|
FDA: March 2009 Safety Labeling Changes - 38 drugs with changes to Boxed Warning, Warnings, Contraindications, Precautions, Adverse Reactions
The following 19 drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:
Epzicom, OsmoPrep, Raptiva, Sporanox, Trizivir, Visicol, Diabeta, Macrobid, Macrodantin, Rocephin, Theophylline, Tracleer, Advair, Altace, Axert, Cymbalta, Frova, Lexiscan, and Spiriva
|
|
|
|
|
The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. The “quick view” table below provides the drug name and sections modified. Click on the drug name to go to the detailed view. The detailed view includes sections and subsections modified, a description of new or modified safety information in the BOXED WARNING, CONTRAINDICATIONS, or WARNINGS sections, and a link to the revised prescribing information.
Key to Label Section Acronyms:
BW=BOXED WARNING, C=CONTRAINDICATIONS, W=WARNINGS, P=PRECAUTIONS
AR=ADVERSE REACTIONS, PPI/MG=PATIENT PACKAGE INSERT/MEDICATION GUIDE |
|
|
|
|
|
|
|
|
DRUG NAME
|
SECTIONS MODIFIED |
| (Click on drug name to go to detailed view) |
BW |
C |
W |
P |
AR |
PPI/MG |
| Epzicom (abacavir sulfate and lamivudine) tablets |
X
|
X
|
X
|
X
|
|
MG
|
| OsmoPrep (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets |
X
|
|
|
|
X
|
MG |
| Raptiva (efalizumab) |
X
|
X
|
X
|
X
|
X
|
MG |
| Sporanox (itraconazole) Oral Solution, 10 mg/mL |
X
|
X
|
X
|
X
|
X
|
|
| Trizivir (abacavir sulfate, lamivudine, and zidovudine) Tablets |
X
|
X
|
X
|
X
|
|
MG |
| Visicol (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) |
X
|
|
|
|
X
|
MG |
| (Click on drug name to go to detailed view) |
BW |
C |
W |
P |
AR |
PPI/MG |
| Diabeta (glyburide) Tablets |
|
X
|
|
X |
|
|
| Macrobid (nitrofurantoin monohydrate/macrocrystals) capsules, 100 mg |
|
X
|
|
|
|
|
| Macrodantin (nitrofurantoin macrocrystals) capsules, 25, 50 and 100 mg |
|
X |
X |
|
|
|
| Rocephin (ceftriaxone sodium) for injection, 250 mg, 500 mg, 1 g and 2 g |
|
X
|
X |
|
X
|
|
| Sporanox (itraconazole) Capsules, 100 mg |
|
X
|
X |
X |
X |
PPI |
Sporanox (itraconazole) Injection, 10 mg/mL |
|
X
|
X |
X |
X
|
PPI |
| Theophylline in 5% Dextrose injection, USP, Flexible Plastic Container |
|
X
|
X |
X |
X |
|
| Tracleer (bosentan) 62.5 and 125 mg Tablets |
|
X
|
|
X |
|
MG |
| (Click on drug name to go to detailed view) |
BW |
C |
W |
P |
AR |
PPI/MG |
| Advair Diskus (fluticasone propionate and salmeterol xinafoate inhalation powder) |
|
|
X |
X |
|
|
Altace (ramipril) 1.25, 2.5, 5, and 10 mg Capsules
Altace (ramipril) 1.25, 2.5, 5 and 10 mg Tablets |
|
|
X |
X |
|
|
| Axert (almotriptan malate) Tablets 6.25 and 12.5 mg |
|
|
X |
X |
X
|
PPI |
| Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules 20, 30 and 60 mg |
|
|
X |
X |
X |
MG |
| Frova (frovatriptan succinate) Tablets 2.5 mg |
|
|
X |
X |
X
|
X |
| Lexiscan (regadenoson) Injection |
|
|
X |
X |
X
|
|
| Spiriva HandiHaler inhalation powder |
|
|
X |
|
X
|
X |
| (Click on drug name to go to detailed view) |
BW |
C |
W |
P |
AR |
PPI/MG |
| NegGram (nalidixic acid) Caplets |
|
|
|
X |
|
|
| Novothyrox (levothyroxine sodium) Tablets |
|
|
|
X |
|
|
| Tarka (trandolopril/verapamil hydrochloride) 2/180, 1/240, 2/240, 4/240 mg ER Tablets |
|
|
|
X |
|
|
Zithromax (azithromcyin) for Oral Suspension, 200 mg, 500 mg, Single Dose Packet, 600 mg, IV |
|
|
|
X |
|
|
| (Click on drug name to go to detailed view) |
BW |
C |
W |
P |
AR |
PPI/MG |
| Clinoril (sulindac) Tablets |
|
|
|
|
X
|
|
| Cosmegen (dactinomycin) for Injection |
|
|
|
|
X
|
|
| Crestor (rosuvastatin calcium) Tablets |
|
|
|
|
X |
|
| Demerol (meperidine hydrochloride) Tablets and Oral Solution |
|
|
|
|
X
|
|
Eloxatin (oxaliplatin) powder for solution for intravenous use
Eloxatin (oxaliplatin) concentrate for solution for intravenous use |
|
|
|
|
X
|
|
| Lipitor (atorvastatin calcium) Tablets |
|
|
|
|
X
|
|
| Niaspan (niacin extended release) tablet |
|
|
|
|
X |
|
| Vancocin Hcl (vancomycin for injection, USP) 500 mg/100mL and 1g/200mL |
|
|
|
|
X
|
|
| (Click on drug name to go to detailed view) |
BW |
C |
W |
P |
AR |
PPI/MG |
| Dalmane (flurazepam hydrochloride), 15 mg and 30 mg oral Capsules |
|
|
|
|
|
MG
|
| Prozac (fluoxetine hydrochloride) capsules |
|
|
|
|
|
MG
|
| Symbyax (olanzapine/fluoxetine) capsules |
|
|
|
|
|
MG
|
| Synagis (palivizumab) |
|
|
|
|
|
PPI
|
Zyprexa (olanzapine) Tablet
Zyprexa Zydis (olanzapine) Tablet, Orally Disintegrating |
|
|
|
|
|
MG
|
|
Source
Added April 9, 2009
|
