Drug Safety Developments

Birth Control Pills Series: Creating a Clinical Disorder for Profit

 

Written by: Heather Helmendach, Legal Assistant 
Law Offices of Thomas J. Lamb, P.A.

 

---

Series Overview:

Article 1 - Creating a Clinical Disorder for Profit
Article 2 - The Devastating Side Effects
Article 3 - Are the Current FDA Label Warnings Enough?

---

 

To start my blog series on Yaz, Yasmin, Ocella, Gianvi, Safyral, and Beyaz, I will focus on Yaz in particular, and one of the conditions that it is prescribed to treat.

Though drugs are generally created for the purpose of treating existing medical conditions, this is not always the case.  In fact, corruption in the system can sometimes result in the creation of a medical condition after the approval of the drugs designed to treat it.  This provides drug companies with a way to deepen their pockets by expanding the market potential of their drugs.

This very phenomenon occurred with the treatment of "premenstrual dysphoric disorder" (PMDD) by prescribing Yaz and several antidepressants.  More details are provided in the article "Lowering the Bar: How PMDD Went from an Idea to a Diagnosis" by John Faubner, whose information is referenced and summarized in this post.

PMDD is a severe form of PMS, and Faubner provides the following information in his article:

"According to the DSM, which recognized PMDD as a disorder in 2013, the condition is defined as having at least 5 of 11 symptoms, which include feeling angry, irritable, depressed, or anxious, and having mood swings.

Several antidepressants were approved for the treatment of "the not-yet-existent diagnosis of PMDD in 2000"; just two years after a private meeting was paid for by the drug manufacturer, Eli Lilly, and conducted by four of its executives along with various researchers and six FDA officials.  Yaz was later approved as a treatment for PMDD in 2006.

However, PMDD was not formally considered a distinct psychiatric condition by the American Psychiatric Association until 2013.  Even then, its validity was still questioned by some medical professionals, and the majority of the members on the panel responsible for the decision had ties to drug companies.

In addition, the numbers of women who supposedly had PMDD were severely inflated.  While initial reports in 2011 touted that 30% of women have PMDD, later studies determined that only 1.3% of premenopausal women have PMDD.  That means that initially, 6 million women were thought to have PMDD, when in actuality, the number was just under 1 million.

The previously-referenced article by Faubner includes the following information provided by Amanda LaFleur, executive director of the National Association for Premenstrual Dysphoric Disorder:

[For] many women the only other approved drug, Yaz, only made symptoms worse.

In two clinical trials, Yaz reduced PMDD symptoms, but not a lot more than a placebo.

Women who took Yaz showed a 37.5-point improvement on a symptom scale that had a maximum of 126 points, but those who get a placebo had a 30-point improvement.

And the drug's effectiveness beyond three menstrual cycles is not known.

Faubner also includes statements by Diana Zuckerman, PhD, president of of the National Center for Health Research:

Treating PMDD with birth control pills, such as Yaz, that include the drug drospirenone is especially concerning...

The drug's label warns that women over 35 who smoke should not use Yaz, because of the risk of clots and the increased likelihood of a serious cardiovascular event.

"Safer drugs are available to effectively treat PMDD," Zuckerman said. "How bad is your PMDD that you are willing to put your life at risk?"

The next article in my Yaz, Yasmin, Ocella, Gianvi, Safyral, and Beyaz series will provide information on some of the lawsuits that have previously been filed due to complications of these drugs following their approval for PMDD treatment.

In the meantime, we will continue to monitor the medical literature concerning these drugs, and more information can be found on our website.

 

Drug Injury Watch: Side Effects News & Reports

Drug Injury Law: Medical & Legal Information

Manufacturers of Depakote Face Lawsuits at Home and Abroad

 

Written by: Heather Helmendach, Legal Assistant 
Law Offices of Thomas J. Lamb, P.A.

 

Recently, the drug manufacturers of Depakote (valproate) and its derivatives have come under legal fire for failing to warn about the possible side effects of the drug, and blatantly concealing warnings in order to increase their profits.

In the United States, AbbVie Inc. (formerly Abbott Laboratories) manufactures Depakote, Depakine, and Depacon.  In Europe, however, the drug is called Depakine and is manufactured by Sanofi.  

Depakote is used to treat seizures and bipolar disorder.  When used by pregnant women, it has the potential to harm their unborn children by causing still births, slowed neurological development, and congenital birth defects.

