called the International Active Surveillance Study of Women Taking Oral Contraceptives (INAS-OC), which was started in August 2005 and continues to date, is intended to evaluate the risk of those cardiovascular side effects for women who use DRSP/EE birth control pills like YAZ.

According to a May 11, 2009 article, "ACOG 2009: Preliminary Findings Favor 24-Day Regimen of Drospirenone and Ethinyl Estradiol for Contraception", published online by Medscape:

[P]reliminary findings from the International Active Surveillance Study of Women Taking Oral Contraceptives (INAS-OC) study were presented here at the American College of Obstetricians and Gynecologists (ACOG) 57th Annual Clinical Meeting by Jürgen Dinger, MD, PhD, from the Berlin Center for Epidemiology and Health Research in Germany....

"The INAS study is a transatlantic prospective cohort study that was requested by the [US Food and Drug Administration] to investigate the safety of a 24-day regimen of 3 mg DRSP and 20 μg ethinyl estradiol (24/4 regimen)," Dr. Dinger told the audience. To date, the INAS study has enrolled 52,219 women....

The study's objectives are to compare the cardiovascular safety of the 24/4 regimen of DRSP/EE to established oral contraceptives (OCs) during standard clinical practice (eg, deep venous thrombosis, pulmonary embolism, acute myocardial infarction, stroke); to investigate the incidence of rare serious adverse events associated with the use of 24/4 and established OCs; and to investigate contraceptive failure rates associated with the use of the 24-day and 21-day regimens of DRSP/EE and all other OCs.

For women using YAZ, here is some important information about the symptoms of these serious cardiovascular side effects from the WebMD.com web site:

This medication may rarely cause serious (sometimes fatal) problems from blood clots (e.g., pulmonary embolism, stroke, heart attack). Seek immediate medical attention if you experience: sudden shortness of breath, chest/jaw/left arm pain, confusion, coughing up blood, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, tingling/weakness/numbness in the arms/legs, headaches that are different from those you may have experienced in the past (e.g., headaches with other symptoms such as vision changes/lack of coordination, existing migraines becoming worse, sudden/very severe headaches), slurred speech, weakness on one side of the body, vision problems/changes.

A quick Internet search for the word "YAZ" will show among the results that there are discussion forums with "threads" like "WARNING ABOUT YAZ BIRTH CONTROL PILLS", at the SteadyHealth.com web site, where numerous women have reported having a DVT or PE while using YAZ pills.

All of this leaves us wondering whether YAZ is a possible unsafe birth control method, like Ortho Evra and NuvaRing....

If you or someone you know has developed a deep vein thrombosis (DVT), pulmonary embolism (PE), heart attack, or stroke while using YAZ -- and you want to share your experience with others -- you can do so by submitting a Comment, below.

Visit the YAZ, Yasmin, and Ocella Information page at our Drug Injury Law web site for more recent developments regarding personal injury and wrongful death lawsuits that involve YAZ, Yasmin, and Ocella. 

Our Focus Page on YAZ / Yasmin / Ocella has a complete collection of our articles about these birth control pills as well as selected news reports about YAZ, Yasmin, and Ocella.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

Beware The Potential Dangers Of Free Drug Samples

Some Ways That Free Drug Samples Can Harm Patients

(Posted by Tom Lamb at DrugInjuryWatch.com)

PLoS Medicine-- which is a peer-reviewed open-access journal published by the Public Library of Science -- published an essay by Susan Chimonas and Jerome P. Kassirer in May 2009 called "No More Free Drug Samples?" which provides a fresh perspective on a well-established practice in doctors office across the U.S.

This essay starts with the ideas that many of us may have about this practice:

Everybody likes something free, and free prescription drug samples are no exception. Patients love to receive them, and doctors feel good about handing them out. The practice of providing free drug samples is based on the tacit assumption that “sampling” does much more good than harm.

Chimonas and Kassirer go on from there to deconstruct these preconceptions, working at various levels:

In this essay, we question the assumption that good trumps harm when prescription drugs are provided free to practicing doctors. We argue that “sampling” is not effective in improving drug access for the indigent, does not promote rational drug use, and raises the cost of care.

I want to focus on the drug-safety aspect of this free drug samples issue. 

In their May 2009 PLos Medicine essay, Chimonas and Kassirer make these points in support of their contention that samples can have "negative consequences" when it comes to patient-health:

• In drugstores, pharmacists often identify potentially harmful drug interactions, intercept inadvertent medication errors, and offer a patient-friendly printout of instructions. In doctors' offices, however, detailed patient education regarding sample use rarely occurs, and when it does, it usually lacks information about drug interactions or instructions on how the drug should be taken. [footnote omitted]

• Moreover, if distribution is inadequately documented in patients' records, some people who receive samples in doctors' offices may not be notified or told to discontinue the medication in the event of a product recall or the emergence of new drug complications.

