[U.S. Food and Drug Administration]

MedWatch

Index Of Safety-Related Drug Labeling Change Summaries
Approved by FDA Center for Drug Evaluation and Research (CDER)
Year 1997

(Updated: 2/1/98)

Note: The summaries include only those safety-related sections that have been modified, and therefore do not contain all the information needed for safe and effective prescribing. Contact the manufacturer for the complete labeling/package insert.

NB: Comparison made to the Physicians' Desk Reference (PDR) if drug's labeling included in the PDR.


|A |B |C |D |E |F |G |H |I |J |K |L |M |N |O |P |Q |R |S |T |U |V |W |X |Y |Z|


| Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec |



A

ACCOLATE (zafirlukast) - apr97, jul97
ACEON (perindopril erbumine) - jan97
ACETIC ACID -nov97
ADDERALL (amphetamine/dextroamphetamine) -jul97
ADENOSCAN (adenosine) - dec97
ALDACTONE (spironolactone) -jul97
ALDACTAZIDE (spironolactone/hydrochlorothiazide) - nov97
ALDOCLOR (methyldopa/chlorothiazide) - aug97
ALDOMET (methyldopa) -aug97
ALDORIL (methyldopa/hydrochlorothiazide) - aug97
AMICAR (aminocaproic acid) - apr97
AMPHOTEC (amphotericin B) - aug97
ANAFRANIL (clomipramine HCl) - apr97
ARIMIDEX (anastrozole) - sep97
ASACOL (mesalamine) -aug97
ASTELIN (azelastine HCl) - sep97
ATIVAN (lorazepam) - sep97
AUGMENTIN (amoxicillin/clavulanate potassium) - mar97

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B

BACTERIOSTATIC WATER - nov97
BECLOVENT (beclomethasone dipropionate) - dec97
BECONASE AQ (beclomethasone dipropionate) - may97
BIAXIN (clarithromycin) - aug97, sep97
BiCNU (carmustine) - sep97
BREVITAL (methohexital Na) - dec97
BRICANYL (terbutaline sulfate) - oct97

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C

CALCIJEX (calcitriol) - jun97, dec97
CYLERT (pemoline) - dec97
CAMPTOSAR (irinotecan HCl) - mar97
CARDIZEM (diltiazem HCl) - sep97
CARDURA (doxazosin mesylate) - jul97
CASODEX (bicalutamide) - dec97
CEDAX (ceftibuten) - may97
CEFTIN (cefuroxime) - jun97, sep97
CEFZIL (cefprozil) - apr97, may97, aug97
CIPRO (ciprofloxacin) - aug97, sep97
CHROMITOPE SODIUM (sodium chromate Cr 51) - oct97
CITANEST PLAIN (prilocaine HCl) - may97
CITANEST FORTE (prilocaine and epinephrine) - may97
CLARITIN-D (loratadine/pseudoephedrine sulfate) - feb97, mar97, oct97
CLEOCIN (clindamycin) - mar97, jul97, dec97
CLIMARA (estradiol) - apr97
CLOZARIL (clozapine) - apr97, jun97, sep97
COGNEX (tacrine HCl) - oct97
CORDARONE (amiodarone HCl) - dec97
COREG (carvedilol) - may97
COZAAR (losartan potassium) - nov97
CRIXIVAN(indinavir sulfate) - mar97, sep97
CUTIVATE (fluticasone propionate) - apr97
CYTOTEC (misoprostol) - aug97

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D

DEMADEX (torsemide) - sep97
DEPO-PROVERA (medroxyprogesterone acetate) - jan97, nov97
DESFERAL (deferoxamine mesylate) - apr97
DEXEDRINE (dextroamphetamine sulfate) - jul97
DIDRONEL (etidronate disodium) - jun97
DIFLUCAN (fluconazole) - feb97, aug97
DILACOR XR (diltiazem HCl) - jun97
DIOVAN (valsartan) - jun97
DIZAC (diazepam) - dec97
DOPAMINE - jun97
DURAGESIC (fentanyl) - jul97
DYNABAC (dirithromycin) - dec97

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E

EDECRIN (ethacrynic acid) - nov97
E.E.S. (erythromycin ethylsuccinate) - apr97
ELDEPRYL (selegiline HCl) - aug97
ENDRATE (edetate disodium) - oct97
EPIVIR (lamivudine) - dec97
ERY-PED (erythromycin ethylsuccinate) - apr97
ESTRADERM (estradiol) - dec97
ETHMOZINE (moricizine HCl) - may97

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F

FAMVIR (famciclovir) - jan97, jul97, sep97
FASTIN (phentermine HCl) - oct97
FEMSTAT (butoconazole nitrate) - may97
FLOVENT (fluticasone propionate - oct97
FML (fluorometholone) - nov97
FOSAMAX (alendronate sodium) - apr97
FURADANTIN (nitrofurantoin) - mar97

