Topamax Side Effects Lawsuit
FDA Warns Against Use of Topamax During Pregnancy
The Food and Drug Administration warns females of childbearing age and expectant mothers against using anticonvulsant drug Topamax, which poses risk of development of cleft lips or cleft palate deformities in their newborns. The FDA warns that, according to its new research data, newborns of women who take Topamax during the first trimester or childbearing age are 20 percent more at risk to develop cleft lips than those taking other anticonvulsant drugs.
The FDA says that Topamax, considered an epilepsy and migraine drug, increases the risk of oral birth defects in newborns, whose mothers take the prescription medication during their first three months of pregnancy. Topamax side effects The FDA warns doctors to caution their female patients against the use of Topamax to prevent their newborn babies from developing oral birth defects and deformities. Issuing a warning against the use of the drug, the FDA says that the defects occur in the initial three months of pregnancy when a woman might not even know she is expecting, which poses a danger of oral birth deformities and malformations in their newborns.
The FDA urges health professionals to carefully study their female patients’ childbearing condition before prescribing the anticonvulsant drug; rather, it recommends using "alternative medications” having a lower risk of oral birth defects or other malformations. Further, the FDA urges female patients to take effective birth control while taking anticonvulsant drugs to prevent pregnancy while they are under topiramate therapy. The FDA believes that topiramate is an effective anticonvulsant drug, but it is not appropriate medication for a woman of childbearing age. The agency asks doctors to inform their female patients about the risks and benefits of the drug before prescribing it. Topamax side effects and the side effects of other drugs are another reason why more drug oversight may be the best option the FDA has. We feel that regulating the prescription drug industry should not be the responsibility of Do I Have A Lawsuit affiliated consumer justice attorneys.
The FDA also warns female patients against suddenly stopping the use of the anticonvulsant drug if they realize they are pregnant; rather, it urges patients to consult their physicians before deciding to suddenly stop the use of the medication. The FDA warns that sudden discontinuation of the medication can have serious repercussions for the expectant female and her fetus. Also, not treating epilepsy during pregnancy can be dangerous to the mother and her child. Therefore, the FDA suggests consulting one’s doctor before discontinuing the use of Topamax, who can prescribe any other anticonvulsant drug that would not have such serious complications during pregnancy.
The FDA says that the drug is most harmful for women in the first trimester of pregnancy, when the lip or palate in the fetus does not fuse properly. Further, the FDA urges caution on the part of physicians before prescribing topiramate to female patients using estrogen containing birth control, as these drugs together have the potential of decreasing hormonal exposure and contraceptive efficacy. The FDA warns that women using topiramate are 20 percent more likely to have babies suffering from oral birth deformities, such as cleft lips, than those not treated with this antiepileptic or anticonvulsant drug.
Topamax, known as topiramate in generic version, has been on the market since 1996. It is known to be an effective remedy for epilepsy and prevention of migraine. Numerous female patients, including expectant mothers, have taken this medication before the FDA issued this warning, which comes as a surprise for most of the families that have babies with cleft lips. In fact, between 2007 and 2010, 32 million prescriptions were dispensed in the country for over 4 million patients. Fetuses exposed to Topamax had a 1.4 percent rate of oral defects, more than three times the other seizure drugs.
The FDA warning comes 14 years after the anticonvulsant drug has been in use. Despite pre-approval testing of the drug, which showed up fetal deformities in laboratory animals, it continued to be sold in the market without any clear warning labels for pregnant or expectant mothers. The drug was classified as a category C drug for pregnancy, as data from human clinical trials was inadequate. Category C includes those drugs that are associated with miscarriages, birth defects, and decreased fetus weight in laboratory animals. Categorization of the drug under C gave enough of a warning to the manufacturer to study its possible effects on humans and potential of causing birth deformities in human fetuses; however, Johnson and Johnson/ Ortho-MacNeil Pharmaceutical did make any effort in this regard. This means that unknowingly numerous expectant mothers have taken the drug as anticonvulsant medication, thus posing a risk of oral birth deformities. Therefore, Johnson and Johnson/Ortho-McNeil are to be blamed for the relentless sale of the drug without even marking a proper warning label for pregnant ladies or even identifying the risks associated with the use of the drug by pregnant women.
The manufacturer of any drug that causes birth deformities and debilitating malformations caused by the use of their product should be held accountable and liable to pay compensation for damages.
Cleft lips cause a gap in the upper lip and roof of the mouth, wherein the two palates of the skull, responsible for making the roof, are unable to join. Such a condition results in speech and eating problems in kids, thus indirectly hampering the growth of the baby, as adequate nutrition supply to the body is choked. Such deformities can be only corrected with surgery, although sometimes numerous operations may be required. The attorney will take this and other side effects lawsuit related information into consideration when fighting for your rights.
