By Diane S.

Aschenbrenner, MS, APRN-BC

Additional information on the risks of valproate products during pregnancy has emerged from data gathered in the Antiepileptic Drug Pregnancy Registry, which was created by Massachusetts General Hospital in Boston. Women taking any antiepileptic drug (for any indication) during pregnancy can voluntarily enroll in the registry, allowing data about their pregnancy and their babys health to be recorded and analyzed. Pregnancy registries are an important source of information on how drugs actually affect pregnant women, a group about whom little is known because theyre usually excluded from clinical drug trials. According to the FDA, registry data on 149 women with epilepsy who used valproate alone revealed a rate of major malformations of almost 12%, nearly four times that of women taking other antiepileptic drugs. The FDA will revise the labels of these drugs to more clearly indicate the increased risk of major birth defects. A medication guide, which explains the possible risks from a drug and accompanies each prescription, will be developed. Nurses should tell female patients of childbearing age who are receiving valproate sodium or any of its related products about the risk of fetal defects. They should also tell patients to thoroughly read the medication guide that comes with each dispensed prescription because the information can change. Its important that women taking valproate sodium and related medications be taught to use an effective contraceptive because many of the adverse effects occur in the early weeks of a pregnancy, before the pregnancy is confirmed. Patients taking these drugs who wish to become pregnant should
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be weaned off of them before they attempt to do so, if at all possible. Because suddenly stopping an antiepileptic drug can precipitate seizures or a flareup of bipolar disease, women shouldnt just stop drug therapy but should work with their health care provider to make the transition to an alternative therapy; failure to treat epilepsy or bipolar disorder can also result in poor fetal outcomes or create pregnancy complications. Women who wish to become pregnant should take a folic acid supplement before becoming pregnant, as well as during pregnancy, which decreases the risk of neural tube defects in the baby. Some women wont be able to switch from valproate sodium to another medication. Women who become pregnant while taking valproate sodium or any other antiepileptic drug should be encouraged to enroll in the Antiepileptic Drug Pregnancy Registry. They can do so by calling the toll-free number, (888) 233-2334, or by going to www. aedpregnancyregistry.org. REVISED WARNING FOR THE ANTIDEPRESSANT DESIPRAMINE
Desipramine (Norpramin) should be used with great caution in patients with a family history of sudden death, cardiac arrhythmias, or cardiac conduction disturbances. It should also be used with caution in patients with a history of seizure disorder. An overdose of desipramine is more likely to cause death than an overdose of other tricyclic antidepressants.

tachycardia, strokes, and acute myocardial infarction, the label had already warned prescribers to use extreme caution when giving the drug to patients with a history of cardiovascular disease. Now the scope of the warning has been broadened to include patients with a family history of sudden death, cardiac arrhythmias, or cardiac conduction disturbances. Another new warning is that desipramine must be used with extreme caution in patients with a history of seizure disorder because the drug can lower the seizure threshold, precipitating seizures; some patients have had seizures that preceded cardiac arrhythmias and death. Further, according to the manufacturer, overdoses of desipramine are more likely to cause death than are overdoses of other tricyclic antidepressants. Electrocardiographic changes can occur in overdosage, including a widening of the QRS complex, the presence of a terminal S wave seen in lead I and aVL, and an R wave seen in aVR. Nurses should assess patients carefully for these risk factors if theyre to begin therapy with desipramine and teach patients and their families about possible adverse effects. Because all antidepressants carry a warning of an increased risk of suicidality or suicide, families should be aware of the signs of depression and notify the physician or NP if depression occurs or worsens. The patient may take an overdose as a suicide attempt, and the cardiovascular adverse effects from overdosage may be fatal. M
Diane S. Aschenbrenner is the course coordinator for undergraduate pharmacology at Johns Hopkins University School of Nursing in Baltimore, MD. She also coordinates Drug Watch: dianea@son.jhmi.edu.

he warnings on the label of desipramine (Norpramin), a tricyclic antidepressant, have been revised (go to http://bit.ly/d064qf). Because the drug can produce conduction defects, arrhythmias,

AJN M May 2010

Vol. 110, No. 5

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