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AndroGel 179 articles

AbbVie, plaintiff say jury on their side

Both AbbVie Inc. and a man who sued the company over claims that its AndroGel testosterone treatment caused him to suffer a heart attack say the Illinois federal jury that handed the man a $150 million award was on their side, Law360 reports. The second testosterone side effects bellwether case to go to trial – and the first to be decided – concluded last month in a lawsuit brought by Jesse Mitchell and his wife. Mitchell says he was lured by AndroGel ads to ask his doctor about the testosterone treatment, which he took off and on for several years. Studies ... Read More

Testosterone makers fight proposed class action lawsuit

Endo Pharmaceuticals and its unit Auxilium Pharmaceuticals LLC filed a motion to compel compliance against UnitedHealthcare (UHC) in an Illinois federal court, arguing that the insurance company should hand over subpoenaed information about its dealings with testosterone replacement therapies if it wants to be part of a proposed class of insurers and third-party payors accusing testosterone manufacturers of fraudulently marketing the drugs. UHC isn’t a party in the litigation but is the largest member of the proposed class, making its information key to Endo and Auxilium, which are fighting against certification. But UHC has been avoiding calls, not returning messages, ... Read More

$150M verdict sends message to testosterone makers

The Illinois jury that awarded an Oregon couple $150 million in a case alleging AbbVie Inc.’s testosterone replacement therapy AndroGel caused his heart attack sent a loud-and-clear message to drug companies: Lay off the heavy advertising. Jesse Mitchell and his wife Kimberly filed their lawsuit in November 2014. It became one of more than 7,000 lawsuits against AbbVie and other manufacturers of testosterone replacement therapies alleging the drug caused heart attacks, strokes and blood clots. The lawsuits were consolidated into a multidistrict litigation (MDL) in the Northern District of Illinois in 2014. Mitchell’s case was the first bellwether trial in ... Read More

FDA considers first oral testosterone treatment

Two drug companies – both plagued by fits and starts– are racing to see which will be the first to gain Food and Drug Administration (FDA) approval for the first testosterone pill that can be taken by mouth. This week Lipocine announced it had resubmitted a New Drug Application (NDA) to the FDA for LPCN 1021, it’s oral testosterone replacement therapy designed to boost testosterone in men with low levels of the male hormone, a condition called hypogonadism. Lipocine had previously submitted an NDA to the FDA in June 2016 but was rejected. The agency cited problems with the dosing ... Read More

AndroGel verdict sends message to testosterone makers

AbbVie may have skirted claims that its testosterone replacement therapy AndroGel caused a man’s heart attack in the first trial to reach a verdict, but drug company was slapped with $150 million in punitive damages for misleading advertising, according to Law360. The jury’s action sends a strong signal to drug makers about deceptive direct-to-consumer advertising. Plaintiff Jesse Mitchell sued AbbVie, blaming his heart attack on AndroGel. His lawsuit cited studies that indicated testosterone treatments could increase the risk of heart attacks, strokes, blood clots and death. Mitchell also had other health problems that may have contributed to his injuries. But ... Read More

AbbVie hit with $150M punitive damages in testosterone trial

AbbVie Inc.’s AndroGel may not have caused Jesse Mitchell’s heart attack, but the company was sorely fraudulent in marketing its testosterone replacement therapy to Mitchell and other men for a made-up ailment, an Illinois federal jury found while laying out a $150 million verdict against the drug company, Law360 reported. Mitchell’s case was one of thousands in a multidistrict litigation (MDL) accusing manufacturers of testosterone treatments of not adequately warning that the hormone replacement therapy could cause heart attacks, strokes and blood clots, some of which can be fatal. The lawsuits also blame testosterone makers for creating a condition, called Low T, to ... Read More

Axiron safety label updated

The Patient Counseling Information/Patient Information/Medication Guide for the topical testosterone gel Axiron has been updated to include clarifications such as ensuring patients know how to administer the correct dosage as well as understanding that they should not drink the product. Axiron is a testosterone supplement intended for men with low levels of the male hormone due to injury or disease. It is a topical gel that is applied to the armpits. Patients are advised to wash their hands right away with soap and water after applying the gel and, once the solution has dried, to cover the area with clothing to ... Read More

Testosterone heart risk not worth benefit

Jesse Mitchell was in his mid 40s when he was stricken with lethargy, anxiousness and depression. He started taking AndroGel testosterone replacement therapy, lured by the aggressive marketing campaigns geared directly to consumers informing them that AndroGel could cure so-called Low T. Mitchell said the gel did boost his energy and he continued to use the hormone treatment, Law360 reported. But in 2012, after using the medication for about two years off and on, Mitchell suffered a heart attack. He learned that testosterone treatments had been linked to cardiovascular risks including heart attacks, strokes, blood clots and death, and in ... Read More

Doctor testifies about testosterone heart risks

There is plenty of evidence to show that testosterone replacement therapy increases the risk for hear attacks, a cardiologist told an Illinois federal jury during the first trial among thousands in a multi district litigation alleging Abbie’s AndroGel causes heart risks, Law360 reports. Dr. Hossein Ardehali, a cardiologist at Northwestern University’s Feinberg School of Medicine, is an expert witness testifying for plaintiff Jesse Mitchell. Dr. Ardehali told jurors that he reviewed several studies involving men who took AndroGel and concluded that there was sufficient evidence to show the testosterone treatment increases cardiovascular risks. For example, he pointed to a 2010 ... Read More

AndroGel needed heart risk warning, witness says

Peggy Pence, the president and CEO of pharmaceutical consulting firm Symbion Research International Inc., told an Illinois federal jury that there was enough evidence that testosterone replacement therapies may cause heart attacks that warnings should be placed on the hormone treatments’ labels and further testing should be conducted, Law360 reports. Pence told the jury in the first bellwether among thousands in a multidistrict litigation (MDL) to go to trial alleging cardiovascular risks with testosterone treatments that Abbvie had received so many reports of heart problems in patients who had used its AndroGel testosterone gel that further testing was warranted. Pence ... Read More