Commentary and insight about the complex legal, medical and social issues surrounding pharmaceutical litigation.

European Union Begins Review of Testosterone Replacement Therapy

April 24, 2014

Several studies on the risks of testosterone replacement therapy have prompted a review by the European Union’s drug regulator, the European Medicines Agency. The studies found that testosterone therapies can increase risk of heart attack, stroke and death among men.

The review by the agency will examine the benefits and risks of testosterone replacement therapy. Following the review, the organization will issue an opinion as to whether the current marketing authorizations for the drugs should be maintained, altered, discontinued or permanently withdrawn. The decision will impact the EU’s 28 member countries including France, Germany, Spain, Sweden and the United Kingdom.

Many low T drugs have been approved in numerous countries across Europe. The drugs come in various forms, including patches, implants under the skin, capsules and gels. In the EU, use of testosterone therapy is prohibited among healthy, older men.

The release of the study results linking low T treatments to heart attack, stroke and death has prompted similar responses throughout the United States. The U.S. Food and Drug Administration (FDA) began reviewing the popular medications in January of this year.

Patients are reminded to never discontinue use of any type of medication without first consulting with a physician. If you have questions or concerns about testosterone replacement therapy, speak with your doctor or pharmacist.

If you or a loved one has suffered a heart attack, stroke or death while taking low T treatments, contact the testosterone lawyers at the Simmons Firm today.

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The Psychological Effects of Gynecomastia Linked to Risperdal

A study conducted by the American Society of Plastic Surgeons (ASPS) and colleagues of Boston Children’s Hospital examined the mental and emotional effects of gynecomastia, a condition in which men develop female breasts. Researchers found that persistent gynecomastia negatively affects self-esteem, especially in adolescent boys.

In the study, researchers ran a series of psychological examinations on 47 healthy boys with an average age of 16.5. All of the study participants were being evaluated for gynecomastia and results were compared to boys who did not have breast enlargement.

Specific findings from the study were adjusted for weight and body mass index (BMI), since 64 percent of the gynecomastia participants were overweight or obese, while only 41 percent of the comparison group was overweight or obese. The results revealed that the patients with gynecomastia had lower scores in the following areas:

  • Standard quality of life
  • General health
  • Social functioning
  • Mental health
  • Self-esteem

The lower scores in the above areas, including lower self-esteem, were directly attributed to breast enlargement.

Risperdal and Gynecomastia

Risperdal, a prescription medication used to treat schizophrenia, autism and bipolar disorders, has been linked to the development of breasts in adolescent males. Many young males who take Risperdal have developed breasts and consequently experienced psychological trauma in line with the results of the above study. Some young males have needed surgery to remove the breasts.

Risperdal’s manufacturer may have failed to disclose information on Risperdal’s serious side effects to consumers while marketing the drug. If you or someone you know has taken Risperdal and later experienced male breast enlargement, consider contacting a Simmons Firm lawyer today. Our Risperdal lawyers will work with you to determine if you are eligible to file a lawsuit.

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Low Testosterone Diagnosis: Are Current Testing Methods Substantial?

Since 2000, the number of American men taking testosterone replacement therapy has quadrupled. More than 5 million prescriptions were written for testosterone therapy in 2011 alone.

Men experience a decline in natural testosterone production as they age. This can cause less than desirable health effects such as declining sex drive, erectile dysfunction, decreased bone density, lower muscle mass and fatigue and depression. Because of this, more and more men are turning to prescription low T treatments to ease the symptoms.

Some experts are beginning to worry about the extent to which testosterone treatments are prescribed. Many believe there is a failure to get adequate testing from certified medical experts in the area of hormone therapy. This can create a dangerous path for men taking low T treatments who might not necessarily need them or be properly monitored while taking the prescription.

How Doctors Diagnose Patients with Low Testosterone

When a patient gets tested for low testosterone levels, they will generally have a morning office visit because this is the time of day testosterone levels are highest. A blood test is performed. The doctor may also use hormone or genetic testing to check for low testosterone levels.

Some health experts believe more should be done to prevent unnecessary testosterone use. They recommend that doctors perform a physical exam in addition to blood and hormone testing to check for physical symptoms of low testosterone.

“A mildly low level of testosterone alone, without any signs or symptoms, typically does not require treatment,” said Dr. Todd Nippoldt, of the Mayo Clinic in a Chicago Tribune article. “Follow-up tests and exams can usually show if a medical condition may be contributing to low testosterone. If an underlying medical condition is identified, treatment for that disorder may be all you need to bring your testosterone level back into the normal range.”

Patients should be aware of the recent link between testosterone replacement therapy and risk of heart problems and stroke. Several studies have linked low T treatments to increased risk of stroke, heart attack and death among men. The U.S. Food and Drug Administration (FDA) is currently investigating this link.

Learn more about testosterone therapy and its associated health dangers, or contact an experienced testosterone lawyer at the Simmons Firm today.

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Louisiana Jury Orders Actos Manufacturer to Pay $9 Billion

April 11, 2014

Takeda Pharmaceutical Co. and Eli Lilly & Co. have been ordered to pay a total of $9 billion in punitive damages in connection to the diabetes drug Actos. A Louisiana jury found that the companies did not disclose the proper information about cancer risks associated with Actos.

