Topamax treats epilepsy. Epilepsy is a chronic brain disorder that causes uncontrollable seizures. Topamax also treats children two years of age and older who suffer seizures from Lennox-Gastaut syndrome. Lennox-Gastaut syndrome is a syndrome with a patient who has epilepsy and developmental delay. It typically develops when a child is between the ages of two and six.
Is your child suffering injuries? You may be able to file a lawsuit.
Topamax received approval from the U.S. Food and Drug Administration (FDA) in 1996. In 2004, Topamax gained further FDA approval for use in treating migraines. The manufacturer is Janssen Pharmaceuticals, a Johnson & Johnson subsidiary. While Topamax helps many patients, it also causes side effects such as metabolic acidosis and birth defects.
If your child is suffering from birth defects, you should consult with a lawyer about your options. Talking to an attorney can help.
What Is Topamax?
The active ingredient in Topamax is the anticonvulsant topiramate. Topamax helps to suppress excessive and rapid brain activity that causes epileptic seizures. In 2012, topiramate got FDA approval to be taken for weight loss with phentermine.
The FDA-approval topiramate weight loss drug is called Qsymia. Doctors prescribe it for obese and overweight patients who also suffer one other weight-related issue such as type 2 diabetes and high blood pressure.
Topamax Marketing Controversy
The FDA has approved Topamax for epilepsy conditions and migraines, but doctors may also give it to patients for other reasons. Without FDA approval, however, it can be dangerous for patients to take this drug for other uses. This can lead to serious and life-changing side effects.
Topamax is given by doctors for problems such as alcohol dependency, bipolar disorder, drug addiction, and post-traumatic stress disorder. It comes in a sprinkle capsule and tablet form.
In 2010, former Topamax manufacturers Ortho-McNeil-Janssen Pharmaceuticals and Ortho-McNeil Pharmaceuticals entered a plea agreement with the Department of Justice. The companies agreed to pay $81.5 million in fines for illegal promotion, branding, and marketing of Topamax.
Examples of Topamax misconduct by the manufacturer include:
- Promoting the drug for several off-label and unapproved uses
- Illegally marketing and misbranding Topamax
- Sendingf false claims about Topamax to government health programs
Topamax Side Effects
As with many other prescription drugs, Topamax features side effects that range from mild to severe. Your doctor should tell you about the side effects for the drug before you take it, but the manufacturer may not provide all the information you need to make a decision.
A common side effect is a change in food and beverage taste. Many users report that carbonated drinks such as beer and soft drinks taste particularly bad.
Mild Topamax side effects include:
- Blurred or double vision
- Unsteadiness or clumsiness
- Dizziness or drowsiness
- Trouble with thinking and concentration
Common Topamax Side Effects
When Topamax was first marketed, the label originally warned users only of the more common Topamax side effects. These Topamax side effects were described as “mild to moderate.” The more common Topamax side effects typically include symptoms such as fatigue and nausea. Topamax patients may also develop a condition called pareshesia. Paresthesia is characterized by a sensation of tingling, tickling, pricking, burning, or numbness. These sensations are known to primarily occur in the legs and arms.
Other Topamax side effects include:
- Unusual weight loss
- Taste change
- Appetite loss
- Infection of the upper respiratory tract
Severe Topamax Side Effects
The most severe Topamax side effects can cause death if the patient fails to receive proper and timely treatment. Patients may also suffer Topamax side effects that influence cognitive or neuropsychiatric function. Patients have reported symptoms such as confusion, slowing of psychomotor function, concentration and memory difficulty, and problems with language or speech. Oligohydrosis, or decreased sweating, may occur. This can lead to hyperthermia, or a dangerous increase in body temperature.
Topamax side effects include serious eye conditions that may lead to blindness. Acute myopia is a reported Topamax side effect. This condition can cause headaches and blurred vision due to increased pressure within the eye. Secondary angle closure glaucoma is another condition that results as a Topamax side effect. Patients should seek medical attention immediately if they experience pain or discomfort in the eyes.
A number of reports have indicated suicide as a Topamax side effect. Patients may experience suicidal thoughts and tendencies during use. It is recommended that all patients are carefully monitored during treatment. Medical attention should be sought if the patient experiences symptoms such as anxiety, panic, onset or increased depression, or other significant changes in behavior or mood.
Metabolic acidosis is a Topamax side effect that results in an excessive amount of bodily acid in the bloodstream. This is caused by acid production that occurs so rapidly that the kidneys cannot filter quickly enough. Severe metabolic acidosis can cause shock or death. Symptoms include rapid breathing, low blood pressure, lethargy, and confusion.
Topamax Birth Defects
Topamax side effects include severe birth defects if taken during pregnancy. The FDA listed Topamax in pregnancy category D. Drugs in pregnancy category D show sufficient evidence of causing harm to human fetuses. It is highly encouraged for pregnant women to avoid taking Topamax in order to avoid pregnancy-related Topamax side effects.
Oral Cleft Deformities
A 2008 study showed that babies born during Topamax treatment were 16-times more likely to suffer birth defects. The primary Topamax birth defect is oral cleft, such as cleft lip and cleft palate. These Topamax side effects are orofacial disorders that cause the skull’s plates to improperly fuse together. This results in an opening at the roof of the newborn’s mouth. In many cases, these malformations require multiple surgeries to correct.
Persistent pulmonary hypertension of the newborn
Another Topamax side effect is persistent pulmonary hypertension of the newborn (PPHN). PPHN constricts the arteries that lead to a newborn’s lungs. This restricts the amount of blood flow to the lungs. In turn, the amount of oxygen entering the bloodstream is also restricted. Intubation and ventilation is often required to treat PPHN. It is estimated that up to 20 percent of infants with this condition do not survive.
