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Montelukast (Singulair)

Singulair (montelukast) is a medi- cine in the drug class known as leu- kotriene receptor antagonists (blockers). Leukotrienes are chemi- cals the body releases in response to an inflammatory stimulus, such as an inhaled allergen. Singulair is used to treat chronic persistent asthma, exercise induced asthma, and the symptoms of allergic rhini- tis (sneezing, stuffy nose, runny nose, itching of the nose). This medication shouldn’t be used to stop an asthma attack that has al- ready started. It is used to prevent attacks from occurring.

Singulair (montelukast) is on the VA National Formulary, but is re- stricted to certain indications. It may be considered in some pa- tients with Persistent Asthma, Exer- cise Induced Asthma, or Allergic Rhinitis after failure to first line rec-

ommended therapy. It should not be used for the treatment of Chronic Obstructive Pulmonary Disease (COPD) as there is not enough scien- tific or clinical information to support its use in COPD. At present, there is no evidence for triple therapy use (antihistamine + nasal steroid + leu- kotriene modifying agents) for Aller- gic Rhinitis. For most patients, ster- oid inhalers appear to be a more ef- fective treatment.

On March 27, 2008, the FDA an- nounced that it was reviewing safety data that raised concerns about a possible association between the use of montelukast and behavior/mood changes, suicidality (suicidal thinking and behavior) and suicide. Patients and providers should be aware of the potential for neuropsychiatric events (e.g., suicidal ideation, depression, agitation, aggression, anxiousness,

irritability, rest- lessness, dream abnormalities and hallucinations, and insomnia) with montelukast. Providers are en- couraged to document that they have discussed the risks vs. benefits with their pa- tients. Providers should also con- sider discontinuing these medica- tions if patients develop any neuro- psychiatric symptoms.

COPD and Asthma are two condi- tions which affect a large portion of our Veteran population. Your VA pharmacy is committed to promot- ing safe and effective use of this medication for our Veterans.

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    submitted by

Laura Miller, PharmD

Chantix (Varenicline)

Chantix (varenicline) is a non-nicotine prescription drug that works by preventing nicotine from attach- ing to nicotine receptors in the brain. In February of 2008, the FDA issued a Public Health Advisory on varenicline to alert health professionals and patients about new warnings related to changes in behavior, agitation, depressed mood, suicidal ideation, and ac- tual suicidal behavior. These serious adverse effects have occurred in patients with and without pre-

existing psychiatric disease, but they are more prevalent in patients with pre-existing psychiatric dis- ease. Varenicline is on the VA Na- tional Formulary, but is restricted for patients who have failed other pharmacological agents. The VA Center for Medication Safety collected and analyzed spontaneous reports of adverse events with Vareni- cline use. The evaluation of these data was used to formulate the current criteria for use.

Varenicline is not recommended in patients whose moni- toring is only via non-VA telephone counseling, based on a prescription written by a non-VA prescriber, history of sui- cidal, homicidal, or assaultive behavior (within previous 12 weeks), current persistent suicidal/homicidal ideation or an active plan or intent to harm self or others, or with an untreated or unstable mental disorder. Patients without an active mental health disorder meet criteria if they have had more than 1 relapse on nicotine replacement therapy and/or bupropion, or have a medical contraindication to these medications OR a medical contraindication to these medications. For Patients with a mental health disorder, in addition, if the mental disorder is clinically stable AND the prescriber obtains concurrence for treatment from the patient’s mental health provider (if the patient is not un- der mental health care, a mental health provider should be consulted).

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    submitted by

Lindsey Jackson, PharmD. Candidate University of Georgia College of Pharmacy

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