Based in Japan, Takeda is the manufacturer of Actos, a prescription medication for the treatment of type 2 diabetes. Eli Lilly & Co. helped to promote the drug. Both companies are accused of failing to warn consumers about the increased risk of bladder cancer linked to Actos.

Actos had previously been a major seller for Takeda until its patent expired in 2011 and it began facing generic competition. Additionally, sale of Actos was suspended in both Germany and France in 2011 due to its connection to increased cancer risk.

Takeda executives failed to provide clear warnings about the associated cancer risk for seven years, Bloomberg reports. Research definitively showed Actos’ link to bladder cancer wasn’t an accident or oversight, yet the company did not issue a warning to consumers.

More than 2,700 Actos lawsuits have been consolidated before the U.S. District Judge Rebecca Doherty in Louisiana, the Bloomberg article states.

The Simmons Firm has been actively litigating claims that the diabetes drug Actos has led to an increased risk of bladder cancer. If you have questions, please contact our attorneys today.

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Pharmaceutical News Wrap Up: March 2014

March 31, 2014

Here at the Simmons Firm, our pharmaceutical lawyers strive to keep you caught up on the latest pharmaceutical news. Below is a short list of some of the most recent headlines concerning FDA recalls, approvals and warning label changes, medical studies and other pharmaceutical news taking place across the country and world.

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Takeda Pharmaceuticals Intentionally Destroyed Actos Files, Bloomberg Reports

March 19, 2014

The Osaka, Japan-based pharmaceutical company Takeda said they cannot find files pertaining to the development, marketing and sale of Actos that were compiled by 46 different employees, according to a recent Bloomberg news report. The company admitted to U.S. District Judge Rebecca Doherty that even though executives warned employees to retain Actos-related materials, some files were deleted from company computers.

Because of this, Judge Doherty ruled Asia’s largest drug maker must let a jury hear claims that it intentionally destroyed Actos files. Lawyers of a former Actos user will tell jurors about the document destruction during the on-going trial. The ex-Actos user is suing the company over his development of bladder cancer since taking the drug.

Actos, a type 2 diabetes medication, has been linked to an increased risk of bladder cancer, especially among patients who use the drug for longer than one year. Many former Actos users contend that Takeda researchers ignored or downplayed the serious health concerns associated with the drug’s cancer-causing potential. They also believe researchers misled U.S. regulators about its health risks.

Takeda’s sales for Actos peaked in March 2011 at $4.5 billion. Actos sales made up 27 percent of Takeda’s total revenue at the time, according to the Bloomberg article.

The Simmons Firm lawyers are actively investigating claims that Actos use has led to the development of bladder cancer. If you or your loved one has been injured by Actos and has since been diagnosed with bladder cancer, the manufacturer may have failed in its duty to label the product appropriately.

Contact us today to see if you are eligible to file an Actos lawsuit, or learn more about Actos and bladder cancer today.

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Former Yaz User Shares Her Story of Unspoken Side Effects

The hormonal birth control Yaz has been linked to dangerous side effects including blood clots, stroke, heart attack, kidney failure, cardiac arrhythmia, pulmonary embolism and even death. Hannah Kohlman, a former Yaz user, experienced some of these severe side effects which put her in the hospital and almost ended her life.

Six months after starting to take the birth control, Hannah began experiencing symptoms she thought were associated with asthma, like rapid exhaustion while climbing stairs, sleepiness and being constantly short of breath. Her coworkers told her she appeared very pale.

One morning Hannah woke up with chest pains, which she thought were a pulled muscle in her chest. The next day she had severe chest pain, a racing heart and difficulty breathing. She collapsed on the floor before gradually pulling herself to her phone, which she used to call for help before losing consciousness.

Hannah woke up in the hospital where she was told her blood pressure was less than half of what a normal adult’s blood pressure should be. A CT scan found two major blood clots blocking two of her arteries in her heart – one was blocked 100 percent and the other was blocked 75 percent.

She spent the next week in intensive care with 24-hour surveillance monitors. Doctors were worried her clots would move to her heart and cause a heart attack or move to her brain and cause a stroke. She was later released from the hospital, but suffered from chest pains for the next six months and is dealing with increased risk of blood clots for the remainder of her life.

Doctors told Hannah the only cause of the blood clots was Yaz, her contraceptive pill. Hannah states she had no knowledge of the serious side effects of Yaz such as pulmonary embolism and blood clots. She had always lived a healthy, active life and thought blood clots only happened to unhealthy people.

“If I had been even slightly aware of the negative side effects, I never would have started taking [Yaz] in the first place,” Hannah said. “I hope by sharing my story it inspires other young healthy women to educate themselves on some of the potential side effects from taking common and popular contraceptive pills such as Yaz.”

The Simmons Firm is dedicated to helping individuals who have been harmed by drugs such as Yaz. If you are interested in learning more about Yaz side effects or would like to speak to one of our Yaz lawyers, please contact us today.

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