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AbbVie 91 articles

Humira generates most adverse event reports in FDA database

Drugs that treat autoimmune disorders like psoriasis, rheumatoid arthritis and Crohn’s disease generate the largest number of adverse event reports to the Food and Drug Administration (FDA), according to an analysis by the Milwaukee Journal Sentinel and MedPage Today. These immune-suppressing drugs make users more prone to serious infections such as tuberculosis, invasive fungal infections, and cancers of the immune system. Among these drugs, Humira has generated the most adverse events. Humira is manufactured by AbbVie Inc. and was first approved by the FDA in 2002. It is now approved to treat 10 conditions including rheumatoid arthritis, juvenile arthritis, psoriatic ... Read More

Study: Testosterone replacement therapy not a ‘fountain of youth’

A year of testosterone replacement therapy did not improve memory but did increase the fatty plaque in coronary arteries, a condition that increases the risk for heart disease, according to a study newly published in the Journal of the American Medical Association and JAMA Internal Medicine. Testosterone replacement therapy, widely promoted by pharmaceutical companies for the treatment of so-called Low T, has become a $2 billion market. The prescription treatment is intended for men with hypogonadism, a condition in which the body does not produce enough of the male hormone. But because it has been heavily marketed and, thus, widely ... Read More

Pediatric use of testosterone suppressant Lupon linked to serious adverse events

The testosterone suppressant Lupon used to treat prostate cancer, endometriosis, uterine fibroids and, in girls, premature puberty, is widely used off-label to help children and adolescents grow taller. The drug has been linked to more than 10,000 adverse events. However, AbbVie, the drug’s maker, and the Food and Drug Administration (FDA) have not done enough to warn consumers about these risks, according to a recently released report by Kaiser Health News. Kaiser’s investigation involved interviews and online forums, and found that women who took the drug as young girls or initiated a daughter’s treatment reported serious side effects later in life. ... Read More

AndroGel makers try to shake testosterone side effects lawsuits

AbbVie Inc., and Abbott Laboratories are trying to wiggle their way out of a massive multidistrict litigation (MDL) over side effects allegedly caused by testosterone replacement therapies by arguing to an Illinois federal judge that plaintiffs have not shown that use of testosterone supplements increases the risk of heart attacks or strokes. Days earlier, the drug companies filed a separate summary judgment arguing that plaintiffs’ claims that they marketed testosterone treatments for unapproved uses was incorrect because Food and Drug Administration (FDA) officials had OK’d their marketing materials. The motions for summary judgment were filed just months before the companies ... Read More

AbbVie paid docs $20 million to promote AndroGel testosterone replacement therapy

Pharmaceutical company AbbVie Inc. paid more than $20 million to 191,555 doctors from August 2013 to December 2015 to promote its testosterone replacement therapy AndroGel, according to ProPublica’s Dollars for Doc’s analysis. AndroGel is a top-selling drug for AbbVie. In June, the company – along with other testosterone manufacturers – will face trial in the first of more than 5,500 lawsuits pending in a multidistrict litigation (MDL) alleging testosterone supplement makers aggressively marketed the treatments but failed to warn about cardiovascular risks with use of the hormones. In total, AbbVie paid $94.1 million to 92,095 doctors to promote dozens of its products, ... Read More

AbbVie fights sharing physician notes with lawyers suing over testosterone replacement therapy side effects

Drug maker AbbVie Inc., embroiled in lawsuits alleging its testosterone replacement therapy AndroGel caused heart attacks, strokes and blood clots, told an Illinois federal judge that allowing plaintiffs access to documents belonging to a doctor employed by the company was beyond what was proper in the multidistrict litigation (MDL). The plaintiffs steering committee (PSC) asked U.S. District Judge Matthew Kennelly to compel AbbVie to produce the documents of Dr. Adrian Dobbs, an endocrinologist and professor at The Johns Hopkins University School of Medicine, who plaintiffs consider a “key opinion leader” with the drug company because she was paid to persuade ... Read More

Judge rules expert witness report is admissable in testosterone replacement therapy MDL

Studies cited in a doctor’s report involving alleged cardiovascular events in men who underwent testosterone replacement therapy are fair game and are admissible in court, said an Illinois federal judge overseeing a multidistrict litigation (MDL) involving testosterone gel AndroGel maker AbbVie Inc. The drug company had asked U.S. District Judge Michael Kennelly to trim Dr. B. Bud Gerstman’s report to the agreed-upon scientific articles pertaining to testosterone treatments and heart health. Gerstman, a professor at San Jose State University, wrote the original report for the plaintiffs’ steering committee in October followed by a rebuttal report that included more information. Judge ... Read More

Testosterone replacement therapy sales expected to grow despite serious side effects

Sales of testosterone replacement therapy (TRT) have skyrocketed in recent years, and the market is expected to gradually increase in the years ahead, according to Transparency Market Research. “However, the market is currently at a crucial juncture with top performing products losing their patents in the next few years. This will no doubt cause a major dent in revenues of key market players. However, some of this impact could be reduced by the heightened demand for and awareness levels about the benefits of advanced TRT products. Many of these products that are now being utilized in testosterone deficiency treatment are likely ... Read More

First testosterone side effects trials involve heart attacks, strokes, blood clots

Of the eight cases scheduled to be tried as bellwethers in a multidistrict litigation (MDL) in the Northern District of Illinois involving hundreds of lawsuits alleging cardiovascular risks with testosterone replacement treatments, the first four involve plaintiff claims of heart attack or strokes, and the final four are cases in which plaintiffs allege venous thromboembolism, or blood clots. Plaintiffs include Jeffrey Konrad, Jessee Mitchell, Edward Cribbs, Cecile Frost, Arthur Myers, Froylan Garcia, Robert Nolte and Robert Rowley. While numerous testosterone treatment manufacturers are named in the multidistrict litigation – such as Auxilium Pharmaceuticals Inc., Eli Lilly & Co., and Endo Pharmaceuticals ... Read More

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

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