CLOBAZAM INDUCED DERMATOLOGICAL REACTIONS

CLOBAZAM INDUCED DERMATOLOGICAL REACTIONS

SHINU.C,

ASST PROFESSOR,

ALSHIFA COLLEGE OF PHARMACY

                              Clobazam is a benzodiazepine which affects chemicals in the brain that may become unbalanced and cause anxiety. It is used in combination with other medications to treat seizures caused by Lennox-Gastaut syndrome, a severe form of childhood epilepsy.

                              FDA is warning the public that the anti-seizure drug clobazam can cause rare but serious skin reactions that can result in permanent harm and death. Patients taking clobazam 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 clobazam 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 clobazam treatment. However, the likelihood of skin reactions is greater during the first 8 weeks of treatment or when drug 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.

                        Patients should not stop taking drug without first talking to their health care professionals.  Stopping the drug 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. 

                        clobazam may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur while taking clobazam:

More common

·         Difficulty with swallowing

·         fever

·         shakiness and unsteady walk

·         unsteadiness, trembling, or other problems with muscle control or coordination

Less common

·         Change in speech pattern

·         restlessness

·         slurred speech

·         trouble sitting still

·         trouble with speaking

Some side effects of clobazam may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Patient Information

·         Advise patient to check with health care provider before taking with other CNS depressants, including alcohol.

·         Caution patients about operating hazardous machinery, including automobiles, until they are reasonably certain that clobazam does not affect them adversely (eg, impair judgement, thinking, or motor skills).

·         Inform patients to consult their health care provider before changing the dose or abruptly discontinuing clobazam. Advise patients or caregivers that abrupt withdrawal may increase their seizure risk.

·         Counsel women to also use non hormonal methods of contraception when clobazam is used with hormonal contraceptives and to continue these alternative methods for 28 days after discontinuing treatment to ensure contraceptive reliability.

·         Counsel patients, caregivers, and families that antiepileptic drugs may increase the risk of suicidal thoughts and behaviors and advise them of the need to be alert for the emergence of worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts of self-harm. Instruct them to immediately report behaviors of concern.

·         Instruct patients to notify their health care provider if they become pregnant or intend to become pregnant during therapy. Instruct patients to notify their health care provider if they are breast-feeding or intend to breast-feed during therapy.