The FDA originally gave the anticonvulsant medication Topamax its approval in 1996. It is typically used to treat migraine headaches and epileptic seizures, but it has also been used off-label to help people lose weight.
Psychiatrists have also utilized Topamax to treat bipolar illness. Recently, clinical trials using it to treat post-traumatic stress disorder (PTSD) have been conducted.
Additionally, research is being done to determine how well it works to treat obesity, methamphetamine addiction, and alcoholism. Topamax is made by Janssen Pharmaceuticals, a Johnson and Johnson company that was originally known as Ortho-McNeil. Its American sales have generated well over $10 billion in profits.
The makers of Topamax have already faced legal repercussions for how they handled this medication, much like the makers of many other risky products.
Ortho-McNeil (now Janssen Pharmaceuticals) was forced to pay more than $81 million to resolve allegations that they improperly promoted Topamax for treating bipolar illness, weight loss, and alcoholism without the FDA’s approval. According to those judicial proceedings, they allegedly paid doctors to promote the medicine to patients for off-label usage.
You should speak with a Topamax attorney if you, your kid, or someone you know has experienced medical problems due to using the drug because you may be entitled to compensation.
No monetary reward can fully compensate you for what you’ve been through, but it can help cover your medical costs, missed wages, and pain and suffering. A monetary award may also be used to express regret for an injustice you experienced.
The Purpose of Topamax Is to Treat Epilepsy
Epilepsy, which is characterized by persistent seizures brought on by aberrant brain activity, is most prevalent in young children and the elderly. While there may be a few instances where the disease goes away as a child gets older, it is usually incurable.
There are millions of sufferers of the problem globally, and many people find it difficult to manage their condition without medication.
Topamax is one of the most widely used medications for reducing epilepsy symptoms and preventing seizures from starting. The US Food and Drug Administration (FDA) has approved Topamax to treat migraine headaches and epilepsy. The drug relieves tension and pain, which may last a few hours to a few days, by enlarging the blood arteries in the brain.
Topamax Off-Label Uses
Topamax has been used successfully as an off-label weight-loss medication in the past. Even though the FDA has never approved the medicine for this particular usage, many doctors have prescribed it. It was reported that several of the participants lost weight throughout the clinical trials for the drug’s approval to treat epilepsy.
Although the precise cause of the weight loss is unknown, roughly 25% of people using the medication reported it as an “effortless side effect.” According to one idea, Topamax decreases saliva production and alters taste perception, which may make certain people less likely to eat and promote weight loss.
The FDA did approve a medication for adult weight loss sold under the brand name Qsymia in July 2012. It contains both phentermine and topiramate, which is Topamax’s generic name.
Side Effects of Topamax
Topamax has a lot of positive reports for use, but it also has a lot of potential negative effects.
Approximately 10% of drug users report:
- Diarrhea
- Nausea
- Tingling in the feet and hands
- Hunger loss
Reports of issues that are more significant include:
- Confusion and forgetfulness
- Extreme fatigue
- Metabolic acidosis, which results in fast breathing, exhaustion, and a state resembling a stupor
Birth Defects and Topamax
The FDA required a revision to Topamax’s safety label and issued a safety advisory in March 2011. Studies have revealed that cleft palates and cleft lips are much more common in newborns whose mothers used Topamax while pregnant (especially in the first trimester).
Compared to infants exposed to other epilepsy medications, Topamax-exposed infants have more than three times higher risk of oral malformations.
According to one study, pregnant women using Topamax have a chance of having babies with oral congenital disabilities—most notably, cleft lips or cleft palates—21.3 times higher than the risk in the general population of untreated women.
Let’s imagine that the risk is half what the data suggests and that the study has overstated it without any supporting evidence. That would imply that there is still a 10-fold risk of an oral congenital disability for infants delivered to pregnant mothers using Topamax.
They ought to have known that pregnant women taking Topamax put their unborn infants at an absurdly high risk of having a cleft lip or palate.
Even worse, the injury frequently happens before a woman realizes she is pregnant. Therefore, any woman of childbearing age runs the chance of becoming pregnant without knowing it and giving birth to a kid with a cleft lip or palate.
Misbranding Legal Action
For misbranding Topamax, Ortho-McNeil has paid criminal fines of $6.14 million. Ortho-McNeil additionally paid an additional $75.37 million (mostly reimbursement for fraudulent Medicare claims) to settle legal claims.
According to the US authorities, Ortho-McNeil promoted Topamax by enlisting doctors to work with salespeople to push it for unapproved purposes in unapproved doses for medical indications not covered by those programs. The legal settlement’s federal and state Medicaid portions total $50,688,483.52 and $24,681,516.48, respectively.
Selling Topamax has generated a lot of revenue. Over 4 million Americans had their 32.3 million Topamax prescriptions filled between January 2007 and December 2010 in the US. Topamax has brought in enormous profits for Ortho-McNeil. This truth won’t change no matter how the Topamax litigation turns out.
However, Ortho-McNeil/Johnson & Johnson may be forced to return some of that money to the kids who will be traumatized by having to deal with these birth injuries. This could include paying for the corrective surgery that very young kids — infants — must have because their mother was prescribed Topamax while she was pregnant.
Contraindications
Be sure to let your doctor know if you are taking other medications. Topamax and other medications may interact in ways that have unforeseen results. Your doctor must research the medications to ensure they do not contraindicate Topamax.
You may not be able to use Topamax if you have certain physical issues in addition to drug use.
You should speak to your doctor if you have any of the following conditions since you may not be able to use the medication:
- Difficulties with your eyes
- Diabetes or conditions related to diabetes
- Kidney injury or illness
- Breathing problems
- A liver condition or injury
- Mood swings or a mood disorder
Should I Contact a Lawyer?
If you or your child developed major health issues after using Topamax, consult a doctor immediately.
Additionally, you might want to get in touch with a qualified class action lawyer in your area who can assist you in defending your legal rights and recovering damages for your injuries. If there are any changes to the law or updates about Topamax, your attorney can keep you informed of your legal rights and options.
It is important to remember that you must have used the name brand of Topamax, not a generic version, to succeed in your claim. While Topamax may offer some disabling conditions alleviation, there is always a chance of unfavorable side effects.