• The samples that drug representatives offer are almost never time-worn and well-tested drugs, nearly never generics, and usually comprise the newest agents on the market. As such, they expose patients to risks not yet identified in clinical trials. The experience with Vioxx is a case in point.

Chimonas and Kassirer discuss in this insightful essay, also, several other concerns they have with the seemingly "generous" practice of doctors dispensing free drug samples to patients.  It total, the authors conclude that:

The tradition of physicians dispensing samples has many serious disadvantages and is as anachronistic as bloodletting and high colonic irrigations. As the profession begins to slowly extract itself from the influential grip of industry, it must also deal with the undue influence of free samples.

If this topic interests you, "No More Free Drug Samples?" is a relatively short essay that is worth reading when you have an opportunity.

May 2009 Digoxin Recall By AS Medication Solutions Seems To Be About Six-Weeks Late

This Company Repackaged Caraco Digoxin Tablets That Were Recalled March 31, 2009; Why Did They Delay Their Recall Notice?

(Posted by Tom Lamb at DrugInjuryWatch.com)

On May 11, 2009 AS Medication Solutions, LLC -- which is a drug repackage company --announced that it has recalled all tablets of Caraco digoxin tablets because those pills may differ in size and therefore could have more or less of the active ingredient, digoxin.

If this sounds vaguely familiar, it should.  On March 31, 2009 Caraco Pharmaceutical Laboratories issued a recall notice for all of its digoxin tablets due to pill-size problems.

Why did it take AS Medical Solutions until mid-May to issue its recall notice for the Caraco digoxin tablets that it simply repackaged and distributed when Caraco recalled its digoxin pills at the end of March 2009?

From the company's May 11 press release, "AS Medications Solution LLC. Announces a Nationwide Recall of All Lots of Digoxin Tablets 0.25mg Due to Size Variability":

Digoxin is a drug product used to treat heart failure and abnormal heart rhythms. It 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 slow heart rate. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of heart failure and abnormal heart rhythms.. Consequently, as a precautionary measure, A S Medication Solutions, LLC is recalling these tablets to the consumer level to minimize any potential risk to patients.

Consumers with the products with the following NDC codes that are within expiration should return these products to the place of purchase.

Product Identification

Caraco Digoxin
A-S Medication Solutions, Digoxin 0.25 mg is a scored round biconvex white tablet imprinted with “441”

NDC Numbers:
Digoxin Tablets, USP, 0.25 mg
54569-5758-0 (30-count)

As seen above, the company's press release suggests that patients who have any remaining A-S Medication Solutions digoxin 0.25 mg tablets should return those pills to the pharmacy where they were purchased.

If, however, a patient suffered from digitalis toxicity, low blood pressure, cardiac instability, or bradycardia (slow heart rate) while using A-S Medication Solutions digoxin pills, I urge you not to return those pills because they may be important evidence in any possible personal injury or wrongful death case.

In closing, I will ask once again:  What took this drug repackaging company so long to issue its digoxin recall knowing that the A-S Medication Solutions digoxin 0.25 mg tablets it was distributing were the Caraco digoxin pills that had been recalled at the end of March 2009?

Possible Heparin-Related Deaths In Delaware Are Different Than Last Year's Illness Outbreak

These New Cases Involve Premixed IV Bags of Heparin And Initial Tests Did Not Detect Oversulfated Chondroitin Sulfate Contamination

(Posted by Tom Lamb at DrugInjuryWatch.com)

The headline used by the Wall Street Journal (WSJ), "Heparin Stirs New Fears", alluded to last year's heparin-illness outbreak when roughly 80 deaths were linked to contaminated heparin and led to a recall of the medicine from several companies.

According to this May 12, 2009 WSJ article, however, there are some important differences between last year's contaminated heparin problem and two possible heparin-related death cases that were reported by a Delaware hospital this past weekend:

• Baxter spokeswoman Erin Gardiner said that, unlike the earlier cases, the Delaware patients didn't have severe hypotension, or low blood pressure. The current symptoms involve intracranial bleeding, she said.
• Ms. Gardiner said the new complications involve premixed intravenous bags of heparin. Last year's problems involved bulk supplies, vials of the medicine and drug-coated medical devices.
• Baxter tests on the Delaware incidents didn't detect a contaminant found in last year's heparin-illness outbreak, oversulfated chondroitin sulfate.

A Wilmington, Delaware newspaper, The News Journal, first reported this still-developing story in a May 11, 2009 article, "FDA investigating deaths at Beebe", from which we get these details:

Two Delaware residents have died after being administered the anticoagulant drug heparin at Beebe Medical Center in Lewes, the hospital said today, as federal authorities took over an investigation into a possible batch of tainted medication.

