Reuters (9/18, Nathan) reports that the Food and Drug Administration approved Allergan Plc’s new antipsychotic drug, Vraylar (cariprazine), to treat patients with bipolar disorder and schizophrenia. The drug has a boxed warning of increased risk of death in older patients who have dementia-related psychosis.

MedPage Today (9/18, Fiore) reports that the drug “is a partial agonist of the dopamine D3 and D2 and serotonin 5-HT1A receptors,” is “an antagonist of the serotonin 5-HT2B and 5-HT2A receptors, and it also binds to histamine H1 receptors.”

Related Links:

— “Allergan gets FDA nod for new antipsychotic,” Vidya L Nathan, Reuters, September 17, 2015.

Bloomberg News (9/18, Koons) reports that the Food and Drug Administration requested Pfizer Inc. in August to “alter Zoloft’s [sertraline] warnings to show some researchers have found an ‘increased risk of congenital cardiac defects’ in babies whose mothers took the drug,” according to court papers filed earlier this month.

Legal experts believe that the label change could help “bolster claims by those who have already sued over Zoloft,” but could also “help the company fend off future lawsuits.” According to a statement by Pfizer, the new label language, although still being drafted, “reflects the extensive science supporting the safety and efficacy of Zoloft, stating a complete review of the scientific evidence finds that there is no difference in birth defect risks between pregnant women who took Zoloft and those who did not.”

Related Links:

— “Pfizer Weighing FDA Request to Change Zoloft’s Warnings,” Cynthia Koons and Jef Feeley, Bloomberg News, September 17, 2015.

The Wall Street Journal (9/17, McGinty, Subscription Publication) “The Numbers Column” reports that according to a study published online July 22 in the American Journal of Medical Genetics, the global increase in youngsters diagnosed with autism may be attributed to diagnostic substitution, not to an actual increase in actual autism cases. In other words, more children may now be correctly diagnosed with an autism spectrum disorder instead of another disability or condition.

Related Links:

— “‘Diagnostic Substitution’ Drives Autism Spike,” Jo Craven McGinty, Wall Street Journal, September 16, 2015.

The New York Times (9/17, A20, Carey, Subscription Publication) reports that in 2001, GlaxoSmithKline “published a study showing that the antidepressant Paxil [paroxetine] was safe and effective for teenagers.” Yesterday, however, the BMJ “posted a new analysis of the same data concluding that the opposite is true.”

Reuters (9/17, Kelland) reports that the British Medical Journal criticized GlaxoSmithKline for providing delayed access to critical data from a clinical trial of paroxetine showing that the medication can cause an increased risk of suicide in adolescents. BMJ associate editor Peter Moshi, of the University of Maryland School of Pharmacy, argues in a recent re-analysis that GSK should have provided the data in 2001, while GSK claims that its disclosure of the data now displays its commitment to transparency.

The Washington Post (9/17, Bernstein, Cha) reports in “Health & Science” that “using 77,000 pages of previously unavailable documents, a team of researchers concluded that paroxetine…was no more effective than a placebo and considerably more dangerous than the original study indicated.” While “similar criticism of what is known as ‘Study 329’ began within a year of its publication,” yesterday’s “reappraisal…may be the most thorough yet.”

Related Links:

— “Antidepressant Paxil Is Unsafe for Teenagers, New Analysis Says,” Benedict Carey, New York Times, September 16, 2015.

HealthDay (9/16, Mozes) reports, “The cost of caring for a woman with Alzheimer’s disease is ultimately about six times more than it is for a man with this form of dementia,” according to a study published in the September/October issue of the journal Women’s Health Issues. After examining “data collected by the Medicare Current Beneficiary Survey between 2000 and 2010,” researchers found that “when the patient is a man, the true value of the time and energy a female family member typically puts into her caregiving job is 20 times greater than that performed by a male family member when the patient-caregiver roles are reversed.”

Related Links:

— “Women the Bigger Losers in Terms of Alzheimer’s Costs,” Alan Mozes, HealthDay, September 15, 2015.