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Topamax

The Topamax injury attorneys at the Drug Law Center are evaluating and accepting topiramate lawsuits involving clients that have suffered serious injuries using the anticonvulsant medication.

Introduction

Topamax Drug RecallTopamax (topiramate) is an anticonvulsant medication prescribed to control or prevent epileptic seizures. Doctors also prescribe Topamax to prevent migraines and decrease their recurrence. However, the drug does not specifically treat a migraine when it appears. Many individuals suffering from manic-depression (bipolar disorder) are prescribed Topamax or its generic version topiramate.

The History of Topamax

In 1996, the FDA approved topiramate as an anti-epileptic, anticonvulsant medication. The drug has been proven effective as an adjunctive therapy or monotherapy for onset seizures. Topamax (topiramate) received its approval from the US Food and Drug Administration (FDA) in 2012 for weight loss when used in combination with phentermine. Topamax and its generic version have also been approved as a prophylaxis for migraine headaches. However, there is numerous off-label uses that have not been approved by the Food and Drug Administration. These include:

  • Bipolar disorder
  • Cocaine dependency
  • Alcohol dependency
  • Chronic daily headaches
  • Cluster headaches
  • Bulimia nervosa
  • Neuropathic pain
  • PTSD (posttraumatic stress disorder)
  • Smoking cessation (quick smoking)
  • Infantile spasms
  • Binge eating disorder
  • SRED (sleep related eating disorder)
  • NDS (Nocturnal Eating Disorder)
  • Prevention of migraines and children
  • Scar therapy
  • Pathologic gambling

Topamax Side Effects

All prescription medications have some form of side effects, including brand-name Topamax and its generic formula topiramate. Common side effects of the drug include:

  • Weight loss
  • Dizziness
  • Diminished appetite
  • Coordination problems
  • Tingling or numbness
  • Nervousness
  • Dizziness
  • Sensory Distortion
  • Tiredness or drowsiness
  • Language/speech problems
  • Confusion
  • Unexpected vision changes
  • Slow thinking
  • Memory issues
  • Difficulty paying attention
  • Common cold symptoms including a sore throat, sneezing or stuffy nose

The most common side effects Topamax (topiramate) creates in children suffering from epilepsy include:

  • Sleeplessness
  • Fatigue
  • Aggressiveness
  • Nervousness
  • Memory issues
  • Weight loss
  • Difficulty in concentrating
  • Diminished appetite (anorexia)

Common side effects when children 10 years to 16 years old with epilepsy take Topamax (topiramate) include:

  • Mood problems
  • Anorexia (diminished appetite)
  • Tingling of the legs or arms
  • Upper respiratory tract infection
  • Weight loss

Topamax Contraindications

Nearly every prescription medication and nonprescription over-the-counter drug will have some type of interaction or contraindication when the drug is taken concomitantly with other medications, the patient is suffering from some specific medical condition, or is allergic to the product or its ingredients. The most common disease interactions patients experience when taking Topamax (topiramate) include:

  • Severe liver disease
  • Hemodialysis
  • Metabolic acidosis
  • Renal dysfunction
  • Angle-closure glaucoma
  • Nephrolithiasis
  • Metabolic acidosis
  • Blood Dyscrasias
  • Hypothermia/oligohydrisis
  • Suicidal ideation and/or suicidal action

Patients taking Topamax (topiramate) should discuss the medications they take with their doctor. This is because there are specific interactions with some medications that include:

  • Ambien
  • Clonazepam
  • Lexapro
  • Cymbalta
  • Flexeril
  • Klonopin
  • Lyrica
  • Lexapro
  • Prozac
  • Seroquel
  • Xanax
  • Zoloft
  • Vitamin D
  • Trazodone
  • Tramadol
  • Singulair
  • Omeprazole
  • Synthroid
  • Neurontin
  • Gabapentin
  • Lamictal
  • Generic versions of all the drugs listed above

Who Should Avoid Taking Topamax (topiramate)?