The patients – a 71-year-old man and a 64-year-old woman – died over the weekend, said Wallace Hudson, Beebe’s vice president for corporate affairs. Both reportedly suffered intra-cranial bleeding, as did a third patient who now is being treated at Christiana Hospital. That patient’s condition is not known.

Two other patients initially believed to have been sickened by the drug were not actually affected by heparin, based on additional testing, Hudson said.

While the Beebe cases remain under investigation, it apparently is not part of a widespread problem, the FDA said in a statement.

“This appears to be an isolated incident,” agency spokeswoman Karen Riley said.

This News Journal article also provided some earlier comments from Erin Gardiner, the Baxter spokeswoman:

“At this point, it is premature to speculate on the relationship, if any, between the reactions the unfortunate patient events and our products,” Gardiner said.

Baxter has made inquiries to other hospitals that use large quantities of the pre-mixed bags including Heparin to determine if they’ve seen any similar reports. She said the reports in Delaware were the only ones Baxter has heard of thus far.

“In terms of where we’re at, it’s three reports from a single institution,” she said. “There isn’t enough information to conclude that the events are associated with the Heparin IV bag yet, but we’re conducting a proactive, thorough investigation.”

If anyone knows about a patient who recently developed intracranial bleeding or any other serious side effect after being administered premixed intravenous (IV) bags of heparin, they should contact the FDA immediately to assist with this ongoing investigation.

P.S.  News Update:  Baxter, FDA Say Heparin Not Responsible for Delaware Deaths (5/15/09)

Some Reasons To Support The Medical Device Safety Act Of 2009, And A Dissent

May 12 Hearing In Washington Begins The Debate About Whether The Medical Device Industry Should Have Total Immunity From Legal Liability

(Posted by Tom Lamb at DrugInjuryWatch.com)

On May 12, 2009 the Health Subcommittee of the House Energy and Commerce Committee will have a hearing on the Medical Device Safety Act of 2009.  This hearing is the first step to legislatively moving this important piece of legislation through the House of Representatives.

In more detail, the Medical Device Safety Act (S. 540/H.R. 1346) would address the Supreme Court’s Riegel v. Medtronic decision and restore the ability of injured patients to hold negligent medical device manufacturers accountable when their products cause an injury or death.

The February 2008 Riegel decision by the Supreme Court serves to give total immunity to device manufacturers who fail to adequately warn patients about device risks.  As a result of the Riegel decision, any patient who is injured by a faulty medical device cannot get legal compensation from the manufacturer who would be legally liable but for the federal preemption defense available to the company.

In Riegel, the device that failed was a Medtronic balloon catheter used in heart surgery.  The patient in Riegel required additional surgery and eventually died.  But the Supreme Court's decision allowed Medtronic to walk away and, accordingly, there was no corporate accountability in that case.

Looking beyond that one case, when patients with serious injuries are unable to hold the negligent manufacturer accountable, the patients and the taxpayers are left footing the bill.  Where a patient has private health insurance, their insurance company would likely cover the additional surgery required, but this raises the cost of insurance for all of us.  For Medicare or Medicaid-covered patients, the costs of the additional medical care are passed onto the taxpayers.  And for patients who can no longer work, they may need additional taxpayer supported programs, such as Social Security disability.  

Not only is this "bad" cost-shifting, this immunity does not encourage the manufacturer of the faulty device to fix the problem(s) with its product -- and the cycle continues.

The Medical Device Safety Act of 2009 would effectively reverse the Supreme Court’s Riegel decision handed down last year.

If ultimately passed by the House and the Senate, and thereafter signed into law by the President, the Medical Device Safety Act would apply to cases brought on or after the date of enactment as well as to any cases that are still pending prior to the date of enactment.

For an article in support of this legislation, see this editorial published by The New England Journal of Medicine (NEJM), titled simply "The Medical Device Safety Act of 2009", which concludes in this manner:

Patients and physicians deserve to be fully informed about the benefits and risks of medical devices, and the companies making the devices should be held accountable if they fail to achieve this standard. We urge Congress to swiftly pass this legislation and to allow lawsuits by injured patients, which have been an important part of the regulatory framework and very effective in keeping medical devices safe, to proceed in the courts. The critical issue of preemption, which directly affects the disclosure of risks and thus the safety of the nation's supply of medical devices and drugs, should properly be decided by officials elected by the people, with whom the responsibility for the health of the public rightfully resides.

To get a sense of what the medical device manufacturers will be asserting in Washington at next week's hearing, here is a May 6 press release about a brand new report by Ernst Berndt and Mark Trusheim of the Massachusetts Institute of Technology (MIT), which was funded by the Advanced Medical Technology Association: "Removing Medical Device Preemption Impacts Jobs, Health Care Costs, Patient Access".

