Zofran Causes Serious Birth Defects

Posted by Lawsuit Information on July 3rd, 2015

It is important that the public is aware of a drug that has been causing birth defects and promoted as safe to pregnant women illegally. If you took Zofran during your pregnancy for nausea you may not even be aware that it could be the culprit for birth defects your child may have experienced and still may be experiencing. We are going to look in depth at what some of these abnormalities are so you can be informed about your options for compensation. There was a common string among birth defects associated with this drug but it is not limited to those. There are many symptoms considered birth defects you many not be aware of so we have gone over them in detail for you. You can consult with a lawyer to see if you have a case that could either be an individual case or perhaps part of a class action lawsuit.

Many people are seeking compensation for the physical, emotional and financial hardships they incurred from the false advertisement of this unsafe drug. This can be for your spouse, yourself or your child.

In addition to causing birth defects, this drug can also cause many other harmful side effects. If you have taken it for the FDA approved reasons or are considering it, it’s important to know it can interfere with other drugs and supplements. Certain medical conditions such as heart problems are not good to combine with this drug. Sometimes these complications can lead to death and they should not be taken lightly.

History of Zofran

This drug has a dark past. It came into the market approved by the FDA to help reduce vomiting in cancer patients undergoing chemotherapy treatment and radiation. The second approval was for patients who have had surgery to help keep them from vomiting. The FDA never approved this drug for use by pregnant mothers for morning sickness but it has been mass marketed for this cause. The manufacturer of this drug also has a dark past. They are a huge company with many allegations and lawsuits against them.

Just to give you an idea of the type of business they operate you should know about a major lawsuit in 2012 in which they plead guilty for fraud and criminal charges having to do with the illegal marketing of Zofran. The Department of Justice was the one who originally sued this company in 2012. The outcome was bleak. The company ended up pleading guilty for criminal charges and for fraud. The company is accused of knowingly marketing a product that was unsafe for the fetus. They had done animal testing that showed the drug caused toxicity and they knew the drug caused birth defects because it passes through the placenta and breast milk. The company withheld information about the animal testing and claimed it was safe.

Believe it or not this ended up being the largest lawsuit for the entire pharmaceutical and healthcare industry with a three billion dollar settlement. The company was illegally paying doctors to prescribe this drug to pregnant mothers and they were marketing it as safe. The company saw an open opportunity in the market to sell this drug ‘off label’ and now so many have been harmed. ‘Off label’ refers to prescribing the drug for something other than it’s approved use. If you have been affected by the negligence and complete disregard for humanity that this company has displayed, you should consider filing a lawsuit. This is essentially the only power the people have against these big companies. This is one of the top ten largest drug manufacturing companies in the world and they have so much money it’s hard to stop them. Also remember that you deserve compensation if you were lied to or misguided.

There have been plenty of studies in various countries that prove that Zofran causes birth defects. Basically the active ingredient in this drug brand is called onandsetron and the company making it is called GlaxoSmithKline. Sadly at least two infant mortalities have been directly linked to this unsafe drug. In Canada, 20 cases of birth defects have been directly linked to Zofran. It’s important to know that the most common birth defect, but not nearly the only one, is heart defects. Sometimes this is called congenital heart defects which is essentially an abnormality in the structure of the baby’s heart. The other two most common birth defects are cleft lip and cleft palate which are a deformed mouth which can cause all sorts of other complications for the baby.

A little bit about how ‘off-label’ prescribing is conducted. The reason it’s not something the doctors are responsible for is because it’s legal for doctors to prescribe ‘off-label’ which means for purposes the FDA did not approve. However it’s illegal for the company to promote the drug for anything other than what it is prescribed for. Off-label drug use (OLDU) is risky and when greedy companies like GlaxoSmithKline decide to pay doctors for OLDU, they are deliberately breaking the law. Still there are a million women taking Zofran or the same drug made by another company. The company has made profits in the millions for this illegal behavior and many have suffered because of their illegal behavior.

