FDA Drug Information Updates

FDA Drug Information Updates

reachmd.com/programs/FDA-Drug-Information-Updates
Experts from the U.S. Food and Drug Administration (FDA) discuss important new drug information as well as urgent insights about approved drug products.


The FAERS Public Dashboard and its Value to the Pharmaceutical Industry
Jul 31, 2018
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…
FDA Warns of Serious Immune Reaction with Seizure/BPD Medicine Lamotrigine (Lamictal)
May 4, 2018
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…
FDA D.I.S.C.O.: First Biosimilar Approval for the Treatment of Cancer
Jan 7, 2018
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…
FDA Requires New Class Warnings for All Gadolinium-Based Contrast Agents
Jan 5, 2018
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…
FDA Review: Adding LABAs to ICS Treatment Does Not Significantly Increase Serious Asthma Outcomes Risk
Jan 4, 2018
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…
Pinpointing the Top Questions about Biosimilars in Rheumatology
Nov 30, 2017
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
Oct 29, 2017
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…
FDA D.I.S.C.O.: L-Glutamine for Sickle Cell Disease
Aug 17, 2017
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
Jul 28, 2017
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
Jul 25, 2017
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.: First Tissue/Site Agnostic Cancer Treatment Approval
May 30, 2017
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.: Avelumab in Merkel Cell Carcinoma
May 22, 2017
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.: Niraparib in Ovarian Cancer
May 18, 2017
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…
FDA D.I.S.C.O.: Rucaparib in Ovarian Cancer
May 17, 2017
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
Introducing FDA’s Drug Information Soundcast in Clinical Oncology (DISCO)
May 16, 2017
In the FDA’s inaugural Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.) episode, Dr. Richard Pazdur, director of the FDA Oncology Center of Excellence, talks with hosts Dr. Sanjeeve Bala and Dr. Abhilasha Nair about this new podcast series.
FDA Confirms Leg and Foot Amputation Risk with Diabetes Medicine Canagliflozin
May 16, 2017
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,…
FDA Restricts Use of Prescription Codeine and Tramadol Pain Medicines in Children
Apr 20, 2017
The Food and Drug Administration (FDA) is restricting the use of codeine and tramadol medicines in children. Codeine is approved to treat pain and cough, and tramadol is approved to treat pain. These medicines carry serious risks, including slowed or…
New Safe Use Requirements for Long-Acting Beta-Agonists (LABAs)
Feb 23, 2010
FDA is recommending new safety measures to improve the safe use of long acting beta agonists (LABAs).
FDA: Product Confusion with Maalox Total Relief and Maalox Liquid Products
Feb 18, 2010
The FDA has issued a public health advisory regarding serious medication errors that have arisen when consumers used Maalox Total Relief, the upset stomach reliever and anti-diarrheal medication,by mistake, when they had intended to use one of the…
FDA: Advisory on Body Building Products
Jun 17, 2009
On July 28th, 2009, the FDA issued an advisory recommending that consumers do not use body building products marketed as containing steroids or steroid-like substances, due to potential serious health risks. Listen now for the full advisory.