So the stage is set.  You can let us know what you think about the federal preemption of medical device lawsuits by submitting a Comment, below. 

More importantly, you can contact your representatives in Washington and tell them whether or not a medical device manufacturer should have total immunity when its product seriously injures or kills a patient.

P.S.  The Subcommittee on Health held its hearing on H.R. 1346, the Medical Device Safety Act of 2009 on Tuesday, May 12, 2009, as scheduled.  Here is a list of the witnesses who testified:

David Vladeck, J.D., Professor of Law, Georgetown University Law Center
 
William H. Maisel, M.D., M.P.H., Director, Medical Device Safety Institute, Department of
Medicine, Beth Israel Deaconess Medical Center, Boston

Gregory Curfman, M.D., Editor, New England Journal of Medicine

Bridget Robb, Gwynedd, Pennsylvania

Richard Cooper, Partner, Williams & Connolly LLP
 
Michael Kinsley, Seattle, Washington

Transcripts of their testimony and audio from the hearing is available, now.

(5/13/09)

Hydroxycut Weight-Loss Products Are Recalled Due To Cases Of Serious Liver Injury

Reports Made To The FDA Have Involved Hepatitis, Liver Failure, Liver Transplant, And Death

(Posted by Tom Lamb at DrugInjuryWatch.com)

On May 1, 2009 the FDA warned people to stop using Hydroxycut products -- made by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. -- due to the fact that some Hydroxycut products are associated with a number of serious liver injuries. Furthermore, the manufacturer, Iovate, has agreed to immediately recall Hydroxycut products from the U.S. market.

The list of Hydroxycut 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

The FDA's reasoning for this May 2009 recall of Hydroxycut products can be found in a Health Hazard Evaluation Board document entitled "The Problem: Liver toxicity following consumption of dietary supplement, Hydroxycut".  From the Conclusion section of this Health Hazard Evaluation document:

Three lines of evidence derived from multiple disparate sources suggest it is very likely that exposure to Hydroxycut can cause idiosyncratic hepatotoxicity. First, many of the subjects described in the adverse event reports to CAERS, in the peer-reviewed literature, and in the case series described by hepatologists reported no history of liver disease or risk factors for liver disease (e.g., alcohol consumption, previous viral infection, hereditary factors, etc.) prior to experiencing liver injury following the ingestion of Hydroxycut. Second, in many subjects, thorough diagnostic evaluations performed in multiple settings ruled out a number of known causes of liver disease, including viral hepatitis, autoimmune diseases, and metabolic/inherited disorders. Third, prompt resolution of liver disease occurred in a number of patients following cessation of Hydroxycut ingestion.

In a Consumer Advisory, "FDA Warns Consumers Not to Use Dietary Supplements Labeled Hydroxycut because of the Potential Risk of Severe Liver Injury", the FDA provides the following medical information:

Consumers who use a Hydroxycut dietary supplement and who experience signs of illness associated with liver disease should immediately consult their health care provider. Symptoms of serious liver disease include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Non-specific symptoms of liver disease can include nausea, vomiting, light-colored stools, unusual tiredness, weakness, stomach or abdominal pain, itching, and loss of appetite.  FDA has also identified several other serious adverse events associated with Hydroxycut, including cases of seizures, rhabdomyolysis (a type of muscle damage that can lead to other dangerous problems, such as kidney failure), and cardiovascular problems, ranging in severity from irregular heart beat to a heart attack.  [bold in original]

The FDA -- as opposed to Iovate, the manufacturer of Hydroxycut products --has issued a "Dear Doctor" letter to healthcare providers in the U.S.

In addition, the FDA has put on its web site a Consumer Questions and Answers document regarding this Hydroxycut recall.

In closing, the FDA has stated that it will continue to investigate the relationship between the use of Hydroxycut dietary supplements and liver injury.

If you are aware of any case of liver damage caused by the use of Hydroxycut products, please consider sharing that information with us by submitting a Comment, below.

P.S.  North of FDA-land, Health Canada says it will continue to monitor adverse reaction reports associated with Hydroxycut products, and will provide Canadians with any new safety information. 

From "Health Canada Reviewing Hydroxycut Products in light of U.S. Advisory":

Health Canada has received 17 domestic adverse reaction (AR) reports associated with Hydroxycut products in Canada. These adverse reactions relate to the cardiovascular, respiratory, gastrointestinal, and neurological systems. None of the adverse reactions reported in Canada relate to liver injury.

It will be interesting to see if Health Canada follows the lead of our FDA and issue a Hydroxycut recall in Canada.  (5/4/09)

P.S.  On May 7, 2009 the FDA announced that Iovate Health Sciences USA, Inc. has provided Universal Product Codes (UPCs) for its products that were part of the May 1 Hydroxycut recall.  (5/8/09)