Pharmaceutical_industry - Articles

What’s Wrong With Generics?

May 4, 2021

Katherine Eban

Katherine Eban is an investigative journalist whose 2019 book Bottle of Lies: The Inside Story of the Generic Drug Boom uncovered problems in generic drug manufacturing. Ms. Eban has disclosed no relevant financial or other interests in any commercial companies pertaining to this educational activity.

Generic recalls are on the rise: Bupropion, methylphenidate, and metformin, to name a few. Katherine Eban explains the limits of FDA oversight, and what we can do to protect our patients when quality control cones under suspicion.

Nuedexta in Agitated Dementia

February 10, 2020

Nuedexta is indicated for pseudobulbar affect, but when the manufacturer attempted to expand its use into agitation in dementia they ran into some heavy legal penalties. Here we take a closer look at the published and unpublished trials to see what ─ if anything ─ is salvageable. We’ll also show you how to prescribe this high-cost drug as a generic equivalent.

TMS: Deeper is not Better

January 13, 2020

Edmund S. Higgins, MD.

Edmund S. Higgins, MD. Dr. Higgins has disclosed that he has no relevant financial or other interests in any commercial companies pertaining to this educational activity.

Two devices are available for transcranial magnetic stimulation (TMS). Neurostar came first with the figure-8 coil, which is now off-patent, while Brainsway’s H-coil which claims to reach deeper into the cerebral cortex. See how they compare in the first head-to-head controlled trial, undertaken without industry support.

Is Paxil the Best SSRI for Anxiety?

August 30, 2019

Chris Aiken, MD

Chris Aiken, MD Dr. Aiken has disclosed that he has no relevant financial or other interests in any commercial companies pertaining to this educational activity.

Paxil built its reputation as the best SSRI for anxiety, but the data suggests the opposite.

Concerta: Brand vs Generic

January 1, 2017

Glen Elliott, MD, PhD

Glen Elliott, MD, PhD Editor-in-chief, The Carlat Child Psychiatry Report

In November 2016, the FDA announced that it was requiring two companies to withdraw their generic versions of Concerta (OROS methylphenidate) because of efficacy concerns. Such actions are quite unusual, and when they occur, they tend to shake doctors’ confidence in the generic drug system—which branded drug companies are often eager to encourage. But the Concerta case is hardly an indictment of generic drugs, or even of generic stimulants. Let’s dig a little deeper for some insight into the generic drug process.

Managing Pain: A Cognitive Behavioral Therapist’s Approach [Free Article]

October 26, 2016

John D. Otis, PhD

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Managing Pain: A Cognitive Behavioral Therapist’s Approach

September 28, 2016

John D. Otis, PhD

As a clinical psychologist with a specialty in chronic pain management, I am often referred patients with both chronic pain and psychiatric issues. Many of these patients see a psychiatrist and a therapist, and are taking with both psychotropic and pain medications. The referral is often made because there is...

What’s New with the FDA Labeling for Pregnancy and Lactation?

July 25, 2016

Talia Puzantian, PharmD, BCPP

We’ve been hearing for some time now about the FDA’s plans to revise the long-standing categories A, B, C, D, and X designations for risk of using medications in pregnancy. The new rule (referred to as PLLR for Pregnancy and Lactation Labeling Rule) was proposed in 2008, finalized in 2014,...

What’s New with the FDA Labeling for Pregnancy and Lactation?

July 1, 2016

Talia Puzantian, PharmD, BCPP

Talia Puzantian, PharmD, BCPP Deputy Editor, The Carlat Psychiatry Report Dr. Puzantian has disclosed that she has no relevant financial or other interests in any commercial companies pertaining to this educational activity.

We’ve been hearing for some time now about the FDA’s plans to revise the long-standing categories A, B, C, D, and X designations for risk of using medications in pregnancy. The new rule (referred to as PLLR for Pregnancy and Lactation Labeling Rule) was proposed in 2008, finalized in 2014, and implementation began during the summer of 2015.

EXPERT Q&A

How to Evaluate and Treat Mood Disorders in Pregnancy

July 1, 2016

Vivien Burt, PhD, MD

Vivien Burt, PhD, MD

Founder and co-director at UCLA Women’s Life Center, a perinatal outpatient program in Los Angeles, CA.

Dr. Burt discloses that she has been a paid consultant to Otsuka, Sunovion, Lundbeck, and Takeda. Dr. Puzantian has reviewed this article and has found no evidence of bias in this educational activity.

Dr. Vivien Burt discusses mood disorders and pregnancy. It’s now pretty widely recognized that pregnancy does not protect against mental illness, and the postpartum period is certainly a time of very high vulnerability for women, especially if they’ve had a history of psychiatric illness.