The U.S. Food & Drug Administration (FDA) first approved Topamax for treatment of epilepsy in 1996. The regulatory agency expanded the drug’s uses to include migraine prevention in 2004.
Throughout the next seven years, the FDA added several warnings to the drug’s label, including increased risks for high levels of acid in the blood, eye disorders that could lead to permanent vision loss, and suicidal thoughts and behaviors.
In 2011, the agency warned of Topamax’s link to birth defects and injured users began suing the drug’s manufacturer. Also in 2011, J&J recalled 57,000 bottles of Topamax because of possible chemical contamination.
Johnson & Johnson said it recalled tens of thousands of Topamax bottles after consumers complained about a strange odor coming from the medicine.
According to Bloomberg News, Topamax controlled 21 percent of the $10.2 billion epilepsy drug market in 2007. Topamax sales reached $2.7 billion in 2008. However, Topamax lost its patent protection in 2009 and sales dropped to $1.15 billion.
Current FBI director Christopher A. Wray represented Topamax manufacturers in federal lawsuits over “off-label” marketing of the drug. The prosecution resulted in an $81 million fine in 2010, and the companies agreed to stop promoting Topamax illegally.
Today, Janssen continues to sell Topamax in the U.S. at a price of nearly $100 for sixty 15 mg oral capsules.
Topamax and Seizures
During a seizure, brain cells are forced to work much faster than they normally would. Topamax is designed to stop seizures when they first begin by preventing brain cells from working in overdrive.
Topamax gained FDA approval in 1996 for treatment of epilepsy, a neurological disorder characterized by recurrent, uncontrolled seizures. Doctors also prescribe the medicine for patients 2 years or older whose seizures are associated with Lennox-Gastaut syndrome, a disorder that accounts for up to 10 percent of all cases of childhood epilepsy. Topamax is not approved for use in children younger than 2 years of age.
The FDA approved Topamax for use by itself or with other medications to treat:
- Partial onset seizures
- Primary generalized tonic-clonic seizures
- Seizures associated with Lennox-Gastaut syndrome
Topamax and Migraines
In 2004, the FDA approved Topamax for the prevention of migraine headaches in people 12 years of age and older. Topamax does not relieve the pain of a migraine after it starts, but it is believed to reduce migraine frequency by calming overactive pain-signal firing in nerve cells.
Topamax’s manufacturers recommend doctors “start low and grow slow” when prescribing Topamax. This means a doctor will likely prescribe a low dose to start and then slowly increase the amount of Topamax a patient takes until reaching the dosage that works best for the patient.
The Right Topamax Level
It takes time for Topamax to build up to the right level in the bloodstream. It may take two to three months of daily Topamax use for the medication to start working.
Off-Label Uses of Topamax
In mid-2010, Topamax manufacturers admitted to misbranding and illegally marketing the drug for several unapproved, or off-label, uses, including bipolar disorder, alcohol dependency, cocaine and methamphetamine addiction, obsessive-compulsive disorder, borderline personality disorder and post-traumatic stress disorder.
Under a plea agreement with the U.S. Department of Justice, the J&J subsidiaries agreed to pay fines of $81.5 million for promoting Topamax for off-label uses, misbranding and illegally marketing the drug, and causing false claims about it to be submitted to government health programs. The federal government received $50.69 million, state Medicaid programs shared $24.68 million, and three whistleblowers received the rest.
The U.S. Department of Justice says Topamax manufacturers misbranded the drug and illegally marketed it for psychiatric uses.
According to federal investigators, makers of Topamax paid doctors as much as $3,000 a day plus expenses to visit their colleagues and talk to them about off-label Topamax uses. Court records show one doctor received $500,000 for meeting with doctors 200 times.
The program called “Doctors-for-a-Day” allowed drug officials to engage in off-market labeling by enlisting doctors to join sales representatives in visiting other doctors. Company documents show drug executives told physicians that their colleagues “can talk to you about things I can’t talk to you about,” Bloomberg News reported.
