First standardized REMS approved
- Fentanyl. // AHFS Consumer Medication Information;Sep2016, p1
Fentanyl is used to treat breakthrough pain (sudden episodes of pain that occur despite round the clock treatment with pain medication) in cancer patients at least 18 years of age (or at least 16 years of age if taking Actiq brand lozenges) who are taking regularly scheduled doses of another...
- Efficacy of spinal ropivacaine versus ropivacaine with fentanyl in transurethral resection operations. Chaudhary, A.; Bogra, J.; Singh, P. K.; Saxena, S.; Chandra, G.; Verma, R. // Saudi Journal of Anaesthesia;Jan-Mar2014, Vol. 8 Issue 1, p88
Background: The low-dose ropivacaine provides differential spinal block to reduce adverse hemodynamic effects in elderly patients. Addition of intrathecal fentanyl with ropivacaine may enhance analgesia and early postoperative mobility. The present study was performed to evaluate the efficacy of...
- New rules for opioid prescribing. // Primary Care Reports;Apr2009 Pharmacology Watch, p2
The article reports on the restrictions on use of opioid drugs being considered by the U.S. Food and Drug Administration. It states that a Risk Evaluation and Mitigation Strategy will be required by manufacturers to ensure that the benefits of the drugs continue to outweigh the risks. The...
- REMS, Patient Safety, and Professional Liability Risks. Heagerty, Kathryn E. // Innovations in Clinical Neuroscience;Mar2012, Vol. 9 Issue 3, p27
The article provides an answer to a question of what Risk Evaluation and Mitigation Strategy (REMS) is and the reasons as to why it is so important.
- Challenges for FDA Mount. // Chain Drug Review;4/26/2010, Vol. 32 Issue 8, p223
The article reports on the challenges faced by the Food and Drug Administration in protecting Americans from contaminated drugs in the U.S.
- Droperidol/anaesthetics/haloperidol. // Reactions Weekly;6/5/2010, Issue 1304, p15
The article describes the case of an 18-year-old woman who acquired either catatonia or neuroleptic malignant syndrome (NMS) following intake of propofol, fentanyl, droperidol and haloperidol.
- New drugs and dosage forms. // American Journal of Health-System Pharmacy;2/15/2011, Vol. 68 Issue 4, p284
No abstract available.
- Opioid therapy for persistent cancer pain. // Clinical Advisor;Apr2011, Vol. 14 Issue 4, p32
The article offers information on opioid therapy for persistent cancer pain, which acts on breakthrough pain in patients already receiving and are tolerant to continuous opioid therapy. It mentions the Abstral sublingual tablets from ProStrakan Inc. which is indicated for opioid-tolerant...
- Recent innovations in breakthrough cancer pain management. Thai, Vincent // International Journal of Palliative Nursing;Feb2012 Supplement, p9
The article provides an overview of medications for breakthrough cancer pain (BtCP). The median duration of BtCP episodes is 45 to 60 minutes while the duration of effect of the standard rescue mediations is approximately 4 hours. Parenteral opioids can be regarded for BtCP treatment in certain...
- New Fentanyl Approvals Hint At Track for Class-Wide REMS. Serebrov, Mari // BioWorld Insight;7/11/2011, Vol. 19 Issue 28, p3
The article reports on the essence of risk evaluation and mitigation strategies (REMS) on the Federal Drug Administration (FDA) approval of fentanyl products. It discusses the competition between Onsolis and the fast-acting fentanyl products for cancer pain discovery wherein the REMS for Onsolis...