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G

GARAMYCIN (gentamicin sulfate) - jul97
GENOTROPIN (somatropin [rDNA] origin) - oct97
GLUCAGON - apr97, may97
GLUCOPHAGE (metformin HCl) - nov97
GLYNASE (glyburide) - apr97

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H

HALFAN (halofantrine HCl) - aug97
HELIDAC (bismuth subsalicylate/metronidazole/tetracycline HCl) - aug97
HUMATROPE (somatropin [rDNA] origin) - oct97
HYZAAR (losartan potassium/hydrochlorothiazide) - nov97

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I

ILOSONE (erythromycin estolate) - apr97
INDERAL(propranolol HCl) - nov97
INDERAL LA (propranolol HCl) - nov97
INDERIDE (propranolol HCl/ hydochlorothiazide) - nov97
INDIUM In 111 Oxyquinoline - oct97
INOTROPIN (dopamine HCl) - jun97
INSULIN - apr97
INTAL (cromolyn Na) - may97, jul97
INVIRASE (saquinavir mesylate) - feb97
IOPIDINE (apraclonidine HCl) - nov97

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J

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K

KADIAN (morphine sulfate) - jul97
KLONOPIN (clonazepam) - apr97
KYTRIL (granisetron Hcl) - jan97, oct97

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L

LACRISERT (hydroxypropyl cellulose) - jun97
LAMICTAL (lamotrigine) - mar97
LESCOL (fluvastatin Na) - oct97
LEUCOVORIN CALCIUM - jul97
LIPITOR (atorvastatin Ca) - oct97, nov97
LOPRESSOR HCT (metoprolol tartrate/hydrochlorothiazide) - nov97
LOTENSIN HCT (benazepril HCl/hydrochlorothiazide) - apr97
LOTREL (amlodipine/benazepril HCl) - mar97
LOVENOX (enoxaparin sodium) - jan97
LUDIOMIL (maprotiline HCl) - apr97
LUPRON DEPOT (leuprolide acetate) - may97, sep97
LUPRON DEPOT-PED (leuprolide acetate) - jan97
LYSODREN (mitotane) - sep97

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M

MACROBID (nitrofurantoin) - mar97
MACRODANTIN (nitrofurantoin) - mar97
MAGNESIUM SULFATE - apr97
MAVIK (trandolapril) - jul97
MAXAQUIN (lomefloxacin HCl) - feb97
MAXIPIME (cefepime HCl) - may97
MAXZIDE (triamterence/hydrochlorothiazide) - jan97
MEFOXIN (cefoxitin) - apr97
MEGACE (megestrol acetate) - aug97, sep97
MENTAX (butenafine HCl) - nov97
MEPRON (atovaquone) - may97
METHERGINE (methylergonovine maleate) - may97
METHOTREXATE - may97
METROGEL (metronidazole) - may97
MEVACOR (lovastatin) - feb97, aug97
MEZLIN (mezlocillin sodium) - aug97
MIACALCIN (calcitonin-salmon) - jul97
MICRONASE (glyburide) - apr97
MICRONOR (norethindrone) - nov97
MIRALUMA (technetium Tc99m sestamibi) - may97

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N

NASACORT AQ (triamcinolone acetonide) - sep97
NAVELBINE (tartrate) - aug97
NEBCIN (tobramycin sulfate) - may97, oct97
NEORAL (cyclosporine) - jun97
NEUTREXIN (trimetrexate gluronate) - aug97
NIZORAL (ketoconazole) - may97, oct97
NOROXIN (norfloxacin) - jan97
NORVASC (amlodipine besylate) - jan97
NORVIR (ritonavir) - jan97, mar97, oct97
NOVANTRONE (mitoxantrone) - sep97
NULYTELY (PEG 3350/NaCl/NaHCO3/KCl) - dec97
NUMORPHAN (oxymorphone HCl) - oct97
NUTROPIN (somatropin) - dec97
NUTROPIN AQ (somatropin) - dec97
NYDRAZID (isoniazid) - aug97

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O

OMNISCAN (gadodiamide) - oct97
ORAP (pimozide) - aug97
ORTHO-CEPT (desogestrel/ethinyl estradiol) - feb97
ORTHO-NOVUM 1 + 50 (norethindrone/mestranol) - nov97
ORUDIS (ketoprofen) - aug97
ORUVAIL (ketoprofen) - aug97
OVCON-50 (norethindrone/ethinyl estradiol)- jun97
OVRAL (norgestrel/ethinyl estradiol) - aug97
OXISTAT (oxiconazole nitrate) - aug97
OXYCONTIN (oxycodone HCl) -jan97, jul97

