Lawsuit funding is NO LONGER AVAILABLE on Topomax
What is Topamax?
Topamax is an oral medication tablet carrying the generic name topiramate. The drug was first approved for the use of patients who frequently have seizures, precisely because it is an anticonvulstant, or an antiepilepsy drug.
Topiramate is used to control and treat seizures in both adults and children who are two years old, at the very least. The FDA approved the drug in 2004 for the prevention and treatment of migraine headaches in adults and in teenagers starting at 12 years old.
However, the medication only seeks to prevent migraine headaches or reduce the number of occurrences; it cannot treat a headache that has already taken place.
It was in late 2012 when the drug was approved by the United States Food and Drug Administration to be used in combination with phentermine for weight loss. The drug was previously prescribed off-label for weight loss purposes.
Approved by the United States Food and Drug Administration in 1996, the drug is manufactured by Janssen Pharmaceuticals (previously Ortho-McNeil-Janssen, Inc.) – a subsidiary of Johnson & Johnson — and is also used to treat Lennox-Gastaut syndrome in patients of at least 2 years old.
Generic alternatives for topiramate were available in Canada, and were eventually approved by the U.S. FDA in September 2006.
Topamax carries the generic name topiramate. The United States Food and Drug Administration initially approved the drug (in 1996), more commonly known as an anti-convulstant or anti-epilepsy drug, for the prevention of seizures in adults and in children at least two years old.
In 2004, the United States Food and Drug Administration approved the drug for prevention and treatment of migraines, a more severe form of headache, in adults and teenagers beginning age 12.
It is strictly noted that the drug aims to prevent migraines from happening, not to stop them from occurring once they have already started. Topiramate is also prescribed to patients suffering from Lennox-Gastaut syndrome of at least two years of age.
By 2012, the drug was consequently approved by the United States Food and Drug Administration in combinations with phentermine for weight loss purposes, after the drug was used for the same reason, but prescribed off-label.
The drug was formerly manufactured by Ortho-McNeil-Janssen, Inc. Currently, topiramate is manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson.
Generic alternatives for topiramate were available in Canada, before it was approved by the United States Food and Drug Administration in September 2006.
There are many symptoms and side effects that come with the usage of the drug, including vision problems, paresthesia, diarrhea, somnolence, nausea, fatigue, the common cold, unsteadiness, dizziness, drowsiness, menstrual changes, menstrual pain, nervousness, and loss of appetite.
However, its most adverse side effects are the reason behind the multiple lawsuits filed against the drug manufacturer. Most common Topamax lawsuits are filed by parents in behalf of their children who have been born with birth defects, because the mothers were prescribed the drug during pregnancy and were not warned of the risks.
Other serious side effects to using topiramate include acute myopia, secondary angle closure glaucoma, hyperthermia, oligohydrosis, metabolic acidosis, suicide, cognitive/neuropsychiatric adverse reactions, and hyperammonemia.
There is an ongoing litigation against Janssen Pharmaceuticals for Topamax. Many were consolidated in the Philadelphia Court of Common Pleas’ Complex Litigation Center.
As the drug has yet to be banned or recalled, Topamax patients are still at an increased risk for these adverse side effects. Thus, more and more lawsuits are currently being filed against the drug manufacturer for several various claims including failure to warn, negligence, fraud, misrepresentation, breach of express and implied warranties, and inadequate labeling of the drug. A number of plaintiffs have also been awarded millions through jury verdicts for birth defects associated with Topamax.
Symptoms and Side Effects
Common side effects include vision problems (blurred vision, double vision, eye pain, rapidly decreasing vision), burning, prickling or tingling sensations (paresthesia), diarrhea, somnolence, nausea, fatigue, common cold, clumsiness or unsteadiness, confusion, continuous and uncontrolled rolling eye movements, dizziness, drowsiness, eye redness, generalized slowing of mental and physical activity, increased eye pressure, memory problems, menstrual changes, menstrual pain, nervousness, speech or language problems, changes in taste, upper respiratory tract infection, loss of appetite, trouble concentrating or paying attention, and unusual tiredness or weakness.
There are also less common side effects to using the drug, these include abdominal or stomach pain, fever, chills, or sore throat, lessening of sensations or perception, loss of appetite, mood or mental changes (aggression, agitation, apathy, irritability, mental depression), red, irritated or bleeding gums, and weight loss.
However, there are more serious side effects to using topiramate. These include:
- Acute Myopia and Secondary Angle Closure Glaucoma: If left untreated, both illnesses can result in permanent blindness. The symptoms for these adverse eye problems include acute onset of decreased visual acuity and/or ocular pain.
- Hyperthermia and Oligohydrosis: Increased body temperature due to decrease sweating can lead to hospitalization in individuals.
- Metabolic Acidosis: An illness wherein the body produces too much acid, or when the kidneys are unable to eliminate sufficient acid in the body. This illness can cause brittle or soft bones, kidney stones, slow the rate of growth in children, and can even lead to comas and death.
- Suicide: Topiramate can increase the risk of suicidal thoughts or behavior in users. Thus, patients using the drug must be regularly checked for the appearance or progression of depression, increased anxiety or panic, and/or any uncommon mood or behavioral changes.
- Cognitive/Neuropsychiatric Adverse Reactions: These conditions can include confusion, slowing of the psychomotor, difficulty with memory and concentration, and speech or language troubles.
- Hyperammonemia: High blood ammonia levels in the body can have an impact on mental activities. It can also slow alertness and can result in fatigue or vomiting.
