American Medical Systems (AMS), a subsidiary of Endo International, enrolled the first patient in its mandatory post market surveillance study for the Elevate™ Anterior and Apical Prolapse Repair System. The study is being conducted after the U.S. Food and Drug Administration (FDA) required all transvaginal mesh manufacturers to conduct post market surveillance studies. The purpose is to compare the risks versus benefits of TVM products currently on the market.
The study will involve approximately 494 patients from 40 different locations throughout the U.S. It will compare the Elevate Anterior and Apical Prolapse Repair System with a native tissue repair control group.
“The Embrace study will provide valuable information to clinicians and patients about the role of mesh for the treatment of pelvic organ prolapse,” said Dr. Eric Sokol, Co-Chief of Urogynecology and Pelvic Reconstructive Surgery at Stanford University School of Medicine, in an article. Dr. Sokol is also the primary investigator for the Embrace study.
The study is expected to take two years to enroll participants and an additional three years to follow for a total length of five years.
Used to treat women suffering from pelvic organ prolapse (POP), transvaginal mesh has been linked to serious health complications that may require additional follow-up surgeries.… Read the rest
Parents with teething infants should not use “gum-numbing” anesthetics known as viscous lidocaine, the U.S. Food and Drug Administration (FDA) recently reported. When used among infants and young children, such medications can lead to serious harm or even death.
In 2014, the FDA received 22 reports of hazardous incidents (including death) involving viscous lidocaine and children under three and a half years of age. Such incidents involved the overdose of the medication among teething babies. Symptoms of overdose included:
- Falling asleep too easily
- Vision problems
The FDA has since required a warning on all oral viscous lidocaine prescription drugs that cautions against the use in babies and small children for teething pain. Normally, viscous lidocaine is prescribed to chemotherapy patients experiencing mouth ulcers.
In addition, the FDA warning addresses the use of over-the-counter medications containing benzocaine, such as Anbesol, Hurricaine, Orajel, Baby Orajel and Orabase for teething children under age two. These products have been linked to a rare but serious condition called methemoglobinemia, which is a disorder that reduces the amount of oxygen carried in the blood. Children under age two are at increased risk for this condition.
The agency stated it “does not recommend any sort of drug, herbal or homeopathic medication or therapy for teething in children,” a HealthDay article reported.… Read the rest
The Firm pharmaceutical lawyers are dedicated to providing you with 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 globe.
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The US Food and Drug Administration (FDA), announced last week that there has been another risk associated with testosterone treatments. The FDA is now requiring manufacturers of testosterone or low T products must add a general label warning about the increased risk for blood clots in veins. Venous blood clots, or venous thromboembolism (VTE), include deep vein thrombosis (DVT) and pulmonary embolism (PE).
This new risk adds to the continuing investigation of the negative side effects of testosterone medications. Earlier studies have noted the association between testosterone use and cardiovascular injuries such as heart attacks and strokes. In February 2014, Simmons Hanly Conroy filed the first testosterone treatment lawsuits for several men who suffered cardiovascular injuries, including heart attacks and strokes, after using low T treatments.
The FDA noted that current testosterone product labels include language about venous blood clots but only as a possible consequence of polycythemia, an abnormal increase in red blood cells. However, the FDA has received post-market reports of venous blood clots with no connection to polycythemia. As a result, the FDA is requiring testosterone manufacturers to provide a more general warning regarding venous blood clots.
Testosterone medications are only approved for use in men to treat conditions related to hypogonadism, a condition associated with genetic disorders or procedures such as chemotherapy.… Read the rest
The U.S. Judicial Panel on Multidistrict Litigation has ordered the consolidation of all federal testosterone therapy lawsuits before the Hon. Matthew F. Kennelly in the Northern District of Illinois, U.S. District Court.
Currently, 45 plaintiffs have filed testosterone replacement therapy lawsuits alleging they or their loved ones were harmed while taking AndroGel or another similar prescription testosterone replacement drug, according to the order. The plaintiffs allege the popular treatment for low testosterone caused them or their loved ones to experience a heart attack, stroke, deep vein thrombosis or pulmonary embolism after starting the treatment.
The panel ruled to consolidate the cases because they shared similar facts and doing so would streamline the plaintiffs’ cases.
“All testosterone replacement therapy actions will share factual questions regarding general causation and the background science regarding the role of testosterone in the aging body…as well as involve common regulatory issues in the light of the FDA’s announcement and subsequent actions,” the panel wrote in the order.
Earlier this year, the U.S. Food & Drug Administration issued a safety announcement about low testosterone treatments’ increased risk. Based on new research which found men taking testosterone treatments had a greater chance of suffering a heart attack or stroke, the FDA launched its own investigation of testosterone replacement therapy.… Read the rest