Topamax
How Topamax Helps with Epilepsy
The anticonvulsant drug topiramate was discovered in the late 1970’s. Over the next 17 years scientists working for subsidiaries of Johnson & Johnson developed the drug into what is now known under the brand name Topamax. The drug was initially used to help those with epilepsy.
Simply put an epileptic seizure occurs when the brain becomes over stimulated and a sort of electrical storm occurs. Too many signals are being sent in too many directions, and it causes the body to spasm, convulse, and basically shut down. To combat this Topamax works with the brain to calm these signals and allow normal firing patterns between the neurons.
How Topamax Helps with Migraines
Similar to seizures, migraines start with overactive firing of nerve cells in the brain. This brain activity gets out of hand, and causes the overproduction of serotonin and estrogen. These hormones, which are naturally found in the body and essential for everyday life, affect constriction of the blood vessels. This constriction serves to worsen the effects of the migraine. Without treatment the migraine sufferer must wait until brain activity levels out, and the excess hormones are removed from the system.
Topamax works to help prevent this overactive brain activity. While the exact method of how the drug works is unknown, the effects are known to help calm the nerve cells. The drug does not help with the pain when an individual is already suffering from a migraine, but taking it daily the individual can help prevent the migraine from occurring.
History of Topamax
Back in the late 1970’s scientists with McNeil Pharmaceutical discovered topiramate (the generic drug used to create Topamax). For the next 17 years the drug was developed, tested, and finally approved in 1996. During this time the drug was tested on lab animals, and despite the fact that some of the animals had abnormal gestations (their offspring were born with birth defects), the drug was approved without any warning as to this increased risk.
During the late 1990’s the drug was heavily prescribed as a method of reducing seizures due to epilepsy. This anticonvulsant drug worked well in this department, but it was noticed to help with other medical conditions as well. By 2004 the drug was known to help prevent migraine headaches, and in August of that year the FDA approved it for such use.
This approval saw a surge in the popularity of the drug. Still used as an epilepsy drug, it started seeing more prescriptions written for migraine prevention than epilepsy. Janssen Pharmaceuticals (the marketing company behind the drug and a subsidiary of Johnson & Johnson) started more marketing endeavors focused around the drug as a migraine preventer. Between the years 2004 and 2010, when it lost its patent, the drug was selling over $1 billion annually.
But just because the drug rose to the 13th most popular drug of 2008 did not mean it was safe. In fact that was the year that researchers from the United Kingdom published the results of their study. The study, the first to look at the effects of taking Topamax during pregnancy, found that there was a significant increase in the risk of the baby being born with birth defects when the mother became pregnant while taking Topamax. In fact, the child was 11 times more likely to be born with oral clefts if the mother used Topamax than if she was not using any medication.
In 2011 the FDA concluded their investigation of these claims, and issued a warning. The warning indicated that women of child bearing age should carefully consider the risks of using Topamax as oral clefts are developed during the first trimester. It is at this time that women may not realize they are pregnant, and they may not discontinue their Topamax use soon enough.
By 2014 there are over 100 lawsuits filed against Janssen Pharmaceuticals due to their failure to warn about this risk of birth defects. These follow on the heels of two settlements totaling over $15 million for cases filed against the drug company.
Topamax Revenues
The drug saw nearly instant sales success as well. With so many people using it for seizure treatment, as well as migraine prevention, help with drug and alcohol addiction, and in some cases a remedy for bipolar disorder, it is no wonder that Janssen was making millions of dollars every year. By the year 2004 Topamax was bringing in over $1 billion annually for parent company Johnson & Johnson.
At its peak in 2008 the drug was the 13th most prescribed drug in the country (based on revenue from sales) and helped to bring in a little over $2.1 billion. After this time the drug slipped a little, and once the patent ran out it dropped off the top 100 best selling drugs chart.
Topamax Side Effects
The popular anticonvulsant drug Topamax, now predominantly prescribed for the treatment of chronic migraines, comes with a huge list of side effects. While most are benign, and will dissipate as the body becomes adjusted to the new chemical influx, some are serious and potentially deadly. The most serious comes to women who use Topamax during pregnancy.
Like all drugs, Topamax has a huge list of side effects that accompany its use. They range from the common and relatively harmless such as:
- Dizziness
- Weight Loss
- Nausea
- Fatigue
To the less common and more severe including:
- Rash
- Insomnia
- Mood Swings
- Problems with eyes and vision
- Paranoia
- Drooling
- Problems with ears and hearing
And there are many rare and potentially fatal side effects as well:
- Essential Tremors
- Glaucoma
- Blindness
- Raynaud’s Phenomenon
- Panic Disorder
- Stevens Johnson Syndrome (which can lead to toxic epidermal necrolysis)
- Birth Defects
These severe side effects have lasting consequences on those who take them, and in the case of birth defects the child will have to live with those for his or her entire life. Some of these severe side effects were never fully disclosed before the drug was made available to the public. Studies have shown that the risk of having a baby born with oral clefts is increased 11 fold when taking Topamax. The FDA did not provide a warning about the risk until March 2011, fifteen years after the drug was initially approved for use.
