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Law Offices of Thomas J. Lamb

Zofran Use During Pregnancy: Cleft Palate And Fetal Heart Malformations

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In this December 2015 Medscape Pharmacists article, “[Zofran] Ondansetron in Pregnancy”, there is mixed evidence in the medical literature about what birth defects specifically and the extent of that danger.

In that article, Darren J. Hein, PharmD, summarizes the findings of several medical studies concerning Zofran-associated birth defects, a few of which you will see below.

For his review of “National Birth Defects Prevention Study. Medications used to treat nausea and vomiting of pregnancy and risk of selected birth defects” (Birth Defects Res A Clin Mol Teratol. 2012;94:22-30), Dr. Hein writes:

A larger, case/control study associated [Zofran (ondansetron)] with a significantly increased risk for cleft palate. The odds of cleft palate were 2.4 times higher with exposure to [Zofran (ondansetron)] during the first trimester (n = 55) vs unexposed pregnancies (n = 4479); however, the risk for cleft lip, hypospadias, or neural tube defects was similar in both groups. [footnote omitted]

A  second study for which Dr. Hein presents his summary of the findings is “Ondansetron use in early pregnancy and the risk of congenital malformations—a register based nationwide cohort study” (Program and abstracts of the 29th International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 25-28, 2013; Montreal, Quebec, Canada. Abstract 25. Abstract 25, Pregnancy session 1):

Another group of Danish researchers, using the same Medical Birth Registry and National Patient Register, evaluated the teratogenic effects of [Zofran (ondansetron)] exposure during the first trimester using 1997-2010 data. Of the 897,018 births in this timeframe, prescription records suggested that 1248 women were exposed to ondansetron. The odds of fetal heart malformation were two times higher in infants of women exposed to [Zofran (ondansetron)] compared with unexposed women; the risk for major birth defects overall was similar. [footnote omitted]

And lastly, we get his take on “Use of ondansetron during pregnancy and congenital malformations in the infant” (Reprod Toxicol. 2014;50:134-137):

Swedish researchers used the Swedish Medical Birth Register and Swedish Register of Prescribed Drugs to gather data on pregnancies and exposure to [Zofran (ondansetron)] early in pregnancy. During the period between 1998 and 2012, 1349 women received [Zofran (ondansetron)] in early pregnancy. [Zofran (ondansetron)] exposure was not associated with an increased risk for severe birth defects; however, the odds of general heart defects were 1.6 times higher, and the odds of heart septum defects were 2.1 times higher. [footnote omitted]

As seen by these studies done by several different groups of international medical researchers, the fetal risks associated with the use of Zofran or ondansetron during the first trimester of pregnancy remain unclear.

[Read this article in full at original source]

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Zofran MDL Pending In Massachusetts With Judge Dennis Saylor Presiding

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In October 2015 the Judicial Panel on Multidistrict Litigation decided to send all federal court Zofran lawsuits to the District Court of Massachusetts in Boston. Judge F. Dennis Saylor will be presiding over this new Zofran MDL.

From the Transfer Order establishing IN RE: ZOFRAN (ONDANSETRON) PRODUCTS LIABILITY LITIGATION MDL No. 2657:

After considering the argument of counsel, we find that the actions in this litigation involve common questions of fact, and that centralization in the District of Massachusetts will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation. These actions share factual questions arising from allegations that Zofran and its generic equivalent, a prescription medication for the treatment of nausea, causes birth defects in children when their mothers ingest the drug while pregnant. Centralization will eliminate duplicative discovery; prevent inconsistent pretrial rulings; and conserve the resources of the parties, their counsel, and the judiciary.

Next Judge Saylor will start to organize this federal court Zofran MDL by means of issuing Case Management Orders.  These will serve to guide the litigation through the discovery process and towards eventual “bellwether” test case trials.

Here is a quick overview of the Zofran litigation.

Some women with severe morning sickness were prescribed Zofran (ondansetron) and have had babies born with congenital malformations such as cleft palate and cleft lip, or various types of heart-related birth defects including:

  • Atrial Septal Defect / ASD (a hole in the atria of the heart)
  • Ventricular Septal Defect / VSD (a hole in the ventricle of the heart)
  • Tetralogy of Fallot / TOF (cardiac anomaly that refers to a combination of four related heart defects which commonly occur together; it affects normal blood flow through the heart)

We are investigating possible Zofran drug injury lawsuits against GlaxoSmithKline for cases where Zofran used by pregnant women resulted in congenital heart defects and cleft palate as well as other birth defects, deformities, and malformations in children born to those women.

