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Pharmaceutical News Wrap Up: March 2015

Interested in the latest pharmaceutical news? Simmons Hanly Conroy’s pharmaceutical attorneys understand the importance of staying up to date, which is why we’re providing the list of recent news stories below. Read about U.S. Food and Drug Administration (FDA) recalls, approvals and warning label changes, medical studies and other pharmaceutical news that took place in the month of March.

  • Drugs using testosterone will label heart risks
    pharmaceutical newsAs mentioned by Simmons Hanly Conroy attorneys earlier this month, the FDA has ordered testosterone manufacturers to update the labels to include warnings of increased risk of heart attacks and strokes. The update also describes how testosterone should not be prescribed to treat symptoms in men brought about by natural aging.
  • Statins increase risk of type 2 diabetes, study suggests
    A new study discovered that statins (drugs used to lower blood cholesterol) increase risk of type 2 diabetes by 46 percent. Researchers found that this is a result of decreases in insulin sensitivity and secretion.
  • FDA adds alcohol and seizure warnings to Pfizer’s quit-smoking pill
    The popular smoking cessation drug Chantix now flaunts a new safety alert warning from the FDA. The label warns consumers about its risk of seizures and dangers of taking the drug with alcohol.
Read the rest

Pelvic Organ Prolapse Patients: Follow FDA's Precautions For TVM Surgery

Pelvic organ prolapse (POP), caused by the weakening of the tissues that hold pelvic organs, may be experienced by 30-50 percent of women. Despite its controversial results, transvaginal surgical mesh is the primary treatment for pelvic organ prolapse. Unfortunately, pelvic organ prolapse repair with surgical mesh can sometimes lead to complications and additional surgeries without much added benefit. Some of the transvaginal mesh (TVM) side effects include:

  • transvaginalmeshMesh erosion
  • Pain
  • Organ perforation
  • Urinary problems

Before pursuing transvaginal mesh lawsuits, patients should read about the precautions they can take to avoid dangerous complications, as recommended by the U.S. Food and Drug Administration (FDA).

  1. Ask About All of Your POP Options
    Transvaginal mesh is not always the best option. In fact, a review of scientific research has shown that treatment of POP with surgical mesh repair does not decrease symptoms or improve the patient’s quality of life more than options without mesh. If your surgeon does insist on using mesh, make sure to understand his or her reasons for doing so.
  2. Practice Consistent Post-Surgery Care
    Routine checkups and follow up care are vital to a healthy recovery from pelvic organ prolapse treatment. By staying aware of your body and keeping your doctors informed, you can catch surgical mesh side effects before they advance.
Read the rest

The Ovarian Cancer Risk Factor You May Not Know

Ovarian cancer is one of the most common cancers among women. According to the American Cancer Society, an average woman’s risk of developing ovarian cancer is 1 in 75. Approximately 21,290 women receive an ovarian cancer diagnosis every year.

ovarian cancer risk factorHowever, there are certain risk factors that can increase a woman’s chances of developing ovarian cancer. Some of the risk factors are uncontrollable, while others can be avoided. Below is a short list of some of the most common ovarian cancer risk factors:

  • Increased age
  • Obesity
  • Pregnancy after age 35
  • Reproductive difficulties (never carrying a pregnancy to term)
  • Fertility drugsAndrogens (male hormones)
  • Estrogen therapy and hormone therapy
  • Family and/or personal history of ovarian, breast or colorectal cancer
  • High-fat diets

There is one ovarian cancer risk factor that many women may not know. Talcum powder, which can be found in baby powder, body and facial powders, deodorant powders and other cosmetic products, has been linked to an increased ovarian cancer risk. When applied directly to the genital area or on sanitary napkins, studies have shown that cancer-causing components from the powder may reach the ovaries.

Specifically, one study found a possible 30 percent increased risk of ovarian cancer with the perineal or genital use of talcum powder.… Read the rest


Testosterone Lawsuit News: FDA Orders Label Warnings on Testosterone Drugs

Testosterone therapy manufacturers must update the labels of all testosterone products to inform men about the increased risk of stroke, heart attack and death in patients taking testosterone, according to a testosterone safety announcement issued by the U.S. Food & Drug Administration (FDA) earlier this week.

“The benefit and safety of testosterone have not been established in men who have low testosterone levels for no reason other than age,” according to the FDA warning.

testosterone-use-increaseBetween 2001 and 2011, The Journal of the American Medical Association reported that the use of hormones in men over 40 increased by almost 360 percent. This may have been due to an overwhelming amount of advertising about the inappropriate use of testosterone drugs, including consumer ads that promised aging men renewed vitality and strength.

A variety of factors can influence testosterone levels. However, testosterone therapy is only approved by the FDA for men who have low testosterone levels due to a disorder of the testicles, pituitary gland or brain that cause a condition called hypogonadism.

A recent FDA analysis showed that only about half of men taking testosterone therapy have been officially diagnosed with hypogonadism. This means many men are being prescribed hormones without a clear indication for its use, and are being unnecessarily put at risk for serious cardiovascular side effects.… Read the rest


Xarelto and Internal Bleeding Frequently Asked Questions

Xarelto, an oral anticoagulant drug, is prescribed by doctors to reduce the risk of blood clots that may cause strokes. It is easier to use than many other blood thinners on the market because it does not require patients to have routine blood tests to determine the dose. However, many are now questioning whether Xarelto’s convenience factor is worth the risk.

If you or a loved one has been prescribed Xarelto, read the frequently asked questions below to learn more about the drug.

  1. What is Xarelto?

Xarelto is a fairly new drug approved by the Federal Drug Administration (FDA) in 2011. Doctors prescribe Xarelto to reduce the risk of stroke and blood clots in patients with atrial fibrillation and to treat patients with deep vein thrombosis and pulmonary embolism.

Xarelto was invented and manufactured by Bayer Healthcare Pharmaceuticals and is marketed by Jassen Pharmaceuticals, a division of Johnson & Johnson.

  1. Why is Xarelto dangerous?

The Institute for Safe Medication Practices has found that blood thinners were the most dangerous drugs with the highest number of serious side effects reported to the FDA.

Xarelto has several side effects, but the most dangerous is internal bleeding, which can be fatal. Uncontrollable internal bleeding may occur in the rectum, intestines, abdomen, brain and blood vessels.… Read the rest

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