The Terrifying Effects of Off-Label Use: What Patients Should Know

Posted on November 25, 2015 by Shapiro Law Group

When patients receive prescriptions from their doctors, there should be an expectation their medications are safe to use. Unfortunately, off-label uses for medications are becoming increasingly popular, jeopardizing the safety of patients. Some patients will deliver children with birth defects and others will suffer severe allergic reactions. In worse case scenarios, patients will lose their lives.

Off-label use refers to the practice of using medications in ways that have not been approved by the Food and Drug Administration (FDA). Doctors are still permitted to prescribe medications for off-label use, but pharmaceutical companies cannot legally market these drugs for off-label purposes.

Off-label use of medications is extremely popular in the medical community. WebMD estimates one in five prescriptions is written for off-label use, even after several hundred recent lawsuits have targeted doctors and pharmaceutical companies.

Why Should I Be Afraid of Off-Label Use?

In 1991, GlaxoSmithKline introduced Zofran to the world, a drug that was initially developed to treat nausea caused by cancer. After its initial success, the company suggested doctors should prescribe the drug to pregnant women for morning sickness. That decision was a big mistake on their part. Many of these women had children born with birth defects, such as clubbed feet and heart defects. By authorizing the use of Zofran to pregnant women instead of only cancer patients, many innocent people and babies had their lives destroyed.

According to an interview in the New York Times, 80 percent of psychiatric medications issued to children are for off-label uses. The consequences on the lives of children could potentially be catastrophic. For example, the off-label use of Risperdal, an antipsychotic, can cause boys to develop breasts. In most other cases, the developing brains of children could be severely affected.

Doctors, hospitals and other health care professionals must take into account how off-label use can impact the lives of patients and their families.

Tags: FDA


What Our Clients Say

Our Medical Negligence Lawyers

Video Library