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NOWCOALITION
FOR BIPOLAR DISORDER
NOW Bipolar Pharmacotherapy Safety Concerns and Recommended Monitoring
Common Side Effects
Fine hand tremor, thirst, polyuria, nausea, diarrhea, weight gain Less Common, Potential y
Nephrotoxicity, teratogenicity, neurotoxicity (serum level related) Serious Side Effects
Early Signs of Lithium Toxicity
New onset of diarrhea, vomiting, drowsiness, muscular weakness, lack of coordination Long-term Concerns Require
Decreased thyroid function, nephrotoxicity Monitoring
Baseline Evaluations
BUN, creatinine; thyroid function; serum pregnancy test or assessment Monitoring
• 12 hrs post dose serum lithium level for monitoring; 5 to 7 days after initiating treatment and after each dose change (2 levels to establish therapeutic dose); then every 6 months • TSH, Ca2+, and weight after 6 months, then annual y Comments
• Monitoring lithium levels and creatinine every 6 months minimizes the risk associated • Obtain a lithium level if there is a concern about lithium toxicity, as indicated by new findings of nausea, diarrhea, or change in tremor in someone previously stable on lithium • Be alert to signs of possible hypothyroid disorder, as indicated by increased weight, cold intolerance, or fatigue in someone stabilized on lithium treatment • Recheck lithium levels if any diuretic medications are started or adjusted • Long term lithium use may result in hyperparathyroidism and elevated Ca2+ levels; thus DIVALPROEX/VALPROIC ACID
Common Side Effects
GI symptoms, weight gain, headache, fatigue, dizziness, tremor Less Common, Potential y
Teratogenicity, pancreatitis, polycystic ovary syndrome (in young women), Serious Side Effects
Baseline Evaluations
• Initial CBC + platelets, LFTs: be aware of bleeding during first 6 months Monitoring
• Weigh initial y more often, then every 6 months Comments
• Reinforce the importance of avoiding pregnancy for female patients • Many potential y important drug-drug interactions. Tends to increase serum level of other w w w . N O W B i p o l a r . o r g
NOWCOALITION
FOR BIPOLAR DISORDER
NOW Bipolar Pharmacotherapy Safety Concerns and Recommended Monitoring
CARBAMAZEPINE
Common Side Effects
Dizziness, drowsiness, unsteadiness, nausea, vomiting Less Common, Potential y
Serious, but very rare dermatological reactions (Stevens-Johnson syndrome, toxic Serious Side Effects
epidermal necrolysis), teratogenicity, agranulocytosis, neutropenia Baseline Evaluations
• HLA-B*1502 genotype screening in patients of Asian descent (screen for increased genetic risk of Stevens-Johnson syndrome) Monitoring
• Alert to signs of rash early in treatment course • CBC, platelets, LFTs, serum sodium every 6 months Comments
• Many important drug-drug interactions. Can significantly decrease serum levels of many medications, including decreased ef ectiveness of many contraceptives • Reinforce the importance of contraception for female patients LAMOTRIGINE
Common Side Effects
General y wel tolerated: initial nausea, dizziness, somnolence, headache sometimes Less Common, Potential y
• Serious dermatological reactions (Stevens-Johnson syndrome, toxic epidermal Serious Side Effects
necrolysis) much more frequent if medication is started at ful dose rather than increased very slowly over time; use standard titration protocol or prepackaged "start-up" packs Monitoring
• Alert to signs of rash early in treatment: especial y of mucosal membranes, palmar surfaces, contiguous rash over upper chest and face Comments
• If medication is discontinued > 3 days, must be restarted with same slow taper as with w w w . N O W B i p o l a r . o r g
NOWCOALITION
FOR BIPOLAR DISORDER
Adverse Events Associated with Atypical Antipsychotics FDA-Approved for Bipolar Disorder
Olanzapine Risperidone
Quetiapine
Ziprasidone Aripiprazole
Asenapine
Metabolic
Neurologic
Cardiovascular
Hormonal
Adverse Events Associated with Atypical Antipsychotics Used Off-Label for Bipolar Disorder
Clozapine
Iloperidone
Lurasidone
Paliperidone
Metabolic
Neurologic
Cardiovascular
Hormonal
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NOWCOALITION
FOR BIPOLAR DISORDER
Monitoring Protocol for Patients Treated with Atypical Antipsychotics†
Parameter
Baseline
Quarterly
†More frequent assessments may be warranted depending on clinical status References
1. Correl CU. Individualizing treatment for patients with bipolar disorder: optimizing ef icacy, safety, and tolerability.
Current Psychiatry. 2010;9(11):49-81.
2. McIntyre RS, Konaski JZ. Tolerability profiles of atypical antipsychotics in the treatment of bipolar disorder. J Clin 3. Ng F, Mammen OK, Wilting I, et al. The International Society for Bipolar Disorders (ISBD) consensus guidelines for the safety monitoring of bipolar disorder treatments. Bipolar Disorders. 2009;11:559-565.
4. American Diabetes Association, American Psychiatric Association, American Association of Clinical Endocrinologists, North American Association for the Study of Obesity. Diabetes Care. 2004;27:596-601.
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Source: http://www.nowbipolar.net/resources/NOW-safety-tool.pdf