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    Zofran Lawyers Monheit Law Review FDA Data Reporting Hundreds Of Birth Anomalies

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    Zofran, a common “off label” treatment for morning sickness, has now been linked to an increased risk for major birth defects. Analyzing adverse event reports submitted to the FDA, Monheit Law has found more than 450 associating exposure to Zofran with birth defects, congenital anomalies and adverse fetal events.

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    According to Michael Monheit, Esq., managing partner of Monheit Law and lead sponsor of ZofranLegal.com, adverse event reports are essential to the US Food & Drug Administration’s efforts to promote patient safety. “Approval is only the first step in the medical community’s understanding of a new pharmaceutical drug,” Monheit says. “It’s only after these products are released onto the market, and prescribed to a wider array of patients, that we begin to really learn about their effects.”

    Adverse event reports, or AERs, are key data in this search for risks that initial clinical trials, limited to specific patient populations, may not have uncovered. Submitted to the FDA by physicians, patients or pharmaceutical manufacturers, AERs describe serious adverse health outcomes that reporters believe may have been caused by an approved drug. In conjunction with large-scale medical studies, adverse event reports provide regulatory authorities with vital data, information that can be used to identify emerging health trends and safety risks that may warrant further FDA action.

    Monheit has joined with an alliance of plaintiffs’ attorneys to investigate potential lawsuits against GlaxoSmithKline, whose anti-nausea drug Zofran was recently linked to an increased risk for cleft palate and congenital heart defects. “Several major epidemiological studies have now found an association between Zofran’s active ingredient and major birth defects,” Monheit continued.  “The real problem is that Zofran is commonly used ‘off label’ as a morning sickness treatment. In effect, it’s being prescribed to pregnant women at the moment their unborn babies are most at risk of developing congenital abnormalities.”

    But for Monheit, those studies were only part of the story. “Beyond the work of researchers, we wanted to find out how many clinical practitioners and pharmaceutical manufacturers had themselves indicated a potential link between Zofran and birth defects.” In search of this needed perspective, Monheit Law sent a Freedom of Information Act (FOIA) request to the FDA, asking for every adverse event report filed in relation to Zofran or its active ingredient ondansetron between January 1, 1991 and April 30, 2015. Eventually, the firm received two data files, containing more than 8,600 individual reports. Then it was a matter of searching through the data, and identifying those reports that listed Zofran as a suspected cause of birth defects, congenital abnormalities and other adverse fetal events.

    In total, so far Monheit Law has discovered 475 adverse event reports in which maternal exposure to Zofran was linked to fetal harm. “First we identified the reports themselves: more than 5% of the total had been submitted in relation to congenital anomalies or other types of fetal harm. Then we went through and pulled out every prenatal condition referenced and categorized them.” In line with a number of European studies that found a 2 to 4 times higher risk of congenital heart defects among babies exposed to Zofran prenatally, Monheit found 170 references to fetal heart conditions among the FDA’s data. “Most frequent were cardiac septal defects, like ventricular and atrial septal defects. We identified 21 reports of children born with a VSD, 16 with an ASD and 6 with an atrioventricular septal defect.” Monheit notes that among congenital heart defects, researchers have identified a specific link between Zofran and these so-called “cardiac septal defects,” which involve improperly formed barriers in the heart. “Craniofacial abnormalities, like cleft palate, were also common.”

    “It’s widely understood that adverse event reporting in the US is inadequate,” Monheit continues. In fact, the Food & Drug Administration itself has made statements to this effect, and continually criticizes pharmaceutical manufacturers, who are required by Federal Law to submit the reports they receive, for sending poor quality reports that are missing key information. According to QuarterWatch, an independent nonprofit that uses AER to highlight emerging safety issues, this problem is particularly pronounced in relation to birth defect reports. “It’s important to keep that in mind,” Monheit says, “Our findings may not represent the total number of adverse fetal events with a suspected link to Zofran.”

    Monheit’s team has put together an infographic to present the highlights of their analysis, along with a full report including every adverse fetal event mentioned in the FDA’s data. But the firm also decided to make the data files sent by the agency public as well: “we believe that everyone has a right to this information: healthcare professionals and expectant mothers, along with women who were already prescribed Zofran during pregnancy.”

    Monheit Law’s full report on FDA adverse event reports linking Zofran exposure to adverse fetal events is available here. The firm is providing free consultations to women who were prescribed Zofran as an “off label” morning sickness treatment and then delivered children with major birth defects. For more information, call 1-877-620-8411.

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    Michael Monheit, Esq.



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