Has your healthcare provider ever talked to you about using an FDA-approved drug for an unapproved use (sometimes called an “off-label” use) to treat your disease or medical condition?
It may be something to consider if you live with status epilepticus (SE), a condition characterized by a prolonged episode of seizure activity.
Early this year, it was discovered that a breast cancer drug could be effective for suppressing seizures. Click here to read more.
Status epilepticus is said to occur when a seizure lasts too long or when seizures occur close together, and the person doesn’t recover between seizures. People with diagnosed epilepsy who have a status seizure also have an increased risk of death if their condition is not stabilized quickly—this makes the “off label” drug discovery even more vital.
But, there may be some thoughts to consider.
It is important to know that before a drug can be approved, a company must submit clinical data and other information to FDA for review. The company must show that the drug is safe and effective for its intended uses. “Safe” does not mean that the drug has no side effects. Instead, it means the FDA has determined the benefits of using the drug for a particular use outweigh the potential risks.
Food for Thought Questions
If your healthcare provider is thinking about using an approved drug for an unapproved use, you may want to ask your healthcare provider questions like these:
- What is the drug approved for?
- Are there other drugs or therapies that are approved to treat my disease or medical condition?
- What scientific studies are available to support the use of this drug to treat my disease or medical condition?
- Is it likely that this drug will work better to treat my disease or medical condition than using an approved treatment?
- What are the potential benefits and risks of treating my disease or medical condition with this drug?
- Will my health insurance cover treatment of my disease or medical condition with this drug?
- Are there any clinical trials studying the use of this drug for my disease or medical condition that I could enroll in?
Whatever the case, the research to help the status epilepticus community is both needed and exciting.