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Click here to view New York Times story: September 24, 2004 | COMPANY NEWS; U.S. FAULTS JOHNSON & JOHNSON PROMOTION OF DRUG
Babies born to women taking Topamax, Johnson & Johnson’s epilepsy drug, may be 20 times more likely to suffer birth defects side effects, from oral clefts, cleft lips to cleft palates as compared to children whose mothers didn’t take the drug. In March 2011, the U.S. Food & Drug Administration (FDA) placed Topamax due to its side effects in a new pregnancy risk category and updated its labeling because of its association with oral clefts, cleft lips, cleft palates, and genital defects.
If you took Topamax while pregnant and gave birth to a child with an oral cleft – cleft palate or cleft lip – you and your child may be entitled to receive compensation from Johnson & Johnson. Lawyers at our firm who understand defective drug litigation are offering free legal consultations to victims of Topamax birth defects, side effects from the drug, including cleft lip, cleft palate, other oral clefts and genital deffects. To learn how we can help you, please contact one of our Topamax lawyers today.
Topamax and Oral Clefts Side Effects
Topamax is an anticonvulsant medication approved for use alone or with other medications to treat patients with epilepsy who have certain types of seizures. Topamax is also approved for use to prevent migraine headaches.
In March 2011, the FDA announced it was moving Topamax from Pregnancy Category C to Pregnancy Category D. Pregnancy Category D means there is positive evidence of human fetal risk based on human data but the potential benefits from use of the drug in pregnant women may be acceptable in certain situations despite its risks. The agency also said the Topamax medication guide and labeling information would be updated with the new information regarding the risk of oral clefts in babies born to women who took Topamax in pregnancy.
Oral clefts are birth defects that occur when parts of the lip or palate do not completely fuse together early in the first trimester of pregnancy, a time when many women do not know they are pregnant. The defects range from a small notch in the lip to a groove that runs into the roof of the mouth and nose, possibly leading to problems with eating, talking, and to ear infections. Surgery often is performed to close the lip and palate.
The FDA decided to move Topamax to Pregnancy Category D after Data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry indicated that infants exposed to Topamax as a single therapy during the first trimester of pregnancy experienced a 1.4 percent prevalence of oral clefts, compared with a prevalence of 0.38 percent – 0.55 percent in infants exposed to other antiepileptic drugs. Infants of mothers who did not have epilepsy and were not being treated with other antiepileptic drugs had a prevalence of 0.07 percent.
Other Defective Drugs Made by Johnson & Johnson
This is not the first safety issue to involve Topamax or another Johnson & Johnson product. Less than a year before the FDA change the pregnancy category for Topamax, Johnson & Johnson agreed to pay a $6.1 million fine for illegally marketing Topamax for psychiatric conditions. In 2004, the FDA warned Johnson & Johnson that its marketing materials downplayed the “serious side effects associated with Topamax, including oligohidrosis (decreased sweating), hyperthermia, and metabolic acidosis.”
In 2006, the FDA warned that Topamax can cause a serious eye condition “characterized by acute myopia and secondary angle closure glaucoma” that has the potential to cause permanent vision loss. In 2008, the agency also warned that patients on all antiepileptic drugs, including Topamax, should be “monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior,” and warnings on drug labels were soon required.
Unfortunately, Topamax is just one in a long line of Johnson & Johnson products that have been at the center of safety problems. In the year-and-a-half or so before the FDA changed the Topamax pregnancy category, Johnson & Johnson recalled more than 200 million bottles of over-the-counter medicine, including Children’s Tylenol, Motrin and Benadryl, made by its McNeil Consumer Healthcare unit. One McNeil plant in Pennsylvania was temporarily closed due to the recall fiasco, and it and two others were placed under an FDA consent decree that required manufacturing deficiencies at the facilities to be addressed.
Other Johnson & Johnson recalls the same year involved two DePuy hip replacement implants sold by its DePuy Orthopaedics unit, as well as a recall (an initial action and an expansion) of 100,000 boxes of 1-Day Acuvue TruEye contact lenses.
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