Labeling change for antipsychotic drugs highlights risk to newborns
FDA has updated the pregnancy section of drug labels for the entire class of antipsychotic medications to provide more information about the potential risk of extrapyramidal signs and withdrawal symptoms in newborns whose mothers take antipsychotics during the third trimester of pregnancy.
FDA has updated the pregnancy section of drug labels for the entire class of antipsychotic medications to provide more information about the potential risk of extrapyramidal signs and withdrawal symptoms in newborns whose mothers take antipsychotics during the third trimester of pregnancy.
Symptoms of EPS and withdrawal in newborns may include agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and feeding problems. These may subside within hours or days without specific treatment, although some infants require longer hospital stays.
FDA warns that women who become pregnant while taking antipsychotic medication should not discontinue these drugs without consulting their healthcare provider because abrupt discontinuation can lead to significant treatment complications.
Drugs affected by the labeling change include haloperidol, clozapine, iloperidone, risperidone, olanzapine, quetiapine, aripiprazole, ziprasidone, paliperidone, loxapine, molindone, thiothixene, pimozide, asenapine, trifluoperazine, chlorpromazine, and olanzapine plus fluoxetine.
David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
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