Topamax is an anti-seizure medication that may also be used for other conditions including migraines. It was created and developed by Janssen Pharmaceuticals, part of Johnson & Johnson. In addition to being approved as an anticonvulsant to treat seizure disorders, the generic form of Topamax combined with a psychostimulant drug is used to treat obesity in some people.
For people who experience seizures and migraines, including children, Topamax may be a medication that provides much needed relief. Unfortunately for some patients, though, this drug has caused some serious consequences, including suicidal thoughts and behaviors, complications of pregnancy, and even birth defects. Lawsuits are pending against the makers of Topamax.
Uses for Topamax
The U.S. Food and Drug Administration (FDA) approved Topamax, generic drug topiramate, in 1996 to treat epilepsy, which is characterized by uncontrollable seizures. It can be used in children as young as two who suffer from the seizure disorder called Lennox-Gastaut syndrome.
The FDA also approved Topamax to be used in the treatment of migraines headaches for adults and adolescents between the ages of 12 and 17. Although it does not relieve migraines once they have started, it can reduce the frequency and duration of migraines when taken regularly. Doctors may prescribe Topamax off-label for treating alcohol dependence and other addictions, certain anxiety disorders, eating disorders, obesity, and weight gain caused by the use of antipsychotic medications.
How it Works
Topiramate belongs to a class of drugs called anticonvulsants, which are most often used to treat seizures, but can also help with other conditions. Exactly how topiramate works to stop or reduce the severity of seizures is not known, but generally anticonvulsants slow down excited neurons in the brain. It may also dilate blood vessels in the brain to allow for better blood flow, which may explain why it helps to prevent migraines.
Topiramate and Qsymia
Topiramate combined with a drug called phentermine is the brand name obesity drug called Qsymia. The FDA approved it in 2012 for weight loss in patients with at least one health-related complication like type 2 diabetes or high blood pressure or for patients with obesity. Phentermine is a psychostimulant similar to methamphetamine. Both phentermine and topiramate alone contribute to weight loss, and the effect is more significant in combination.
Topiramate, both alone and in combination as Qsymia, has the potential to cause a number of side effects in users. The most common of these are loss of appetite, and changes in how food tastes, nausea, tingling in the arms and legs, diarrhea, nervousness, weight loss, and upper respiratory infections. Most of these are not serious, but should be reported to a doctor if they persist or become severe.
Other possible side effects, which may be more serious, include metabolic acidosis, characterized by fatigue, loss of consciousness, and an irregular heartbeat. Topiramate may also cause kidney stones, dizziness, and loss of coordination, as well as high levels of ammonia in the blood when taken with certain other medications.
In 2009 the FDA announced that anti-seizure drugs, including topiramate, required labeling changes to warn that they can cause suicidal thoughts and actions in patients. Anyone taking Topamax or Qsymia should be monitored for changes in mood or behavior that may indicate an increase in thoughts of suicide.
Clinical trials with Topamax found that the risk starts as early as the first week of treatment and can persist for as long as 24 weeks. Although the incidence of suicidal thoughts was relatively low in trials, it was higher than in the general population and had serious consequences. There were four suicides during trials with Topamax.
Pregnancy Complications and Birth Defects
Another serious and controversial issue with Topamax and Qsymia is that topiramate may cause complications during pregnancy and birth defects in infants. The FDA announced this risk in 2011, stating that new evidence from research shows topiramate increases the risk of infants being born with cleft lips or a cleft palate. The evidence does not completely restrict women from using topiramate during pregnancy, but women and doctors are encouraged to weigh the benefits and risks before using or prescribing the drug.
Cleft lip and palate defects develop early in a pregnancy, so women who are using topiramate and not planning to get pregnant are encouraged to use birth control. Some women may find out too late that they are pregnant, having already been using topiramate during the crucial early weeks of a pregnancy.
These birth defects are characterized by an incomplete joining of facial tissues above the lip or in the soft palate in the mouth. The defects may cause other complications like ear infections, and difficulty speaking and eating. Cleft palates and cleft lips require early surgery to correct, followed by more surgeries and later treatments.
The announcement about the risks of birth defects was not communicated on labels of Topamax until 2011. The drug has been on the market since 1996, leaving 15 years during which women and their children were affected by the birth defects caused by Topamax. Lawsuits have been filed by many of the families of children living with cleft palates and cleft lips. They claim that Johnson & Johnson must have known about the risks, failed to communicate them, and falsely marketed a drug as safe.
The number of lawsuits against the company is growing and lawyers are seeking monetary compensation and punitive damages for their clients. If you had a child born with birth defects because you took Topamax, you too could have a case. See what a lawyer can do for you and how you can get in on the suits that may bring millions of dollars in compensation.