From the article on Reuters.com, "Sanofi will accept epilepsy drug blame if court rules that way," we learn the following information about Depakote:

Evidence grew toward the end of the 20th century that the drug could cause deformities in unborn children, but it was not until 2014 that the European Medicines Agency decreed it should be prescribed only when other treatments had failed, and only with accompanying evidence that patients had been informed of the risks during pregnancy.

Given that Sanofi apparently chose to protect their profits--rather than the health and safety of those who need their drugs--many children and families have suffered needlessly.  However, Sanofi declared in October of 2016 that they will accept responsibility for their actions.  At the present time, measures to determine proper compensation for victims is taking place in France.  

We hope to see AbbVie Inc. / Abbott Laboratories follow in Sanofi's footsteps and accept the blame for their actions, then work towards compensating those who have been negatively affected by Depakote.

Presently, lawsuits are also being filed against Abbott Laboratories for failing to provide accurate information to doctors concerning the use of Depakote.  It has been determined that like Sanofi, Abbott Labs intentionally withheld important warning information pertaining to the dangers of Depakote in the name of protecting its profits.

The article "Mo. Appeals Court Upholds $38 Million Depakote Birth Defect Verdict" (paid subscription required) provides these details:

A Missouri appeals court has upheld a $38 million verdict issued in favor of a girl who was born with spina bifida and other birth defects after being exposed to Depakote in utero, finding the evidence supported the jury’s finding that Abbott Laboratories failed to adequately warn doctors that the drug had an increased risk of birth defects versus its competitors and was significantly more dangerous for use in women of childbearing age.

We will continue to monitor the medical literature for more information on arising lawsuits against Sanofi and AbbVie.

In the meantime, you may learn more about Depakote and its possible side effects on our website.

 

Drug Injury Watch: Side Effects News & Reports

Drug Injury Law: Medical & Legal Information

 

 

Warfarin vs. Eliquis, Pradaxa, Xarelto, and Savaysa: Which is Better?

 

Written by: Heather Helmendach, Legal Assistant 
Law Offices of Thomas J. Lamb, P.A.

 

There in an ongoing debate amongst medical professionals concerning the effectiveness and safety of warfarin in comparison to the non–vitamin K antagonist oral anticoagulants (NOACs)--such as Eliquis, Xarelto, Savaysa, and Pradaxa--for patients with atrial fibrillation.

According to the Healio Cardiology today article, "Merits of warfarin, newer oral anticoagulants for patients with AF debated," those in favor of warfarin for stroke prevention in patients with atrial fibrillation argue that:

• The experience in patients spans decades.
• Dosing is once daily, unlike some of the newer drugs.
• It can be monitored, unlike the newer drugs.
• Reversing its effects is easy and the newer drugs either have a brand-new reversal agent or none at all.
• It is effective in patients with mechanical heart valves, unlike the newer drugs.
• It costs much less than the newer drugs, and lower cost benefits adherence.

However, those in favor of NOACs tout them as safer and more effective than warfarin, citing comparative studies of oral anticoagulants.

The Journal of the American Heart Association published an article in June of 2016 discussing the findings of their comparative study.  The study was conducted in order to examine the "Effectiveness and Safety of Dabigatran, Rivaroxaban, and Apixaban Versus Warfarin in Nonvalvular Atrial Fibrillation," as explained by the article's title.

Here is a brief summary of the study's findings concerning the effectiveness of these oral anticoagulants in preventing stroke or systemic embolism:

• Eliquis (apixaban) was associated with reduced risk compared with warfarin
• Pradaxa (dabigatran) and Xarelto (rivaroxaban) were associated with a similar risk compared with warfarin

Here is a brief summary of the study's findings concerning possible safety risks of these oral anticoagulants:

• Stroke or systemic embolism:
  • Eliquis (apixaban) was associated with lower risk than warfarin
  • Pradaxa (dabigatran) and Xarelto (rivaroxaban) were associated with a similar risk to warfarin
• Major bleeding:
  • Eliquis (apixaban) and Pradaxa (dabigatran) were associated with lower risk than warfarin
  • Xarelto (rivaroxaban) was associated with a similar risk to warfarin
• Intracranial bleeding:
  • All NOACs were associated with a lower risk than warfarin

This article also warns that readers should keep the following information in mind when considering the results of this study, as well as similar ones:

Extrapolating findings from trials to general practice is especially challenging for anticoagulation therapies. Because anticoagulants are long‐term preventive medications that address no ongoing symptoms, adherence is substantially lower in observational studies than in clinical trials. Furthermore, appropriate dosing may be hard to achieve in clinical practice because of the complexity of real‐world settings. [Footnotes omitted.]

