After alarming study findings, Food and Drug Administration (FDA) warnings, and a recent drug recall, Topamax lawsuits are currently being prepared to recover damages for those who have suffered Topamax birth defects.
Cleft palate and cleft lip are two of the most devastating Topamax side effects. Both are serious birth defects that occur when part of the lip and palate fail to completely fuse together. Problems include a small notch in the lip to a complete groove that goes into the roof of the mouth and nose. These birth defects result in problems with eating and communicating, and can even increase the risk of ear infections in newborns.
Additional Topamax side effects are numbness and tingling. Known as paresthesia, it is the most common side effect. Other side effects include: fatigue; taste change; weight loss; difficulty with attention, concentration, and memory; serious eye problems; loss of appetite; increased risk of kidney stones; upper respiratory tract infections; diarrhea; and nausea. More seriously, irregular heartbeat, decreased sweating and increased body temperature, and suicidal thoughts have also been identified as possible Topamax side effects.
In a scientific study published in Neurology in 2008, researchers conducted a study of 203 women with epilepsy who became pregnant while taking Topamax. Out of the 168 babies born, 16 had major birth defects. The rate of oral clefts in the study was 11 times higher than the general population. It can only be concluded that Topamax and pregnancy are a dangerous combination.
On March 4, 2011, the FDA issued a warning that women who have used Topamax during pregnancy are more likely to have infants with birth defects, including cleft palate, cleft lip, and other facial malformations. The FDA cited figures from the NAAED Pregnancy Registry, and recommended that all women who took Topamax during pregnancy, and any health care professional aware of any birth defect related to the drug, report these problems to the registry, and to the FDA.
Further, Ortho-McNeil-Janssen Pharmaceuticals, Inc., announced on April 14, 2011, that it has voluntarily recalled two lots of Topamax. The Topamax recall involves approximately 57,000 bottles of the drug. However, Ortho-McNeil believes that fewer than 6,000 bottles remain in the marketplace. This recall is based on consumer reports of an uncharacteristic odor that is thought to be caused by TBA, a byproduct of a chemical preservative applied to wood often used in the construction of pallets on which products are transferred and stored.
Topamax (topiramate) is one of the bestselling drugs in the United States. It is produced by Ortho-McNeil Neurologics, and Noramco, Inc., both divisions of Johnson & Johnson. Topamax was approved by the FDA on December 24, 1996, to treat total and partial seizures resulting from epilepsy. Since then, more than four million people have been treated with Topamax.
In 2004, Topamax was also approved as a migraine preventative. Today, Topamax is the number one prescribed brand for migraine prevention in the United States.
In 2003, Johnson & Johnson subsidiaries Ortho-McNeil Pharmaceuticals and Ortho-McNeil-Janssen Pharmaceuticals, Inc., were alleged to be illegally marketing Topamax for off-label use. The FDA found that the makers of Topamax had hired speakers, and were attempting to persuade doctors to use the medicine as a treatment for bipolar disorder and alcohol dependence. Topamax was not approved by the FDA for treatment of either of those conditions.
In 2010, Johnson & Johnson and Ortho-McNeil agreed to pay $81 million to settle federal charges that it improperly marketed Topamax for unapproved purposes.
Initially, the FDA classified Topamax as a Category C drug, which means there is a risk of harm to the fetus if the drug is taken during pregnancy, but the benefits may outweigh the risk. It was marketed heavily to men and women regardless of their age and/or ability to conceive children.
As of March 2011, based on studies that showed evidence of Topamax birth defects, the drug is now classified as Category D by the FDA. This means that studies have indicated fetal risk, but the drug may still be prescribed if the potential benefits far outweigh the known risks, or if there is a life-threatening situation for which no other drug will be effective. This escalation in category is further indication that Topamax and pregnancy can result in fetal harm.
If you took Topamax during pregnancy, and your child was born with a cleft palate or cleft lip, you may be eligible to participate in an Oklahoma Topamax lawsuit to receive compensation for medical bills and other damages. Medical treatment for your child’s birth defects may be very expensive, and several surgeries may be required. For example, a cleft palate typically requires several surgeries performed over the course of 18 years.
McIntyre Law is currently helping families affected by Topamax birth defects. We are experienced birth injury lawyers. If your child is suffering from Topamax birth defects, please contact us for a free, no-obligation consultation.
We are now accepting Topamax lawsuit cases nationwide in:
Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming.
If you’ve never taken Topamax, you should know that there are several other drugs that have been recalled, and have caused injury to many people. The McIntyre Law team is involved in helping people with several of these drug lawsuits. Please see our other drug information pages to find out if you are affected by any other drug recall: