Drugs

Public Citizen Sues FDA to Force SSRIs Decision

Public Citizen is suing FDA in DC federal court to force the agency to act on a six-year-old petition seeking revised labeling for selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) to warn of serious side effect risks. A Public Citizen statement says the revised labeling would warn of the drugs’ risks of serious sexual side effects that may persist after stopping treatment with the drugs.

The statement says SSRIs and SNRIs are prescription drugs approved by FDA to treat clinical depression and certain other conditions. The drugs are known to cause adverse sexual side effects, it says, and the current U.S. labeling warns of disturbances to sexual functioning during treatment with SSRIs and SNRIs, but does not convey the risk of persistent, worsening, or new symptoms of sexual dysfunction after stopping use of the drugs.

The petition asked for labeling revisions and also for FDA to require that a Dear Healthcare Provider letter be sent to inform prescribers of the risks, and to develop a Medication Guide and communication plan to make patients aware of the risk.

Public Citizen says similar 2018 petitions to drug regulators in Europe and Canada resulted in warnings to patients and healthcare professionals about the risk that sexual side effects may persist after the drugs are discontinued.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome