What Exactly Is Zofran?

Zofran is classified as a “serotonin 5-HT3 receptor antagonist.” Serotonin is a chemical produced in your brain that relays information between the cells in your nerves. Serotonin is found in your lower gastrointestinal tract. It assists in the movement of your intestines. The 5-HT3 receptor is the specific protein molecule that receives serotonin signals.

What Does Off-Label Mean?

As mentioned, the original objective of Zofran was to help chemotherapy patients with nausea and the U.S. Food and Drug Administration has not approved Zofran for the treatment of morning sickness (nor have any studies been performed to test the safety of the drug).

Despite these facts, the prescription drug gained popularity (and thereby generating more profits for GlaxoSmithKline) as “off-label” usage for treating morning sickness. Off-label usage means doctors are prescribing the drug for the treatment of a condition, or conditions, outside of its original purpose.

You may be surprised to learn that there is no law expressly prohibiting doctors from off-label prescriptions. In fact, many prescription drugs are prescribed this way. Nevertheless, it can be dangerous, especially due to the lack of oversight on how and what types of conditions can be treated via off-label usage.

Multiple Medical Studies Indicate Link Between Zofran and Birth Defects

Multiple studies have shown that Zofran can cause an increased risk of babies developing cleft palate. Additionally, a team of researchers found that women who took Zofran while pregnant were twice as likely to have a child with a heart defect.

GlaxoSmithKline Hit with Multi-Billion Dollar Penalty for Marketing Zofran Illegally

The United States Department of Justice ordered GlaxoSmithKline to pay a $3 billion fine for using illegal marketing tactics to promote Zofran and for giving kickbacks to doctors. Specifically, the company was trying to get doctors to prescribe Zofran for unapproved uses to women who were pregnant. The pharmaceutical company pled guilty to committing fraud and failing to report safety data. This is the largest settlement for alleged health care fraud in United States history. Despite this jaw-dropping settlement, GlaxoSmithKline has never officially admitted to doing anything wrong. This is why they need to be held accountable in court through jury trials and civil settlements. A message needs to be sent that this type of egregious corporate conduct is unacceptable.

Speak to an Experienced Miami Zofran Birth Defect Lawyer Today

Do not take on a pharmaceutical behemoth like GlaxoSmithKline alone. Level the playing field by retaining an experienced and skilled law firm like the Miami office of Alan Goldfarb, P.A. Our legal team will advise you and your loved ones of your legal options. Contact one of our attorneys to schedule a free consultation.

Resources:

montco.legalexaminer.com/2015/04/16/studies-possible-link-zofran-birth-defects/

justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report

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.