FDA: February 2008 Drug Safety Labeling Changes for 47 drugs now available on web
The February 2008 posting includes 47 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT PACKAGE INSERTS, and MEDICATION GUIDES.
The Summary Page provides a listing of drug names and safety labeling sections revised: http://www.fda.gov/medwatch/SAFETY/2008/feb08_quickview.htm
The Detailed View Page identifies safety labeling sections and subsections revised along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections: http://www.fda.gov/medwatch/SAFETY/2008/feb08.htm
In February 2008, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:
Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) Tablets
Cleocin Sterile Solution (clindamycin injection)
Cleocin Phosphate (clindamycin injection in 5% dextrose) IV Sterile Solution
Duragesic (fentanyl) Transdermal System
Emsam (selegiline transdermal system) Patches
Fentora (fentanyl buccal tablet)
Lincocin (lincomycin) Injection
Asmanex Twisthaler (mometasone furoate inhalation powder)
Abilify (aripiprazole) Tablets and Oral Solution
Abilify (aripiprazole) Discmelt Orally Disintegrating Tablets
Abilify (aripiprazole) Injection for Intramuscular Use Only
Avastin (bevacizumab) for Intravenous Use
Claforan Sterile (cefotaxime sodium for injection, USP) and Injection (cefotaxime sodium injection, USP)
Cortenema (hydrocortisone retention enema)
Doryx (doxycycline hyclate) Capsule, Delayed Release Pellets
Eryc (erythromycin delayed-release capsules, USP)
Erythrocin Lactobinate (erythromycin lactobionate) Injection, Powder, Lyophilized, For Solution
Geocillin (carbenicillin indanyl sodium) Tablets
Halcion (triazolam tablets)
Janumet (sitagliptin/metformin HCl) Tablets
Letairis (ambrisentan) Tablets
Premarin Intravenous (conjugated estrogens, USP) for injection
Remodulin (treprostinil sodium) Injection
Restoril (temazepam) Capsules
Reyataz (atazanavir sulfate) Capsules
Sensipar (cinacalcet) Tablets
Ultram ER (tramadol HCl) Extended-Release Tablets
Vibramycin Calcium (doxycycline calcium oral suspension, USP) Oral Suspension Syrup
Vibramycin Hyclate (doxycycline hyclate capsules, USP) Capsules
Vibramycin Monohydrate (doxycycline monohydrate) for Oral Suspension
Vibra-Tabs (doxycycline hyclate tablets, USP) Film Coated Tablets
Source
June 23, 2008 |
