Topamax Lawsuits: Cleft Palates
The Food and Drug Administration has notified health care professionals and patients of an increased risk of development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with Topamax (topiramate) during pregnancy. There may be a Topamax lawsuit starting for people injured from taking Topamax.
The agency said the notification was issued because of new human data that show an increased risk for oral clefts and therefore Topamax is being 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.
NEWS: April 14, 2011: Topamax Recall now in effect.
Johnson & Johnson has issued a RECALL of 57,000 bottles of Topamax due to customer complaints of bad odor. Two lots of Topamax 100 mg tablets distributed between Oct 19, 2010 through Dec. 28, 2010 in both the US and Puerto Rico.
FDA Warning for Topamax
The FDA said the patient medication guide and prescribing information for Topamax and generic topiramate will be updated with the new information.
Topamax is an anticonvulsant medication approved for use alone or with other medications to treat patients with epilepsy who have certain types of seizures. Topamax is also approved for use to prevent migraine headaches. The new data was from the North American Antiepileptic Drug (NAAED) Pregnancy Registry.
The FDA recommended that pregnant women and women of childbearing potential should discuss other treatment options with their health care professionals before starting topiramate. Women taking topiramate should tell their health care professional immediately if they are planning to or become pregnant. Patients taking topiramate should not stop taking it unless told to do so by their health care professional.
The FDA said women who become pregnant while taking topiramate should talk to their health care professional about registering with the North American Antiepileptic Drug Pregnancy Registry, a group that collects information about outcomes in infants born to women treated with antiepileptic drugs during pregnancy.
Topamax Birth Injuries may include:
- cleft palate
- cleft lip
- heart defects
- lung defects
- cranial defects
- limb defects
"The benefits and the risks of topiramate should be carefully weighed when prescribing this drug to women of childbearing age, particularly for conditions not usually associated with permanent injury or death",The FDA said in its announcement. "Alternative medications that have a lower risk of oral clefts and other adverse birth outcomes should be considered for these patients. If the decision is made to use topiramate in women of childbearing age, effective birth control should be used. Oral clefts occur in the first trimester of pregnancy before many women know they are pregnant."
Topamax was previously classified as a Pregnancy Category C drug, which means 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, the agency said.
"However, because of new human data that show an increased risk for oral clefts, topiramate is being 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,"the agency said.
The FDA also provided this additional Topamax Information for Patients:
- If you take Topamax during pregnancy, there is a higher risk that your baby will develop a cleft lip and/or cleft palate. Oral clefts happen early in pregnancy, before many women even know they are pregnant. For this reason, women of childbearing age should talk to their healthcare professionals about other treatment options.
- Women of childbearing age who do decide to take topiramate and are not planning a pregnancy should use effective birth control (contraception) while taking Topamax. Women should talk to their health care professionals about the best kind of birth control to use while taking topiramate.
- Before you start Topamax, you should tell your health care professional if you are pregnant or are planning to become pregnant. Health care professionals may discuss other treatment options with you.
- You should tell your health care professional right away if you become pregnant while taking Topamax. You and your health care provider should decide if you will continue to take topiramate while you are pregnant.
- Topamaxe should not be stopped without talking to a health care professional, even in pregnant women. Stopping topiramate suddenly can cause serious problems. Not treating epilepsy during pregnancy can be harmful to women and their developing babies.
- If you become pregnant while taking Topamax, you should talk to your healthcare professional about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect additional information about the safety of antiepileptic drugs during pregnancy. Information about the North American Drug Pregnancy Registry can be found at http://www.massgeneral.org/aed/1.
- Topamax passes into breast milk, but its effects on developing babies remain unknown. You should talk to your health care professional about the best way to feed your baby if you take topiramate.
- You should report any side effects you experience to the FDA MedWatch program using the information in the "Contact Us" box at the bottom of the page.
- You should read the Medication Guide when picking up a prescription for Topamax. It will help you understand the potential risks and benefits of this medication.