The Food and Drug Administration has issued a warning against the use of anticonvulsant drug Topamax during pregnancy, saying that infants born to women using the drug are 20 percent more at risk of developing cleft lips and such other deformities. The warning comes especially for women of childbearing age and expectant mothers, who take Topamax as an epilepsy and migraine drug.
The FDA warns doctors to advise their female patients against using the anticonvulsant drug in the first trimester, when a woman isn’t even aware of her pregnancy. Advising doctors to prescribe alternative medications to pregnant women, the FDA asks physicians and doctors to carefully observe their patients’ childbearing condition before prescribing the drug.
The FDA has another word of caution for pregnant women. It advises them not to suddenly discontinue the use of the drug if they realize they are pregnant and to always consult their physician before voluntarily stopping the use of the medication, which can have serious repercussions on the female as well as her fetus. However, the FDA suggests that such women can seek their doctor’s advice on other anticonvulsant drugs for epilepsy that would not have similar complications during pregnancy.
According to the FDA report, the first trimester is the most vulnerable period, when the fetus’ lip and palate do not fuse properly. The FDA urges women undergoing topiramate therapy to take effective birth control, as it is not an appropriate medication for a female of childbearing age. Further, the government agency cautions physicians before prescribing the anticonvulsant drugs to females using birth control pills comprising estrogen, warning that, if used together, these drugs might reduce contraceptive efficacy and hormonal exposure.
Topamax entered the market in 1996 and has since been known as an effective remedy for migraine and epilepsy. Its generic version topiramate is quite popular with female patients, including pregnant women. Therefore, the FDA warning for pregnant women has given answers to many families that have been struggling to find the reasons for the cleft lips of their newborns. According to the FDA report, fetuses exposed to the drug were 1.4 percent more vulnerable to developing oral defectsree times the other seizure drugs.
Following laboratory tests on animals, Topamax was classified as category C drug for pregnancy, associated with decreased fetus weight, miscarriages, and birth defects. However, despite its categorization under C and evident signs of warning, topamax stayed in the market for human use. It took the FDA several years to link the problem of cleft lips, which means thousands of expectant mothers have consumed topamax, thus unknowingly exposing their fetuses to the side effects of the drug.
Drugs like topamax that cause birth deformity are also known as teratogens. Some of these drugs are isotretinoin, Angiotensin II antagonist, thalidomide, lithium, hormone diethylstilbestrol, and warfarin. Many anticonvulsant, rheumatoid, and thyroid medications are also feared to cause birth defects.
Some of the commonly used drugs that cause birth deformity are given below: Anticonvulsant drug valproate poses a high risk of birth defects if the expectant mothers use the drug. Anti-seizure drug Phenytoin causes birth deformities, such as cleft palate and lip and heart malformation. Antidepressant drug Paxil manufactured by GlaxoSmithKline was in the news for causing birth defects. GlaxoSmithKline faces a number of lawsuits for not disclosing the side effects of the drug for pregnant women. A timely action could have saved a number of babies from developing birth defects. Anticonvulsant drug Depakote should also be avoided during the first three months of pregnancy. The anticonvulsant and its generic version Divalproex Sodium are blamed for causing birth deformities, including facial dysmorphism, facial asymmetries, ear deformations, cleft palate, and cleft lip.
Antiseizure drugs, like Tegretol and Neurontin, are also feared to cause birth deformities, including heart defects, brain damage, and even mental retardation. Other antiepileptic drugs, including Lamictal, Carbatrol, Tegretol, Phenytek, Dilantin, and are also feared to cause birth deformities, such as oral birth defects, cleft lip, when fetuses are exposed to them. Novartis and Roche are often prescribed to organ transplant patients; however, these are feared to lead to oral birth defects and miscarriages. Coumarins and Warfarin cause major birth deformities, including fetal warfarin syndrome, when pregnant ladies take them during the first trimester. Anti-acne drug Accutane is also known to cause serious birth deformities, miscarriages. Fetuses exposed to this drug develop facial malformations, visual and hearing impairment, and mental retardation. Fertility medications, Clomid, Serphene, cause serious birth deformities, such as limb deformities and defects in the central nervous system, if fetuses are exposed to them during the first trimester of pregnancy.
Two Johnson and Johnson subsidiaries reached a settlement for $81 million as compensation for misbranding the drug and illegally promoting Topamax. The two companies claimed that the drug was an effective treatment for bipolar and eating disorders, sleep disorders, obsessive-compulsive disorder, posttraumatic stress disorder, depression, obesity, smoking, and alcoholism.
The manufacturers and marketers of Topamax may be liable to pay damages to parents of children who were born with birth defects if the mothers were taking the drug Topamax during pregnancy. Lawsuits currently being filed are alleging that the drug companies put their own profits ahead of the safety of babies by downplaying the risks of Topamax.
I recently spoke to a young mother who had been taking Topamax to prevent migraine headaches. She was not intending to become pregnant but had no idea that Topamax could cause birth defects in a baby. She became pregnant and her doctor then advised her to stop taking Topamax. She stopped immediately but the damage was done. Her baby was born with a cleft palate deformity that was not immediately visible. The baby did not gain weight and maintain nourishment in the first few months of life. After several months the cleft palate deformity was discovered and it became clear that the baby could not feed properly because of the defect. This failure of nourishment in the early months may have caused developmental disabilities with the child in addition to the cleft palate problem.
If the drug companies had properly warned of the risks this unfortunate outcome might have been avoided.
In March of 2011, The U.S. Food and Drug Administration (FDA) increased its pregnancy drug risk classification from a “C” drug to a “D” drug. Pregnancy Category “D” means that there is positive evidence of human fetal risk based upon human data but that the benefits from the use of the drug in some patients may justify the risk of birth defects.
Topamax is a prescription medicine approved for the treatment of epilepsy and for migraine headache prevention. Brand name Topamax is made by Ortho-McNeil Neurologics. However, there are a number of generic manufacturers that make the drug since the original patent has expired. Some of the generic manufacurers are Apotex Corporation, Aurobindo Pharma, Mylan Pharmaceuticals, Ranbaxy Pharmaceuticals, Inc., Roxane Laboratories, Inc., and Teva Pharmaceutical Industries, Ltd.
The FDA approved the marketing of topiramate in 1998 as an antiepileptic drug. Within several years after approval of Topamax the FDA became concerned that Johnson & Johnson subsidiary Ortho-McNeil was illegally over marketing Topamax for unapproved uses such as for psychiatric care. Johnson and Johnson paid $81 million in fines and pled guilty to misdemeanor criminal conduct for “misbranding” Topamax.
This illegal marketing of Topamax is likely to be significant in the current birth defect lawsuits because it is evidence that the drug companies may have been more concerned with making profits than in people’s safety.
Another issue that will likely be significant in the lawsuits will be the fact that data from the North American Antiepileptic Drug Pregnancy Registry shows that cleft lip and cleft palate occurred in 1.4% of infants exposed to topirate alone in the first trimester of pregnancy. The comparable rate for infants exposed to other antiepilepsy drugs is only .38% to .55%. This scientific data demonstrates that there are other drugs on the market to treat epilepsy that have a lower risk of birth defects than Topamax.
Parents of children born with any cleft lip or cleft palate deformity should contact a qualified attorney immediately if the mother took Topamax during pregnancy. There are limited time periods in which such a lawsuit can be brought and the drug company be able to win the case if it is not promptly filed in court.