Author

Jennifer Walker-Journey

5672 posts

Jennifer Walker-Journey is a professional writer whose 20-year career spans from newspapers and magazines to Ezines and business blogs. Her primary focus is corporate and business writing, though she relishes any opportunity to write features. In her limited free time, Jennifer strives to finish the novel she is writing. She lives in Birmingham with her husband, Rick, and their insatiably curious son, Truman.

Lawsuits filed over injuries allegedly caused by Ethicon’s Physiomesh for hernia repair

hernia mesh - Wikimedia Commons

A Florida woman is suing Johnson & Johnson’s Ethicon alleging the company’s Physiomesh device implanted in her during hernia repair embedded into her abdominal wall, blocked her intestines and caused her chronic pain. Her lawsuit comes just five months after an Illinois man filed a similar lawsuit over Ethicon’s Physiomesh alleging the device caused him to develop an infection, two abscesses and an intestinal fistula. Physiomesh is a fibrous plastic device that is intended for hernia repair. It is made from polypropylene, the same product used in Ethicon’s controversial transvaginal mesh, which has been the subject of hundreds of lawsuits ... Read More

China heparin producer warned by FDA over violations of current good manufacturing practices

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U.S. Food and Drug Administration (FDA) officials inspecting Chinese drug maker Dongying Tiadong Pharmaceuticals Co., Ltd., found “significant deviations” from current good manufacturing practices in its manufacturing of the blood thinner heparin. Dongying Tiadong was warned by French regulators over similar violations last March. The agency cited the company in its testing of crude heparin batches saying it failed to adequately investigate and document out-of-specification (OOS) results “repeatedly and without justification.” “Disregarding the OOS results, and resampling and retesting without scientific justification, constitutes ‘testing into compliance.’ This practice is unscientific and objectionable under current good manufacturing practices,” the agency said ... Read More

FDA approves two new combination type 2 diabetes treatments

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Two new treatments for type 2 diabetes were approved by the Food and Drug Administration (FDA), and both contain a combination of the same types of medications – an anti-diabetic drug from the GLP-1 receptor class, and a long-acting insulin. The approvals for both Sanofi’s LixiLan and Novo Nordisk’s IDegLira, were delayed for three months after being recommended for approval by FDA advisory panels last May. LixLan’s approval in the U.S. is its first worldwide for the combination treatment, which includes the GLP-1 receptor agonist lixisenatide (Lyxumia/Adlyxin)and the insulin glargine (Lantus). It is intended for patients with type 2 diabetes ... Read More

AbbVie asks judge to toss bellwether case in testosterone side effects MDL

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Drug maker AbbVie Inc. asked a federal judge to toss a lawsuit alleging the company’s testosterone replacement therapy AndroGel causes injuries, arguing the plaintiff withheld information about his condition until after the discovery process was completed. AbbVie told U.S. District Judge Matthew Kennelly in Chicago that Froylan Garcia’s claim was no longer valid because his attorney did not find an expert witness to back up his claims that AndroGel caused him to develop a blood clot in 2013. Garcia’s case was one of eight selected by Judge Kennelly to serve as bellwether trials in a multidistrict litigation (MDL) of more than 5,500 ... Read More

Generic drug maker cited for lax adverse event reporting

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Pennsylvania-based generic drug maker STI Pharma LLC was warned by the Food and Drug Administration (FDA) for its lax approach in handling post-market adverse event reports related to its products. The FDA said that the company did not accurately convey adverse drug events to its contractors who manufacture and distribute its products, a requirement for all companies that market medications in the United States. In one case, a patient taking an unnamed STI Pharma drug to treat red spots on his scalp reported having a dry mouth. The patient also said he was using an inhaler but he did not know ... Read More

J&J pays big for Risperdal’s gynecomastia side effect

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Johnson & Johnson and its subsidiary Janssen Pharmaceuticals face more than 13,000 lawsuits over claims that their antipsychotic drug Risperdal causes adolescent boys to grow large, disfiguring breasts. The sixth trial is currently underway and time will tell if jurors will hold the drug companies accountable. In February 2015, the first Risperdal side effects lawsuit went to trial. The jury awarded Austin Pledger, who was 20 at the time, $2.5 million after finding that Johnson & Johnson and Janssen didn’t adequately warn that the medication could cause boys and young men to grow female breasts, a condition known as gynecomastia. ... Read More

Megajex ED supplement recalled, contains hidden prescription drugs

supplement - Wikipedia

Megajex Natural Male Sex Enhancer capsules contain undeclared prescription drug ingredients that may be hazardous to the health of certain individuals, a Food and Drug Administration (FDA) analysis has found. As a result, Megajex manufacturer, MS Bionic, Inc., is recalling all lots of the male erectile dysfunction dietary supplement. The FDA says that Megajex contains the pharmaceutical ingredients tadalafil and sildenafil, the active ingredients in Cialis and Viagra, respectively. These ingredients may pose a threat to consumers because they can interact with some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Consumers with diabetes, high ... Read More

Ultimate Body-Tox Pro diet pills recalled, contain dangerous hidden ingredient

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Three weeks after the Food and Drug Administration (FDA) warned the public not to purchase or use Ultimate Body-Tox PRO diet pill capsules because the dietary supplements contained a dangerous, hidden ingredient, the company announced it is recalling all lots of the product. An FDA analysis of Ultimate Body Tox PRO diet pills revealed that it contained sibutramine, a controlled substance that was removed from the U.S. market in October 2010 because it can substantially increase blood pressure and/or pulse rate in some people and may present a significant risk for patients with a history of coronary artery disease, congestive heart ... Read More

Canadian health officials offer new guidelines for diagnosing, treating Low T

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Canadian health officials have issued new guidelines designed to help doctors and patients with the diagnosis and treatment of low testosterone, and to curb over-prescribing in particular to men whose testosterone levels were never checked for low levels of the hormone. The guidelines, published in the Canadian Medical Association Journal, were created by a task force a year after Health Canada warned that testosterone replacement therapy may lead to “serious and possible life-threatening health and blood vessel problems such as heart attack, stroke,” blood clots and irregular heart rhythm. Health Canada has also warned that research suggests that men with ... Read More

FDA approves updated warnings for Xarelto safety label

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The Warnings and Precautions section on the safety label of the blood thinner Xarelto has been updated to include more information about the risk of developing an epidural or spinal hematoma (bleeding), which can result in long-term or permanent paralysis, in patients using the drug undergo spinal or epidural anesthesia or spinal puncture. To reduce this risk, the safety label recommends health care professionals not remove an indwelling epidural or intrathecal catheter before at least two half-lifes have elapsed, or about 18 hours in patients age 20 to 45 years, or 26 hours in elderly patients aged 60 to 76 ... Read More