Topamax Lawsuit Lawyer
Please note: Our law firm no longer accepts Topamax cases.
Topamax taken during pregnancy can cause birth defects that include heart, lung and brain abnormalities, along with cleft palate, cleft lip, and other serious health problems. Cleft abnormalities can occur when parts of the soft and hard palate fail to properly fuse together. A notched lip can result. More severe cases can leave an open groove extending from the nose to the roof of the mouth. A New York Times story in March 2011 detailed FDA warnings of Topamax raising the risk of birth defects.
Topamax Recall Information
On April 14, 2011, Ortho-McNeil Neurologics, a division of Johnson & Johnson, the maker of Topamax, recalled roughly 57,000 bottles of the drug after reports that an unusual odor emanated from the pills. WebMD reported that the odor apparently derived from a compound known as TBA, a byproduct of a chemical used to treat wood. That treated wood is used to construct pallets made to transport or store products.
FDA Warnings for Topamax
The FDA on May 15, 2011 issued a warning about the potential danger of Topamax causing birth defects. The FDA mandated that the manufacturer of Topamax alter its label to warn that women who may become pregnant while taking the drug stand at greater risk of delivering a baby with possible Topamax-related birth defects.
What is Topamax?
Topamax is a drug approved by the FDA to treat seizures or epilepsy in both children and adults. It may be taken alone, or it may sometimes be taken in conjunction with other anticonvulsant drugs. Topamax has also been approved by the FDA for use in migraine headache treatment.
- goes by the generic name topiramate®.
- contains the active ingredient topiramate
- was originally approved December 24, 1996
- is manufactured by Ortho-McNeil Pharmaceutical, Inc.
- is approved for the treatment of epileptic seizures and migraine headaches
Off –label Uses of Topamax
Despite severe side effects related to the use of Topamax, many users take the drug for —
- bipolar disorder
- eating disorder
- post traumatic stress disorder (PTSD)
Topamax Side Effects
While Topamax may be effective in the treatment of epilepsy or migraine headaches, side effects associated with the drug can be severe. They include:
- cleft palate
- cleft lip
- heart defects
- lung defects
- brain defects
- arm and limb defects
- Sleepiness, Fatigue, Lethargy
- See other Topamax side effects here
Topamax FDA Alerts
In May 2011 the FDA released an alert regarding the potential link between Topamax and birth defects.
Further Information Topamax Litigation
We also would like to update Topamax clients regarding the investigation and pursuit of your Topamax claim if you have one. We initially must obtain all pertinent medical records so as to allow our Birth Defect Medical Review Team to verify the time period you ingested the drug and whether this occurred during a period in your pregnancy which could have resulted in your child’s injury. Our Birth Defect Medical Review Team will also review the medical records to determine if there may be some other credible cause for your child’s injures. This is a very arduous process, as it requires a detailed review of many records which often leads to the ordering of additional records for review. After this process has been completed, your case will be reviewed by the attorneys, in consultation with scientific and medical experts. If it is determined that you have, in our opinion, a meritorious case against the drug maker, we expect to file a lawsuit for you and your child.
In this lawsuit we will assert that the drug maker is liable for injuries and damages suffered by you and your child because it failed to warn you, your physician, and others that the ingestion of the drug by you during your pregnancy could result in the injuries inflicted upon your child. Currently, our Birth Defect Litigation Team is actively involved in pending lawsuits for other clients like you over this drug. We are aggressively pursuing discovery of the drug maker’s documents, files, records, internal communications and scientific information which we believe will demonstrate the drug maker knew or should have known of the risks of its drug and failed to advise the FDA, you, and your physician of such risks. Of course, we anticipate and are ready for a hard fought battle between our firms and the drug maker.