Topamax FDA Warning

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Topamax is a drug that has been FDA approved for treating epilepsy and preventing migraines. Topamax is the brand name for the anticonvulsant topiramate. Topiramate was also approved by the FDA for weight loss in 2012, but it is marketed under the name Qsymia. Topamax has come under fire for a number of side effects, including birth defects and the development of suicidal tendencies. Topamax is facing a number of lawsuits by patients who have been harmed as a result of taking the drug.

In May 2010, Ortho-McNeil-Janssen Pharmaceuticals (now Janssen Pharmaceuticals) paid a total of $81.5 million in fines. This was part of a plea agreement with the US Department of Justice for misconduct on the part of the company. This misconduct included prescribing the drug for issues not approved by the FDA and illegally marketing the drug. The FDA has responded to the large number of serious side effects associated with Topamax by issuing warnings and mandating that all topiramate labels and medication guides clearly state these warnings.

Increased Risk of Birth Defects

The most recent Topamax FDA warning is for women who are pregnant or are considering becoming pregnant. In 2011, the FDA released data linking Topamax use to an increased risk of birth defects cleft lip and cleft palate. Topamax was also downgraded from a Pregnancy Category “C” to “D”, which means that there is positive evidence of fetal risk, but the potential benefits of the drug may outweigh the risk in some situations.

Studies have shown that the risk of oral defects in babies born to mothers that have been treated with Topamax during pregnancy is twenty-one times more likely than for woman not taking the drug, and three times more likely than for women taking other medications to prevent seizures. However, Topamax has proven to be effective at preventing seizures, which could be detrimental to both the mother and unborn child.

Topamax may lower the effectiveness of certain birth control methods that utilize hormones. Patients should consult a doctor about effective forms of birth control while taking Topamax. If a patient becomes pregnant while taking Topamax, it may be dangerous to suddenly stop taking the drug, as the risk for recurring seizures is high.

Development of Suicidal Thoughts and Actions

The increased risk of suicidal thoughts and actions as a result of using Topamax and other antiepileptic drugs is an issue that was brought to the attention of the public by the FDA in 2008. The FDA initially considered adding a black box warning, which is the strongest warning put out by the FDA. Instead, the FDA decided to add the warning to the labels and require manufacturers to develop and disperse a medication guide to warn patients of the dangers. In clinical trials, patients receiving an antiepileptic drug were twice as likely to have suicidal tendencies as those receiving the placebo.

Eye Disorders from Topamax Use

In 2006, there was a Topamax FDA warning issued about the potential of developing eye disorders after using Topamax. These are thought to be caused by an allergic reaction to sulfa that causes fluid accumulation and swelling in the eyeball. Patients are urged to contact a doctor at the first sign of decreased vision or discomfort of the eyes, as conditions may worsen rapidly, and in rare cases permanent blindness has occurred.

Eye disorders from using Topamax:

  • Glaucoma, or pressure that results in damage to the optic nerve of the eye
  • Myopia, or nearsightedness
  • Double vision or dry eyes
  • Nystagmus, during which patients eyes dart quickly back and forth

Metabolic Acidosis, Oligohydrosis, and Hyperthermia

The first Topamax FDA warning that was issued was in 2004. At this time, the FDA began to require manufacturers of the drug to issue warnings about the increased risk of metabolic acidosis, oligohydrosis, and hyperthermia.

Metabolic acidosis is an electrolyte Imbalance, or increase in acid in the blood. This can cause osteoporosis, rickets, and kidney stones if untreated. Children’s growth rate may be stunted by this condition. If patient is pregnant, this condition could possibly cause harm to the baby.  Symptoms of metabolic acidosis include heartbeat irregularities, rapid breathing, and fatigue.

Oligohydrosis is a decrease in sweating that can be very dangerous if exercising. Hyperthermia is an increase in body temperature, or fever.  In conjunction with oligohydrosis, this can be very dangerous.  Patients should seek hospitalization if experiencing these symptoms.

View Sources

  1. Monson, Kristi, and Arthur Schoenstad. Emed TV: Health information brought to life. Clinaero inc, 04 Apr 2011. Web. 17 May 2013.
  2. “FDA US Food and Drug Administration.” . US Department of Health and Human Services, 07 Mar 2011. Web. 17 May 2013.
  3. “Drug Information Online.” . Cerner Multum, Inc, 02 Aug 2011. Web. 17 May 2013.
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