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Zofran and the Risk of Arrhythmia


Zofran (Ondansetron) use during pregnancy and it’s risk to developing babies has simultaneously garnered a nationwide spotlight and backlash. Additionally, Zofran can cause adverse reactions in adults, like cancer patients and pregnant women, taking the drug.

In 2011, the Food and Drug Administration (FDA) announced it was investigating reports of “abnormal changes in the electrical activity of the heart” in patients taking Zofran. The FDA instructed GlaxoSmithKline (GSK) to perform a study determining Zofran’s effects on heart activity.

The study was completed in 2012. The FDA said of the study, “preliminary results from a recently completed clinical study suggest that a 32 mg single intravenous dose of ondansetron (Zofran, ondansetron hydrochloride, and generics) may affect the electrical activity of the heart (QT interval prolongation) which could pre-dispose patients to develop an abnormal and potentially fatal heart rhythm known as Torsades de Pointes.” Torsades de Pointes can potentially lead to sudden cardiac death.

GlaxoSmithKline pulled the 32 mg dose off the market, and altered Zofran’s warning label to alert doctors and medical providers of the increased risks. Dr. Gideon Koren of the The Motherisk Program of Toronto, Canada , found that physicians are not following the FDA’s new guidelines. In his article, Scary Science: Ondansetron Safety in Pregnancy, Koren states, “…counseling of women who receive ondansetron for morning sickness reveals that these FDA precautions are not being followed.”

 

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Are you currently pregnant and taking Zofran?


A mother’s worry tends to set in as soon as the pregnancy test comes back positive. You’re concerned about having that cup of regular instead of decaf, the sushi you grabbed for lunch a few days prior, and the glass of wine you had with dinner.

There’s no question being pregnant is simultaneously a joyful and worrisome experience. During your pregnancy, what you don’t put into your body matters just as much as what you do put into your body, especially for your baby’s health. A teratogen is an agent such as drugs, medications, infections, or chemicals causing birth defects or harm to a fetus. Zofran, an antiemetic medication, is potentially linked to birth defects including cleft lip, cleft palate, and congenital heart defect (CHD).

We’ve received calls from many individuals who are currently pregnant and taking Zofran for their morning sickness. If you are currently pregnant and taking Zofran, we urge you to speak with your doctor about the potential risk of birth defects linked with Zofran during your first trimester of pregnancy. It’s important to have a discussion with your healthcare professional about how best to manage your symptoms and finding a safe treatment for you and your baby. There are other medications approved by the FDA for morning sickness, such as Diclegis (doxylamine succinate and pyridoxine hydrochloride).

If you took Zofran during your first trimester of pregnancy, and have a child with birth defects, contact us for a free case consultation. We will discuss your legal options regarding your potential case.

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Kershaw|Talley files first Zofran lawsuit in California


On March 6, 2015, William A. Kershaw and Stuart C. Talley, lead attorneys at Kershaw|Talley, filed the first California Zofran lawsuit in the Superior Court for the State of California, in the county of Alameda. The complaint is filed on behalf of a little boy who was born with Supraventricular Tachycardia,or SVT, a serious heart birth defect. In the lawsuit, Mr. Kershaw and Mr. Talley allege the child’s birth defect was suffered after his mother took Zofran, also known as Ondansetron, during her first trimester of pregnancy.

According to the filing, the baby’s mother was prescribed Zofran, off-label, to alleviate morning sickness she experienced in the early weeks of her pregnancy. The complaint alleges the little boy’s SVT was the direct result of exposure to Zofran in utero.

Complaint-Filed

(Case No. RG15761042)

The law firm of Kershaw|Talley accepts clients nationwide. If you took Zofran in your first trimester of pregnancy, and your child has birth defects, call us for a free, confidential case consultation at 877-234-8859.

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Do I have a Zofran Case?


A frequently asked question from potential clients is, “Do I have a Zofran case?” As you may know, Zofran is linked to various birth defects. Typically, in these cases, the mother took Zofran during her first trimester of pregnancy and her child is born with a birth defect(s).

It is difficult to know if you have a potential case without all the facts. Many factors determine whether or not you have a case. The statute of limitations, or the time period you have to bring a lawsuit, affects your ability to file a claim against Zofran. The statute of limitations varies between states. Therefore, the statute of limitations on your case depends on your state of legal residence. A thorough analysis of your state’s statute of limitations is required to assess your potential case.

There is also an analysis of the mother’s medical history and medical records.  This helps determine whether or not the mother took other medications during her pregnancy as well. Other medications taken during pregnancy could also contribute to the birth defect experienced. You also have to look at smoking history, genetic history of both parents, and take into account if there was recreational drug use during pregnancy. Attorneys will need to know, “Is the birth defect genetic?”, “Or could it be attributed to another drug (e.g. recreational, medicinal)?”, “Or was it caused by Zofran?”

The other factor to take into consideration is the type of birth defect. Right now, there is limited research and scientific data connecting Zofran use during pregnancy with birth defects. Currently, the specific birth defects linked to Zofran include orofacial clefts and septal heart defects (i.e. hole in the heart). However, science is always changing and evolving. We expect future studies will reveal Zofran causes additional birth defects.

An attorney evaluates all of these factors and can provide you with an idea of whether or not you have a case. If you speak with an attorney, and they do not believe you have a case, we recommend contacting other attorneys. Attorneys may have differences of opinion regarding what constitutes a strong case and it’s always beneficial to get multiple opinions. If you took Zofran in your first trimester of pregnancy, and you have a child with a birth defect, contact our attorneys immediately at 877-234-8859 for a free case evaluation.

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Zofran Statute of Limitations


What is the statute of limitations on Zofran cases? The statute of limitations is the time period in which you can bring a lawsuit. Unfortunately, the answer to the question what is the statute of limitations really involves a detailed analysis of the facts of each individual’s case and the law in their state of legal residence. Every state has a different statute of limitations. In some states, it is only one year. In other states, it could be up to six years.

Every state also has different exceptions to the statute of limitations. Some states have what we call the “discovery rule”. The discovery rule is the theory that the statute does not start to run until you discover that you have a claim. So, if you just discovered the link between Zofran and birth defects, the statute would start to run from the date of that discovery.

However, some states do not have the discovery rule. Another exception to the statute of limitations is “fraud”. If a defendant is intentionally concealing a link between a drug and a birth defect, that concealment or fraud can “toll” the statute of limitations. Tolling means the statute does not run during the period the statute is tolled, or legally suspended.

Other states have statutes where if there is a birth defect being alleged that the statute runs from the date that the child is born. Most states with this kind of statute have no exceptions. For example, in some states there may be a statute that says if you’re born with a birth defect you have six years from the date of birth to bring a claim and that your date of discovery is irrelevant to the running of that statute.

The statute of limitations on a case really involves a detailed analysis of your state’s law and the facts of your particular case. So, if you took Zofran and have a child with a birth defect, it’s very important to call an attorney immediately. Our attorneys will do an analysis of your individual circumstances to determine when you have to file a case. At our firm, we do this every day. Call us for a free case consultation at 877-234-8859.

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