Zofran (ondansetron) in Pregnancy: A Review
Background facts:
Zofran is currently being used off-label for pregnancy-induced nausea. While off-label use is common for many medications, this means the FDA has not gone through testing to get an approval from the FDA specifically for this indication. It is currently listed as a category B in pregnancy. The manufacturer states to use Zofran “only when clearly needed” and the data available are currently conflicting. There may be an increased risk of certain birth defects (most notably cleft palate), particularly when used during the 1st trimester. In the fetus, the lip and palate are formed between the 4th and 9th weeks of pregnancy2.
The drug’s manufacturer GSK was sued by the Department of Justice for unlawfully promoting Zofran to treat morning sickness in pregnant women as well as failure to report safety data on a number of its drugs. In 2012, GSK paid $3 billion to settle the lawsuit. Families of children who suffered birth defects after having been given Zofran are now suing the company because Zofran’s drug label does not contain safety warnings regarding birth defects.
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QT prolongation is a known side effect of Zofran and usually occurs either in high doses, or when other medications are given concomitantly in which QT prolongation can also occur. Serotonin syndrome is a known potential drug interaction. If a patient is receiving serotonin agents (often used for depression in pregnant women) Zofran should be used with
...crine disruptors, to alter fetal and childhood development.” According to the OCA, formal studies have never been performed to check if residues from these hormones have any consequences in depleting human population. It can be inferred that the fetus could be susceptible to the sex steroids causing post-natal hindrances that become visible later in the humans life. These problematic health issues may present themselves at any time in the span of a humans life. One instance of a noticeable problem is females that encounter puberty prematurely are at a higher risk to develop breast cancer later in life. Men can undergo tribulations just as well as women in that they may be at risk to become fertile. Besides the negative effects on humans, some cattle become lame after receiving the drug. This factor caused Tyson foods to stop buying cattle that had been administered
...pecially with the use of DTC advertising, to such a wide range of afflictions greatly increased their consumer base, but one of them proved to be deadly. In 1999, four years after Lilly sent study results to the U.S. Food and Drug Administration showing Zyprexa didn’t alleviate dementia symptoms in older patients, it began marketing the drug to those very people, according to documents unsealed in insurer suits against the company for overpayment.(Applbaum, 248). Soon after it began to be used in those suffering from dementia, there were studies produces that showed an increase in death rate among elderly patients taking Zyprexa. In January of 2009, Eli Lilly and Company, who produced the drug, ended up settling the lawsuit and agreed to pay $1.415 billion which was one of the biggest corporate settlements in the history of pharmaceutical companies (Applbaum, 237).
To continue the license, Merck had to convince the FDA that the effectiveness stayed at a similar rate over the years. Merck then designed an even more scientifically flawed methodology, this time incorporating the use of animal antibodies to artificially inflate the results, but it too failed to achieve Merck’s fabricated efficacy rate. Confronted with two failed methodologies, Merck then falsified the test data to guarantee the results it desired. Having achieved the desired efficacy threshold, Merck submitted these fraudulent results to the FDA and European Medicines Agency.
FDA, so many people were harmed. Even other countries versions of the FDA approved it which
Jacobson, S.J., Jones, K., Ceolin, L., Kaur, P., Sahn, D., Donnerfeld, A.E., Rieder, M., Santelli, R., Smythe, J., Patuszuk, A., Einarson, T., and Koren, G., (1992). Prospective multicenter study of pregnancy outcome after lithium exposure during the first trimester. Laricet. 339: 530-533.
Being presented with the problems in the implementation of the SAP ERP system, it is evident that Novartis Pharmaceuticals requires a comprehensive action plan that resolves key issues and the underlying problem. Refer to Exhibit A for a graphical representation of the action plan.
...heir diet during their pregnancy to treat all types of ailments. It is important to rule out any side effects, drug interactions or harm if any associated during pregnancy.
Imagine being in a family that is expecting their first child. Articles in the newspaper are showing how the chances of miscarriages are increasing. As soon as anxiety starts to take over, a flip of a page in the newspaper changes everything. An article about a new drug called Diethylstilbestrol seems to be on the next page. Diethylstilbestrol, also known as DES, is a medicine that helps prevent women from having pregnancy complications including miscarriages. “This is amazing!” one may say, but do they really know the consequences of taking this new medication? Diethylstilbestrol was a huge turning point for most pregnant women in the early twentieth century; however, it had many underlying negative consequences that would later affect the mother and child with the word no one ever wants to hear; cancer.
