Topamax

Topamax (topiramate) is a drug approved to treat seizures in adults and children and to reduce the frequency of migraine headaches in people 12 years of age and older. For the treatment of seizures, Topamax may be used alone or in combination with other medications. Johnson & Johnson subsidiary Janssen Pharmaceuticals  manufacturers Topamax.

Topamax Pills
Topamax Facts
  1. Dosage 25 mg, 50 mg, 100 mg, and 200 mg tablets; 15 mg and 25 mg sprinkle capsules
  2. Used to Treat Epilepsy; Prevent migraines
  3. Related Drugs Qudexy XR; Trokendi XR
  4. Manufacturer Janssen Pharmaceuticals Inc. (subsidiary of Johnson & Johnson)
  5. Active Ingredient Topiramate
  6. FDA Approval Status Initial approval in 1996

Topamax is a prescription medication known as an anticonvulsant. The U.S. Food & Drug Administration (FDA) first approved Topamax for the treatment of seizures in 1996. The regulatory agency expanded the drug’s uses to include migraine prevention in 2004.

By 2007, Topamax controlled 21 percent of the $10.2 billion epilepsy drug market, according to Bloomberg News. Topamax sales reached $2.7 billion in 2008.

As Topamax was used more widely in the 2000s, people began to report various side effects. As a result, the FDA added several warnings to the drug’s label, including decreased sweating with an elevated body temperature, increased risks for high levels of acid in the blood, eye disorders that could lead to permanent vision loss, and suicidal thoughts and behaviors among others.

In 2011, the FDA warned of Topamax’s link to birth defects (eg, cleft lip and clef palate) 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.

Topamax lost its patent protection in 2009, and its market share has dropped significantly since this occurrence.

Topamax 25mg pill
Topamax 25mg pill
Topamax 50mg pill
Topamax 50mg pill
Topamax 100mg pill
Topamax 100mg pill

FDA-Approved Topamax Uses

When Topamax first hit the market, the FDA limited the drug for use in treating seizures from various forms of epilepsy. After about eight years, the agency added migraine prevention as an FDA-approved use. Seizures and migraines continue to be the only government-approved uses for Topamax in the U.S.

Seizures

During a seizure, brain cells 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 the treatment of various forms 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
overactive brain cells
Topamax is designed to prevent brain cells from over activity

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 go 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 Use for Weight Loss, Psychiatric Disorders

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.

Topiramate, the active ingredient in Topamax, is also a main ingredient in the weight-loss drug Qsymia, along with phentermine. 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 effect profile of the combination product (eg, birth defects and possible heart problems).

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.

In addition to weight loss, Topamax has also been used — and illegally marketed — to treat:
  • Bipolar disorder
  • Alcohol dependency
  • Cocaine and methamphetamine addiction
  • Obsessive-compulsive disorder
  • Borderline personality disorder
  • Post-traumatic stress disorder

Topamax Side Effects

Topamax has a number of common side effects, which its manufacturer states are “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:
  • Fatigue/sleepiness
  • Nausea
  • Weight loss
  • Nervousness
  • Upper respiratory tract infection
  • Burning or prickling in the hands, arms, legs and feet (paresthesia)
  • Dizziness
  • Slowing down of thought and movements (psychomotor slowing)
  • Fever
  • Taste change
  • Anorexia
  • Diarrhea
  • Speech problems
  • Abdominal pain
  • Numbness (hypoesthesia)
  • Abnormal vision
  • Difficulty with memory

FDA Warnings

Over the years, post-marketing studies have revealed several serious health risks associated with Topamax. 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:
  • 2004
    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)
  • 2006
    FDA required a warning about serious eye disorders, such as acute myopia and secondary angle closure glaucoma, which can lead to permanent visual loss
  • 2008
    FDA required a warning about increased risk of suicidal thoughts and behaviors
  • 2011
    FDA required a warning about the risks of oral birth defects (eg, cleft lip and cleft palate). The FDA reinforced that Topamax can cause fetal harm when given to a pregnant woman.

