Drug Injury Watch

Bayer: Essure Permanent Birth Control Device Removal From US Market Is "Business Decision"

Or Is This Really An Essure Recall Due To High Numbers Of Adverse Events Reported To FDA And Related Essure Lawsuits

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

We have reported developments concerning Bayer's Essure birth control device a few times over the past couple of years:

• The Essure Birth Control Product: Safety, Regulatory, And Legal Developments Over The Past Several Months  (September 2016) 
• Bayer Fails to Warn About Serious Complications from Essure  (November 2016) 
• FDA Restricts Sales of Essure Permanent Birth Control Device  (April 2018)

But this article may be our final article about the Essure birth control device, due to the fact that Bayer recently announced that it will be pulling this product from the market at the end of 2018.

As for why there is this arguable "Essure recall", we will start with Bayer's spin on the situation. From this July 20, 2018 Washington Post news report, "Sales of Essure birth control implant to be halted by Bayer; U.S. last to sell controversial device":

The company said Essure's removal from the market was "business decision" prompted by precipitous declines in sales in recent years. It said in a statement that it stands by the safety and effectiveness of the device, and added that women who currently have Essure in place can continue to “confidently” rely on it.

The United States is the last country where Essure is being sold. Last September, citing "commercial reasons,” Bayer announced it was ending sales outside the United States....

Bayer said Essure sales in the United States have plummeted by about 40 percent a year in recent years. On Friday, the company attributed the decrease to several factors: a decline in the number of women using permanent contraception; increased reliance on long-acting contraceptives that are reversible, such as intrauterine devices, and “inaccurate and misleading publicity” about the implant.

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Essure

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For some background and so as to put this Bayer action regarding Essure in perspective, we get this timeline from another item issued July 20, 2018, "Statement from FDA Commissioner Scott Gottlieb, M.D., on manufacturer announcement to halt Essure sales in the U.S.; agency’s continued commitment to postmarket review of Essure and keeping women informed":

When [the FDA] first became aware of an increase in adverse events submitted to our database concerning [the Essure permanent birth control device], we launched an ongoing effort to review these reports to better understand concerns.

September 2015: The FDA convened a panel of experts to get their input on how we should investigate patient complaints that included abdominal pain, abnormal uterine bleeding and device migration.

February 2016: The FDA ordered Bayer to conduct a postmarket (522) study to better evaluate the safety profile of the device when used in the real world. The agency announced that it intended to require labeling changes to help patients better understand the potential risks of the device.

October 2016: The FDA issued the final guidance, “Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization” and in November 2016, the FDA approved updated labeling for Essure consistent with the guidance that added a boxed warning and a Patient Decision Checklist.

February 2018: FDA officials met with women implanted with Essure and patient advocates to listen to their concerns and experiences with the device.

March 2018: The FDA reported on a rise in new medical device reports submitted to the agency’s public database in 2017 with more than 90 percent of the reports involving potential device removal.

April 2018: In order to address concerns that not every patient was receiving adequate risk information, the FDA restricted the sale and distribution of the Essure device.

One last observation and nothing more: Thousands of Essure products liability lawsuits have been filed against Bayer in U.S. courts during the past few years.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review done by attorney Tom Lamb)

Zecuity Recall: Teva Migraine Drug Patch Gets FDA Warning About Reports Of Serious Burns And Potential Permanent Scarring

Drug Company Announces It Will Recall Zecuity Skin Patches From Pharmacies As Well As Temporarily Suspend Sales, Marketing, And Distribution Of Product

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

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UPDATE: Zecuity Migraine Patch Product No Longer Available

FDA 10/19/17 notification: "Product manufacture has been discontinued and it is no longer available."

(10/23/17)

 

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On June 10, 2016 Teva Pharmaceuticals sent a so-called "Dear Doctor" letter to health care providers about Zecuity, its migraine drug patch. From this PDF document we get the following:

Dear Health Care Provider:

The purpose of this letter is to inform you that we are suspending the sale, marketing and distribution of ZECUITY® (sumatriptan iontophoretic transdermal system), indicated for the acute treatment of migraine with or without aura in adults. Teva has received postmarketing reports of application site reactions described as “burn” and/or “scar” in patients treated with ZECUITY. Descriptions of these reactions have included severe redness, cracked skin, blistering or welts, and burns or scars where the patch was worn. Patients described severe pain, itching, or burning. Although many cases resolved within hours to weeks, there are reports of cases with unresolved skin reactions, typically skin discoloration, after several months.

