Topamax Lawsuits
TOPAMAX®
You can join the ongoing lawsuit against the manufacturer of Topamax® by contacting our law firm. We are representing clients nationwide.
Topamax® (topiramate) is used alone or with other medications to treat seizures in people who have epilepsy. Topamax® is also used with other medications to control seizures in people who have Lennox-Gastaut syndrome (a disorder that causes seizures and developmental delays). Topamax®is used to treat patients who continue to have seizures even when they take other anti-seizure medications. Topamax® is also used to prevent migraine headaches, but not to relieve the pain of migraine headaches when they occur. Topamax® is in a class of medications called anticonvulsants. It works by decreasing abnormal excitement in the brain.
Antiepileptic drugs (AEDs) such as Topamax® are widely used as long-term adjunctive therapy or as monotherapy in epilepsy. Several AEDs including Topamax® are also increasingly used in other indications as psychiatry, neuropathic pain and migraine. Topamax® has also been used for anger control, posttraumatic stress disorder (PTSD)-associated nightmares, adiposopathy ('sick fat') and metabolic disease, self-injurious skin-pricking, essential tremor, cluster headaches and even alcoholism.
FDA WARNING
The Food and Drug Administration has warned the public of an increased risk of cleft lip and cleft palate in infants born to women treated with Topamax during pregnancy. This warning about serious adverse side effects to unborn children from the drug Topamax will have a definite impact on litigation.
Ortho-McNeil's Topamax is approved by the FDA for the treatment of epilepsy and migraines. It was reported that the incidences of cleft lip and cleft palate are 21 times the normal rate of those birth defects.
In March, the FDA issued a warning letter and placed Topamax in Pregnancy Category D, meaning that pregnant women who take the drug are at high risk for developing serious birth defects. Both Topamax and its generic alternatives have been widely promoted for "off" label uses like weight loss and alcohol and drug dependency. As a result, it's difficult to know exactly how many people actually used the drug. There are about a dozen generic manufacturers of this drug, Manufacturers are spread across the United States in states that include Florida, New Jersey and West Virginia.
Last year, Ortho McNeil's parent company, Johnson & Johnson, pled guilty to a misdemeanor under the Food, Drug and Cosmetic Act and paid a $6.14 million criminal fine for promoting the off-label use of the drug for non-approved uses such as weight loss, alcohol dependence, eating disorders and mood and anxiety disorders. In addition. another subsidiary of the company agreed to pay more than $75 million in a False Claims Act suit alleging it illegally promoted Topamax and caused false claims to be submitted to the government for unapproved uses.
EPILEPSY AND PREGNANCY
March 2011 Fetal Toxicity: Topamax® use during pregnancy can cause cleft lip and/or palate
Each year 25,000 children are born to women with epilepsy in the USA. March 3, 2011, the FDA informed the public that there is an increased risk for the development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with Topamax® and generic products during pregnancy.
Topamax® was previously classified as a Pregnancy Category C drug, meaning that data from animal studies suggested potential fetal risks, but no adequate data from human clinical trials or studies were available at the time of approval. However, because new human data show an increased risk for oral clefts, Topamax® has been placed in 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.
Topamax® can cause fetal harm when administered to a pregnant woman.
Data from pregnancy registries indicate that infants exposed to topiramate in utero have an increased risk for cleft lip and/or cleft palate (oral clefts). When multiple species of pregnant animals received topiramate at clinically relevant doses, structural malformations, including craniofacial defects, and reduced fetal weights occurred in offspring.
TOPAMAX® AND ORAL CONTRACEPTIVES
Oral contraceptives: Decreased contraceptive efficacy and increased breakthrough bleeding should be considered, especially at doses greater than 200 mg/day. The possibility of decreased contraceptive efficacy and increased breakthrough bleeding should be considered in patients taking combination oral contraceptive products with Topamax®. Patients taking estrogen-containing contraceptives should be asked to report any change in their bleeding patterns. Contraceptive efficacy can be decreased even in the absence of breakthrough bleeding. In summary, oral contraceptive failure rates are high among women taking enzyme-inducing AEDs.
If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.
Consult your health care provider before making any medical or health related decisions about Topamax® use.
