Topamax Side Effects

Topamax side effects when taken during pregnancy may include birth defects such as cleft palate, cleft lip, and hypospadias genital defects.  Topamax lawsuits may help affected families.

Recent studies have indicated that taking the anticonvulsant drug Topamax during pregnancy may be associated with an increased risk of serious side effects, particularly major birth defects among infants exposed to the drug during pregnancy. Topamax is a prescription anticonvulsant medication currently manufactured by Ortho-McNeil Pharmaceutical, a subsidiary of Johnson & Johnson. Topamax has been available in the U.S. since 1996, when the FDA approved the drug for the treatment of epilepsy, particularly partial onset and generalized tonic-clonic seizures. In 2004, the FDA approved Topamax additionally for the prevention of migraine headaches. Topamax (topiramate) functions by inhibiting the firing of certain impulses in the brain which are responsible for causing seizures.

As new studies focus on the adverse effects of fetal exposure to anticonvulsant drugs like Topamax, these medications have become the subject of significant scrutiny in recent years. Researchers have identified Topamax use during pregnancy as a potential risk factor for the development of side effects among infants, some of which may even be life-threatening. After reviewing new data collected by the North American Antiepileptic Drug (NAAED) Pregnancy Registry, the FDA recently elevated the pregnancy category of Topamax from C to D. This means that there is positive human evidence of the drug's potential to cause serious fetal side effects when taken during pregnancy. If you took Topamax while pregnant and your child was born with a birth defect, fill out the Topamax Claim Review Form to discuss your claim with an experienced Topamax attorney.

Birth Defect Side Effects

In March 2011, the FDA issued a safety announcement warning patients and healthcare providers about the increased risk of side effects like cleft lip and cleft palate in children whose mothers take Topamax while pregnant. In light of this Topamax side effect information, the FDA has advised physicians to carefully consider all benefits and risks of Topamax before prescribing the drug to women of childbearing age, especially for conditions not typically associated with permanent injury or death. According to the FDA, alternative medications with a lower risk of birth defect side effects should be considered for these patients.

This FDA notice was largely influenced by data collected by the NAAED Pregnancy Registry, which indicated that infants born to women who took Topamax during the first trimester of pregnancy were an alarming twenty times more likely to develop cleft lip or cleft palate, compared to infants whose mothers received no anticonvulsant treatment. Another study published in the journal Neurology in 2008 concluded that infants whose mothers took Topamax while pregnant were eleven times more likely to develop cleft lip or cleft palate, and fourteen times more likely to develop genital defects like hypospadias, compared to the expected side effect rate among the general population.

Cleft Lip and Cleft Palate Side Effects

Cleft lip is characterized by a vertical fissure in one or both sides of the upper lip, which may even extend up through the nose in serious instances. This congenital malformation is caused by the failure of the upper lip to form properly in utero, caused by a lack of tissue in the lip area during fetal development. Cleft palate is similar in nature to cleft lip, but affects the child's palate, or roof of the mouth, instead. The severity of a cleft palate can range from a small opening in the back of the mouth to a large crevice in the palate. Both cleft lip and cleft palate can cause significant complications for an affected child, including feeding difficulties, dental problems, frequent ear infections, hearing loss, and speech and language delay.

Hypospadias Side Effects

Hypospadias is a genital birth defect involving the malformation of a male infant's genitals in utero. In children born with hypospadias, the opening of the urethra is located on the underside of the penis, rather than at the end. Cases of hypospadias can vary from minor, in which the opening is located near the end of the penis, to severe, in which the opening is located at the mid-shaft or base of the penis, or even in or behind the scrotum. Infants born with hypospadias are likely to struggle with serious complications, including problems during urination, a malformed foreskin making the penis look hooded, a curvature of the penis, and difficulties during toilet training and sexual intercourse later in life.

Topamax Attorneys for Side Effect Help

Due to new information about potential Topamax side effects, the FDA advises that, if the decision is made to use Topamax in women of childbearing age, effective birth control be used. Birth defects like cleft lip, cleft palate and hypospadias occur during the first trimester of pregnancy, before many women are even aware they are pregnant. This means that all women of childbearing age taking Topamax may be at risk of suffering significant side effects, including unknowingly causing irreversible harm to their unborn child. If you or a loved one has suffered from a serious side effect which you believe to be associated with the use of Topamax, fill out the Topamax Claim Review Form to discuss your claim with an experienced Topamax attorney. You may be entitled to financial compensation for your injuries and medical expenses, which you can collect by filing a Topamax lawsuit against Ortho-McNeil Pharmaceutical (Johnson & Johnson) with the help of a Topamax lawyer.






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