FDA logo over pills

Reporting Birth Defects Associated With Zofran To The FDA

The US Food & Drug Administration maintains a vast database of Adverse Event Reports, or AERs. AERs describe unfavorable health outcomes that physicians and other health practitioners believe may be related to a pharmaceutical product.

Doctors are allowed to submit AERs directly to the FDA on a voluntary basis, while pharmaceutical manufacturers are required to submit any reports they receive to the agency. After amassing numerous reports, FDA clinical reviewers analyze the data, looking for trends and signals of emerging safety risks.

But consumers and patients can add to our understanding of how pharmaceuticals work, too. The FDA’s MedWatch program allows consumers to report adverse events directly to the agency.

How To Report A Birth Defect With Suspected Ties To Zofran

Whether or not you have contacted our Zofran birth defect lawyers for a free consultation, whether or not we have declined to accept your case, we urge you to report any adverse events that you believe are associated to Zofran directly to the FDA. Doing so is easy and, as we’ll see in the rest of this article, essential to the world’s understanding of potential safety risks.

Below, you’ll find a .PDF version of the FDA’s voluntary adverse event reporting form (Form FDA 3500B).

Report A Birth Defect To The FDA

You can fill the form out on your computer, print it and then send it to the FDA at:

Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Or you can simply report the event online. Follow this link and then select “Consumer/Patient” on the right side of your screen to get started.

Filling Out The MedWatch Form

In either case, submitting your report is intuitive.

First, you’ll find a section titled “About the Problem” in which you’ll be asked to define the adverse event in broad terms and then be given room to elaborate in your own words. Note that beneath the question “Did any of the following happen?” is an option for “Birth defect.”
MedWatch form for reporting birth defects

Next, you’ll be asked to describe the product that you believe may have caused the adverse event you detailed in Section A. Try to fill out this form as completely as possible, but don’t worry if you can’t remember specifics. If you still have a pill bottle at home, just copy the information on its label into the form. If you took a branded form of Zofran, the manufacturer is GlaxoSmithKline.

Adverse event reporting form

Then you’ll be asked to enter some details on the person who experienced the problem you’re reporting.

If your child was born with a birth defect that you believe may have been linked to prenatal exposure to Zofran, you’ll be describing your child at the time of the event in Section D:

Birth defect reporting to the FDA

Finally, you’ll have an opportunity to enter your own contact details. While the FDA may contact you for additional information, the agency guarantees that none of your personal information will be made public.

Why Should I Report An Adverse Event?

FAERS, the FDA’s Adverse Event Reporting System is key to the agency’s post-marketing surveillance efforts. After a drug is approved and released onto the market, there are many things we still don’t know about its effects. For instance, we may not know how a specific molecular agent operates in a specific patient population.

Zofran is a perfect example. When Zofran was initially approved, it was only approved to treat the severe nausea and vomiting that many cancer patients experience while undergoing chemotherapy. And up to that point, Zofran’s manufacturer, GlaxoSmithKline, had only studied the drug’s safety and efficacy in that specific patient population: cancer patients undergoing chemotherapy.

But soon after its approval, physicians began to prescribe Zofran to a completely different patient population: pregnant women suffering from morning sickness. To date, no controlled clinical trials have been conducted to investigate either Zofran’s safety or efficacy during pregnancy. But now that millions of women have ingested the drug or generic forms of its active ingredient ondansetron, independent researchers have been able to perform epidemiological studies, reviewing large bodies of birth and prescription records in search of Zofran’s potential effects on fetal development.

As we’ve mentioned many times, these studies have found an association between Zofran and major birth defects. Researchers at Harvard and Boston Universities, along with teams in Denmark and Sweden, have found that women prescribed Zofran during the first trimester are between two and four times more likely to deliver babies with a cleft palate and congenital heart defects. This is one step on our road to understanding the effects of Zofran during pregnancy. Adverse Event Reports are another.

Using data logged in FAERS, FDA researchers may be able to derive certain conclusions about Zofran’s potential to increase the risk of birth defects, and those conclusions may in turn allow the agency to evaluate potential regulatory actions.

Consumer AER Reports Are Essential To The FDA’s Work

Unfortunately, Adverse Event Reporting is often incomplete, especially when the reports are coming from pharmaceutical manufacturers. After an exhaustive review of reports submitted to the FDA between 2013 and 2014, QuarterWatch found that less than half of the reports sent by drug companies were “reasonably complete,” missing basic details like a patient’s age or the date on which the adverse event occurred.

Consumers and health care professionals, on the other hand, submit complete, informative reports most of the time. In their analysis, the nonprofit found that “85% of serious reports sent directly to the FDA were reasonably complete.”

Further, certain types of adverse event are chronically underreported. The main gap in FAERS reporting? Birth defects. In fact, according to QuarterWatch, the FDA has even acknowledged this problem: “the FDA […] ha[s] previously reported that the number of reports in children were too few for effective postmarket surveillance. For birth defects, reporting is even more limited, compounded by poor quality reporting.”

In the absence of industry-wide reform, it falls to consumers, patients and healthcare professionals to pick up some of the slack dropped by pharmaceutical companies. Adverse Event Reports provide the FDA an essential tool in identifying health risks, and ultimately saving lives. We can all contribute to a robust understanding of drugs in America, and reporting an adverse event is the first step.