Today’s post comes from guest author Brenda Fulmer from Pasternack Tilker Ziegler Walsh Stanton & Romano.
Topamax, also known as topiramate, was originally approved by the Food & Drug Administration (FDA) for the treatment of seizures in epileptic patients. However, it is often prescribed “off-label” for weight loss, chronic pain, headaches, alcoholism, bulimia, and psychiatric conditions. Off-label use of medications is controversial, but not illegal.
A drug company is only permitted to market its drugs for uses that are part of the warning label and for indications for which the FDA has approved the drug after reviewing available safety data. Many pharmaceutical manufacturers, however, have faced civil and criminal penalties over the last decade for also promoting their drugs for uses for which they have not been approved by the FDA and for which they have failed to provide adequate safety information. Many physicians are unaware of the lack of safety data to support a number of off-label uses of medications, which has resulted in harm to patients.
Recently, Topamax has been linked to birth defects in children.
Topamax has been the subject of safety concerns for many years, especially since most of the prescriptions written for the drug are for use for conditions for which it has never been approved by the FDA.
Shortly after the drug first went on the market in the United States, its warning label had to be updated to warn prescribing physicians and patients of the drug’s potential to cause glaucoma, an increase pressure in the eye which can lead to impaired vision and even blindness.
More recently, Topamax has been linked to birth defects in children. The FDA issued a press release to alert expectant mothers regarding the increased risks of taking Topamax during pregnancy, after determining that topiramate increased the risk of infants being born with oral clefts – clip lip and/or cleft palate. In its Safety Alert, the FDA stated the following:
- Before a patient starts taking topiramate, they should tell their doctor if they are pregnant or if they are planning to become pregnant.
- Patients should tell their doctor right away if they become pregnant while taking topiramate.
- A patient should read the medication guide when picking up a prescription for topiramate because it will help a patient understand the potential risks and benefits of this medication.
- Patients should not cease taking topiramate without talking to a doctor because it can cause serious problems.
While almost every type of prescription drug carries the possible risk of side effects, it is important to be aware of the nature of those side effects and the frequency at which they occur, as it is critical that all patients be able to have the information necessary to accurately weigh the risks of a drug versus the benefits to be gained.
Women who are pregnant or who may become pregnant need to also be aware of the FDA’s Pregnancy Category assigned to each medication that they take on a regular basis, as this categorization helps to determine the strength of any relationship between ingestion of a particular drug and harmful effects on a growing fetus. Anyone taking Topamax (topiramate) should reassess on a regular basis with their physician whether use of the drug for their condition is supported by the FDA approved warning label or solid scientific evidence.
Further, any expectant mother or one who might be planning to get pregnant needs to undergo a thorough evaluation of the special risks posed by their medications on their child, preferably before becoming pregnant, so that appropriate adjustments can be made to medications that will provide sufficient benefits to the mother without causing unnecessary risk of birth defects and other harm to the unborn child.
Brenda Fulmer is a shareholder at the law firm Searcy Denney Scarola Barnhart & Shipley in West Palm Beach and partners with Pasternack Tilker Ziegler Walsh Stanton & Romano in the litigation of drug and pharmaceutical mass tort cases. Ms. Fulmer graduated from the University of South Florida with a B.S. in Finance, and received her Juris Doctor degree cum laude from Stetson University College of Law. For the past 17 years, she has represented thousands of mass torts plaintiffs in both state and federal courts who have been injured by defective medical devices and drugs.