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Topamax is an anticonvulsant drug used to treat epilepsy and migraines, manufactured by Janssen Pharmaceuticals. Janssen and parent company, Johnson & Johnson, have faced multiple Topamax lawsuits for birth defects and other side effects caused by Topamax.
Topamax is an anticonvulsant drug used to treat epilepsy and migraine headaches. It is manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson and is one of the most popular drugs available for treating epilepsy. It has also been used “off-label” for bipolar disorder and other mental health conditions.
|Manufacturer||Janssen Pharmaceuticals, division of Johnson & Johnson|
|Dosage form(s)||25mg tablet|
15mg sprinkle capsule
25mg sprinkle capsule
10mg/5ml oral suspension
|Normal dosage||200 to 400mg/day in divided doses|
Pediatric dosing by weight
Topamax is approved for:
- Monotherapy for Epilepsy with partial or generalized tonic-clonic seizures in adults and children age 2 and up
- Adjunctive therapy for Epilepsy with partial or generalized tonic-clonic seizures in adults and children age 2 and up and in seizures associated with Lennox-Gastaut syndrome
- Prophylaxis of Migraine in adults and adolescents age 12 and up
Topamax has also been used “off-label” for the treatment of bipolar disorder, neuropathic pain, refractory depression and other conditions. Medications may be used off-label for conditions which have not been approved by the U.S. Food and Drug Administration (FDA), but manufacturers are prohibited from marketing or advertising drugs for off-label purposes.
Despite the drug’s success, many users claim taking Topamax while pregnant caused them to give birth to babies with debilitating birth defects, and Janssen and Johnson & Johnson have faced numerous lawsuits regarding the safety of the drug. There have also been allegations the companies illegally marketed Topamax to doctors and consumers.
Topamax Side Effects
All medications may cause side effects, most of which are mild to moderate and may go away with time. Other Topamax side effects may be more severe or serious.
Common Topamax side effects include:
- Burning, prickling, or tingling sensations
- Decreased sensitivity in skin
- Difficulty with memory
- Slowed thinking
- Lack of appetite
- Change in the way foods taste
- Nausea or abdominal pain
- Speech problems
- Tiredness or drowsiness
- Clumsiness or unsteadiness
More severe side effects include:
- Eye and vision problems including angle-closure glaucoma
- Eye pain
- Blurry vision
- Double vision
- Decreased sweating and increased body temperature (fever)
- Metabolic acidosis
- Loss of appetite
- Changes in heartbeat
- Mental confusion
- Suicidal thoughts or actions
- Anxiety or irritability
- Aggressive behavior
- Panic attacks
- Birth defects
Sudden or worsening symptoms should be reported to a medical professional right away.
In 2011, the FDA issued a warning concerning Topamax 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 Pregnancy Category D classification. Category D indicates there is sufficient evidence proving the drug could harm developing babies if taken during pregnancy.
A separate study compared Topamax to other anti-seizure medications used during pregnancy and found that the risk of oral defects like cleft lip or palate was three times greater when using Topamax than for other medications. Other birth defect reports indicated babies whose mothers had taken Topamax were born with heart, lung, limb and neural tube defects.
Birth defects caused by Topamax have included:
- Cleft palate or lip
- Limb malformations
- Low birth weight
- Heart defects
- Spina bifida
- Neural tube defects
- Lung defects
- Persistent Pulmonary Hypertension of the Newborn (PPHN)
- Fetal death
The FDA has advised that alternative medications that have a lower risk of birth defects should be considered.
Topamax and Weight Loss
Topamax has been highly profitable for Janssen and Johnson & Johnson, possibly in part because unlike many other medications for mental and nervous system disorders which cause weight gain, Topamax may be prescribed for its weight loss benefits. Weight loss is one of the most common side effects of the medication, 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 in combination with other medications or dietary changes. Prescribing a drug off-label is a common practice allowed by law, but it is illegal for a drug’s manufacturer to market it for any off-label uses.
Though Topamax was investigated for treating obesity in patients with type 2 diabetes and is still prescribed off-label for its weight-loss properties, researchers have ultimately concluded the risks are not worth the weight loss and health benefits for most people.
Topamax Lawsuit Settlements
Many users of Topamax have filed lawsuits against Janssen and Johnson & Johnson after using the drug during pregnancy and experiencing birth defects of their babies or after experiencing other severe side effects. 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.
In 2010, Janssen and Johnson & Johnson 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.
By 2013, more than 200 cases had been filed in local, state and federal courts in Philadelphia and around the country. Two plaintiffs were awarded $4 million and $11 million in decisions which were upheld on appeal. Ultimately, Janssen agreed to settle the cases for an undisclosed amount.
No further lawsuit settlements or dispositions have been publicly announced but as Topamax or topiramate is still a popular medication which may cause injury or harm, Topamax attorneys and lawyers will remain watchful.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.
- Topamax Prescribing Information, RxList (12/2018)
- FDA Drug Safety Communication: Risk of oral clefts in children born to mothers taking Topamax (topiramate), FDA (3/2011)
- Two Johnson & Johnson Subsidiaries to Pay Over $81 Million to Resolve Allegations of Off-Label Promotion of Topamax, U.S. DOJ (4/2010)
- ORTHO-McNEIL PHARMACEUTICAL, LLC PLEADS GUILTY TO ILLEGAL PROMOTION OF TOPAMAX AND IS SENTENCED TO CRIMINAL FINE OF $6.14 Million, U.S. Department of Justice (5/2010)