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P

PAREMYD (hydroxyamphetamine hydrobromide/tropicamide) - jun97
PAXIL (paroxetine HCl) - may97
PCE (erythromycin) - apr97
PENETREX (enoxacin) - apr97
PENTAM 300 (pentamidine isethionate) - feb97, oct97
PEPCID (famotidine) - nov97
PERIDEX (chlorhexidine gluconate) - jan97
PERSANTINE (dipyridamole) - jul97
PHYSIOSOL IRRIGATION - nov97
PONDIMIN (fenfluramine HCl) - apr97
POSICOR (mibefradil dihydrochloride) - dec97
PRAVACHOL (pravastatin sodium) - apr97
PRELAY (troglitazone) - apr97, aug97
PREVACID (lansoprazole) - feb97, jun97
PRILOSEC (omeprazole) - apr97, oct97
PRIMAXIN (imipenem/cilastatin) - jun97
PROCARDIA (nifedipine) - apr97, aug97
PROCARDIA XL (nifedipine) - jan97, apr97, aug97
PROGRAF (tacrolimus) - apr97
PRONESTYL (procainamide HCl) - may97
PROSTIN E2 (dinoprostone) - aug97
PROVENTIL-HFA (albuterol sulfate HFA) - apr97
PROVENTIL REPETABS (albuterol sulfate) - sep97
PROZAC (fluoxetine HCl) - mar97

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Q

QUESTRAN (cholestyramine) - aug97

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R

REZULIN (troglitazone) - apr97, aug97, nov97, dec97
RISPERDAL (risperidone) - oct97
RITALIN (methylphenidate HCl) - jul97
ROCEPHIN (ceftriaxone Na) - dec97
RYTHMOL (propafenone HCl) - mar97, dec97

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S

SALAGEN (pilocarpine HCl) - mar97
SECTRAL (acebutolol HCl) - nov97
SELDANE (terfenadine) - aug97
SELDANE-D (terfenadine/pseudophedrine HCl) - aug97
SEPTRA (trimethoprim/sulfamethoxazole) - mar97
SEREVENT (salmeterol xinafoate) - nov97
SERZONE (nefazodone HCl) - may97, aug97
SODIUM CHROMATE Cr 51 - jun97
SODIUM LACTATE - nov97
SODIUM PHOSPHATES - nov97
SORBITOL-MANNITOL - nov97
SORIATANE (acitretin) - jun97
SPORANOX (itraconazole) - aug97
STATROL (neomycin/polymyxin B sulfates) - sep97
SULAR (nisoldipine) - feb97

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T

TAVIST-D (clemastine fumarate/phenylpropanolamine) - oct97
TAXOL (paclitaxel) - aug97
THALLOUS CHLORIDE T1 201 - feb97
TIAZAC (diltiazem HCl) - oct97
TIMENTIN (ticarcillin/clavulanate) - dec97
TIMOPTIC (timolol) - may97, aug97
TORECAN (thiethylperazine maleate) - aug97
TRANSDERM SCOP (scopolamine) - oct97
TRASYLOL (aprotinin) - aug97, sep97
TRAVASOL (amino acid) - nov97
TRECATOR-SC (ethionamide) - mar97
TRENTAL (pentoxifylline) - apr97

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U

ULTANE (sevoflurane) - dec97
ULTRAVIST (iopromide) - jul97
UNASYN (ampicillin Na/sulbactam Na) - feb97

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V

VALTREX (valacyclovir HCl) - apr97, sep97
VANCOCIN (vancomycin HCl) - may97
VASERETIC (enalapril maleate/hydrochlorothiazide) - jun97
VASOTEC (enalapril maleate) - jun97
VENTOLIN (albuterol sulfate) - jun97, oct97, nov97
VERELAN (verapamil HCl) - jul97
VIRA-A (vidarabine) - aug97
VIRACEPT (nelfinavir mesylate) - jul97, sep97
VIROPTIC (trifluridine) - oct97
VISIPAQUE (iodixanol) - oct97
VIVELLE (estradiol) - may97
VOLMAX (albuterol sulfate) - oct97, nov97
VOSOL (acetic acid) - jul97
VOSOL HC (hydrocortisone/acetic acid) - jul97

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W

WELLBUTRIN SR (bupropion HCl) - dec97
WYTENSIN (guanabenz acetate) - jul97

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X

XYLOCAINE (lidocaine HCl) - feb97

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Y

YUTOPAR (ritodrine HCl) - may97, aug97

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Z

ZOCOR (simvastatin) - may97, aug97, oct97
ZOFRAN (ondansetron HCl) - apr97, oct97
ZOLADEX (goserelin acetate) - feb97, jun97
ZOLOFT (sertraline HCl) - jul97, oct97
ZOVIRAX (acyclovir) - jan97, may97

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