On a different front, at Teva's Zecuity.com web page, we get this information:

Teva Pharmaceuticals has voluntarily suspended sales, marketing and distribution of ZECUITY (sumatriptan iontophoretic transdermal system). Teva has received post-marketing reports of application site reactions described as burns and scars in patients treated with ZECUITY, and is working in full cooperation with the U. S. Food and Drug Administration (FDA) to better understand these adverse events.

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Free Zecuity Case Evaluation

Strictly Confidential, No Obligation

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These recent developments closely follow a June 2, 2016 FDA safety alert regarding Zecuity and the apparent increased risk of these unusual side effects. From this notification, "FDA Drug Safety Communication: FDA evaluating the risk of burns and scars with Zecuity (sumatriptan) migraine patch", we get these details:

The U.S. Food and Drug Administration (FDA) is investigating the risk of serious burns and potential permanent scarring with the use of Zecuity (sumatriptan iontophoretic transdermal system) patch for migraine headaches. We are investigating the cause and extent of these serious side effects and will update the public with new information when our review is complete.

Patients who experience moderate to severe pain at the Zecuity patch site should immediately remove it to avoid possible burns or scarring, regardless of how long the patch has been worn, and contact your health care professional. Do not bathe, shower, or swim while wearing the patch....

Since marketing of the Zecuity patch began in September 2015, a large number of patients have reported they experienced burns or scars on the skin where the patch was worn. The reports included descriptions of severe redness, pain, skin discoloration, blistering, and cracked skin. As a result, we are investigating these serious adverse events to determine whether future regulatory action is needed.

Of course, we will continue to monitor this newly emerging drug safety issue regarding the migraine patch Zecuity, as well as the Zecuity recall issued by Teva in mid-June 2016.

 

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review done by attorney Tom Lamb) 

Mirena Associated With Levonorgestrel-Related Neurological Conditions PTC/IIH Caused By Increased Buildup Of Cerebrospinal Fluid On Brain

PTC/IIH Symptoms Include Migraines With Blurred Or Double Vision, Temporary Blindness, Other Visual Problems, And Wooshing Or Ringing In The Ear

(Posted by Tom Lamb at DrugInjuryWatch.com)

Mirena is an intrauterine system (IUS) from Bayer Healthcare Pharmaceuticals, Inc. that releases 20 μg/day of levonorgestrel.  Basically, the Mirena releases levonorgestrel, a synthetic progestogen, directly into the uterus for birth control.  The FDA approved Mirena in December 2000 and it is used by more than 2 million women in the US.

The Prescribing Information for Mirena (accessed 5/30/14) does not warn about neurological conditions such as pseudotumor cerebri (PTC), also known as idiopathic intracranial hypertension (IIH) or benign intracranial hypertension. In fact, the Mirena Prescribing Information (also known as the package insert or label) makes no mention of PTC/IIH, despite a known link between levonorgestrel and PTC/IIH.

Pseudotumor cerebri or idiopathic intracranial hypertension (PTC/IIH) is a non-stroke neurological condition that develops in the skull when a person’s cerebrospinal fluid becomes elevated, causing increased pressure.

PTC/IIH symptoms include:

• severe migraines or migraine-like headaches
  with blurred vision
• diplopia (double vision), temporary blindness, blind spots, or other visual
  deficiencies
• papilledema, or optic disc swelling, due to
  increased intracranial pressure
• a “whooshing” or ringing in the ear, clinically called tinnitus

When patients present with symptoms of PTC or IIH they often first undergo an MRI, CT scan, and/or other diagnostic radiology tests to rule out an actual tumor or blood clot in the brain.  This differential diagnosis is warranted because PTC derives its name from the fact that the condition acts like a tumor but it is not actually a tumor.

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Free Mirena Case Evaluation 

Strictly Confidential, No Obligation.

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It is important to note, here, that because the current Bayer label for Mirena does not have any warnings of PTC or IIH, once a woman's doctor rules out transient cerebral ischemia or stroke as a cause of the above symptoms her doctor does not know to advise her to remove Mirena.  And with the Mirena left in place, it causes or contributes to the development and/or progression of PTC/IIH.

Unfortunately, the failure to timely diagnose and treat PTC or IIH may lead to permanent vision loss and even blindness.

Ultimately, a lumbar puncture, or spinal tap, is how pseudotumor cerebri or idiopathic intracranial hypertension is frequently diagnosed.

