Topamax is an anticonvulsant medicine approved for the use, either alone or with other medicines, of treating epilepsy and certain kinds of seizures. It is also approved for the prevention of migraine headaches, chronic pain, and mood disorders.
Topamax Linked to Birth Defects
Studies have shown that if a woman takes Topamax during her pregnancy there is an increased risk of her baby being born with a cleft lip or other birth defects. Additional warnings also show that Topamax can cause harm to newborns who are breastfeeding.
In 2014, a national law firm won a $3 million verdict against Janssen Pharmaceuticals for the family of a 5-year-old who was born with a bilateral cleft palate and lip because his mother had taken Topamax while she was pregnant. The lawyers hope that this verdict sends a clear message to the makers of Topamax that their negligence of failing to make patients aware of the dangers is completely inexcusable.
In March of 2010, $81 million was paid out by Johnson & Johnson due to their illegal marketing of the drug for off-label uses of treating bipolar disorder, weight loss and alcohol abuse. These off-label uses were not approved by the FDA.
FDA Warnings for Topamax
The FDA issued a warning in 2011 to women who are of child-bearing age concerning the serious side effects that Topamax can have on a newborn baby. This warning was issued after millions of babies were probably already exposed to the effects.
Healthcare workers and patients were notified by the FDA of the increased risk of the development of a cleft lip or cleft palate during pregnancy. Because of this, Topamax is being placed in Pregnancy Category D. Category D means there is real evidence of fetal risk based on data. Despite the risks involved, Topamax may still be used in particular situations during pregnancy.
Before taking Topamax, pregnant mothers and women who may become pregnant need to talk to their doctors about other treatment options. Women who become pregnant while taking Topamax should talk to their doctor about registering with the North American Drug Pregnancy Registry. They collect information pertaining to the outcomes of infants who were born to women who were taking antiepileptic medications during their pregnancy.
Topamax Side Effects
It has been reported that over 3% of oral birth defects in children were due to the fact that their mothers used Topamax during the first trimester of their pregnancy. Two risks in particular are cleft lip and cleft palate in newborns. Cleft lips and palates are widely known to develop in the first trimester of pregnancy.
Another common defect is a genital birth defect knows as hypospadias. This is found mostly in male babies. This condition is where the urethra opens on the underside of the penis.
Topamax can also pass through a mother’s milk during breastfeeding, which can cause small amounts of the drug to be passed on to the baby. Some of the symptoms a baby might experience include drowsiness, weight loss, appetite loss, confusion, aggressiveness and infections.
If your child has suffered from the side effects of Topamax, a drug you thought was safe to take during your pregnancy and while you were breastfeeding, you need to speak with an experienced personal injury attorney as soon as possible.
CONTACT the Lieser Law Firm for a FREE case evaluation.