Gregg W. Stone, MD (professor of medicine at Columbia University, director of cardiovascular research and education at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center, and co-director of medical research and education at the Cardiovascular Research Foundation) states that “ensuring adherence with warfarin or a [newer oral anticoagulant] is more important than the issue of warfarin vs. a [newer oral anticoagulant].” 

While the debate continues, perhaps one of the most important safety factors to examine when considering which oral anticoagulant to use is the availability of a reversal agent.  While warfarin and Pradaxa have antidotes, Eliquis, Savaysa, and Xarelto do not.

The lack of FDA-approved reversal agents has led to the serious injury--and even death--of many patients taking NOACs.  As such, a number of lawsuits against the manufacturers of these drugs have arisen.  If you have taken Eliquis, Savaysa, or Xarelto and has suffered a serious bleeding event, please fill out the appropriate free case evaluation form, using the links below, to learn whether you may have a possible case.

• Free Eliquis Case Evaluation
• Free Savaysa Case Evaluation
• Free Xarelto Case Evaluation
• Free Pradaxa Case Evaluation

If you would like to learn more information about these drugs, please visit our website using the links below:

• Eliquis Information
• Savaysa Information
• Xarelto Information
• Pradaxa Information

We will continue to monitor the medical literature concerning these particular oral anticoagulants and their future possible antidotes.

 

Drug Injury Watch: Side Effects News & Reports

Drug Injury Law: Medical & Legal Information

 

Bayer Fails to Warn About Serious Complications from Essure

 

Written by: Heather Helmendach, Legal Assistant 
Law Offices of Thomas J. Lamb, P.A.

 

In May of this year, Health Canada released a Health Product Risk Communication for Essure, a permanent and irreversible birth control system.  Essure is a device implanted in the fallopian tubes that prevents pregnancy by causing tissue growth which prevents an egg from being released and fertilized.

While many possible side effects of Essure are listed in Health Canada's warning, perhaps the most serious complications are device migration, organ perforation, and chronic pain.  Such complications can necessitate surgical removal of Essure, which may include hysterectomy.

Health Canada also states in their article that "Post-marketing information suggests that some patients may not always be fully informed of the various possible device and procedure-related complications before they choose whether to proceed with ESSURE."  As a result, Health Canada states that the following actions are being taken:

• Bayer HealthCare LLC in collaboration with Health Canada is developing a Patient Information Sheet and Checklist intended to be reviewed and signed prior to the use of the device.
• The product labeling for ESSURE will be updated including a new Boxed Warning section to reflect this safety information.

The Modern Healthcare article, "Essure court ruling in California could bring more lawsuits," provides the FDA's perspective on Essure:

The FDA approved Essure as a Class III medical device in 2002. Thirteen years later, its Manufacturer and User Facility Device Experience database had racked up more than 5,000 adverse event reports, from abnormal bleeding to “device migration," linked to Essure.

In September 2015, the FDA convened a panel of independent experts who recommended the agency limit the use of Essure because too little research had been done to prove its safety. In February, it recommended a black box warning for Essure, amid calls for it to recall the device entirely.

On October 31, 2016, the FDA released the document, "Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization," which provided the following example of a Black Box Warning to be included on Essure's label in the near future:

WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System for Permanent Birth Control during discussion of the benefits and risks of the device.

At the present time, lawsuits are being filed against Bayer by women who have experienced serious health complications due to Essure.  The FierceBiotech article, "California judge boosts plaintiffs’ cases against Bayer’s Essure birth control device" provides this additional information:

A judge in Oakland, CA, ruled in favor of plaintiffs suing Bayer over its Essure birth control device by granting a motion that coordinates 55 cases currently pending in the state.

Under the pretrial motion approved Friday [October 4, 2016], attorneys for the plaintiffs in each case can now pool their resources in their claims the pharma giant failed to warn women about the dangers of the Essure birth control implant. The suits involve about 900 women.

We will continue to monitor the medical literature concerning the Essure litigation, label changes, and complications.

 

Drug Injury Watch: Side Effects News & Reports

Drug Injury Law: Medical & Legal Information