Notably, there is currently no treatment to reverse permanent injury to the optic nerves that is caused by increased intracranial pressure. Because of this, once the PTC/IIH is correctly diagnosed, treatment going forward is focused only on halting visual loss that has already occurred.

Although PTC or IIH is considered reversible in some patients, it may take years before normal pressure is maintained. In other patients, PTC/IIH may be irreversible, or the condition recur throughout the patient’s lifetime.

In severe cases of PTC/IIH a lumbarperitoneal shunt (“LP shunt”) or a ventriculo-peritoneal shunt (“VP shunt”) may be used to help drain cerebrospinal fluid from the lower back or from the skull.
 
Because of Bayer's failure to warn in the Mirena package insert or label about the risk of developing pseudotumor cerebri or idiopathic intracranial hypertension (PTC/IIH) due to the release of levonorgestrel by the Mirena, women have filed products liability lawsuits against the drug company.

We are currently reviewing possible Mirena drug injury cases involving these non-stroke neurological conditions PTC and IIH at our firm.

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DrugInjuryLaw.com: Current Legal And Medical Information About Prescription Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free & Confidential  (Legal case review done by attorney Tom Lamb)

Kidney Dialysis Anemia Drug Recall: Omontys: Hypersensitivity / Allergic Reactions And Anaphylaxis; Serious Side Effects With Some Being Fatal

Omontys: Deaths During Initial Injection Within 30 Minutes During Treatment Of Anemia Due To Chronic Kidney Disease In Hemodialysis Patients

(Posted by Tom Lamb at DrugInjuryWatch.com)

The Omontys (peginesatide) injection was approved in March 2012 to treat adult patients on hemodialysis with anemia stemming from chronic kidney disease. Omontys is one of the synthetic erythropoiesis-stimulating agents (ESAs). It is given by injection and packaged in 10- and 20-mg multidose vials.  Takeda Pharmaceutical Co. and Affymax Inc. are the responsible drug companies.

A February 24, 2013 New York Times article, "Anemia Drug Is Recalled After Allergic Reactions", by reporter Andrew Pollack, provides a concise yet insightful report of this new and still emerging drug safety issue:

The F.D.A. said in a news release on Sunday that it had received 19 reports of anaphylaxis, a severe allergic reaction, and that three of the patients had died, while others required prompt medical intervention or hospitalization....

Affymax and Takeda said that hypersensitivity reactions have been fatal in 0.02 percent of the roughly 25,000 patients treated with Omontys since its approval. That would suggest there have been five deaths, a slight discrepancy from the F.D.A. figures that was not explained. Over all, the companies said, about 2 of every 1,000 patients had a hypersensitivity reaction.

The companies and the F.D.A. said the reactions occurred within 30 minutes of patients receiving their first dose by intravenous administration. No problems have been reported with subsequent doses, which are given once a month. Still, the companies and the F.D.A. advised that Omontys use be discontinued even by patients who have already had more than one dose....

Dr. Daniel W. Coyne, a kidney specialist at Washington University in St. Louis, said that unless the problem was because of contamination, “this could easily lead to withdrawal of drug approval.” He said that “two in 10,000 deaths on first exposure is unacceptable, compared to nothing like this” with Epogen.

Here are links to some of the source material referenced above:

• Omontys (peginesatide) Injection by Affymax and Takeda: Recall of All Lots - Serious Hypersensitivity Reactions [February 23, 2013 FDA MedWatch Safety Information]
• Affymax and Takeda Announce a Nationwide Voluntary Recall of All Lots of OMONTYS® (peginesatide) Injection [February 23, 2013 Press Release from drug companies]

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This February 24, 2013 article, "Fatal Reactions Prompt Omontys Recall", published online by MedPage Today, gives some interesting background information about the FDA approval of Omontys:

The drug was approved by the FDA in March 2012 after an advisory panel had endorsed the drug by a 15-1 vote, with one member abstaining.

During that meeting, panel chair Wyndham Wilson, MD, PhD, chief of the lymphoma division at the National Cancer Institute in Bethesda, Md., said it appeared that [Omontys (peginesatide)] "doesn't have any safety signals."

Some 2,600 patients had participated in the drug's phase III trials, about half of them assigned to [Omontys (peginesatide)].

Steve Nissen, MD, of the Cleveland Clinic, cast the lone "no" vote at the advisory committee meeting. He had cited the lack of blinding in the trials as his rationale for opposing approval.

