Table 3.
Pharmacotherapeutic options for maintenance treatment in patients with bipolar disorder
| Drug class/name | Regulatory approvala,b | Pregnancy-safety rating (US)c | Summary of major reproductive safety concerns |
|---|---|---|---|
| Mood stabilizers | |||
| Lithium | Adultsd,mono | D | See Table 1 |
| Valproate | – | D | See Table 1 |
| Carbamazepine | – | D | See Table 1 |
| Lamotrigine | Adultse | C | See Table 2 |
| Antipsychotics, atypical | |||
| Clozapine | – | B | See Table 1 |
| Risperidone | Adultsf,mono | C | See Table 1 |
| Olanzapine | Adults | C | See Table 1 |
| Quetiapine | Adultscom | C | See Table 1 |
| Ziprasidone | Adultscom | C | See Table 1 |
| Aripiprazole | Adultsmono,com | C | See Table 1 |
| Asenapine | – | C | See Table 1 |
| Lurasidone | – | B | See Table 2 |
| Antipsychotics, typical | –g | C | See Table 1 |
Notes: monoapproval as a monotherapy; comapproval as combination therapy with lithium or valproate
regulatory approval in the US
no psychotropic medications (including those used to treat bipolar disorder in any of its phases) are approved for use in the context of pregnancy in the US; information on regulatory approval in the US is for general treatment of bipolar disorder in adults, or in children or youth where specified
FDA pregnancy-safety categories are generally defined as: A = adequate, well-controlled human studies fail to show risk to fetus; B = animal studies fail to show risk to fetus, but no adequate, well-controlled studies in humans; C = animal studies show evidence of adverse fetal effects, but no adequate studies in humans – benefits of use in pregnancy may still outweigh risks; D = investigational or postmarketing studies in humans show evidence of adverse fetal effects, but benefits of use in pregnancy may still outweigh risks; E = contraindicated in pregnancy
prospective observational studies suggest increased risk of antepartum relapse when effective maintenance treatment is continued during pregnancy compared with discontinuation during pregnancy69–72
FDA approval for maintenance treatment in adults with bipolar I disorder
long-acting injectable form
caution is advised with long-term use of typical neuroleptics for treating patients with bipolar disorder, due to risk of worsening depressive symptoms and tardive dyskinesia.
Abbreviation: FDA, US Food and Drug Administration.