FDA Warns Against Zofran Use in Pregnancy The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk. The FDA has issued an updated warning against Ondansetran, better known by its brand name, Zofran, use in pregnancy discussed in OBGYN News. FDA will complete its evaluation of each potential signal/new safety information and issue additional public communications as appropriate. [Original Article: http://www.fertilitycenter.com/fertility_cares_blog/fda-warns-against-zofran-use-in-pregnancy/] Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) January - March 2013 Product Name: Active Ingredient (Trade) or Product Class Potential Signal of a Serious Risk / New Safety Information Additional Information (as of March 1, 2014) Metoprolol succinate extended release products Lack of therapeutic effect, possibly related to product quality issues FDA decided that no action is necessary at this time based on available information. Serotonin-3 (5-HT3) receptor antagonist products (Aloxi, Kytril, Zofran, Zuplenz) Serotonin syndrome FDA is continuing to evaluate this issue to determine the need for any regulatory action. . It has been used off-label to treat nausea and vomiting in pregnancy. There are also potential maternal risks associated with taking Zofran especially in pregnant women with electrolyte imbalance due to severe nausea and vomiting. This http://www.huffingtonpost.com/2013/02/27/zofran-pregnancy_n_2776753.html anti-nausea medication provides a safer alternative to pregnant women experiencing nausea and vomiting. The table below lists the names of products and potential signals of serious risks/new safety information that were identified for these products during the period January - March 2013 in the FAERS database. Zofran is a 5-HT3 receptor antagonist approved by the FDA for preventing nausea and vomiting related to cancer chemotherapy and surgery. Patients who have questions about their use of the identified drug should contact their health care provider. It means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk. Therefore Zofran should not be taken during pregnancy.

FDA Warns Against Zofran Use in Pregnancy

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FDA Warns Against Zofran Use in Pregnancy

The appearance of a drug on this list does not mean that FDA has concluded that the drug has thelisted risk.

The FDA has issued an updated warning against Ondansetran, better known by its brand name,Zofran, use in pregnancy discussed in OBGYN News. FDA will complete its evaluation of eachpotential signal/new safety information and issue additional public communications as appropriate.

[Original Article:http://www.fertilitycenter.com/fertility_cares_blog/fda-warns-against-zofran-use-in-pregnancy/]

Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse EventReporting System (FAERS) January - March 2013

Product Name: Active Ingredient (Trade) or Product Class

Potential Signal of a Serious Risk / New Safety Information

Additional Information

(as of March 1, 2014)

Metoprolol succinate extended release products

Lack of therapeutic effect, possibly related to product quality issues

FDA decided that no action is necessary at this time based on available information.

Serotonin-3 (5-HT3) receptor antagonist products (Aloxi, Kytril, Zofran, Zuplenz)

Serotonin syndrome

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

. It has been used off-label to treat nausea and vomiting in pregnancy. There are also potentialmaternal risks associated with taking Zofran especially in pregnant women with electrolyteimbalance due to severe nausea and vomiting. Thishttp://www.huffingtonpost.com/2013/02/27/zofran-pregnancy_n_2776753.html anti-nauseamedication provides a safer alternative to pregnant women experiencing nausea and vomiting.

The table below lists the names of products and potential signals of serious risks/new safetyinformation that were identified for these products during the period January - March 2013 in theFAERS database. Zofran is a 5-HT3 receptor antagonist approved by the FDA for preventing nauseaand vomiting related to cancer chemotherapy and surgery. Patients who have questions about theiruse of the identified drug should contact their health care provider. It means that FDA has identifieda potential safety issue, but does not mean that FDA has identified a causal relationship between thedrug and the listed risk. Therefore Zofran should not be taken during pregnancy.

http://www.huffingtonpost.com/2013/02/27/zofran-pregnancy_n_2776753.html

Page 2: FDA Warns Against Zofran Use in Pregnancy

Doxylamine succinate and pyridoxine hydrochloride known as Diclegis is the only PregnancyCategory A, FDA-approved prescription for morning sickness. Based on recent studies regarding theassociation between Zofran use in early pregnancy and congenital cardiac malformations and oralclefts (cleft lip and palate), the FDA has cautioned against its use in pregnancy. If after furtherevaluation the FDA determines that the drug is associated with the risk, it may take a variety ofactions including requiring changes to the labeling of the drug, requiring development of a RiskEvaluation and Mitigation Strategy (REMS), or gathering additional data to better characterize therisk.

FDA wants to emphasize that the listing of a drug zofran birth defects lawsuits and a potential safetyissue on this Web site does not mean that FDA is suggesting prescribers should not prescribe thedrug or that patients taking the drug should stop taking the medication. These risks include theSerotonin Syndrome which is a triad of cognitive or behavioral changes including confusion,agitation, autonomic instability, and neuromuscular changes

http://zofranrecallcenter.com/zofran-birth-defects/