We are reviewing Omontys cases involving serious and sometimes fatal adverse hypersensitivity reactions, including anaphylaxis, as possible drug injury lawsuits against Takeda and Affymax.  Free Case Evaluation

Of course, we will be watching to see whether these reported allergic reactions and deaths will cause Omontys to be withdrawn from the market.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free & Confidential  (Review done by attorney Tom Lamb)

Brandname Accutane Acne Medicine Is Being Removed From U.S. Market By Roche

Accutane Recall Due To Safety Issues Or Declining Sales Or Lawsuit Losses Or Some Combination Of These Factors?

(Posted by Tom Lamb at DrugInjuryWatch.com)_____________________________________________________________________

Update:  Accutane Retrial Verdict: Roche Ordered to Pay $25 Million to Accutane User

By David Voreacos and John Martin

Feb. 16 (Bloomberg) -- Roche Holding AG, the Swiss drugmaker, must pay $25.16 million in damages to a former user of its Accutane drug who blamed the acne medicine for his inflammatory bowel disease, a New Jersey jury ruled.

Andrew McCarrell, 38, won the verdict today at a retrial in Atlantic City, New Jersey. An appeals court ordered the new trial after overturning a $2.62 million award he won in May 2007. McCarrell, a computer technician from Birmingham, Alabama, testified he got sick after taking the drug for acne in 1995. He needed five surgeries, including one to remove his colon....

(2/18/10)

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On June 26, 2009 we learned from a Blooomberg news report, "Roche Pulls Accutane Off Market After Jury Verdicts", that Accutane will no longer be available to American patients:

Roche Holding AG, the world’s biggest maker of cancer drugs, is pulling its Accutane acne medicine from the U.S. market after juries awarded at least $33 million in damages to users who blamed the drug for bowel disease.

Roche notified the U.S. Food and Drug Administration today that it was withdrawing Accutane after a “reevaluation” of its product lines showed it faced serious challenges from generic competitors, company officials said in a statement.

“In addition, Roche has been faced with high costs from personal-injury lawsuits that the company continues to defend vigorously,” according to the statement.

About 13 million people have taken Accutane since it went on the market in 1982. The medication was Roche’s second-biggest selling drug before the patent expired in 2002 and rivals started selling generic versions. Roche’s prescription market share of the drug is now below 5 percent, the company said.

From the above information, the apparent reasons for this June 2009 Accutane recall are loss of market share and mounting personal injury lawsuits. 

This brought to mind the Tequin recall by Bristol-Myers Squibb (BMS) in April 2006. 

Here is an article from September 2009 regarding what the FDA had to say about how and (really) why BMS decided to remove its unsafe antibiotic Tequin from the U.S. market -- "FDA: Tequin Was Withdrawn From U.S. Market "For Reasons Of Safety Or Effectiveness" -- Recall That Bristol-Myers Had Said Decline In Sales Was Reason For Its Decision To Stop Selling Tequin" (emphasis added):

On September 2, 2008 the FDA issued a Notice entitled "Determination That TEQUIN (Gatifloxacin) Was Withdrawn From Sale for Reasons of Safety or Effectiveness" which provides (and confirms) the real reason that Bristol-Myers Squibb Co. (BMY) decided to pull Tequin from the U.S. market in the spring of 2006:

SUMMARY: The Food and Drug Administration (FDA) has determined that TEQUIN (gatifloxacin) Tablets, Injection, and Oral Suspension, were withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not accept or approve abbreviated new drug applications (ANDAs) for gatifloxacin oral tablets, injection, or oral suspension that refer to any previously approved dosage forms and strengths of TEQUIN (gatifloxacin).

As you may recall, in April 2006 when the news first broke that Bristol-Myers had decided to stop selling Tequin -- an antibiotic which was increasingly associated with potentially fatal blood-sugar problems -- the drug company said a continuing decline in Tequin sales was its reason for deciding to stop selling Tequin.

Returning to the June 26 Bloomberg article and its headline which implicates the Accutane lawsuit losses as being the primary reason for Roche deciding to pull Accutane, there have been some recent developments in the Accutane litigation. 

In mid-June a New Jersey Superior Court judge ruled that Roche could not name new experts in the retrial of Andrew McCarrell v. Hoffman-La Roche Inc., et al.(No. ATL-L-1951-03-MT, N.J. Super., Atlantic Co.), a personal injury case where the plaintiff had alleged Accutane caused his inflammatory bowel disease (IBD).  I defer to a March 13, 2009 post on the Drug and Device Law blog, "Accutane: McCarrell Remanded For New Trial", concerning the appeal of this Accutane jury verdict for the plaintiff.

