Paxil

Legal Developments

$3M Awarded to Widow After Husband’s Suicide Linked to Paxil

Wendy Dolin’s husband, Stewart, was only 57 when he abruptly ended his life in 2010. He’d been administered a prescription of Paxil to treat his depression and anxiety.

Last week, on Aug. 21, a Chicago jury ordered pharma giant GlaxoSmithKline (GSK) to pay Dolin $3M for alleged negligence and wrongful death. Dolin and her lawyers claim GSK failed to alert her husband’s doctor of Paxil’s increased risk of suicidal behavior.

Wendy Dolin has since started the Medication-Induced Suicide Prevention and Education Foundation in memory of her husband.

Abilify

Regulations 

Abilify Patch Development Gets Abbreviated Clinical Pathway From FDA

The U.S. Food and Drug Administration (FDA) has given the go-ahead for Abilify’s manufacturer, Aequus, to seek a 505(b)(2), or clinical pathway, to market sooner. This pathway would modify Abilify’s existing treatment for antipsychotic disorders.

Business Insider has reported that “This would provide a bridge to the aripiprazole safety and efficacy data from the approved Abilify® label at the target therapeutic doses.” Abilify has been linked to serious side effects, including erratic and impulsive behaviors, most notably gambling addiction.

Testosterone

Advocacy

Testosterone: Men Get Hormone Therapy, Too

CBS19 News claims that “around 10 percent of men report symptoms of depression following the birth of a child, about double the typical rate of depression in males.” Anthropologist Lee Gettler studied 600 Filipino men for five years. Those who became partnered fathers experienced decreased testosterone levels, compared to their single counterparts.

While the benefits of testosterone therapy include increased energy and mental ability, it could also increase the risk of prostate cancer or cardiovascular disease. It is advised by all physicians to only seek this treatment under close medical supervision.

Risperdal

Legal

Philadelphia Judge Refuses to Overturn Risperdal Plaintiff Verdict

When Austin Pledger, age 22, was awarded $2.5M in damages by a Philadelphia jury in 2015 for complications resulting from using Risperdal, Janssen Pharmaceuticals appealed the decision.

Risperdal is used to treat serious mental conditions such as schizophrenia, manic depression, and autism. Pledger, only 8 years old when he was given the prescription, developed gynecomastia, or male breasts, after taking the drug for autism. Janssen sought a new trial, but the verdict and award were upheld.

Nexium

Regulations 

FDA Approves OTC Nexium Equivalent Amidst Lawsuit Filings

Perrigo Company plc has announced the U.S. Food and Drug Administration’s (FDA) approval for the store brand OTC equivalent of heartburn medication Nexium® 24HR capsules. This OTC brand of proton pump inhibitor is slated to launch in late September.

Meanwhile, the U.S. District Court of New Jersey is moving forward with federal lawsuit filings claiming Nexium is responsible for such serious side effects as kidney failure, acute interstitial nephritis, and chronic kidney disease. Pre-trial proceedings will begin Sep. 12.