Before taking Topamax (topiramate), it is important to check with your doctor if you suffer from any of the following conditions including:

  • Suicidal ideation
  • Mood changes
  • Confusion
  • Inherited efficacy of Carbamyl Phosphate Synthetase
  • Difficulty in focusing
  • Kidney disease
  • Liver problems
  • Kidney stones
  • Decreasing vision sharpness
  • Increased eye pressure
  • Depression
  • N-acetyl glutamate synthase deficiency -related hyperammonemia
  • Excess body acid
  • Arginase deficiency

Pros and Cons of Taking Topamax (topiramate)

Like many medications approved by the FDA, Topamax (topiramate) has significant advantages and disadvantages to taking the medication.

Advantages to taking Topamax

  • Minimal interaction with other drugs
  • Effective in treating different types of seizures
  • Effective as an alternative mood stabilizer antidepressant when other medications have failed
  • Can lower blood pressure
  • Significant alternative treatment over neuroleptics because there is no potential risk of developing tardive dyskinesia
  • Can produce weight loss and reduce BMI
  • Can be taken with or without food
  • Likely does not destabilize patient’s moods suffering from comorbid bipolar disorder

Disadvantages of taking Topamax

  • Potential birth defects including an increased potential for developing oral clefts in pregnant women taking topiramate
  • Known to decrease hormonal contraceptive efficacy
  • Potential to develop nephrolithiasis (kidney stones)
  • Causes cognitive disturbances including difficulty in remembering things and abnormal thinking
  • Can produce optimal logical side effects including angle closure glaucoma
  • Potential drug interaction that reduces birth control pill effectiveness
  • Sudden withdrawal problems

Topamax Birth Defects

The FDA and researchers are warning pregnant women to avoid taking Topamax because of the known birth defects associated with taking the medication. These defects include brain and lung abnormalities, heart deformities, cleft lip, cleft palate, and other serious health issues. Many women taking Topamax have given birth to children with cleft abnormalities where the hard and soft palate failed to fuse together properly. Some cases were more severe where the child was born with an open groove that extended from the roof of the mouth into the nose.

Topamax Lawsuits

  • US DOJ Alleges Topamax Drug Maker Violated the Federal False Claims Act

In 2010, Ortho-McNeil-Janssen, Inc., the maker of Topamax, was part of the federal false claims act initiated by the U.S. Department of Justice. The company agreed to a settlement worth more than $75 million for illegally marketing their medication for numerous off-label psychiatric conditions. The Food and Drug Administration (FDA) never approved these off-label uses of Topamax.

The DOJ had alleged that the drug makers paid doctors for promoting Topamax for use with their patients. Representatives for the companies’ Doctor for a Day program were accompanied by paid doctors when visiting health care providers to discuss off-label usage of Topamax. The manufacturers of the medication pled guilty to DOJ charges that they and their representatives illegally promoted the drug for off-label uses. They paid the government a $6.1 million fine for violating the False Claims Act. The DOJ defined off-label uses in their allegations to include:

  • The treatment of anxiety and mood disorders
  • The treatment of eating disorders
  • The treatment of alcohol dependency
  • Weight loss

The Food and Drug Administration issued a warning the doctor should not prescribe and patient should not take Topamax for any off-label use, especially pregnant women or those wanting to become pregnant. This is because the drug has been associated with a higher potential risk of developing birth defects. Even so, the FDA recommended that Topamax users avoid stopping Topamax medication treatments before discussing it with their doctor.

  • J & J Subsidiary Recalls Tens of Thousands of Bottles of Topamax Due to Strange Odor

2011 — A Johnson & Johnson subsidiary Ortho-McNeil Neurologic, a pharmaceutical company that makes Topamax was ordered to recall approximately 57,000 bottles of their medication. This is because there were substantial and numerous reports that unexpected odors were emanating from the pills.

The following month (May 2011) the Food and Drug Administration issued a warning of a correlation between taking Topamax in the development of birth defects. The FDA mandated that the drug maker alters their black box warning label to ensure that women who were pregnant or may become pregnant were made aware of the greater potential risk of delivering a newborn with birth defects caused by the medication.

