April 2008 drug safety-related labeling changes for 47 drugs.
The Detailed View Page identifies safety labeling sections and subsections revised along with a brief summary
the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:
Aldurazyme (laronidase) Solution for Intravenous Infusion Only
Emtriva (emtricitabine) Capsules and Oral Solution
Lotronex (alosetron hydrochloride) Tablets
Advair Diskus (fluticasone propionate and salmeterol inhalation powder)
Amitiza (lubiprostone) Capsules
Crixivan (indinavir sulfate) Capsules
Tigan (trimethobenzamide hydrochloride) Injectable for Intramuscular Use Only
Actonel (risedronate sodium) Tablets
Augmentin (amoxicillin/clavulanate potassium) Tablets
Augmentin ES-600 (amoxicillin/clavulanate potassium) Powder for Oral Suspension
Augmentin XR (amoxicillin/clavulanate potassium) Extended Release Tablets
Declomycin (demeclocycline hydrochloride) Tablets
Evamist (estradiol transdermal spray)
Levaquin (levofloxacin) Tablets and Oral Solution, Levaquin (levofloxacin) Injection, for Intravenous Use
Levaquin (levofloxacin in 5% dextrose) Injection, for Intravenous Use
Luvox (fluvoxamine maleate) Tablets
Nafcillin Injection, USP in PL 2040 Plastic Container For Intravenous Use Only (Galaxy Container)
Neulasta (pegfilgrastim)
Orencia (abatacept) Lyophilized Powder for Intravenous Infusion
Oxacillin (oxacillin) Injection, Solution in Plastic Container For Intravenous Use Only - Galaxy Container (PL 2040)
Pipracil (piperacillin for injection) for Intravenous and Intramuscular Use
Prevacid (lansoprazole) Delayed-Release Capsules and Oral Suspension, Prevacid SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets
Timentin (ticarcillin disodium and clavulanate potassium) for Intravenous Administration
Timentin (ticarcillin disodium and clavulanate potassium) Injection - Galaxy (PL 2040) Plastic Container
Unasyn (ampicillin sodium/sulbactam sodium)
Vyvanse (lisdexamfetamine dimesylate) Capsules
Zosyn (piperacillin and tazobactam injection) in Galaxy Containers (PL 2040 Plastic)
Zosyn (piperacillin and tazobactam for injection) Individual Vials and Zosyn (piperacillin and tazobactam for injection) Pharmacy Bulk Package
The benefits of green tea in reducing an important risk factor for heart disease The study, performed by Dr. Nikolaos Alexopoulos and colleagues at the 1st Cardiology Department,
Athens Medical School in Greece, was a randomised trial involving the
diameter measurement (dilatation) of the brachial artery of healthy
volunteers on three separate occasions - after taking green tea,
caffeine, and hot water (for a placebo effect). The measurements were
taken at 30, 90 and 120 minutes after consumption. Dilatation of the
brachial artery as a result of increased blood flow (following a brief
period of ischaemia of the upper limb) is related to endothelial
function and is known to be an independent predictor of cardiovascular
risk.
July 2008 FDA Patient Safety News Stories edition include:
New Skin Graft Adhesive Approved
The fibrin sealant Artiss has a lower thrombin concentration than other sealants, giving surgeons more time to position the skin graft over a burn…
"http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=77#2">New Non-Refrigerated Coagulation Product
A new formulation allows NovoSeven RT to be stored at room temperature for up to two years, giving greater flexibility in managing blood disorders…
Update on Potentially Contaminated Heparin
Healthcare professionals should report adverse reactions involving drugs or devices that contain heparin and ensure that recalled products have been removed…
FDA Takes Action on Injectable Colchicine
Colchicine for injection is not approved and is especially hazardous because the margin between an effective dose and a toxic dose is very narrow…
FDA Studying Heart Attack Risk with Ziagen, Videx
FDA's evaluation prompted by data from international study of HIV patients…
Preventing Fatal Overdoses with Cerebyx (fosphenytoin)
The Institute for Safe Medication Practices warns about dosing errors that led to pediatric deaths…
Albuterol Inhalers: Making the Switch
People with asthma, emphysema and other airway diseases need to switch to inhalers that don't use CFCs…