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.

In the US News & World Report (9/15) “Policy Dose” blog, Lloyd Sederer, MD, medical director of the New York State Office of Mental Health, writes that “as more people seek” mental healthcare, “thanks to affordability, expanded coverage and greater help-seeking, we won’t have the psychiatric workforce to meet their growing demand.”

In fact, “we now have a serious supply problem when it comes to psychiatrists, as well as other mental health professionals,” he asserts. In two posts to come, Dr. Sederer “will detail a set of potential supply and demand solutions,” which, when “taken together…can help to substantially close the cavernous gap between the real national need for psychiatrists (and other mental health professionals) and the clinical workforce required.”

Related Links:

— “Where Have All the Psychiatrists Gone?,” Lloyd Sederer, U.S. News & World Report, September 15, 2015.

HealthDay (9/15, Dallas) reports that a study published online Sept. 14 in Pediatrics suggests that “natural and man-made disasters can put children’s health and development at risk for years to come.” Researchers found that some “14 percent” of US youngsters “between the ages of two and 17 have been exposed to some” sort of natural or man-made disaster. Many of these children may display “no visible signs of trouble,” and “even those who develop post-traumatic stress disorder may not be diagnosed unless their” physician “specifically asks about their symptoms.”

Related Links:

— “Disaster Aftereffects May Linger for Children,” Mary Elizabeth Dallas, HealthDay, September 14, 2015.

In an editorial, the Baltimore Sun (9/15) points out that “in 2013, more than 41,000 people took their own lives in the United States, or an average of 113 per day.” After listing a number of factors that “put individuals at greater risk for suicide,” the Sun points out that “there is a critical role for all of us to communicate to our friends, our family members and our co-workers, particularly those who might be suffering suicidal thoughts, that there’s nothing wrong with seeking help and support.”

Related Links:

— “The unseen epidemic,” Baltimore Sun, September 14, 2015.

Reuters (9/15, Boggs) reports that seniors with low levels of vitamin D may lose their cognitive abilities faster than seniors whose vitamin D levels are normal, according to a study published online Sept. 14 in JAMA Neurology.

TIME (9/15, Park) reports that researchers studied “383 people enrolled in a long term Alzheimer’s study who participated in a series of cognitive studies and had their blood levels of a version of vitamin D measured yearly for five years.” At study start, “61% of the volunteers had vitamin D levels below recommended levels, and those with dementia showed lower levels of the vitamin.”

The NPR (9/15, Shute) “Shots” blog points out that the “study is notable because of the diversity of the participants: 62 percent were women, 30 percent were African American 25 percent Hispanic and 41 percent white.” The majority of prior “studies looking at cognitive decline and vitamin D were in white people.”

Related Links:

— “Low vitamin D levels linked to faster memory loss in older adults,” Will Boggs, MD, Reuters, September 14, 2015.

The AP (9/14, Crary) reports on the worsening shortage of psychiatrists in the US. “According to the American Medical Association…the number of adult and child psychiatrists rose by only 12 percent, from 43,640 to 49,079,” from 1995 to 2013. Within this same period of time, “the US population increased by 37 percent; meanwhile, millions more Americans have become eligible for mental health coverage under the Affordable Care Act.”

American Psychiatric Association president Renee Binder, MD, “says the perception of inadequate pay is a factor in discouraging some medical students from choosing psychiatry as a specialty.” Yet “another problem,” Dr. “Binder said, is the paperwork requirements imposed by Medicare and private insurance companies,” which, she pointed out, “interferes with our ability to have the time to sit with our patients.”

Related Links:

— “Across much of U.S., a serious shortage of psychiatrists,” David Crary, Associated Press via Express News, September 13, 2015.