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. Topamax graduated to “D” status after studies showed fetuses exposed to Topamax had a 1.4 percent rate of oral defects, which is more than three times that of most other seizure drugs. Pregnancy Category C drug means it has shown evidence of causing birth defects in animal studies but the risk in humans is unknown. In 2009, Pfizer asked pregnant women on Lyrica to enroll in a study to investigate the risk of birth defects — but they did not warn pregnant women against taking Lyrica. Studies to date are inconclusive.
The MGH Center for Women’s Health reports that Topiramate (Topamax) exposure during the first trimester was associated with an increased prevalence of oral clefts, according to study researchers. While previous studies show this birth defect to be as high as 1.5 percent, this study showed a lower prevalence of 0.36 percent. The online issue of Neurology (May 2016) reported on a Lyrica (pregabalin) study. It showed that pregnancies of the women who took pregabalin during the first trimester of pregnancy were three times more likely to result in major birth defects than those of the women who did not take anti-seizure drugs. The major birth defects included heart defects and structural problems with the central nervous system (CNS) or other organs Birth defects due to chromosomal abnormalities, such as oral clefts, were not included in the results.
“My son was born with bilateral club foot. His mother was taking Lyrica for nerve pain when he was conceived and throughout much of his fetal development,” said Gary in an email to LawyersandSettlements.“She was prescribed Lyrica without any warning about possible birth defects. We already had two kids and neither of them have birth defects. My wife only took Lyrica with our third son.”
Commonality: Possibly linked to cleft palate and club foot.
However, neither Lyrica nor Topamax is as dangerous as Depakote (valproate). Unfortunately for some people with epilepsy, valproate is the only effective drug to treat their seizures. But AEDs are also prescribed to treat conditions other than epilepsy, thus bringing in huge profits for the drug companies, even after paying out huge fines and settlements.
Topamax and Lyrica Sales
From January 2007 through December 2010, approximately 32.3 million topiramate (Topamax) prescriptions were filled to 4.3 million patients. Lyrica (pregabalin) generated $5.1 billion in sales in 2014 and dropped in 2015 to $3.6 billion.
Commonality: both are blockbuster drugs.
Topamax and Lyrica Off-Label Fines
Pfizer, the Lyrica manufacturer, in 2009 agreed to pay $2.3 billion to the Department of Justice for illegally promoting sales Lyrica. Pfizer was allegedly urging doctors to prescribe Lyrica for "off-label" use. And the giant drug company “paid bribes and offered lavish hospitality to healthcare providers to encourage them to prescribe [Lyrica], according to the BBC News”.
READ MORE LYRICA BIRTH DEFECT LEGAL NEWS
Commonality: Their profits are greater than sales.
Topamax and Lyrica Lawsuits
A number of Topamax lawsuits were filed in a Philadelphia state court in late 2011.
By April 2014, Law360 reported that a J&J unit has “inked settlement deals with plaintiffs in 76 suits in Pennsylvania court” claiming birth defects in the babies of women who took the anti-epilepsy and migraine drug during their pregnancies.
Difference: To date a Lyrica lawsuit has not been filed, but attorneys are investigating Lyrica birth defects. More Topamax lawsuits are being filed.