onfi (clobazam)

Onfi (clobazam) is one of the two antiepileptic drugs that Calvin takes to control his seizures. It appears to be only partially effective even though his dose is far from small. It is a benzodiazepine derivative related to Valium, which means it has the tendency to cause addiction. As you might imagine, it has bad side effects, the most common of which are headaches, dizziness, drooling, poor coordination and drowsiness, though that list represents just the tip of the iceberg. It makes Calvin drool a lot and it seems to cause him to be hyperactive and agitated and possibly suffer memory problems, which may contribute to his protracted development.

One morning last week I read the following sober news about Onfi in a regular email which I receive weekly from the Epilepsy Foundation's Epilepsy Therapy Project:

The U.S. Food and Drug Administration (FDA) is warning the public that the anti-seizure drug Onfi (clobazam) can cause rare but serious skin reactions that can result in permanent harm and death. We have approved changes to the Onfi drug label and the patient Medication Guide to describe the risk of these serious skin reactions. Patients taking Onfi should seek immediate medical treatment if they develop a rash, blistering or peeling of the skin, sores in the mouth, or hives. Health care professionals should discontinue use of Onfi and consider an alternate therapy at the first sign of rash, unless it is clearly not drug-related.

These rare but serious skin reactions, called Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), can occur at any time during Onfi treatment. However, the likelihood of skin reactions is greater during the first 8 weeks of treatment or when Onfi is stopped and then re-started. All cases of SJS and TEN in the FDA case series have resulted in hospitalization, one case resulted in blindness, and one case resulted in death.

Onfi is a benzodiazepine medication used in combination with other medicines to treat seizures associated with a severe form of epilepsy called Lennox-Gastaut Syndrome. Serious skin reactions have not generally been associated with other benzodiazepines.

Patients should not stop taking Onfi without first talking to their health care professionals. Stopping Onfi suddenly can cause serious withdrawal problems, such as seizures that will not stop, hallucinations (hearing or seeing things that are not real), shaking, nervousness, and stomach or muscle cramps.

The Onfi drug label has been revised to add information about the risk for serious skin reactions to the Warnings and Precautions section and to the Medication Guide.

The revision reads as follows:

Serious Dermatological Reactions
Serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with ONFI in both children and adults during the post-marketing period. Patients should be closely monitored for signs or symptoms of SJS/TEN, especially during the first 8 weeks of treatment initiation or when re-introducing therapy. ONFI should be discontinued at the first sign of rash, unless the rash is clearly not drug-related. If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered.

And so, it is with great anticipation and hope that we will be able to begin Calvin on a medicinal cannabis therapy soon, perhaps just after the turn of the new year. We are full steam ahead and I will be sure to apprise you of our progress.