A better result in June 2009 for Roche came from the federal court system's 11th Circuit Court of Appeals, which upheld a summary judgment in favor of the drug company in a case where it was alleged that Accutane caused the son of U.S. Rep. Bart Stupak, D-Mich., to commit suicide.  The essential ruling reportedly there was that the plaintiff failed to produce evidence that Hoffman-La Roche Inc. knew or should have known that Accutane could cause suicide without premonitory symptoms (Laurie A. Stupak v. Hoffman-La Roche Inc., et al., No. 07-15980, 11th Cir.; 2009 U.S. App. LEXIS 12482).

We will watch to see if more information comes out in the future which will explain why Roche decided to remove Accutane from the market in June 2009.

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?

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)

A Timeline For The Psoriasis Drug Raptiva, From Product Launch In U.S. To Market Withdrawal

Raptiva Recalled in U.S. Due To Link With Fatal Brain Infection, Progressive Multifocal Leukoencephalopathy (PML)

(Posted by Tom Lamb at DrugInjuryWatch.com)

On April 8, 2009 Genentech Inc. -- which was just acquired by Roche Holding AG in March 2009 -- issued a press release announcing "a phased voluntary withdrawal of psoriasis drug Raptiva® (efalizumab) from the U.S. market" due to its link to a brain infection, progressive multifocal leukoencephalopathy (PML).

Here is a basic timeline for Raptiva, from product launch to drug recall.

2003:  Raptiva was approved by the FDA as a once-weekly injection for adults with moderate to severe plaque psoriasis.

October 2008:  FDA announced updated labeling for Raptiva to warn of the risk of life-threatening infections, including progressive multifocal leukoencephalopathy (PML).

December 2008:  U.S. sales of Raptiva were approximately $108 million in its last full year on market.

February 2009:  FDA issued a Public Health Advisory for Raptiva informing patients and doctors about the risk of PML in patients taking Raptiva, after receiving reports of four patients with PML, three of whom died.

February 2009:  The same day (February 19) that the FDA issued its Public Health Advisory, the European Medicines Agency announced the benefits of Raptiva do not outweigh its risks.  Accordingly, this regulatory body recommended that the use of Raptiva should be suspended in the European Union.

February 2009:  Two days later (February 21), at the recommendation of Health Canada, the marketing of Raptiva in Canada was suspended due to safety concerns, including the increased risk of developing PML.

March 2009:  FDA approved a Medication Guide for Raptiva and included additional information in Raptiva's labeling regarding PML.

April 2009:  Genentech announces "phased voluntary withdrawal" of Raptiva and sends out a Dear Healthcare Professional Letter, or "Dear Doctor" letter, about Raptiva as well as a Dear Patient Letter about Raptiva.

June 2009:  Raptiva will no longer be available to patients in the U.S.

To put this Raptiva recall into context, here is some information about progressive multifocal leukoencephalopathy (PML) from the April 8, 2009 Genentech press release about Raptiva:

PML is a rare, progressive, demyelinating disease of the central nervous system that leads to death or severe disability. PML is caused by activation of the John Cunningham, (JC) virus. The JC virus resides in latent form in up to 80 percent of healthy adults, typically only causing PML in immunocompromised patients. The factors leading to activation of the latent infection are not fully understood, though abnormalities in T-cells may be important for reactivation and PML. PML has been reported in the published literature in HIV-positive patients, as well as immunosuppressed cancer patients (including patients with hematologic malignancies), organ transplant recipients, and patients with autoimmune diseases. There are no known interventions that can reliably prevent or adequately treat PML.

Since FDA approval in 2003, approximately 46,000 patients worldwide have been treated with Raptiva, with approximately 2,000 patients in the U.S. currently receiving Raptiva at time this drug recall was announced in early April 2009 by Genentech.

Caraco Digoxin Recall Issued March 31, 2009 Is Due To Pill-Size Problems

Digitek Brand Of Generic Digoxin Tablets Had Been Recalled In April 2008 For Same Reason

(Posted by Tom Lamb at DrugInjuryWatch.com)

On March 31, 2009 the FDA announced another generic digoxin pill recall by posting this company press release on the agency's web site: "Caraco Pharmaceutical Laboratories, Ltd. Announces a Nationwide Voluntary Recall of All Lots of Digoxin Tablets Due to Size Variability".