Other pregnancy-related Topamax side effects include:
- Malformation of the limbs
- Lung and heart defects
- Neural tube defects, such as spina bifida
Post-market studies show several more serious side effects for Topamax and other drugs with topiramate. In response to this new evidence, the FDA has is sharing further information about them. While Topamax and other topiramate drugs had a pregnancy category of C, they were downgraded to D. Since the drug may cause cleft palate or other birth defects, the FDA is still monitoring Topamax.
FDA warnings for topiramate warn users of the risk of:
- Metabolic acidosis, or an increase in blood acidity
- Oligohydrosis, or decreased sweating which can lead to heat stroke
- Hyperthermia, or increased body temperature associated with oligohydrosis
- Dangerous eye disorders such as secondary closure glaucoma and acute myopia
- Increased suicidal thoughts and tendencies
- Oral birth defects such as cleft palate when using topiramate during pregnancy
Topamax FDA Warning
Topamax is a drug that has been FDA approved for treating epilepsy and preventing migraines. Topamax is the brand name for the anticonvulsant topiramate. Topiramate was also approved by the FDA for weight loss in 2012, but it is marketed under the name Qsymia. Topamax has come under fire for a number of side effects, including birth defects and the development of suicidal tendencies. Topamax is facing a number of lawsuits by patients who have been harmed as a result of taking the drug.
In May 2010, Ortho-McNeil-Janssen Pharmaceuticals (now Janssen Pharmaceuticals) paid a total of $81.5 million in fines. This was part of a plea agreement with the US Department of Justice for misconduct on the part of the company. This misconduct included prescribing the drug for issues not approved by the FDA and illegally marketing the drug. The FDA has responded to the large number of serious side effects associated with Topamax by issuing warnings and mandating that all topiramate labels and medication guides clearly state these warnings.
Increased Risk of Birth Defects
The most recent Topamax FDA warning is for women who are pregnant or are considering becoming pregnant. In 2011, the FDA released data linking Topamax use to an increased risk of birth defects cleft lip and cleft palate. Topamax was also downgraded from a Pregnancy Category “C” to “D”, which means that there is positive evidence of fetal risk, but the potential benefits of the drug may outweigh the risk in some situations.
Studies have shown that the risk of oral defects in babies born to mothers that have been treated with Topamax during pregnancy is twenty-one times more likely than for woman not taking the drug, and three times more likely than for women taking other medications to prevent seizures. However, Topamax has proven to be effective at preventing seizures, which could be detrimental to both the mother and unborn child.
Topamax may lower the effectiveness of certain birth control methods that utilize hormones. Patients should consult a doctor about effective forms of birth control while taking Topamax. If a patient becomes pregnant while taking Topamax, it may be dangerous to suddenly stop taking the drug, as the risk for recurring seizures is high.
Development of Suicidal Thoughts and Actions
The increased risk of suicidal thoughts and actions as a result of using Topamax and other antiepileptic drugs is an issue that was brought to the attention of the public by the FDA in 2008. The FDA initially considered adding a black box warning, which is the strongest warning put out by the FDA. Instead, the FDA decided to add the warning to the labels and require manufacturers to develop and disperse a medication guide to warn patients of the dangers. In clinical trials, patients receiving an antiepileptic drug were twice as likely to have suicidal tendencies as those receiving the placebo.
Eye Disorders from Topamax Use
In 2006, there was a Topamax FDA warning issued about the potential of developing eye disorders after using Topamax. These are thought to be caused by an allergic reaction to sulfa that causes fluid accumulation and swelling in the eyeball. Patients are urged to contact a doctor at the first sign of decreased vision or discomfort of the eyes, as conditions may worsen rapidly, and in rare cases permanent blindness has occurred.
Eye disorders from using Topamax:
- Glaucoma, or pressure that results in damage to the optic nerve of the eye
- Myopia, or nearsightedness
- Double vision or dry eyes
- Nystagmus, during which patients eyes dart quickly back and forth
Metabolic Acidosis, Oligohydrosis, and Hyperthermia
The first Topamax FDA warning that was issued was in 2004. At this time, the FDA began to require manufacturers of the drug to issue warnings about the increased risk of metabolic acidosis, oligohydrosis, and hyperthermia.
Metabolic acidosis is an electrolyte Imbalance, or increase in acid in the blood. This can cause osteoporosis, rickets, and kidney stones if untreated. Children’s growth rate may be stunted by this condition. If patient is pregnant, this condition could possibly cause harm to the baby. Symptoms of metabolic acidosis include heartbeat irregularities, rapid breathing, and fatigue.
Oligohydrosis is a decrease in sweating that can be very dangerous if exercising. Hyperthermia is an increase in body temperature, or fever. In conjunction with oligohydrosis, this can be very dangerous. Patients should seek hospitalization if experiencing these symptoms.
Topamax is facing a number of lawsuits from Topamax users with injuries from using the drug. These lawsuits allege that Janssen Pharmaceuticals failed to adequately warn users of the danger caused by Topamax. Additionally, users accuse Janssen of negligence, fraud, and breach of warranties.
Many plaintiffs are females who took Topamax during pregnancy, which can result in cleft lip in their children. Plaintiffs may seek damages to cover the costs of medical bills, lost wages, pain and suffering, and other costs for Topamax side effects. Additionally, many plaintiffs seek punitive damages to deter Janssen from their public misconduct.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.