Topamax’s label also includes warnings regarding depression and mood problems, kidney stones, and the need to withdraw the drug gradually to reduce the potential for increased seizures.

Topamax Drug Interactions

Topamax is known to interact with other substances and patients should be aware of these interactions. The body digests Topamax in the liver and eliminates it from the body through the kidneys. 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. People with liver disease and people with a history of kidney stones must be cautious about taking the drug.

Fact
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 valproic 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 oral birth defects such as cleft lip and cleft palate.

People should not drink alcohol or take sedatives or tranquilizers, such as Valium and Xanax, while taking Topamax. Topamax suppresses the activity of the enzyme, carbonic anhydrase, in the body. Using the drug with any other carbonic anhydrase inhibitor (eg, zonisamide or acetazolamide) may increase the severity of metabolic acidosis and may also increase the risk of kidney stone formation. Topamax may also interact with lithium, resulting in increased lithium levels.

Please seek the advice of a medical professional before making health care decisions.

Related Pages
Emily Miller
Written By Emily Miller Editor

Emily Miller is an award-winning journalist with 7 years of professional experience writing and editing content for reputable media organizations across the U.S. She also has 13 years of personal experience as a patient living with Crohn’s disease. Her coverage of U.S. prescription drug prices for Drugwatch has been published or cited by news outlets, including The Hill, Fox Business and United Press International. Some of her qualifications include:

  • Society of Professional Journalists and The Alliance of Professional Health Advocates member
  • Centers for Disease Control and Prevention Health Literacy certificates
  • 2016 Florida Society of News Editors third place winner in Breaking News
Edited By
Kevin Connolly
Kevin Connolly Managing Editor
Medically Reviewed By

12 Cited Research Articles

  1. FDA.gov. (2017, May). Highlights of Prescribing Information. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020505s057_020844s048lbl.pdf
  2. Hensley, S. (2011, August 14). Latest Smelly Johnson & Johnson Recall: Topamax. Retrieved from https://www.npr.org/sections/health-shots/2011/04/14/135406773/latest-smelly-johnson-johnson-recall-topamax
  3. Ellement, JR. (2017, June 7). FBI nominee played key role in epilepsy drug Topamax case in Boston. Retrieved from https://www.bostonglobe.com/metro/2017/06/07/fbi-nominee-played-key-role-topamax-case-boston/ipbDpb9kgPyHcCf7LaBf1L/story.html
  4. Garde, D. (2016, September 24). The drug industry might finally have an answer for migraines. Retrieved from https://www.pbs.org/newshour/health/migraines-new-drugs
  5. Johnson & Johnson. (2011, April 14). Ortho-McNeil Neurologics Voluntarily Recalls Two Lots of TOPAMAX®. Retrieved from http://www.investor.jnj.com/releasedetail.cfm?ReleaseID=569072
  6. Topamax.com. (2019, May). Topamax prescribing information. Retrieved from https://www.topamax.com/index.html
  7. Epilepsy Foundation. (n.d.). Topiramate. Retrieved from https://www.epilepsy.com/medications/topiramate
  8. U.S. Department of Justice. (2010, April 29). Two Johnson & Johnson Subsidiaries to Pay Over $81 Million to Resolve Allegations of Off-Label Promotion of Topamax. Retrieved from https://www.justice.gov/opa/pr/two-johnson-johnson-subsidiaries-pay-over-81-million-resolve-allegations-label-promotion
  9. Wolfenden, E. (2017, July 18). Topamax & Phentermine for Weight Loss. Retrieved from https://www.livestrong.com/article/483445-topamax-phentermine-for-weight-loss/
  10. Creative Commons. (n.d.). Topamax 25mg https://pillbox.nlm.nih.gov/assets/large/504580639.jpg
  11. Creative Commons. (n.d.). Topamax 50mg https://pillbox.nlm.nih.gov/assets/large/504580640.jpg
  12. Creative Commons. (n.d.). Topamax 100mg https://pillbox.nlm.nih.gov/assets/large/504580641.jpg
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