Drug Injury Watch

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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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)

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Blood Thinner Pradaxa Linked To More Cases Of Serious Bleeding Events And New FDA Study Confirms Increased Risk Of GI Bleeds Compared To Warfarin

More Than 2000 Pradaxa Lawsuits Have Been Filed Against Boehringer, And A Company Official Has Admitted That More Than 1400 Patients Bled To Death

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE: Boehringer Pays $650 Million to End Blood Thinner Cases (5/28/14, Bloomberg)

Boehringer Ingelheim GmbH, the German family-owned drugmaker, agreed to pay $650 million to settle the majority of lawsuits filed over its blood-thinning drug Pradaxa, which has been linked to more than 500 patient deaths....

(5/28/14)

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Earlier this month the drug company Boehringer Ingelheim said a new analysis of a company-funded study of 18,000-patients, known as RE-LY -- which the company used to win FDA approval of its controversial blood thinner Pradaxa -- turned up 22 "new" serious bleeding events that were not included in the original study report.

According to a May 14, 2014 news article, "Boehringer Says New Bleeding Cases Found in Pradaxa Study":

Any correction to the original study, which was published in the New England Journal of Medicine in September 2009, would have to come from the researchers, Smith said. If a correction is made, it would be the second to the trial.

The researchers issued a correction in November 2010, saying they identified several additional events when they were conducting “routine clinical site closure visits.” A broader review at the time found 81 more complications, including clots, major bleeding, a stroke and four heart attacks, in 80 patients.

Further, from that same May 2014 Bloomberg article:

Boehringer faces more than 2,000 lawsuits involving Pradaxa, a treatment used to prevent strokes in patients who suffer from atrial fibrillation, a heart-rhythm disorder. The Ingelheim, Germany-based company conducted the review after plaintiff’s attorneys uncovered patients who experienced major bleeding and died while taking Pradaxa who weren’t included in the original trial results....

More than 1,400 patients bled to death while taking the medicine through Oct. 2, 2013, Andreas Clemens, an executive who oversaw the drug, said in a deposition unsealed Feb. 19 as part of the lawsuits.

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Also in mid-May 2014 the FDA issued a follow-up to its Pradaxa Drug Safety Communication issued on November 2, 2012, and the FDA has reiterated that Pradaxa is associated with an increased risk of major gastrointestinal (GI) bleeding compared to warfarin.

From this Pradaxa safety update item, "FDA study of Medicare patients finds risks lower for stroke and death but higher for gastrointestinal bleeding with Pradaxa (dabigatran) compared to warfarin", issued on May 13, 2014:

FDA completed an observational cohort study of Medicare beneficiaries that compared Pradaxa (dabigatran) and warfarin for rates of ischemic stroke, intracranial hemorrhage, major gastrointestinal (GI) bleeding, myocardial infarction (MI), and death. The study included new users of Pradaxa and warfarin who had received a diagnosis of atrial fibrillation (AF) in the 6 months prior to the first dispensing of medication....

The larger Medicare study, which assessed a relatively older population (all over 65 years of age) found that Pradaxa was associated with an increased risk of major GI bleeding compared to warfarin. This finding is consistent with the RE-LY trial which showed that the risk of GI bleeding with Pradaxa compared to warfarin increased with age.

We will continue to monitor the FDA regulatory realm, the products liability litigation, and the medical research literature for developments about the safety issues surrounding Pradaxa, especially those involving cases of gastrointestinal (GI) bleeding adverse drug events, some which have been fatal to patients.

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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)

Benicar (Olmesartan) Associated With Sprue-Like Enteropathy, Which Is A Chronic / Severe Diarrhea Condition That Can Be Misdiagnosed As Celiac Disease

This Diarrhea With Weight Loss Is Also A Side Effect Of Benicar HCT, Azor, And Tribenzor -- Other Blood Pressure Medicines Containing Olmesartan

(Posted by Tom Lamb at DrugInjuryWatch.com)

An association between the serious side effect sprue-like enteropathy and the oral angiotensin-receptor blockers (ARBs) Benicar, Benicar HCT, Azor, and Tribenzor and has been getting increased attention in the medical literature.

As pointed out by the FDA in July 2013 when it issued this MedWatch alert, "FDA Drug Safety Communication: FDA approves label changes to include intestinal problems (sprue-like enteropathy) linked to blood pressure medicine olmesartan medoxomil", severe and chronic diarrhea with substantial weight loss has been reported in patients taking Benicar and the other related drugs months to years after they first started using these blood pressure pills.

