Lamictal Carries Major Warnings
The first Black Box Warning on the Lamictal label contains the information that Lamictal can cause dangerous, even fatal rashes. The warning (shown below) says that Lamictal treatment should be discontinued at the first sign of any rash.The first Lamictal boxed warning is as follows:
Serious rashes requiring hospitalization and discontinuation of treatment have been reported in association with the use of Lamictal. The incidence of these rashes, which have included Stevens-Johnson Syndrome, is approximately 0.8% (8 per 1,000) in pediatric patients (age <16 years) receiving Lamictal as adjunctive therapy for epilepsy and 0.3% (3 per 1,000) in adults on adjunctive therapy for epilepsy. In clinical trials of bipolar and other mood disorders, the rate of serious rash was 0.08% (0.8 per 1,000) in adult patients receiving Lamictal as initial monotherapy and 0.13% (1.3 per 1,000) in adult patients receiving Lamictal as adjunctive therapy. In a prospectively followed cohort of 1,983 pediatric patients with epilepsy taking adjunctive Lamictal, there was 1 rash-related death. In worldwide postmarketing experience, rare cases of toxic epidermal necrolysis and/or rash-related death have been reported in adult and pediatric patients, but their numbers are too few to permit a precise estimate of the rate.
Because the rate of serious rash is greater in pediatric patients than in adults, it bears emphasis that Lamictal is approved only for use in pediatric patients below the age of 16 years who have seizures associated with the Lennox-Gastaut Syndrome or in patients with partial seizures (see Indications). Other than age, there are as yet no factors identified that are known to predict the risk of occurrence or the severity of rash associated with Lamictal. There are suggestions, yet to be proven, that the risk of rash may also be increased by (1) coadministration of Lamictal with valproate (includes valproic acid and divalproex sodium [e.g., Depakote]; (2) exceeding the recommended initial dose of Lamictal, or (3) exceeding the recommended dose escalation for Lamictal. However, cases have been reported in the absence of these factors.
Nearly all cases of life-threatening rashes associated with Lamictal have occurred within 2 to 8 weeks of treatment initiation. However, isolated cases have been reported after prolonged treatment (e.g., 6 months). Accordingly, duration of therapy cannot be relied upon as a means to predict the potential risk heralded by the first appearance of a rash.
Although benign rashes also occur with Lamictal, it is not possible to predict reliably which rashes will prove to be serious or life threatening. Accordingly, Lamictal should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug related. Discontinuation of treatment may not prevent a rash from becoming life threatening or permanently disabling or disfiguring.
The second black box warning on the Lamictal label tells that there is a possibility of life-threatening or fatal hypersensitivity reactions. The warning reads:
Hypersensitivity reactions: Hypersensitivity reactions, some fatal or life-threatening, have also occurred. Some of these reactions have included clinical features of multiorgan dysfunction such as hepatic [liver] abnormalities and evidence of disseminated intravascular coagulation [formation of small blood clots throughout the body]. It is important to note that early manifestations of hypersensitivity (e.g., fever, lymphadenopathy [swelling of lymph nodes]) may be present even though a rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. LAMICTAL® should be discontinued if an alternative etiology [cause] for the signs or symptoms cannot be established.
Prior to initiation of treatment with LAMICTAL®, the patient should be instructed that a rash or other signs or symptoms of hypersensitivity (e.g., fever, lymphadenopathy) may herald a serious medical event and that the patient should report any such occurrence to a physician immediately.
Other Major Precautions and Warnings
- Unless rash or hypersensitivity reactions appear, Lamictal should not be discontinued abruptly, but should be tapered off over a period of at least two weeks to help avoid the risk of seizures.
- Dosage adjustment will be necessary in most patients who start or stop taking oral contraceptives (birth control pills) containing estrogen while taking Lamictal.
- The safety and effectiveness of Lamictal in patients under 18 with mood disorders have not been established.
- Breast-feeding while taking Lamictal is not recommended.
Page 2: Lamictal Warning on Birth Defects, Side Effects, References
