Welcome to the Nexus of Ethics, Psychology, Morality, Philosophy and Health Care

Welcome to the nexus of ethics, psychology, morality, technology, health care, and philosophy
Showing posts with label FDA Black Box Warning. Show all posts
Showing posts with label FDA Black Box Warning. Show all posts

Friday, October 6, 2017

Lawsuit Over a Suicide Points to a Risk of Antidepressants

Roni Caryn Rabin
The New York Times
Originally published September 11, 2017

Here is an excerpt:

The case is a rare instance in which a lawsuit over a suicide involving antidepressants actually went to trial; many such cases are either dismissed or settled out of court, said Brent Wisner, of the law firm Baum Hedlund Aristei Goldman, which represented Ms. Dolin.

The verdict is also unusual because Glaxo, which has asked the court to overturn the verdict or to grant a new trial, no longer sells Paxil in the United States and did not manufacture the generic form of the medication Mr. Dolin was taking. The company argues that it should not be held liable for a pill it did not make.

Concerns about safety have long dogged antidepressants, though many doctors and patients consider the medications lifesavers.

Ever since they were linked to an increase in suicidal behaviors in young people more than a decade ago, all antidepressants, including Paxil, have carried a “black box” warning label, reviewed and approved by the Food and Drug Administration, saying that they increase the risk of suicidal thinking and behavior in children, teens and young adults under age 25.

The warning labels also stipulate that the suicide risk has not been seen in short-term studies in anyone over age 24, but urges close monitoring of all patients initiating drug treatment.

The article is here.

Sunday, May 19, 2013

Dangers found in lack of safety oversight for Medicare drug benefit

By Tracy Weber, Charles Ornstein and Jennifer LaFleur
ProPublica
Originally published: May 11, 2013

Here is an excerpt:

But an investigation by ProPublica has found the program, in its drive to get drugs into patients’ hands, has failed to properly monitor safety. An analysis of four years of Medicare prescription records shows that some doctors and other health professionals across the country prescribe large quantities of drugs that are potentially harmful, disorienting or addictive for their patients. Federal officials have done little to detect or deter these hazardous prescribing patterns.

Searches through hundreds of millions of records turned up physicians such as the Miami psychiatrist who has given hundreds of elderly dementia patients the same antipsychotic, despite the government’s most serious “black box” warning that it increases the risk of death. He believes he has no other options.

Some doctors are using drugs in unapproved ways that may be unsafe or ineffective, records showed. An Oklahoma psychiatrist regularly prescribes the Alzheimer’s drug Namenda for autism patients as young as 12; he says he thinks it calms them. Autism experts said there is scant scientific support for this practice.

The entire article is here.

Wednesday, February 20, 2013

The Op-Ed: Antidepressants & Controversial Studies

By Ed Silverman
Pharmalot.com
Originally published February 11th, 2013

Several years ago, the Black Box warnings that were added to antidepressants over suicidal thoughts and behaviors for youngsters caused a backlash, as some suggested the language had pushed physicians and parents to avoid usage when the medications could have done some good. The debate may have slipped from view, but never really ended. A pair of papers published last year, in fact, renewed the controversy, and Glen Spielmans, an associate professor of psychology at Metropolitan State University, recounts why the issue remains fraught with challenges and a recent spat that erupted when an effort was made to critique the papers.

Antidepressants can cause suicidality – suicidal thoughts and behaviors – in children and adolescents. This message has been widely disseminated since October 2004, when the FDA placed a Black Box warning on such medications. The warning was based on findings from placebo-controlled trials, in which kids taking antidepressants had an elevated rate of suicidal thoughts and behaviors (see this). But research led by Dr. Robert Gibbons, professor of biostatistics at the University of Chicago, suggests that this warning is counterproductive, scaring parents and kids away from getting safe and effective antidepressant treatment.

Gibbons was the main author on two papers published in 2012 in psychiatry’s premier journal, Archives of General Psychiatry (which was changed to JAMA Psychiatry last month). One paper examined the potential association between antidepressants and suicidality and the other focused on the efficacy of antidepressants.

The entire op-ed is here.

Tuesday, November 15, 2011

Chantix's Suicide Risk Makes It Unsuitable As First Line Smoking Cessation Drug

By Catharine Paddock, PhD
Medical News Today

A new study finds that the smoking-cessation drug varenicline (Pfizer's Chantix) has too poor a safety profile to make it suitable for first-line use. Researchers from Wake Forest Baptist Medical Center, and other research centers in the US, found the drug, known as Champix outside the US, was 8 times more likely to result in reports of suicidal behavior or depression than nicotine replacement products. They report their findings in the 2 November issue of PLoS One, an online journal of the Public Library of Science.

The findings contradict those of a recent review by the US Food and Drug Administration (FDA) that found varenicline, which already carries an FDA "black box warning", did not increase the risk of being hospitalized for psychiatric problems such as depression.

The entire story can be found here.