Pharmacy Focus 2

Neuropsychiatric Events with Certain Asthma Drugs

There is a potential for neuropsychiatric events with leukotriene-modifying drugs including the asthma drugs Accolate (zafirlukast), Zyflo (zileuton) and Zyflo CR (zileuton). Also included is Singulair (montelukast), which is used to treat asthma and allergic rhinitis, and to prevent exercise-induced asthma.

Neuropsychiatric symptoms have included agitation, aggression, anxiousness, irritability, restlessness and insomnia. Patients have also experienced tremors, dream abnormalities, hallucinations, depression and suicide.

If symptoms develop, clinicians should consider discontinuing the medication, according to the FDA.


Anti-epileptic Drugs and Suicide Risk

The labeling for anti-epileptic drugs will now warn of patients having an increased risk of suicidal thoughts and actions, according to the FDA.

The warnings are based on FDA's analysis of placebo-controlled clinical studies of 11 drugs used to treat epilepsy, psychiatric disorders and other conditions. In this analysis, the risk was roughly doubled in patients receiving the anti-epileptic drugs compared with those getting placebo.

The following drugs were included in the analyses:

  • Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
  • Felbamate (marketed as Felbatol)
  • Gabapentin (marketed as Neurontin)
  • Lamotrigine (marketed as Lamictal)
  • Levetiracetam (marketed as Keppra)
  • Oxcarbazepine (marketed as Trileptal)
  • Pregabalin (marketed as Lyrica)
  • Tiagabine (marketed as Gabitril)
  • Topiramate (marketed as Topamax)
  • Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
  • Zonisamide (marketed as Zonegran)
The analyses suggest that this risk applies to all anti-epileptic drugs when they're used for any indication - even those that weren't part of the analysis, according to the FDA.


Recall of Certain Infant Apnea Monitors

Philips/Respironics is recalling some SmartMonitor 2 Infant Apnea Monitors. The affected devices are the SmartMonitor 2, Models 4002 and 4003 with serial numbers 3000033364 through 3000038740.

The devices monitor infants' heart rate and respiration in the hospital or at home. The affected monitors may fail to alarm if the infant experiences breathing problems or an abnormal heart rate.

For more information, call Respironics directly at 1-888-345-4630.

For more information on any of the items above, visit www.fda.gov/psn.