Szilard Molnar

[9/18/2018] FDA approved the Opioid Analgesic REMS, which applies to all opioid analgesics intended for outpatient use. The REMS program requires that training be made available to all health care providers who are involved in the management of patients with pain, including nurses and pharmacists. The agency also approved the FDA Education Blueprint for Health …

New Safety Measures Announced for Immediate Release (IR) Opioids Read More »

[9/18/2018] FDA approved the Opioid Analgesic REMS, which applies to all opioid analgesics intended for outpatient use. The REMS program requires that training be made available to all health care providers who are involved in the management of patients with pain, including nurses and pharmacists. The agency also approved the FDA Education Blueprint for Health …

New Safety Measures Announced for Extended-release and Long-acting Opioids | FDA Read More »

[8-31-16] After an extensive review of the latest scientific evidence, the U.S. Food and Drug Administration announced today that it is requiring class-wide changes to drug labeling, including patient information, to help inform health care providers and patients of the serious risks associated with the combined use of certain opioid medications and a class of …

New Safety Measures Announced for Opioid Analgesics, Prescription Opioid Cough Products, and Benzodiazepines | FDA Read More »

Opana ER (oxymorphone hydrochloride extended-release tablets) was first approved in 2006 for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The product, currently marketed by Endo Pharmaceuticals, is a reformulation of the original product, designed with physicochemical properties intended to make the drug resistant …

Oxymorphone (marketed as Opana ER) Information Read More »

1995.  OxyContin (oxycodone controlled-release) approved; first formulation of oxycodone that allowed dosing every 12 hours instead of every 4 to 6 hours.   1998.  Actiq (fentanyl) approved; first pain medicine approved to treat cancer breakthrough pain, but with additional safety measures.   Early 2000s.  Reports of overdose and death from prescription pain drugs, especially OxyContin, …

Opioid Timeline Read More »

En Español Remove the Risk raises awareness of the serious dangers of keeping unused opioid pain medicines in the home and provides information about safe disposal of these medicines. Use these free toolkit materials—public service announcements (PSAs), social media images and posts, fact sheets, and more—for talking with others about safe opioid disposal. Remove the …

Safe Opioid Disposal – Remove the Risk Outreach Toolkit Read More »

For Immediate Release: June 05, 2018 Español The U.S. Food and Drug Administration today announced that it has warned nine online networks, operating a total of 53 websites, that they must stop illegally marketing potentially dangerous, unapproved and misbranded versions of opioid medications, including tramadol and oxycodone. Companies who fail to correct the violations, as …

FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales Read More »

Opioid addiction and abuse is an immense public health crisis and addressing it is one of FDA’s highest priorities. In 2016, opioids killed more than 42,000 people – surpassing even the number of deaths resulting from traffic accidents in the United States – and there was a 13% increase in 2017 to 47,600 deaths. Given …

FDA Commissioner Invites Internet Stakeholders to Opioid Summit Read More »

Docket Number: FDA-2019-D-1536 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The purpose of this guidance is to describe the benefit-risk assessment framework that the 17 Agency uses in evaluating whether applications for opioid analgesic drugs meet the standard for 18 approval under section 505 of the Federal Food, Drug, and Cosmetic …

Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Fra Read More »

Our website has links to many other federal agencies, and, in a few cases, to private organizations, foreign governments and international organizations. You should be aware that: This graphic notice, External Link Disclaimer, means that you are leaving the U.S. Food and Drug Administration (FDA) site and entering a non-federal website. This external link provides …

Website Disclaimer Read More »