Most prescription drugs are thoroughly tested, helping ensure patient safety. Unfortunately, many medications are only safe for certain indications, and prescription off-label use can cause serious side effects. Now, some drug manufacturers face lawsuits from patients injured by off-label use. Zofran and Risperdal are just two drugs currently in litigation over such side effects. They have little in common other than both causing lasting injuries to their respective patients.
Zofran Off-Label Use and Birth Defects
You might not think an anti-nausea medication could be dangerous. However, will make you think again. The medication treats nausea and vomiting caused by chemotherapy and post-operative pain. Despite GlaxoSmithKline’s $3 billion settlement in 2012, Zofran is still on the market. Doctors prescribe Zofran to pregnant women for horrible morning sickness – an off-label use.
While the drug effectively quells nausea during pregnancy, Zofran also causes birth defects. Little to no clinical trials on pregnant women exist due to potential danger to the fetus. That means Zofran wasn’t safety tested on developing babies. A 2013 Danish study showed that Zofran increased risk of congenital heart defects in developing babies by twofold.
As a result, GlaxoSmithKline faces many Zofran birth defect lawsuits. Women don’t understand the risks of taking Zofran for morning sickness. While Zofran can cause a variety of birth defects, one is predominant: holes in the heart. This is also true for a class of antidepressants called SSRIs. Though they are used for their approved use in pregnant women (depression), not enough safety testing was done to determine whether they were safe for babies. Unfortunately, SSRIs don’t just cause birth defects while a woman is pregnant – they also cause heart problems if she took the drug immediately before a pregnancy.
Risperdal Off-Label Use and Gynecomastia
Risperdal is an antipsychotic drug that treats various mental health and behavioral conditions. It wasn’t FDA-approved for adolescent use until 2006, but many doctors prescribed it for off-label use. As a result, many young boys developed enlarged breasts. The condition, called gynecomastia, can cause physical and mental anguish in young, pubescent boys.
Risperdal causes gynecomastia thanks to increased prolactin production. The hormone’s usually found in females, as it causes breast growth and lactation. Young boys taking Risperdal can grow breasts up to a female size DD. While surgery can sometimes help, boys are often bullied and isolated during their most sensitive years.
Manufacturer Johnson & Johnson faces many Risperdal lawsuits as a result. Plaintiffs and doctors blame sales reps from J&J’s subsidiary company, Janssen. These reps aggressively marketed Risperdal to pediatricians long before its approval for adolescent use. They also failed to disclose potential gynecomastia risks.
It wouldn’t be the first time Johnson & Johnson hid serious side effect risks from consumers. The company’s baby powder is linked to a two- to threefold increase in ovarian cancer risk. Worse, J&J became aware of the association as far back as the early 1960s.
What You Can Do
Off-label use can turn an otherwise safe, approved drug into a nightmare r permanent side effects. If you or a loved one took any of the above drugs for off-label use and were injured, you may have a case. If so, you can file a Zofran lawsuit or Risperdal lawsuit. Before you file your claim, fill out your free case review today. An attorney will review your information and contact you shortly to discuss your case.
Lori Polemenakos is Director of Consumer Content and SEO strategist for LeadingResponse, a legal marketing company. An award-winning journalist, writer and editor based in Dallas, Texas, she's produced articles for major brands such as Match.com, Yahoo!, MSN, AOL, Xfinity, Mail.com, and edited several published books. Since 2016, she's published hundreds of articles about Social Security disability, workers' compensation, veterans' benefits, personal injury, mass tort, auto accident claims, bankruptcy, employment law and other related legal issues.