Drug Safety Oversight Board Meeting: July 27, 2005, Public Meeting
The Food and Drug Administration’s (FDA) Drug Safety Oversight Board (DSOB or Board) held its second meeting on July 27, 2005, from 11:00 a.m. until 3:00 p.m. The following items were discussed:
FDA staff briefed the Board about the role of the Office of New Drugs in drug safety, and the safety activities of the Office of Drug Safety.
FDA staff described for the Board the actions taken since the last Board meeting (June 17, 2005) on significant emerging drug safety issues, in particular the actions on the Fentanyl Transdermal Patch and Palladone (see the recent Public Health Advisories on these drugs at Public Health Advisories). The Board members then discussed and commented on some of the actions, including issues related to the safe use of opioids in complex drug delivery systems such as extended release products.
FDA actions on emerging drug safety issues included posting new or updated information for patients and healthcare professionals at: CDER's home page on the following drugs:
Updated Healthcare Professional and Patient Information Sheets
Antidepressants – Celexa (citalopram), Cymbalta (duloxetine), Effexor (venlafaxine), Lexapro (escitalopram), (fluvoxamine), Paxil (paroxetine), Prozac (fluoxetine), Remeron (mirtazapine), Serzone (nefazodone), Wellbutrin (bupropion), Zoloft (setraline)
New Healthcare Professional and Patient Information Sheets
Erectile Dysfunction Drugs – Cialis (tadalafil), Levitra (vardenafil), and Viagra (sildenafil citrate)
Fentanyl Transdermal Patch
Palladone (no patient information sheet because sponsor suspended sales and marketing)