Additionally, women who are undergoing pregnancy whilst taking the drug can also give birth to children with birth defects, an adverse side effect of the drug.
Lawsuits and Litigation
There is an increasing number of state and federal lawsuits against the Janssen Pharmaceuticals anticonvulsant drug.
In fact, dozens of lawsuit filings in Pennsylvania have been consolidated in the Philadelphia Court of Common Pleas’ Complex Litigation Center, which is the first United States courthouse intended to serve complicated multi-filed Mass Tort cases.
In late 2013, the first trial from the Philadelphia Court of Common Pleas regarding a birth defect linked with the drug won in favor of the plaintiff. The jury awarded the family $4 million in October, and another $11 million to a different family in November.
The two juries who awarded the said two families in the birth defect Topamax cases found Janssen guilty of failing to warn doctors about the full birth defect links associated with the drug. Furthermore, the juries also found the company’s negligence as a vital factor in causing the injuries of the plaintiffs.
In May 2010, Ortho-McNeil Pharmaceuticals and Ortho-McNeil-Janssen Pharmaceuticals agreed to pay $81.5 million in fines, thanks to a plea agreement with the U.S. Department of Justice under the False Claims Act.
$6.15 million was paid by Ortho-McNeil, while Ortho-McNeil-Janssen Pharmaceuticals paid up the remaining $75.37 million.
The millions-worth fine was due to the companies’ marketing of topiramate for off-label uses, misbranding and illegal marketing of the drug, and producing false claims about the drug, which are submitted to government health programs.
The agreement stipulates that the federal government obtained $50.69 million, while state Medicaid programs received $24.68 million. The rest was given to three whistleblowers.
In November 2013, Haley Powell and her family was awarded $11 million after seven hours of jury deliberation in the Philadelphia Court of Common Pleas. The verdict included $335,000 for future medical expenses, while $10.6 million was for non-economic compensation (pain and emotional distress).
Powell was taking topiramate to treat migraine headaches and hand tremors. She had already been taking the drug for over a year when she became pregnant with her son, Brayden Gurley, in 2007. Brayden Gurley was born with a cleft lip, which left him with nasal malformations, requiring at least five surgeries all before he turns 21.
Alex Czimmer had a similar case, who took the drug for migraine treatment between August 2006 until February 2007. Czimmer’s son, Blake, was born with a cleft lip and palate in September 2007 due to his mother’s use of the drug.
Alex Czimmer filed a lawsuit in Philadelphia in behalf of her son and won by jury verdict after a 12-day trial. The jury awarded Alex Czimmer and her son $4 million – including $562,184.68 for future health care expenses and the remaining $3.44 million for pain and suffering damages.
Most lawsuits filed against Janssen Pharmaceuticals for this antiepilepsy drug allege the drug manufacturer of the following:
- Failure to warn
- Breach of express and implied warranties
- Inadequate labeling of the drug
Plaintiffs continue to seek both compensatory and punitive damages from the company for children who were born with oral cleft birth defects following the mothers’ usage of the drug during pregnancy.
FDA Recalls, Reports and Warnings
Although Janssen Pharmaceuticals continually marketed the drug to have “mild to moderate” side effects, post-market studies over the last few years have revealed that the drug is linked to some serious health risks
This then prompted the United States Food and Drug Administration to consistently require all labels and medication guides of the drug to be updated with warnings and precautions that are related to the drug’s usage.
In 2004, the United States Food and Drug Administration required the drug manufacturer to include a warning regarding the link between topiramate and its increased risks for metabolic acidosis (increase in acid levels found in the blood), oligohydrosis (decreased sweating), and hyperthermia (increased body temperature).
Two years later, in 2006, the United States Food and Drug Administration required another warning to be added to the topiramate label. It was in 2006 when a warning regarding serious eye disorders, particularly acute myopia and secondary angle closure glaucoma was added.
Come 2008, the United States Food and Drug Administration started informing doctors of a review comprising of 200 medical studies. It was found that the drug resulted in a growth of suicidal thoughts and actions among the drug users. The topiramate warning was eventually update to include the study findings.
It was in March 2011 when the United States Food and Drug Administration issued a warning to patients who were pregnant or potentially pregnant while taking topiramate.
In it, the warning stipulated that infants born to mothers who were taking the drug during pregnancy are 21 times more prone to develop oral cleft defects, as compared to those who did not use the drug.
The warning further noted that pregnant or potentially pregnant drug users have a higher risk of birth defects, such as: cleft lip or cleft palate, genital malformations (including Hyposadias), spina bifida or limb malformations, persistent pulmonary hypertension of the newborn (PPHN), and heart, lung and neural defects.
A study conducted by the North American Antiepileptic Drug Pregnancy Registry discovered that mothers who had taken topiramate are at a 21.3 percent increased risk of giving birth to a baby with a cleft lip or cleft palate.
The United Kingdom Epilepsy and Pregnancy Register also found a 1,600 percent increase in newborns that were born with a cleft lip or cleft palate when exposed to maternal Topamax usage.
The medical journal Neurology also found that women who were taking the drug had a 11-fold increased likelihood of giving birth to a baby with a cleft lip or cleft palate.
The United States Food and Drug Administration had approved the drug, Qsymia – comprising of topiramate and phentermine – in July 2012. The drug approval was prompted after a 2011 study showed significant weight loss in 3,000 patients who took topiramate.