Off-label Use of Zofran: The Risks

There is an increasing number of lawsuits being filed over the off-label use of Zofran. The lawsuits come in the wake of recent studies and reports that Zofran may cause birth defects if taken during pregnancy. Originally, Zofran was created and intended as a powerful anti-nausea medicine for use by chemotherapy patients and surgery patients. The drug was never labeled by the manufacturer or the Federal Drug Administration to be used during pregnancy. And in fact, the manufacturer of the drug says that the active ingredient in Zofran is not recommended for pregnant women.

Many questions remain that must be answered about the off-label use of Zofran. As the information about this drug increases, doctors and patients alike will want to know whether the drug is safe, or if it causes unreasonable risks. Currently, Zofran does not have a list of potential side effects if used during pregnancy.

Off-Label Use – What It Is

When we talk about off-label use of a drug, it can be confusing. Every drug that is approved by the FDA was approved to treat a certain illness or group of illnesses. That approval comes after extensive studies and trials of a potential medicine to ensure that the drug is safe to use, and is effective. If the drug proves effective but unsafe, it still may be used as long as the negative side effects are communicated to the patient upfront. That way the patient can decide whether taking the drug is worth the risk.

So what is off-label use?

Doctors occasionally discover that an approved drug can be used to effectively treat a disease that it was not approved to treat. Zofran is an example of this. As many know, pregnancy can cause terrible bouts of morning sickness. In his or her mind a doctor may say, “we don’t have a specific drug to treat morning sickness, but we do have this great anti-nausea medicine that will probably work.” When a doctor prescribes a medicine to treat a disease it does not have FDA approval to treat, that is considered off-label use. The problem here is obvious: Zofran was never tested to see what effects it has on pregnant women. Does it cause birth defects? Does it hurt the mother? When it comes to off-label use, that question, too often, is answered in a courtroom after a lawsuit has been filed.

How Can Doctors Prescribe Off-Label?

The FDA has guidelines for off-label use. Doctors should:

• Prescribe only legally available medicines according to their best knowledge and judgment; and
• If doctors are going to prescribe medicine off-label, they bear the responsibility to ensure that the medicine does not have harmful effects.

While these are good guidelines, it also opens patients up to potential risks. The primary risk is that if a medicine has not been studied for its potential side effects, it’s impossible for the patient to know the risks. But now Zofran is being studied. One Danish study shows that the active drug in Zofran does have potential negative side effects for the unborn child, including the potential for causing birth defects.

Reach Out to Us Today

At Alan Goldfarb, P.A. in Miami, we represent victims who are injured by pharmaceutical products, including Zofran. The laws involved in these cases are highly complex and require knowledge and experience to successfully prosecute them. Contact us so we can evaluate your case for you.