“This case should send a strong reminder that the off- label promotion of pharmaceuticals is illegal, whether it is done directly by company employees or through programs such as the doctor for a day program,”
- U.S. Attorney Carmen Ortiz, Bloomberg News
Topamax and Weight Loss
Topamax is also used to control binging and purging, and to promote weight loss. However, this is not an FDA-approved use. Although it is illegal for drug makers to promote drugs for off-label uses, doctors can legally prescribe any drug they consider appropriate to treat a patient’s condition.
Doctors may prescribe Topamax off-label to help patients lose weight.
Topiramate, the active ingredient in Topamax, is also a main ingredient in the weight-loss drug Qsymia. The FDA approved Qsymia in 2012. A year earlier, the same drug — then called Qnexa — was rejected by the FDA because of the adverse side effects of its topiramate component.
The FDA label warns Qsymia may cause mood and sleep disorders, cognitive impairment and increased heart rate. It could also lead to suicidal thoughts, and people who suddenly stop taking it can suffer seizures.
Side Effects of Topamax
Janssen maintains that Topamax is safe when used as indicated. The drug has a number of common side effects, which its manufacturer claims to be “mild to moderate.” One common side effect of the drug is somnolence, or sleepiness. Some doctors and patients have dubbed the drug “Sleepomax” because of its heavy sedative effects.
Commonly reported side effects with Topamax include:
- Weight loss
- Upper respiratory tract infection
- Burning or prickling in the hands, arms, legs and feet (paresthesia)
- Psychomotor slowing
- Loss of appetite
- Taste change
- Speech disorders/related speech problems
- Abdominal pain
- Numbness (hypoesthesia)
- Abnormal vision
- Difficulty with memory
What are the Serious Side Effects of Topamax?
Over the years, post-market studies have revealed several much more serious health risks associated with Topamx. In response, the FDA has continually mandated that all topiramate labels and medication guides contain updated warnings and precautions associated with its use.
Timeline of FDA Topamax Warnings:
FDA required a warning about metabolic acidosis (an increase in the level of acid in the blood); oligohydrosis (decreased sweating); and hyperthermia (increased body temperature)
FDA required a warning about serious eye disorders, such as acute myopia and secondary angle closure glaucoma, which can lead to permanent visual loss
FDA required a warning about increased risk of suicidal thoughts and behaviors
FDA required a warning about the risks of oral birth defects and changed Topamax’s classification from pregnancy category “C” to “D,” which means there is evidence of fetal risk among humans
Topamax’s label also includes warnings for confusion, psychomotor slowing, difficulty with concentration/attention, and difficulty with memory, speech or language problems (difficulty finding words). Other Topamax side effects include depression or mood problems; excess of ammonia in the blood; brain disease that alters brain function or structure; kidney stones and hypothermia.
Topamax Drug Interactions
The body digests Topamax in the liver and eliminates it from the body through the kidneys. People with liver disease and people with a history of kidney stones must be cautious about taking the drug. Taking other medicines that are digested in liver at the same time as Topamax may affect how quickly the drug works and leaves the body.
Birth control pills may not prevent pregnancy in women who also take Topamax.
The body gets rid of Topamax faster if taken at the same time as certain seizure medicines, including carbamazepine (Tegretol, Tegretol XR, Carbatrol), phenytoin (Dilantin, Phenytek), phenobarbital and primidone. Taking Topamax with valporic acid (Depakote and Depakene) has been associated with hypothermia and hyperammonemia.
Topamax makes birth control pills less effective, so the chances of becoming pregnant while on Topamax are greater. If a woman takes Topamax while pregnant, her baby has a higher risk for birth defects called clef lip and cleft palate.
People should not drink alcohol or take sedatives or tranquilizers, such as Valium, Xanax, while taking Topamax. Topamax suppresses the activity of carbonic anhydrase in the body. Using the drug with any other carbonic-anhydrase inhibitor (zonisamide or acetazolamide) may increase the severity of metabolic acidosis and may also increase the risk of kidney stone formation. Topamax also interacts with lithium.
Emily Miller is an award-winning journalist who has held writing and editorial positions with numerous print and online publications around the U.S. She draws on her background as both a patient and a journalist to help readers understand complex health topics. Her most recent experience is in writing about litigation involving medicines that cause life-altering side effects.
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