Topamax is a medication made by Janssen Pharmaceuticals, a division of Johnson & Johnson, designed to treat seizure disorders, but also used for other reasons. The U.S. Food and Drug Administration (FDA) first approved Topamax for the U.S. market in 1996. Since then the medication has helped many people, but has also been proven to trigger a number of side effects, some serious.
While there are some more common and less severe Topamax side effects, this drug is also known to cause birth defects in the children of some women who used it during pregnancy and to trigger suicidal behaviors in some patients. Additionally there are other, rarer side effects that can be just as devastating to patients. Topamax has faced a number of lawsuits over side effects, most notably birth defects and complications of childbirth.
What is Topamax?
Topamax is a generic drug called topiramate. It is considered an anticonvulsant, a type of medication that reduces the stimulation of neurons in the brain. The result is that it can prevent and treat seizures. There is also some evidence that topiramate dilates the blood vessels in the brain. This may also contribute to the anticonvulsant effect.
The FDA approved Topamax to treat seizure disorders, most often epilepsy. It is also approved to treat a seizure disorder called Lennox-Gastaut syndrome in children as young as two years old. The FDA also gave the go ahead to use Topamax to treat chronic migraines in adults and children 12 or older. It is likely the dilation of blood vessels that reduces the frequency and severity of these types of headaches. Off-label uses for Topamax include obesity, eating disorders, medication-triggered weight gain, anxiety disorders, and drug or alcohol dependence.
There is also a combination drug that includes topiramate. Called Qsymia, it combines topiramate and phentermine, an amphetamine-like drug, to treat obesity. The FDA approved it for this use in 2012, but is only supposed to be used in obese patients who also have a serious weight-related health issue. This could be high blood pressure or type 2 diabetes.
Common Side Effects
Topiramate causes some commonly reported side effects, although many people tolerate it well. Those most often reported are appetite loss, a change in the taste of food, weight loss, diarrhea, nausea, upper respiratory infections, and a tingling sensation in the arms and legs. These are not considered serious, but may persist and become more severe. For most people they will decrease and become more tolerable with time.
Birth Defects and Complications
Since it was approved in 1996 Topamax has been found to be associated with an increased risk of birth defects and complications during pregnancy and childbirth. The risk was announced as an FDA safety warning in 2011, more than a decade after the drug first came out. New evidence led the agency to make the announcement to warn women and doctors. Specifically the warning stated that women using Topamax during pregnancy would have an increased risk of giving birth to a child with a cleft palate or cleft lip.
Women are not restricted from using Topamax, but are strongly encouraged to use birth control if there is a chance of becoming pregnant. The risk of developing cleft lip and palate is highest during the first few weeks of pregnancy. Some women may not expect to get pregnant and then find out too late, after already using Topamax during those crucial early stages of development.
Other complications and birth defects are possible for women who took Topamax during pregnancy. These include persistent pulmonary hypertension of the newborn, malformed limbs, lung and heart defects, and spina bifida. Because of the risks the FDA has given Topamax a pregnancy classification of D, which indicates that it is known to cause problems.
Another of the most serious side effects that Topamax may cause in users is suicidal thoughts and suicidal behaviors. The FDA revealed this potential complication in 2009 and required that the drug include a special warning on the label. Topiramate is just one anti-seizure drug and others are known to potentially cause this side effect as well.
The risk of suicide was seen through studies and clinical trials. The results of these studies showed that the suicidal thoughts could begin as soon as during the first week of treatment with the drug. The feelings were found to last as long as 24 weeks in some cases. The risk is serious, because this side effect can be fatal, but it isn’t common. The incidence of suicide is higher in people using one of these anti-seizure drugs, but still relatively low.
Other Serious Side Effects
Birth defects and suicides are among the most serious of Topamax side effects. Either one can be devastating to an individual and that person’s family and have lasting consequences. However, these are not the only potentially serious and life-altering side effects caused by Topamax. There are others, although they are not very common.
One of these is a condition called hyperammonemia, which is characterized by high levels of ammonia in the blood. It can impact cognitive abilities and cause nausea, vomiting, fatigue, and delays in alertness. Another rare side effect is hyperthermia, or dangerous overheating. This can be serious enough to warrant emergency hospitalization.
Metabolic acidosis is another possibility. This occurs when levels of acid in the blood become dangerously high. The potential consequences of this if left untreated include softening of the bones, the development of kidney stones, slowed development in children, and ultimately coma and death. Serious eye problems may also occur with Topamax, including acute myopia and a type of glaucoma that can lead to blindness.
Pregnancy Side Effects Lead to Lawsuits
Because the FDA did not issue a warning about birth defects and other pregnancy complications until 2011, many women feel they were not adequately warned about these serious side effects of Topamax. Many have started lawsuits to seek justice and compensation for defects that can affect a child for his or her entire life. The medical and therapy bills for children with birth defects may be huge and occur over a lifetime. Women affected in this way are suing Johnson & Johnson and cases are ongoing. They are hopeful that the case can be made that the company knew about the risks of Topamax and failed to warn patients and doctors.
If you were adversely affected by any of the Topamax side effects, find out from a lawyer if you too could make a case against Janssen and Johnson & Johnson. If it can be shown that the company knew about some of these side effects early on, compensation and settlements might be just around the corner for patients harmed by Topamax.