Patient/caregiver was educated on contraindications for using Gablofen as follows:
- Gablofen use, especially in individuals with seizure history, can occasionally result in deterioration of seizure control and fresh episodes of seizures. Gablofen must either be avoided for an alternative or used with extra caution in individuals with seizure history, to prevent exacerbation of seizure episodes.
- Gablofen must be avoided in individuals with history of severe head injury and brain damage. Individuals with history of head injury and brain damage can be at a very high risk to present with severe depression of brain and associated respiratory and cardiovascular centers with gablofen, leading to complications such as, coma, respiratory arrest, dangerous hypotension, and bradycardia, which can be fatal.
- Gablofen use in expectant mothers could increase risk for pregnancy complications. Gablofen can cross the placenta and enter the baby. Newborns can also present with harmful side-effects of the medication. Newborns exposed to gablofen in the uterus can present with harmful side-effects of the medication, such as, respiratory depression, breathing difficulties, and other toxicity with the medication. Gablofen can also pass into the breast milk and use in new mothers can also increase risk for complications in breastfed newborns. So, gablofen is avoided for an alternative safer drug or cautiously administered with careful monitoring for complications during pregnancy, in women planning for pregnancy, and in new mothers breastfeeding the newborns. Women in the child-bearing age group taking gablofen regularly must employ effective contraceptive measures in order to avoid getting pregnant.
