FDA Drug Information Updates

Jul 30 2018 20 ep. 42

FDA Drug Information Updates Podcast artwork

Experts from the U.S. Food and Drug Administration (FDA) discuss important new drug information as well as urgent insights about approved drug products.

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The FAERS Public Dashboard and its Value to the Pharmaceutical Industry

The FDA has made strides in improving transparency and data access, and has implemented tools to allow the pharmaceutical industry and the public to transform raw data into usable information. One of these tools is called the FDA Adverse Event Reporting System (FAERS) Public Dashboard. In this episode, the architects of the FAERS Public Dashboard – Deputy Director of the Regulato

FDA Warns of Serious Immune Reaction with Seizure/BPD Medicine Lamotrigine (Lamictal)

The Food and Drug Administration (FDA) is warning that the medicine lamotrigine (Lamictal) for seizures and bipolar disorder can cause a rare but very serious reaction that excessively activates the body’s infection-fighting immune system. This can cause severe inflammation throughout the body and lead to hospitalization and death, especially if the reaction is not diagnosed and

FDA D.I.S.C.O.: First Biosimilar Approval for the Treatment of Cancer

Oncologists Dr. Sanjeeve Bala and Dr. Abhilasha Nair from FDA’s Oncology Center of Excellence discuss the recent approval of bevacizumab-awwb, a biosimilar to US-licensed Avastin, marketed as MVASI. MVASI is the first biosimilar approved in the US for the treatment of cancer. Released on December 21, 2017

FDA Requires New Class Warnings for All Gadolinium-Based Contrast Agents

The FDA announced that it is requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (or MRI) concerning gadolinium remaining in patients’ bodies, including the brain, for months to years after receiving these drugs. Report side effects involving GBCAs to FDA’s MedWatch program at www.fda.gov/medwat

FDA Review: Adding LABAs to ICS Treatment Does Not Significantly Increase Serious Asthma Outcomes Risk

The FDA announced that a review of four large clinical safety trials shows that treating asthma with long-acting beta agonists (LABAs) in combination with inhaled corticosteroids (ICS) does not result in significantly more serious asthma-related side effects than treatment with ICS alone. A link to the full communication detailing information for health care professionals and the

Pinpointing the Top Questions about Biosimilars in Rheumatology

Guest: Leonard H. Calabrese, DO Guest: John R. Tesser, MD This activity provides patient and practice-specific biosimilars content for clinicians in rheumatology practice.

The FDA's Adverse Event Reporting System (FAERS) Public Dashboard

Many listeners may be familiar with the FDA's Adverse Event Reporting System or FAERS. Data in FAERS supports the FDA's post-marketing safety surveillance program for drug products and therapeutic biologic products. Recently, CDER's Office of Surveillance and Epidemiology created and released a tool that makes FAERS data easier to query and retrieve. This new interactive dashboard

FDA D.I.S.C.O.: L-Glutamine for Sickle Cell Disease

FDA medical oncologists discuss the July 7, 2017, approval of l-glutamine to reduce the acute complications of sickle cell disease. Released August 17, 2017

FDA D.I.S.C.O.: Osimertinib for Non-Small Cell Lung Cancer

FDA medical oncologists discuss the approval of osimertinib for EGFR mutation-positive non-small cell lung cancer. Released July 28, 2017

FDA D.I.S.C.O.: Two Approvals for ALK-Positive Non-Small Cell Lung Cancer

FDA medical oncologists discuss the FDA approvals of brigatinib and ceritinib for ALK-positive non-small cell lung cancer. Released July 25, 2017