Here is some more information about the birth defects associated with Zofran that are sad and shocking. There can be complications with the pregnancy such as intrauterine growth restriction which is basically when a fetus cannot achieve the size it would naturally if it were healthy. Other birth defects include the aforementioned mouth defects of cleft lip and cleft palate. Sometimes babies have webbed feet or clubfoot. Sometimes babies are born with jaundice or have atrial septal defects which are holes in the wall in between the top chambers in the heart. Other problems include heart defects like heart holes and kidney deformities. Other musculoskeletal problems can occur and even, sadly enough, death. This is a serious problem as you can see. Also sometimes the birth defects are less severe and women don’t realize it could be caused by the medication. Sometimes a baby is born blue and has terrible circulation. This has been linked to some heart defects from the drug. Even when a child has bad sweating duri
ng nursing or very rapid heart beating , this can be from the drug and indicate a heart problem. Finally, if the child has trouble breathing, this can also be an indicator they have a heart condition from Zofran.

Scientific Evidence About Birth Defects

Here is another sad reality. All the way back into 2006, a scientific study proved that the drug would pass into the placenta. However, the company knowingly still marketed the drug with this information that it would harm the child. To make matters worse, back in 2011 a big study was done between Harvard and Boston University. In this study a shocking 10,000 births were analyzed. The results were monumental. The drug, Zofran, increased the risk of cleft palate by 2.4 fold. At this point there was no question that the drug posed a risk for birth defects. Moving up in history, the company continued to ignore science and prioritize profits. In 2013, the study that needs to be shown more in the public found that this unsafe drug actually increases the risk of both heart and kidney defects by a staggering %30. The BioMed Research International publication gathered this information from women in Australia and other studies have been done in other countries. Furthermore, the study in Australia showed that this drug
made premature birth more likely as well as again, more birth defects. There’s no question that the company is ignoring this evidence.

There is a strong body of scientifically proven results that verify this drug is unsafe for pregnant women but it is still on the market and being used. There are even more studies not mentioned here which prove the drug is linked to heart defects from both 2013 and 2014. This is a big deal because people just don’t know about it and they aren’t prepared or equipped with information that can can protect them.

Laboratory Testing on Zofran

Just to drive the point home that this company, GlaxoSmithKline has knowingly promoted an unsafe drug. The lawsuit in 2012 where the Department of Justice sued the manufacturer, showed they knew there were problems with the drug. They plead guilty to criminal charges and fraudulent charges. The payout was massive and they settled for a whopping three billion. The company was accused of not ensuring the drug was safe for human use. It is known that the company marketed the drug as safe when the animal testing showed it caused bone growth abnormalities and toxicity.

The company should never have claimed it was safe for pregnant mothers knowing that it caused bone growth deformities in animals and they knew it caused birth defects because we mentioned the study in 2006 found the drug passed into the placenta. The drug was not tested properly initially and the company was cutting corners and withholding information about the animal testing showing stunted growth.

The case is clear, if you were a victim of this fraudulent company and the faulty drug they are still promoting, you should file a lawsuit. Speak up and have a voice. Do not sit on the sidelines and let others be hurt by what they do not know. Share the information with your community and find a qualified lawyer to give you a free consultation about your case.

There are many more lawsuits expected over this drug. The fist two lawsuits regading birth defects were only just recently filed in February of 2015. The mother who filed the first lawsuit for the birth defects her baby encountered wants women to be aware of this drug and it’s dangers. Her daughter had many deformities and has already undergone 10 surgeries in her first twelve years. Sadly there have been two deaths reported from this drug for babies. These deaths were reported and we can only guess how many people haven’t come forward or do not know that the complications their child experienced were caused by this drug. This is a terrible injustice and oversight in the system and it must be stopped before more babies become victims.

Even if you are not pregnant, be cautious is your doctor recommends Zofran to you. You should speak at length with your doctor about your family’s medical history as well as your personal medical history. You should disclose all medications and supplements you’re taking with your doctor. Read all possible drug interactions even if your doctor ensures you it’s safe. Don’t rely on their word or the word of your pharmacist. Do you own research. This drug can be fatal if combined with certain drugs or medical conditions. In this day and age with so many drugs on the market and people taking so many things, complications with prescription drugs are a huge problem and a leading cause of death and should not be taken lightly.

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Joined: June 4th, 2015
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