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The most recent medical article we have seen on this still emerging drug safety issue was published online by the Journal of Pharmacy Practice in late March 2014.  From the Abstract for "A Review of Current Evidence of Olmesartan Medoxomil Mimicking Symptoms of Celiac Disease" we get this information:

Objective: To review the evidence of an association between [Benicar, Benicar HCT, Azor, and Tribenzor (olmesartan medoxomil)] and symptoms mimicking celiac disease....

Data Sources: Literature was searched in PubMed (1965-November 2013) using the key words or MeSH terms olmesartan, enteropathy, celiac disease, sprue, and diarrhea.

Data Synthesis: There have been recent implications of [Benicar, Benicar HCT, Azor, and Tribenzor (olmesartan medoxomil)] being linked to symptoms mimicking celiac disease. Investigators first identified the association in 22 patients who presented with presumed refractory celiac disease. Upon further evaluation, it was discovered that these symptoms improved when [Benicar, Benicar HCT, Azor, or Tribenzor (olmesartan medoxomil)] was discontinued. In response to this report, additional case studies have been published.

Conclusions: There is growing evidence supporting the association between [Benicar, Benicar HCT, Azor, and Tribenzor (olmesartan medoxomil)] and sprue-like symptoms; however, further research is warranted. These symptoms can be life threatening and clinicians should be aware of the potential association.

For more information you can take a look at our previous articles:

• Benicar-Induced Enteropathy: Recently Found / New Possible Cause Of Villous Atrophy: Symptoms And Diagnosis
• Blood Pressure Drug Benicar Causes Serious Intestinal Side Effects Such As Chronic And Severe Diarrhea Months Or Years After Starting Drug

Of course, we are continuing to monitor this drug safety issue concerning Benicar, Benicar HCT, Azor, and Tribenzor.

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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)

Viagra May Increase Risk Of Melanoma In Men Who Have Used This ED Drug, According To An April 2014 Medical Journal Article

Viagra Is Associated With A Higher Incidence Of Invasive Melanoma; This Side Effect May Apply Also To Cialis and Levitra, Two Other Popular ED Drugs

(Posted by Tom Lamb at DrugInjuryWatch.com)

Viagra (sildenafil), the most common drug prescribed for male erectile dysfunction (ED), appears to increase the risk for invasive melanoma but not cutaneous squamous cell carcinomas nor basal cell carcinomas.

Essentially, Viagra acts by inhibiting phosphodiesterase 5 (PDE5). Experimental in vitro studies show that PDE5 inhibition augments tumor cell invasiveness, supporting this new Viagra side effect finding.

From the Abstract for the underlying medical journal article, "Sildenafil Use and Increased Risk of Incident Melanoma in US Men: A Prospective Cohort Study", published by JAMA Internal Medicine in April 2014 (as an Online First item):

• Importance  The RAS/RAF/mitogen-activated protein kinase and extracellular signal–regulated kinase (ERK) kinase/ERK cascade plays a crucial role in melanoma cell proliferation and survival. Sildenafil citrate (Viagra) is a phosphodiesterase (PDE) 5A inhibitor commonly used for erectile dysfunction. Recent studies have shown that BRAF activation down-regulates PDE5A levels, and low PDE5A expression by BRAF activation or sildenafil use increases the invasiveness of melanoma cells, which raises the possible adverse effect of sildenafil use on melanoma risk.
• Objective  To evaluate the association between sildenafil use and risk of incident melanoma among men in the United States.
• Conclusions and Relevance  Sildenafil use may be associated with an increased risk of developing melanoma. Although this study is insufficient to alter clinical recommendations, we support a need for continued investigation of this association.

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At the PubMed Commons part of the page where this April 2014 JAMA Internal Medicine article is found on PubMed.gov (U.S. National Library of Medicine) we found this Comment by David L. Keller, MD, MS, that has to do with Cialis and Levitra, two other popular ED drugs:

Are tadalafil and vardenafil also associated with increased risk of melanoma?

Sildenafil (Viagra) was associated with increased risk of melanoma in this study, and a plausible biological mechanism was proposed to explain this association. Two other closely-related phosphodiesterase inhibitors are widely used: tadalafil (Cialis) and vardenafil (Levitra); are these drugs also associated with increased risk of melanoma? One would expect this association to be a class effect.