Stevens Johnson Syndrome
Stevens Johnsons Syndrome (SJS) is a rare condition that can be caused by using the anticonvulsant drug Topamax. What makes this severe side effect even worse is that it can be mistaken for another, less severe, side effect. After it has progressed it is caught, but often after damage has been done.
Basically speaking, SJS is a disorder with the skin and mucous membranes. Those suffering from it feel ill, and a red or purple rash appears on their skin. As the condition spreads the skin dies and begins to peel. The only way to stop the condition is to find the cause and discontinue it; for some people that is discontinuing Topamax.
Unfortunately some of the less severe side effects of this drug are nausea and mild rash. The early stages of SJS can be mistaken for these minor side effects, and the condition can be left untreated. As it progresses SJS can take a toll on the body leading to toxic epidermal necrolysis (TEN).
TEN is a life-threatening condition that is a severe form of SJS. Those suffering see the top layer of their skin dying and detaching from the underlying layer all over their body. But it does not just stop at the skin; the condition also affects the mucous membranes around the eyes and mouth. Many people who suffer from this condition end up with permanent scarring and lung problems such as asthma. In extreme cases a feeding tube is needed and ulceration of the eyes can cause blindness.
SJS and TEN are conditions resulting from using the drug Topamax. However, they are rare and the drug company never fully warned about the potential to develop these life threatening conditions. For those who suffer from them, a warning may have been enough to persuade them to use a different drug and save themselves from the pain and suffering that resulted.
Other Side Effects
Cleft palate and cleft lip aren’t the only birth defects that have been linked to Topamax use during pregnancy. Our attorneys are also familiar with the following Topamax birth defects:
- PPHN (persistent pulmonary hypertension in newborns)
- Heart birth defects
- Cranial birth defects
- Abdominal birth defects
FDA and Topamax
In 1996 the FDA announced approval for the new anticonvulsant drug Topamax. This drug was to be used to help those suffering from epileptic seizures. It was prescribed to thousands of people, and it was discovered to be highly effective treating other symptoms as well.
Topamax was approved by the FDA to be used in conjunction with phentermine (an appetite suppressant) for weight loss. Currently, however, Topamax is generally being marketed as a method of treating chronic migraine headaches.
Despite the vast array of uses for this drug, it is not without dangerous side effects. In fact, a study published in 2008 shows that women who are taking Topamax, and who subsequently become pregnant, are 11 times more likely to have a child with a cleft lip or cleft palate. These birth defects can have serious repercussions for the life of the child.
The FDA took this study into consideration, yet did not issue a warning for 3 years. In March 2011 the FDA warned about the use of Topamax with women who are of childbearing age. Oral clefts occur when the lip or palate fail to fuse together. This fusion occurs during the first trimester of the pregnancy, a time when many women do not realize that they are pregnant. If they are taking Topamax, and do not realize that they are pregnant, they run the risk of having a child with this birth defect. The result can be costly surgery to correct the problem, yet the child will live with scars and possible speech problems for his or her entire life.
The manufacturers and distributors of Topamax, Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson), failed to fully warn the public about the dangers of using the drug during pregnancy. As a result many young lives have been affected with birth defects that could have been prevented with a simple warning.
Research Studies Involving Topamax and Birth Defects
In 2008 the results of a study conducted in the UK were published. The researchers realized that there was very little data on the effects of Topamax when taken while pregnant. By looking at 203 pregnancies, during with the mother was taking Topamax, either by itself or with another drug, at the beginning of the pregnancy, they were able to determine the likelihood of a child being born with defects due to the drug.
The outcome was shocking. There was some speculation that the drug would lead to a higher instance of birth defects, but the results were much higher than expected. In fact, the risk of having a child born with oral clefts is 11 times higher when taking Topamax during pregnancy than if no drugs are taken.
This study prompted an investigation by the FDA to determine if Topamax was safe for women to be taking. It was not until three years later, in 2011, that the FDA issued a warning stating that women of child bearing age should seriously consider the risks of taking this drug. Since the lips and palate close during the first trimester of pregnancy, a time when many women are unaware they are pregnant; the risk of oral clefts is heightened due to not discontinuing the drug use in time.
Topamax found FDA approval as a medication to combat seizures due to epilepsy in 1996. It surged in popularity after 2004 when it was approved as a preventative medication for those prone to suffer from chronic migraines. It was not until 15 years after the drugs initial approval that warnings were made to the public about the risks of taking Topamax during pregnancy. That is 15 years of women taking the drug while pregnant and subjecting their child to a significantly increased risk of being born with a birth defect.