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Topamax, an anticonvulsant generically known as topiramate manufactured by Janssen Pharmaceuticals and marketed by Johnson & Johnson, experienced multiple recalls over the past decade for correlation with birth defects and extreme side effects.

The FDA originally approved the medication to treat certain types of seizures and migraine headaches. However, Johnson & Johnson began marketing it for multiple off-label uses, including as a painkiller and diet pill – both of which the FDA rejected. Johnson & Johnson later paid $6.1 million for illegally marketing Topamax to treat various psychiatric conditions.

Concerning Side Effects

Topamax has been associated with side effects greatly varying in severity, including:

  • Constipation and diarrhea
  • Dizziness
  • Headaches
  • Nausea, upset stomach, and stomach pains
  • Flu-like symptoms, including sore throat and loss of appetite
  • Extreme allergic reactions
  • Blood in urine
  • Blurred or double vision
  • Bone, chest, muscle, or joint pain
  • Confusion and lack of coordination
  • Mood changes
  • Menstrual changes
  • Red, swollen, peeling skin
  • Irregular heart beat
  • Loss of consciousness
  • Rapid and shallow breathing
  • Significant weight loss
  • Suicidal thoughts or actions
  • Tremors
  • Trouble walking
  • Unexplained fevers
  • Atypical bruising or bleeding
  • Unusual eye movements
  • Tiredness

The patient given Topamax may not be the only one who suffers from a defective drug or lack of warning. After pregnant women were prescribed the medication, some children displayed birth defects, including cleft lip and palate, hypospadias, limb malformations, lung defects, heart defects, and spinal bifida. To correct these conditions, children require surgery.

However, pregnant women prescribed Topamax were not given warning about its relation to birth defects, which may start developing as early as the first trimester.

Warnings

Over the years Topamax has been on the market, the FDA released multiple warnings.

In 2004, the FDA issued a statement about “underwhelming side effects,” and then followed it two years later with a warning about potential vision loss.

A later warning concerning birth defects eventually resulted in changing Topamax from a Pregnancy Category C to a Pregnancy Category D drug. This statement cited research from the North American Antiepileptic Drug Pregnancy Registry, which suggested an increase risk of oral clefts from Topamax and its generic form. Specifically, children exposed to Topamax in the womb were found to have a 1.4-percent chance of developing this condition, compared to 0.38 to 0.55 percent with other antiepileptic medications and 0.07 percent for no exposure.

As of 2011, Johnson & Johnson recalled multiple lots of the drug for an atypical odor.

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