Lamictal, an anti-epileptic medication that belongs to a class of drugs known as anticonvulsants, which was first approved by the FDA in 1994. Initially given the green light as an anti-seizure medication, approval to use the drug to treat bipolar disorder was given in 2003. Manufactured by the pharmaceutical giant GlaxoSmithKline, Lamictal has come under fire in recent years due to its negative side effects. Some of the serious side effects that Lamictal has been linked to include suicidal thoughts and behaviors, birth defects, Stevens-Johnson Syndrome, aseptic meningitis, and Toxic Epidermal Necrolysis (TEN). Studies conducted in 2008 showed that numerous patients who were prescribed Lamictal in order to treat seizures or bipolar disorder developed symptoms of suicidal behavior and other life-threatening conditions. The manufacturer of Lamictal has come under fire for the drug’s side effects, even when used properly. This brings up the question of how safe Lamictal is for off-label or experimental use.
Off-label use is the use of pharmaceutical drugs for an unapproved use, dosage, or age group. Basically, when a drug is used in a different way than described by the FDA-approved drug label, it is said to be an off-label drug. Some of the known off-label uses of Lamictal include the following:
- SUNCT syndrome headaches
- Psychiatric side effects from the drug, Keppra
- Preventing stroke-related seizures
- Stroke-related pain
- Certain types of epilepsy
Because Lamictal has not be proven to safely treat the above listed conditions and ailments, it is not recommended for use. Lamictal is linked to numerous serious and even life-threatening side effects even when used properly, which is why it is important to steer clear of the drug when prescribed for off-label uses.
The Dangers of Off-Label Drug Use
Research indicates that at least 21 percent of prescriptions written by American medical professionals are for conditions that the drugs have not been approved by the FDA to treat. As mentioned above, a drug is considered “off-label” when it is used in a way that it has not been formally tested or approved by the FDA as safe and effective. A drug may also be considered off-label if it is used in the following manner:
- For an age group that it has not been tested on (such as children or the elderly)
- At a dosage not approved by the FDA
- By itself, when the label indicates it should be used with other drugs
- With other drugs, when the label indicates it should be used alone
Even though it is illegal for pharmaceutical companies to promote their drugs for off-label use, this is a common practice that comes with the incentive of billions of dollars in possible profits. Off-label prescribing can expose patients to ineffective, risky, and life-threatening treatments. While it is true that some off-label therapies are beneficial, there is not a lot of scientific evidence to prove the overall effectiveness. When it comes to Lamictal, the side effects of the drug when used to treat bipolar disorder and seizures, both of which it is approved for, can be extremely dangerous. Since we do not know the full scope of how dangerous Lamictal is, it is not recommended for off-label use. If you or a loved one has been prescribed Lamictal for an off-label use and has sustained serious injuries or illness, please contact Wormington & Bollinger today. Our knowledgeable Lamictal lawyers will work with you and determine whether or not you have a case, and if so, how to proceed.