It is important to note that the FDA waited for 14 years to issue a warning in this regard, which means that thousands of pregnant and expectant mothers have taken these drugs without knowing its impact on their fetus. This also means that, during these 14 years, the drug possibly caused hundreds of oral birth deformities. In other words, the drug is to be blamed for most of the babies born with cleft palate in these 14 years because their mothers unknowingly took the anticonvulsant drug. The FDA warning comes after the North American Antiepileptic Drug Pregnancy Registry data showed prevalence of a high rate of oral birth defects in babies whose mothers underwent topiramate therapy for epilepsy or migraine.
Other Birth Defect Causing Drugs
Besides topiramate, numerous other prescription drugs are known to cause birth defects. Such birth deformity causing drugs are also known as teratogens, which include Angiotensin II antagonist, thalidomide (Thalomid), isotretinoin (Accutane), lithium, warfarin (blood thinning drug), hormone diethylstilbestrol, and many anticonvulsant, cancer treatment, rheumatic, and thyroid medications.
Paxil, an antidepressant drug, was reported to be causing birth defects. Despite numerous complaints, GlaxoSmithKline did not issue any kind of warning for expectant mothers, which resulted in severe birth defects. A timely warning by the manufacturer could have saved hundreds of babies from developing birth deformities from side effects. Hundreds of lawsuits have been filed against GlaxoSmithKline.
SSRI antidepressants taken by pregnant ladies during the second half of their pregnancy period can cause persistent pulmonary hypertension in their newborns.
Anticonvulsant drug valproate causes a great side effects risk of birth deformity if taken during pregnancy.
Another antiepileptic drug Phenytoin used by pregnant women causes birth defects in their fetuses, such as heart malformation, cleft lip and palate.
Another anticonvulsant drug Depakote and its generic form Divalproex Sodium, known to treat conditions, such as epilepsy, bipolar disorder, should be avoided during the first trimester of pregnancy. These drugs are feared to cause facial dysmorphism, including cleft palate, facial asymmetries, cleft lip, ear deformations, and such birth deformities. Other antiseizure drugs, such as Neurontin and Tegretol, are also associated with suicide and birth defects, including brain damage, mental retardation, and even heart defects.
Antiepileptic drugs, such as Carbatrol, Epitol, Equetro, Tegretol, Lamictal, Di-Phen, Dilantin, and Phenytek are associated with birth deformities when fetuses are exposed to them during the first three months of pregnancy. Such babies have a higher chance of oral birth defects, such as cleft lip or cleft palate.
Zyban, smoking cessation drug known to decrease nicotine cravings, can cause heart defects in newborn babies if their mothers take the drug during pregnancy and heightens the risk of low birth weight, Persistent Pulmonary Hypertension, and respiratory distress. Long after the drug was known to cause malformations of the embryo or fetus in humans, its manufacturer continued to market it without label warnings about the same, which resulted in their continued use even by pregnant women. Side Effects Lawsuit Attorneys Can Help
Roche and Novartis are prescribed to organ transplant patients, but these are known to cause miscarriages and ear and mouth birth defects if used by pregnant women.
Cholesterol-lowering Statin is another drug pregnant women should refrain from during the first trimester of pregnancy. It is known to cause severe limb deformities and central nervous system defects.
Warfarin, Coumarins are known to cause major birth defects and fetal warfarin syndrome if taken during the first trimester of pregnancy.
Accutane, an effective drug to treat severe acne, is related with serious birth defects if taken during pregnancy. This can even cause miscarriage and birth deformities, such as visual impairment, mental retardation, facial malformations, hearing impairment. Such children require special medical treatment.
Clomid, Serphene, or clomiphene generic products are fertility medications that cause serious birth defects if mothers take these during their first three months of pregnancy; however, these do not carry sufficient warning labels to adequately inform expectant women about the side effects.
Earlier Topamax Lawsuit Settlements
In April 2010, two Johnson and Johnson subsidiaries, Ortho-McNeil Pharmaceutical LLC and Ortho-McNeil-Janssen Pharmaceuticals Inc., settled a lawsuit for $81 million to resolve criminal and civil liability issues for misbranding and illegally promoting Topamax for off-label psychiatric uses other than those approved by the FDA, including treatment for bipolar disorders, eating disorders, obesity, depression, sleep disorders, posttraumatic stress disorder, sleep-eating disorders, obsessive-compulsive disorder, alcoholism, smoking cessation, and cocaine dependence.
If your loved one is also suffering from a congenital birth defect caused by the use of these anticonvulsant drugs during pregnancy, we advise you to contact the lead firm handling these cases for Do I Have A Lawsuit by submitting your case via the submit my case link on this page. Johnson and Johnson/ Ortho-McNeil.