Exposure to medications or drugs during pregnancy can result in abnormalities such as withdrawal symptom, respiratory problems, growth retardation, developmental retardation, congenital heart defects, caudal deficiency and CNS defects. Known prenatal birth defects resulting from environmental toxins such as Lead, mercury or PCB’s are miscarriage, CNS damage, spasticity, mental retardation, skin discoloration and low birth weight.
David Hume supported this claim by stating, “the first time a man saw the communication of motion by impulse, as by the shock of two billiard balls, he could not pronounce that the one event was connected: but only that it was conjoined with the other” (202). As I mentioned before, the main difference between causation and correlation is correlation is causation with an added component. It is very important to remember that with a correlation there could be other causes for the effect along with or totally separate from the most common approach. Using the example, I mentioned earlier, how cell phone waves relate to breast cancer. By doing more in-depth research, scientists found that microwaves from cell phones cause great damage to normal blood cells resulting in the nuclei breaking off into micronuclei fragments resulting in abnormal growth of the cells. Although, it seems as if this is the only logical explanation in a patient that stores her cell phone near her breasts, has no family history, or other predisposing factors, there could still be another reason for breast cancer suffering. There are also many ingredients in food that are known to cause the same effects on a person. If a person is eating cancer-causing food, and using a cancer-causing cell phone how can one isolate the cause of this? It truly is not possible, meaning
The metabolism of carfilzomib consists of two pathways peptidase cleavage and epoxide hydrolysis, that were found in peptide pieces with the diol metabolite in carfilzomib. The drug has a half-life of less than one hour and is excreted by biliary and renal excretion, less than one percent of the drug remains complete [7]. All drugs eventually have severe side effects depending on the type of drug used. This drug, carfilzomib has mostly common side effects such as a cough, diarrhea, hypertension, thrombocytopenia, muscle spasms, upper respiratory tract infection, and hypokalemia, these side effects are not life-threatening, but during clinical trials a 3.8% of the patients were reported with cardiac failure [7]. In further studies, researchers were able to understand that the higher the drug dose caused severe side effects, patients experience cardiovascular adverse events (CVAE) mainly heart failure, heart attacks, and arrhythmia [4]. This side effects can be taken into account that they may depend on the age and obesity of the
New research has shown that Zofran, which is an anti-nausea medication, can increase the risk of birth defects. It is often prescribed to pregnant women who are suffering from morning sickness. However, the risk of birth defects is not mentioned on the drug's warning label. That is why many people have filed lawsuits.
All drugs, legal or illegal, are considered to be harmful to the fetus and should be taken with caution and under the doctor’s direct orders only. Drugs can be anything as simple as a cigarette to a major substance like heroin and cocaine. Most mothers who do drugs during their pregnancy don’t think about the detrimental effects they could be causing to their baby. Any amount of these forbidden substances can leave an everlasting effect on the precious defenseless baby. Most women know that when you are pregnant your hormones vary greatly, but when a woman is pregnant it also ...
According to Jimenez-Buedo (2011), it is difficult to make a valid reference that there is a causal relationship when conducting an experiment in a laboratory-style setting. Jimenez-Buedo (2011) also states that both internal and external validity are being inferred without adequate evidence to support the claims being made in many cases. Jimenez-Buedo (2011) also states that generalization of results in the case of external validity should not be taken lightly. In other words, it appears that she feels that neither internal nor external validity should be inferred in many cases associated with experiments that are done in a laboratory setting versus the real world. This appears to mean that in all circumstances Jimenez-Buedo (2011) favors conducting experiments that are as representative as possible of the real world in order to be able to validate the results and in order to infer a causal or generalizable relationship.
Nausea and vomiting are especially common during early pregnancy, particularly within the first trimester. Most women experience nausea and vomiting, commonly referred to as “morning sickness”, which is often attributed to the mother’s reaction to the spike in pregnancy hormones. Although feeling ill is considered normal within the first few months of pregnancy, there are instances of nausea and vomiting that continue on to the second and third trimesters and are then considered more severe. When dehydration, electrolyte imbalances, weight loss, acidosis, or even hepatic and renal damage occur as a result of the hyperemesis, it is then determined to be hyperemesis gravidarum.