  • Philadelphia Jury Awards Family $10 Million in a Topamax Birth Defects Lawsuit

November 2013 – A Philadelphia jury reached a verdict in a Topamax birth defect lawsuit by awarding $10 million to the family of a five-year-old who was born with serious birth defects including a cleft palate after his mother took the anti-convulsion medication while she was pregnant. Jurors in the trial had reached an agreement that Johnson & Johnson and its subsidiary Janssen Pharmaceuticals were aware of the potential risks to pregnant women using Topamax as far back as 2003. The jury awarded the plaintiffs financial compensation because the company failed to warn the patient and her doctors of pregnancy -related Topamax side effects.

  • FDA Publishes Topamax Safety Communication Citing Cleft Palate Birth Defects

March 2011 – The Food and Drug Administration (FDA) has issued a warning through a published safety communication of the potential increased risk of developing a cleft palate or cleft lip in newborns due to exposure of Topamax (topiramate) while the mother was pregnant.

In recent years, Topamax (topiramate) was reclassified by the FDA as a “Pregnancy Category D”. This means known evidence exists linking the antiepileptic drug with birth defects. Even though the FDA has issued this warning, doctors are still allowed to prescribe the anticonvulsant medication to pregnant mothers and women who want to become pregnant in the future so long as the mother receives benefits that justify risking the health and well-being of the fetus.

  • Couple Awarded over $11 Million to Settle Their Topamax Birth Defect Lawsuit

April 2015 – An $11.65 million verdict award was upheld in a Pennsylvania courtroom involving a couple alleging that the popular epileptic medication Topamax caused the cleft lip their son was born with years before. The drug’s manufacturer Janssen Pharmaceutical, a subsidiary of Johnson & Johnson had filed motions in an effort to overturn the ruling.

In 2011, the couple filed a Topamax lawsuit involving allegations that the anti-seizure medication Topamax led to their son’s birth defects when their mother was using the drug while she was pregnant back in 2008. The mother claims she had been taking the medication for nearly three years since it was first prescribed by her doctor in 2005 to treat her seizures. When she found out she had become pregnant in 2007, she stopped taking the drug to avoid any problems.

Her attorney’s claim that she was never made aware of the potentially serious side effects of birth defects caused by Topamax. As a result, the jury awarded the family nearly $11 million in compensatory damages and another $700,000 in delay damages.

Currently Accepting Topamax Lawsuit Cases

The Topamax injury case attorneys at the Drug Law Center are experienced at successfully resolving topiramate lawsuits. Our dangerous drug and product liability litigation team of specially trained trial attorneys have handled many cases involving birth defects, serious side effects in wrongful death. We are currently reviewing Topamax litigation cases and evaluating some claims for compensation to be included in a Topamax class action lawsuit.

If you have suffered serious injury or lost a loved one due to serious side effects caused by taking Topamax (topiramate), contact our law firm immediately. We provide initial free consultations to discuss the merits of your case and provide you with various legal options on the best way to proceed to ensure your family receives the financial compensation they deserve.

We are currently postponing payment of all of our legal services to relieve the financial burden on our clients. This means we will only accept payment to cover our legal representation when we have successfully resolved your case by negotiating a settlement out of court with the defendant’s attorneys or winning the case in front of a judge and jury. All information you share with us concerning your Topamax lawsuit remains confidential. Let’s talk today to begin the process of obtaining your financial compensation from every party who caused your harm.

Sources:
https://my.clevelandclinic.org/health/transcripts/1631_ask-the-expert-complex-regional-pain-syndrome-crps
http://www.mayoclinic.org/drugs-supplements/topiramate-oral-route/description/drg-20067047
https://www.fda.gov/downloads/drugs/drugsafety/ucm152837.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020505s050lbl.pdf
https://www.fda.gov/Drugs/DrugSafety/ucm245085.htm

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