[Read this article in full at original source]

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Federal Court Zofran MDL Motion; Generic Cases Filed In State Courts

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SUMMARY: According to a motion filed by GlaxoSmithKline (Glaxo) with the U.S. Judicial Panel on Multidistrict Litigation (JPML), as of early July 2015 there were 12 Zofran lawsuits filed in 10 different federal court jurisdictions.

Glaxo has requested a multidistrict litigation (MDL) be established for all Zofran lawsuits filed in the federal court system concerning Zofran’s alleged association with birth defects. The drug company asked that the federal court Zofran MDL be assigned to the U.S. District Court, Eastern District of Pennsylvania — in part because its US headquarters are located in Philadelphia, which is in that court jurisdiction.

We turn next to the possible birth defect lawsuits involving the many generic versions of Zofran, which are generally called Ondansetron. Unfortunately, back in 2011 the US Supreme Court basically gave legal immunity to generic drug manufacturers as regards state law “failure to warn” claims in products liability lawsuits involving any generic drug.

But in three states — California, Illinois, and Vermont — either a state court judge or a federal court judge has held that the so-called “innovator liability” is a valid legal cause of action. In those states, at least, it is possible that an Ondansetron – birth defect lawsuit could be filed against Glaxo.

In closing, be assured that we will watch for the federal court JPML decision on this possible Zofran MDL as well as monitor the future filings of birth defects lawsuits involving Zofran or Ondansetron.

[Read this article in full at original source]

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With Zofran – Birth Defects Lawsuits Filed, How Will GlaxoSmithKline Update Its Drug Label To Comply With New FDA Rule Effective June 2015

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New FDA Rule Requires Drug Company To Replace Current Simple Pregnancy Category Designation With A Summary Of The Risks Of Using Zofran During Pregnancy

 
SUMMARY: Starting earlier this year drug injury products liability lawsuits alleging birth defects caused by the use of Zofran (ondansetron) during pregnancy for so-called “morning sickness” have been filed against the pharmaceutical company GlaxoSmithKline (also known as GSK or Glaxo).

In December 2014 the FDA issued a new regulatory rule that seems to require GlaxoSmithKline in the next couple of months to make an important decision which may impact the Zofran lawsuits, those already filed and those that will be filed in the future.

In particular, it seems that Glaxo will need to decide what, if anything, it will disclose, i.e., admits to know, as regards the association between Zofran and birth defects such as congenital heart defects and cleft palate or lip.

It will be interesting to check those Zofran drug label documents in a couple of months from now to see what revisions have been made by Glaxo to conform to this new FDA rule.

And it would not be a surprise if just how those Zofran label changes were made had something to do with the current Zofran – birth defects lawsuits.

[Read this article in full at original source]

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Zofran Associated With Birth Defects When Used During Pregnancy As An “Off-Label” Morning Sickness Treatment

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Medical Researchers Find Increased Risk Of Heart Defects And Cleft Palates In Babies Born To Women Using Zofran

 
SUMMARY: Women with severe morning sickness who were prescribed Zofran (ondansetron) — a GlaxoSmithKline drug approved by FDA for the prevention of nausea and vomiting associated with chemotherapy and radiotherapy — have had babies born with heart-related birth defects and other congenital malformations such as cleft palate and/or cleft lip.

The most concerning medical study to date about the association of Zofran with birth defects is by a group of Danish doctors, “Ondansetron use in early pregnancy and the risk of congenital malformations – a register based nationwide cohort study”, which was first presented in 2013. From a document describing that Zofran – birth defects medical research:

Conclusion

We found a doubling in the prevalence of major congenital heart defects in children whose mothers redeemed a prescription of [Zofran (ondansetron)] in the first trimester of pregnancy.

An earlier medical journal article from 2011, “Medications Used to Treat Nausea and Vomiting of Pregnancy and the Risk of Selected Birth Defects”, indicated that Zofran use as a morning-sickness drug during pregnancy results in an increased risk of cleft palate (CP).

[Read this article in full at original source]

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Law Offices of Thomas J. Lamb, P.A.
1908 Eastwood Road, Suite 225
Wilmington, North Carolina 28403
910-256-2971 | 800-426-9535
TJL@LambLawOffice.com