Category Archives: Pharmaceutical Litigation

FDA Advisory Panel Rejects New Testosterone Drug

An advisory committee for the U.S. Food and Drug Administration has voted to reject a new oral testosterone drug called Rextoro, saying that the drug is “ineffective.” Testosterone replacement therapy (TRT) is a controversial hormone treatment used to help men produce more testosterone naturally. Traditionally, testosterone treatments are applied externally, through gels, lotions and even nasal sprays. What Are the Dangers of Testosterone Gel? Some of the biggest problems with topical testosterone are skin reactions (like rashes, itching or swelling) and secondhand exposure. Patients can leave trace amounts on door handles or countertops, which can expose women and children to high doses of testosterone. Clarus Therapeutics Inc. submitted an application for Rextoro back in January, saying that the “easy-to-swallow softgel capsules” were more convenient than gels or ointments. The drug company also believed that the pills were less likely to cause skin reactions or accidental exposure. Why Wasn’t This Drug…
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Is Low T Making Me Gain Weight?

A recent study published in the New England Journal of Medicine shows that problems like erectile dysfunction and weight gain can be caused by a lack of estrogen as well as testosterone. In men’s bodies, a small amount of testosterone is regularly converted to estrogen to maintain healthy hormone levels. When testosterone production declines in later years, estrogen levels decline as well, causing unpleasant side effects. The experiment observed 400 healthy men between the ages of 20 and 50. All of the subjects took a drug that naturally suppresses testosterone and estrogen production. Then researchers gave them different doses of testosterone, but half of the men also received medication that stopped the hormone from being converted into estrogen. Researchers discovered that both estrogen and testosterone loss can impact a man’s erectile function. Low estrogen levels also appeared to encourage weight gain. Pharmaceutical companies have made big money by marketing testosterone…
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Have You Been Taking Warfarin for Blood Clots?

Sun Pharmaceuticals, an Indian drug manufacturer, is recalling its most successful medication Warfarin after the Food and Drug Administration (FDA) criticized its poor quality. Warfarin (also known as the brand names Coumadin, Jantoven and Mareva) is a blood thinner used to prevent thrombosis and thromboembolism, which are both caused by blood clots. Many common foods and medications can interact badly with Warfarin, like leafy greens and vitamin K. Patients using Warfarin must undergo blood testing to rule out the risk of excessive bleeding. In May 2014, the FDA wrote a letter to Sun Pharmaceuticals, warning the company about one of its foreign manufacturers. Inspectors had discovered that the staff had been hiding batch failures, conducting unofficial testing and deleting files. The letter told Sun that there was a “general lack of reliability and accuracy in the data generated by [the] firm’s laboratory… that raises concerns about the integrity of all…
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