The results of this study will be of particular concern to men who have used sildenafil and may be at elevated risk of melanoma due to history of extensive sun exposure, basal or squamous cell skin cancers, Parkinson disease (which causes autonomic erectile dysfunction and is associated with elevated risk of melanoma) or family history of melanoma....

We will continue to monitor this emerging drug safety issue concerning an increased incidence of melanoma in men who use Viagra, which may also apply to users of Cialis or Levitra, as well.

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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)

The Benefits And Risks Of Popular Testosterone Replacement Therapy For Older Men Are Not Fully Known

This Uncertainty About Drug Safety Of AndroGel, Axiron, Testim, And The Like Is Causing Concern Among Doctors

(Posted by Tom Lamb at DrugInjuryWatch.com)

For patients and doctors who have questions about whether cardiovascular side effects associated with testosterone products are real or not, they may be looking forward to the results from the Testosterone Trial in Older Men clinical study (known as the T Trial) that was sponsored by the US National Institutes of Health.

Unfortunately, however, the lead investigator on that study, Dr. Peter J. Snyder, of the University of Pennsylvania, has already warned that this T Trial, designed to enroll fewer than 800 men, will only be large enough to detect the benefits of testosterone drugs, but not any of the risks.

From this April 4, 2014 Philadelphia Inquirer article, "As testosterone use grows, questions on risks await answers":

In another echo of the female hormone saga, the federal government has stepped in to do the kind of costly, rigorous, placebo-controlled clinical trial that drug companies have no incentive to do. The $50 million Testosterone Trial is now wrapping up and will present results next year, said the leader, University of Pennsylvania endocrinologist Peter J. Snyder.

But size and duration do matter - in life and in research.

The Women's Health Initiative - with 16,600 women taking estrogen-progestin pills for five years - had what scientists call "statistical power." That's why, despite criticism, the results have held sway.

The T Trial - 788 men on hormone or placebo for a year - is designed to detect benefits, but not risks.

"It is nowhere near large enough to determine any important risk," Snyder said. "Not on prostate cancer, or heart disease."

A government advisory panel said in 2003 that a more definitive trial would be premature, given testosterone's scant research record. Still, if pluses emerge without the proper counterbalance of minuses, could that fuel misguided use of testosterone?

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In fact, this continuing uncertainty about the possible cardiovascular side effects, e.g., heart attacks and strokes, caused by AndroGel, Axiron, Testim, and other testosterone replacement drugs -- "uncertainty" because there has never been an appropriate clinical study to assess the drug risks -- is increasingly a drug safety issue being discussed among doctors.

From an April 1, 2014 Medscape article (free registration required), "Don't Prescribe 'T' Without 'E'", under the Risks Associated With Testosterone Therapy section:

At this time, it is prudent to avoid very high dosages of testosterone in older men with known cardiac disease while we await more definitive evidence from future randomized, controlled trials on the benefits and safety of testosterone therapy on men.

And from The Lancet Diabetes & Endocrinology medical journal (free registration required), there is this April 28, 2014 (early online publication) article, with a most-telling title, "Testosterone, cardiovascular disease, and mortality in men: living in the dark":

Observational studies such as those done by Vigen (1) and Finkle (2) and their collaborators should serve to galvanise both the public and medical communities to fund an appropriate clinical study to assess the risks and benefits of testosterone treatment in older men in an era when millions of men are using testosterone every day....

What then can older patients be told about the risks associated with testosterone, and in particular about cardiovascular risk? Testosterone is a billion dollar industry, probably fuelled partly by direct-to-consumer advertising and, undoubtedly, some degree of overprescription. Physicians need to admit they simply do not know and use conservative treatment guidelines (12) to guide therapeutic decisions.

• 1 Vigen R, O'Donnell CI, Barón AE, et al. Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels. JAMA 2013; 310: 1829-1836.
• 2 Finkle WD, Greenland S, Ridgeway GK, et al. Increased risk of non-fatal myocardial infarction following testosterone therapy prescription in men. PLoS One 2014; 9: e85805.
• 12 Bhasin S, Cunningham GR, Hayes FJ, et alfor the Task Force, Endocrine Society. Testosterone therapy in men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2010; 95: 2536-2559.

We will continue to monitor the medical literature for more discussion and information about the safety or side effects of testosterone products like AndroGel, Axiron, and Testim.

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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)