Topamax is an anticonvulsant drug used to treat epilepsy and migraine headaches. It is manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson and one of the most popular drugs available for treating epilepsy with sales peaking at $2.7 billion in 2008.
Despite the drug’s success, many users claim taking Topamax while pregnant caused them to give birth to babies with debilitating birth defects, and now Janssen and Johnson & Johnson are facing numerous lawsuits regarding the safety of the drug. There are also allegations the companies illegally marketed Topamax to doctors and consumers.
The FDA warning concerning Topamax came in 2011 after researchers published a report addressing the use of the drug during the first trimester of pregnancy. The study had shown pregnant users experienced a 21 times increase in having babies with cleft palette and lip. As a result of the study, the FDA assigned Topamax a D classification, meaning there was sufficient evidence proving the drug could harm developing babies if taken during pregnancy.
Another study compared Topamax use to other anti-seizure medications during pregnancy and found that the risk of oral defects when using Topamax was three times what is was for other medications. There were also instances in which the babies of Topamax users were born with heart, lung, and limb defects, as well as spina bifida, which occurs when the embryonic neural tube fails to close.
Other Common Side Effects of Topamax
In addition to giving birth to babies with birth defects, Topamax users experience a wide variety of other side effects ranging from mild to severe and including:
- Burning, prickling, or tingling sensations
- Clumsiness or unsteadiness
- Continuous eye rolling movements
- General slowing of mental and physical activity
- Menstrual pain or other changes related to menstruation
- Speech or language problems
- Difficult concentrating or paying attention, and memory problems
- Vision problems, especially blurred vision, double vision, eye pain, rapidly decreasing vision, eye pressure, and eye redness
- Increased fatigue, drowsiness, or weakness
- Abdominal or stomach pain
- Fever, chills, or sore throat
- Dulling of sensations or perception
- Loss of appetite and weight loss
- Mood or mental changes, including aggression, agitation, apathy, irritability, and mental Depression
- Red, irritated, or bleeding gums
There is an additional list of less frequently seen side effects that could also occur.
Topamax and Weight Loss
One of the reasons Topamax has been so profitable for Janssen and Johnson & Johnson is because the drug is frequently prescribed for its weight loss benefits. Weight loss is one of the most common side effects of the medication and is seen in 16% of adult users and 21% of child users. The drug is not approved by the FDA for weight loss, but many doctors have prescribed it off-label to patients for such purposes. Prescribing a drug off-label is a legal practice and quite common, but it is illegal for a drug’s manufacturer to market it for any off-label uses.
Though Topamax is prescribed off-label, many familiar with it do not consider it a good choice for weight loss because side effects are so plentiful. Many users find it difficult to tolerate the drug because it so frequently causes difficulty concentrating and memory loss. There are a few preliminary studies that show it could be effective for treating obesity in patients with type 2 diabetes, but researchers have ultimately concluded the risks are not worth the weight loss and health benefits for most people.
Many users of Topamax have filed lawsuits against Janssen and Johnson & Johnson after using the drug during pregnancy and experiencing side effects. There have also been allegations in lawsuits claiming the companies illegally marketed the drug.
In 2010, the companies paid more than $81 million to settle illegal marketing claims, admitting they marketed the drug for unapproved uses in the Doctor-for-a-Day program that utilized third party doctors to act as sales representatives.
Plaintiffs in the lawsuits against Janssen and Johnson & Johnson also claim the companies failed to alert consumers to the known dangers of using the drug, therefore breaching its legal duty and acting negligently. Plaintiffs claim that had they known of the dangers of using Topamax, they would have opted to take an alternative medication.
As a result of the problems users have had with Topamax, a number of lawsuits have been filed, many in state court in Philadelphia. Plaintiffs in these cases allege taking the drug during pregnancy contributed directly to the birth defects their children suffered.