FDA Studying 27 Drugs, Drug Classes for Potential Safety Issues
February 20, 2010 — Twenty-seven drugs and drug categories have landed on the watch list of the US Food and Drug Administration (FDA) based on potential signs of serious risks or new safety information identified in the agency's Adverse Event Reporting System (AERS) last year.
The key word here is potential. The FDA states that the appearance of a drug on the AERS list does not mean that the agency has determined that the drug actually poses the listed risk. While the FDA evaluates whether there is a casual relationship between a listed drug and a possible risk, it is not suggesting that physicians stop prescribing these drugs, or that patients stop taking them.
Drugs coming under surveillance include oseltamivir (Tamiflu), used to treat influenza, and cisplatin (Platinol), a staple in cancer chemotherapy. Oseltamivir made the list due to reports of hypothermia, while cisplatin is there based on reports of leukoencephalopathy.
Yet another chemotherapy agent on the watch list is imatinib mesylate (Gleevec). The FDA will evaluate whether hearing disorders and hearing loss are possible adverse effects.
In the case of dexlansoprazole (Kapidex), prescribed for gastroesophageal reflux disease and erosive esophagitis, the possible problem is alphabetical in nature. FDA is wondering if physicians and patients are confusing the brand name Kapidex with Casodex, the brand name for the prostate cancer drug bicalutamide.
Some Safety Issues Have Already Been Addressed
The 27 drugs and drug categories appear on quarterly reports generated by AERS for the second and third quarters of 2009; the reports were made public on Wednesday. AERS is a database for adverse drug events and medication errors reported by clinicians, patients, drug manufacturers, and others.
Because the reports cover the second and third quarters of 2009, the FDA and drug manufacturers have had time since then to address some of the possible safety issues. For example, the antihypertensive agent aliskiren (Tekturna and Tekturna HCT) surfaced in AERS because of reports of angioedema so severe that it required intubation. In November, the warnings and precautions section of aliskiren's labeling was revised to include angioedema as a possible adverse effect.
if you cant open the article, google it:
FDA Studying 27 Drugs, Drug Classes for Potential Safety Issues
Feb 20, 2010 ... Lamotrigine (Lamictal), Central nervous system infection, aseptic meningitis, Under FDA study. Neuromuscular blocking agents, Anaphylactic ...
www.medscape.com/viewarticle/717321 - 7 hours ago
The key word here is potential. The FDA states that the appearance of a drug on the AERS list does not mean that the agency has determined that the drug actually poses the listed risk. While the FDA evaluates whether there is a casual relationship between a listed drug and a possible risk, it is not suggesting that physicians stop prescribing these drugs, or that patients stop taking them.
Drugs coming under surveillance include oseltamivir (Tamiflu), used to treat influenza, and cisplatin (Platinol), a staple in cancer chemotherapy. Oseltamivir made the list due to reports of hypothermia, while cisplatin is there based on reports of leukoencephalopathy.
Yet another chemotherapy agent on the watch list is imatinib mesylate (Gleevec). The FDA will evaluate whether hearing disorders and hearing loss are possible adverse effects.
In the case of dexlansoprazole (Kapidex), prescribed for gastroesophageal reflux disease and erosive esophagitis, the possible problem is alphabetical in nature. FDA is wondering if physicians and patients are confusing the brand name Kapidex with Casodex, the brand name for the prostate cancer drug bicalutamide.
Some Safety Issues Have Already Been Addressed
The 27 drugs and drug categories appear on quarterly reports generated by AERS for the second and third quarters of 2009; the reports were made public on Wednesday. AERS is a database for adverse drug events and medication errors reported by clinicians, patients, drug manufacturers, and others.
Because the reports cover the second and third quarters of 2009, the FDA and drug manufacturers have had time since then to address some of the possible safety issues. For example, the antihypertensive agent aliskiren (Tekturna and Tekturna HCT) surfaced in AERS because of reports of angioedema so severe that it required intubation. In November, the warnings and precautions section of aliskiren's labeling was revised to include angioedema as a possible adverse effect.
if you cant open the article, google it:
FDA Studying 27 Drugs, Drug Classes for Potential Safety Issues
Feb 20, 2010 ... Lamotrigine (Lamictal), Central nervous system infection, aseptic meningitis, Under FDA study. Neuromuscular blocking agents, Anaphylactic ...
www.medscape.com/viewarticle/717321 - 7 hours ago
-
- groups:
- Community
-
- tags:
- Drugs, memory loss, FDA & Pharmaceuticals
