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 Regulatory Science Staff Suranjan De, and Acting Team Lead in Regulatory Science Information Sanjay Sahoo—both of CDER’s Office of Surveillance and Epidemiology, highlight their work with this new online tool.

FDA Drug Information Updates

The FAERS Public Dashboard and its Value to the Pharmaceutical Industry

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 treated quickly. A link to the full communication detailing specific information for health care professionals and a list of FDA-approved GBCAs can be found at www.fda.gov/Drugs/DrugSafety Released 4/25/2018

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

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

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/medwatch. A link to the full communication detailing specific information for health care professionals and a list of FDA approved GBCAs can be found at www.fda.gov/DrugSafety. Released 12/19/2017

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

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 Data Summary can be found at www.fda.gov/DrugSafetyCommunications. Released 12/20/2017

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

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

Pinpointing the Top Questions about Biosimilars in Rheumatology

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 is designed to expand access of FAERS data to the general public. Dr. Janet Woodcock, Director of the FDA Center for Drug Evaluation and Research, discusses the advantages of the tool as well as its limitations.

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

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.: L-Glutamine for Sickle Cell Disease

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.: Osimertinib for 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

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

The D.I.S.C.O. hosts discuss the agency’s first approval of pembrolizumab, a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated. Released May 30, 2017.

FDA D.I.S.C.O.: First Tissue/Site Agnostic Cancer Treatment Approval

FDA medical oncologists discuss the agency’s March 23, 2017 approval of avelumab for the treatment of patients 12 years and older with metastatic Merkel cell carcinoma. Released May 22, 2017

FDA D.I.S.C.O.: Avelumab in Merkel Cell Carcinoma

FDA medical oncologists discuss the agency’s March 2017 approval of niraparib for the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Released May 18, 2017

FDA D.I.S.C.O.: Niraparib in Ovarian Cancer

FDA medical oncologists discuss the agency’s accelerated approval of rucaparib for treatment of patients with deleterious BRCA mutation-associated advanced ovarian cancer who have been treated with two or more chemotherapies. Released May 17, 2017

FDA D.I.S.C.O.: Rucaparib in Ovarian Cancer

Based on new data from two large clinical trials, the FDA concluded that the type 2 diabetes medicine canagliflozin (brand names Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. The FDA is requiring new warnings, including their most prominent Boxed Warning, be added to the canagliflozin drug labels to describe this risk. Amputations of the toe and middle of the foot were the most common; however, amputations involving the leg, below and above the knee, also occurred. Some patients had more than one amputation, some involving both limbs. Report side effects involving canagliflozin and other medicines to the FDA MedWatch program at fda.gov/medwatch. A link to the full communication detailing specific information for health care professionals and the complete Data Summary can be found at fda.gov/DrugSafetyCommunications. If you have drug questions, contact the FDA at druginfo@fda.hhs.gov. Released 5/16/2017

FDA Confirms Leg and Foot Amputation Risk with Diabetes Medicine Canagliflozin

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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FDA Drug Information Updates

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