Important Warnings About Topamax and Diflucan
- April 3, 2021 @ 12:34 pm
- Written by admingil
- Categories: Birth Defects | Drug Injuries | Medical Malpractice
Have You, a Loved One, or Friend Used Topamax During Pregnancy?
Birth defects happen for a variety of reasons. Sometimes, prescription medications are the cause of the birth defect. If you have taken Topamax during pregnancy and your baby has a birth defect, John Bales Attorneys would like to help you!
The U.S. Food and Drug Administration issued a warning, several years ago, about the drug Topamax and its generic versions, saying that new data suggests the drug increases the risk of birth defects. The FDA’s warning came after recently released data showed that women taking the drug while pregnant were more likely to give birth to a child with cleft lip or cleft palate deformities.
Topamax (its generic name is topiramate) is prescribed to treat certain types of seizures in people who have epilepsy. The FDA says health care professionals should warn patients of childbearing age about the potential hazard to the fetus of a woman who becomes pregnant while using the drug.
Dr. Russe Katz, the director of the Division of Neurology Product in the FDA’s Center for Drug Evaluation and Research, said, “Health care professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age. Alternative medications that have a lower risk of birth defects should be considered.”
Cleft lip and cleft palate are birth defects that occur when part of the lip or palate do not completely fuse together early in the first trimester of pregnancy, a time when many women do not know they are pregnant, according to the FDA. The defects range from a small notch in the lip to a groove that runs into the roof of the mouth and nose, possibly leading to problems with eating and talking and ear infections. Surgery is often performed to close the lip and palate, and, the FDA says, most children do well after surgery.
The FDA says data from the North American Antiepileptic Pregnancy Registry indicate an increased risk of oral clefts in infants exposed to topiramate during the first trimester of pregnancy. Infants exposed to topiramate as a single therapy experienced a 1.4 percent prevalence of oral clefts, compared with a prevalence of 0.38 percent-0.55 percent in infants exposed to other antiepileptic drugs.
Based on the data, topiramate will have a stronger warning in its labeling information. The patient medication guide and prescribing information for Topamax and generic topiramate will be updated with new information.
The FDA recommends that before taking topiramate, pregnant women and women of childbearing potential should discuss other treatment options with their health care professional. Women taking topiramate should tell their health care professional immediately if they are planning to become pregnant or become pregnant. The agency also says that patients taking topiramate should not stop taking it unless told to do so by their health care professional.
If you or a loved one took Topamax during pregnancy and gave birth to a child with cleft lip, cleft palate or any other deformity, contact the attorneys at John Bales Attorneys to learn more about your legal rights. You can reach us by calling our toll free number, 1-800-CallJohn (1-813-337-6274) 24 hours a day, 7 days a week. Or you can complete a FREE online case evaluation form by clicking here.
FDA Issues Notification on Antifungal Drug
The U.S Food and Drug Administration issued a notification, several years ago, that we at John Bales Attorneys think the public should be reminded of.
The FDA says that the antifungal drug Diflucan (its generic name is fluconazole), taken in chronic, high doses of 400-800 milligrams a day may be associated with a rare and distinct set of birth defects in infants whose mothers were treated with the drug during the first trimester of pregnancy.
The agency says this risk does not appear to be associated with a single, low dose (150 mg) of the drug that is prescribed to treat vaginal yeast infection.
There are several published case reports of birth defects in infants whose mothers were treated with high doses of fluconazole (400-800 mg/day) for serious and life-threatening fungal infections during most or all of the first trimester.
The FDA says Healthcare professionals should be aware of the potential risks with long-term, high-dose use of fluconazole and counsel patients if the drug is used during pregnancy, or if a patient becomes pregnant while taking the drug.
If you or a loved one has taken fluconazole, contact a John Bales Florida drug injury attorney today. Complete a FREE Online Consultation Form or call us toll free 1-800-CALL JOHN (1-813-337-6274) 24 hours, 7 days a week.