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FDA Advisers Shown to Have Questionable Financial Ties


In July 2014, an adviser on a U.S. Food and Drug Administration (FDA) gynecology panel stepped down after he was questioned about conflicts of interest. It was later discovered that this panel member had received payments from the maker of the device he was evaluating. The FDA had not made this clear to the public. Such incidents influenced The Wall Street Journal to look into the relationship between the FDA, its expert advisers, and their ties to devices being evaluated.

The Wall Street Journal analysis of corporate, state, and federal data showed that some FDA panel experts have ties that could undermine objective panel rulings. Only 1% of these connections were publically acknowledged by the FDA.

Of the 122 members on panels evaluating gynecology, cardiology, and orthopedics devices, one-third had received compensation from a medical-device company. In this analysis, compensation includes anything from sponsored travel to money and research grants. Additionally, nearly 10 percent of the panel members had received compensation from the company whose device they were evaluating. These findings show a conflict of interest from the FDA advisers and the devices they evaluate.

Committees that sit on FDA panels are usually influential in the FDA’s decisions. The agency often follows the advice of their committee members when approving devices and placing regulations.… Read the rest

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The History of Risperdal FDA Warnings


Risperdal was approved by the U.S. Food and Drug Administration (FDA) in 1994. It is recognized as a medication used to treat psychological issues. The antipsychotic drug is approved for use in patients with schizophrenia, schizoaffective disorder, bipolar disorder, and autism with irritability. Despite the drug’s effectiveness for these disorders, Risperdal side effects can be life changing or life threatening for people of different age groups.

In response, the FDA issued a black-box warning for Risperdal in 2005. The administration issued this alert so elderly users were aware of the fatal Risperdal side effects. Based on research at that time, there was a significantly higher risk of death in elderly individuals taking Risperdal. The black-box warning, the strictest warning given by the FDA, on the Risperdal bottle states that Risperdal use is not approved in elderly patients and can cause death in elderly patients.

Before this FDA black box warning, Risperdal was used freely in elderly patients with dementia induced psychosis. Even though Risperdal was never approved for use in elder patients with dementia, it was promoted for this by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. In 2013 Janssen Pharmaceuticals pleaded guilty to misbranding the drug and promoting it for use in elderly patients.… Read the rest

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Blood Thinners Like Xarelto and Pradaxa Classified as “Dangerous”: Here’s Why


Both Xarelto and Pradaxa are popular blood thinners prescribed to reduce the risk of blood clots that can cause a stroke or heart attack. These types of medications, however, come with serious risks because of their effect on the blood. While blood clots are dangerous and can lead to debilitating consequences, internal bleeding – a side effect of blood thinners – can be just as dangerous.

Also known as rivaroxaban (Xarelto) and dabigatran (Pradaxa), the medications are commonly called “blood thinners”, but don’t actually thin the blood.

“The concentrations of blood cells don’t actually change,” said Keith McCrae, MD at the Cleveland Clinic, in an article. “Blood thinners work by either inhibiting the function of one of these clotting factors or lowering levels of these clotting factors by 10 to 20 percent of their normal levels.”

What many patients didn’t realize, however, is the connection between blood thinners like Pradaxa and Xarelto to severe (and irreversible) internal bleeding. While blood thinners are designed to stop blood from clotting, such clots are necessary when an injury occurs – like a fall or hitting your head. If internal bleeding happens as a result of a fall and the person is on blood thinners, the bleeding may not stop until it has caused life-threatening damage.… Read the rest

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Talcum Powder and Ovarian Cancer: What You Should Know


Talcum powder’s link to causing ovarian cancer has been established for decades. Despite this, talcum powder continues to be sold without a warning label. Given that cornstarch is a safe, but relatively unknown, alternative, corporate interests seem to have taken priority over public safety. In fact, talcum powder lawsuits are now being filed against Johnson & Johnson (J&J) alleging that the manufacturer failed to warn consumers about the risk of talc powder causing cancer. As the main supplier of talc powder products, J&J continues to sell its harmful products for women and children alike without warning them of their cancer risk.

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Use of J&J baby powder has been linked to ovarian cancer.

Some J&J talcum powder products to be aware of include:

  • Johnson’s® baby powder
  • Shower to Shower® absorbent body powder
  • Face powder
  • Body powder
  • Deodorizing powder

Though study results have varied, the connection between talcum powder and ovarian cancer is backed by several studies. Talc particles were found in ovarian tumors as early the 1970s, sparking research into the substance that is now known to be a definite risk. Even then, talc powder product manufacturers denied allegations and products were still advertised as a safe way to freshen up.

A 1992 study confirmed suspicions with the finding that genital use of talc powder increases a woman’s risk of ovarian cancer by 33 percent.… Read the rest

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Pharmaceutical News Wrap Up: November 2014


Here at Simmons Hanly Conroy, our pharmaceutical lawyers understand the importance of staying up to date on the latest pharmaceutical news. Below is a list of some of the most recent headlines concerning U.S. Food and Drug Administration (FDA) recalls, approvals and warning label changes, medical studies and other pharmaceutical news taking place throughout the world.

  • Bleeding risk from blood thinner Pradaxa higher than first reported
    This Harvard editorial piece outlines the numerous studies that have linked Pradaxa to increased risk of a major bleed, which has caused dampened enthusiasm for the drug since its FDA approval in 2010.
  • Safety concerns slow sales of testosterone therapy
    Due to a one-year trial by the National Institutes of Health comparing men on a placebo versus men on testosterone, 2015 should shed some light on whether or not testosterone therapy benefits otherwise healthy men. These results could further affect the sales of testosterone medications.
  • Banned drugs still turning up in weight-loss supplements
    Despite FDA recalls for weight loss supplements containing dangerous substances, a study published recently found that two-thirds of the recalled products still contained banned substances. Manufacturers are continuing to produce and distribute the supplements even after FDA intervention.
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