This March 31 press release from Caraco, a generic pharmaceutical company, states that:

[A]ll tablets 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, are being voluntarily recalled to the consumer level. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin."

Almost a year ago, in late April 2008, all digoxin pills manufactured by Actavis Totowa -- marketed under the Digitek brand name -- were recalled due to this so-called "double-dose" manufacturing problem.  Those Digitek pills were distributed by Mylan Pharmaceuticals under the Bertek and UDL labels.

The Digitek recall has resulted in personal injury and wrongful death lawsuits being filed on behalf of patients who used Digitek digoxin tablets.

It is too early to tell whether there will be any product liability litigation involving the possible "double-dose" digoxin pills that are now being by Caraco Pharmaceutical.

P.S.  Read about a "new" May 11, 2009 digoxin recall by a company that repackaged Caraco digoxin tablets -- which were originally recalled in late March 2009. 

Why did AS Medication Solutions delay their digoxin recall notice for six weeks?  (5/13/09)

January 2009: ETHEX Corp. Issues Voluntary Recall Of All Pills Due To Suspected Manufacturing Problems

ETHEX Recall Goes To Retail Pharmacy Level For Hydromorphone HCl Tablets And Metoprolol Succinate ER Tablets, Only; All Other ETHEX Generics Recalled To Wholesale Level

(Posted by Tom Lamb at DrugInjuryWatch.com)

In late December 2008 KV Pharmaceutical announced another drug recall involving its subsidiary ETHEX Corporation, which covered "a single production lot of Hydromorphone HCl 2 mg tablets (Lot 90219, Exp: 3/2010; NDC 58177-0620-04), a pain management drug, following the report of an oversized tablet."

In that same December 23, 2008 press release, we learned that KV Pharmaceutical was voluntarily suspending all shipments of its approved tablet-form drugs" to all the drug company an opportunity to improve its "manufacturing and quality systems".

We ended our article about that 2008 ETHEX one-lot Hydromorphone recall in this manner:  "Now we will wait to see if this Hydromorphone recall is expanded beyond the single lot identified initially by ETHEX."

About a month later we got our answer, which came in the form of a January 28, 2008 press release, "ETHEX Corporation Issues Nationwide Voluntary Recall of [All Its] Products".

This January 2008 press release from KV Pharmaceutical, the parent company of ETHEX, includes a list of the more than 60 generic drugs being recalled by ETHEX.  Only two of these generic drug products, Hydromorphone HCl tablets and Metoprolol Succinate ER tablets, were recalled to the pharmacy, or retail, level.  The recall of all other ETHEX drugs was limited to the wholesale level.

From a January 28 FDA MedWatch Email Alert about this all-pills, all-lots ETHEX recall:

These generic products may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices. Some of these products have had specific lots recalled earlier due to defects found, including oversized tablets delivering higher than labeled doses. These additional products are being removed to assure that no other defective products remain in the marketplace. Patients who may have these medicines in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medication may place patients at risk. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products, or to obtain replacement medications or prescriptions.

As some of you know, there were several recalls of ETHEX drugs in 2008:

• Another "Double-Dose" Pill Problem Demonstrates How And Why The Digitek Recall Is So Unusual

• ETHEX Corporation Expands Its Voluntary June 2008 Recall Of Morphine Sulfate Extended Release Tablets

• A New "Double-Dose" Pill Drug Recall Is Issued By ETHEX Corp.

Related to the Metoprolol Succinate ER tablets aspect of this latest ETHEX recall, on January 30 the FDA issued this "Drug shortage" notice, "Metoprolol succinate extended release tablets".

We have heard from many patients affected by this shortage of Metoprolol ER pills -- the generic of Toprol-XL -- in the numerous Comments that have been submitted to these two articles we did previously concerning the earlier Metoprolol recall issued by Sandoz, a subsidiary of Novartis:

Sandoz Metoprolol Succinate ER Tablets Recall Has Been Done Rather Quietly

FDA Warns Sandoz About Possible Quality-Control Problems At Its North Carolina Generic Drug Manufacturing Facility

We would like to hear how your doctor and/or pharmacist is handling this latest recall by ETHEX, and the current Metoprolol pill shortage in particular.

P.S.  For an update, see this February 3, 2009 drug company Press Release which has been posted on the FDA's web site:

ETHEX Corporation Issues Voluntary Nationwide Recall: Previously Issued Recall to Wholesale Level On Certain Products Expanded to Retail Level

We will continue to monitor this ETHEX 2009 drug recall and report significant developments.  (2/4/09)