Topamax side effects include like cleft lip, cleft palate, septal heart defects, and other malformations as well as SJS. We are now working with some of the more experienced Topamax lawyers, who can file a lawsuit on your behalf, and there are no legal fees unless you receive a settlement or award. Feel free to submit a contact form online or call us anytime.
Topamax (topiramate) is a medicine used to prevent epilepsy and migraines. It has also been used for off-label weight loss. This drug was first approved by the FDA in December 1996. It has been prescribed tens of millions of times and earned billions of dollars in sales. In recent years, doctors and officials at the FDA have been concerned about the risk of birth defects and Stevens Johnson Syndrome (SJS). Recently, Topamax lawyers have looked into these safety concerns and filed lawsuits.
Topamax Side effects
The most common Topamax side effects are drowsiness, weight loss, and nervousness. In rare cases, the medicine can also lead to eye problems that can cause blindness if they are not treated. Other serious complications include mood swings, depression, and suicidal thinking.
- Eye problems: Acute Myopia and Secondary Angle Closure Glaucoma
- Suicidal thinking
- Birth defects
Topamax Birth Defects
In March 2011, the FDA announced that it was going to include this medicine in Pregnancy Category D. “This means that there is positive evidence of human fetal risk based on human data.” After analyzing data, the FDA discovered that women who used the drug during pregnancy had an increased risk of giving birth to a child with cleft lip or cleft palate. The Agency warned that “alternative medications that have a lower risk of birth defects should be considered” (i). If you or a loved one has given birth to a child with the following birth defects due to taking this medicine, then you should talk to an attorney about filing a birth defect lawsuit.
- Cleft lip and palate
- Hypoplastic Left/Right Heart Syndrome
- Limb malformations
- Persistent Pulmonary Hypertenion in Newborns (PPHN)
- Septal Heart defects
- And other birth defects
Topamax & SJS
One rare but very serious reaction that may be associated with this medicine is Stevens Johnson Syndrome (SJS). This is a hypersensitivity reaction that begins as a painful rash and it can quickly evolve into toxic epidermal necrolysis (TEN). The SJS rash covers large areas of the body causing skin to die and fall off in large patches. It also affects the eyes and mouth. SJS and TEN can cause permanent injuries like asthma, scarring, and other serious complications.
Topamax Medical Studies Reveal Dangers
Clinical trials testing the safety of this medicine have found that it may increase the risk of cognitive difficulties and birth defects. In August 2006, a trial found that patients who took drugs containing topiramate had more cognitive side effects than a competing epilepsy drug (ii). In July 2008, the medical journal Neurology published a medical study which found that women who took medicines containing topirmate were 11 times more likely to give birth to a child with a cleft lip or cleft palate. Read the medical study here. In the same year, the FDA compiled adverse event data on epilepsy medicines like Topamax. After reviewing information from more than 40,000 patients, the Agency concluded that patients taking epilepsy medication had twice the risk of suicidal thinking (iii).
According to a June 2010 safety review, the FDA found evidence of 67 birth defects linked to Topamax. Among these were 21 facial defects (including 11 reports of cleft lip/palate), 19 malformations, and 15 cardiovascular defects (iv). Additionally, a review of FDA data has shown that between 1997 and 2012 there were 422 women who reported suffering a complication due to taking topiramate during pregnancy. View more information on common side effects.
Topamax has caused several legal problems for Johnson & Johnson. In 2010, the company reached $81 million settlement for illegally promoting the medicine. This number includes a $75 million charge for illegal promotion and a $6 million criminal penalty. The company promoted off-label uses in its “Doctor-for-a-Day” program where it hired outside doctors to speak at meetings and dinners. Read the news story here.
Patients who have suffered serious Topamax side effects are now filing lawsuits. Johnson & Johnson acknowledged that it was facing 75 Topamax lawsuits in its 2012 Annual Report (v). Furthermore many of these suits have been centralized in Philadelphia’s Complex Litigation Center. See the cases here. These suits allege that the medicine was defectively designed and lacked adequate warning making it unreasonably dangerous. At that time that many women were taking topiramate medicines the label did not warn about the increased risk of birth defects.
Do You Need Advice Regarding a Potential Topamax Lawsuit?
If you or a loved one has suffered an injury due to taking this medicine, then you should talk to a Topamax lawyer about your legal options. You may be entitled to receive money for your medical bills, lost income, pain and suffering, and other losses. Our law firm is working with lawyers across the country, who are filing Topamax lawsuits. There are no legal fees until you receive a settlement or award for your injuries. Feel free to call us toll-free or submit a contact form online for a free legal consultation.
- (i) FDA News Release, March 4, 2011.
- (ii) Neurology, August 2006.
- (iii) Suicidality and Antiepileptic Drugs, 2008.
- (iv) Safety Review: Topiramate Use During Pregnancy, June 1, 2010.
- (v) Johnson & Johnson 2012 Annual Report.