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Home : Unsafe Drugs : Paxil : FDA Information : August 2006 Safety Labeling Changes

August 2006 Safety Labeling Changes

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The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, or ADVERSE REACTIONS 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: BW=BOXED WARNING, C=CONTRAINDICATIONS, W=WARNINGS, P=PRECAUTIONS, AR=ADVERSE REACTIONS
DRUG NAME SECTIONS MODIFIED
(Click on drug name to go to detailed view)

BW

C

W

P

AR
Aptivus (tipranavir) Capsules X   X X X
Dexedrine (dextroamphetamine sulfate) Spansule Sustained-Release Capsules and Tablets X   X    
Prevacid NapraPAC (lansoprazole delayed-release capsules and naproxen tablets kit) X X X X X
(Click on drug name to go to detailed view)

BW

C

W

P

AR
Nafcillin Injection, USP for Intravenous Use Only   X   X  
Prevpac (lansoprazole 30mg capsules/amoxicillin 500mg capsules/clarithromycin 500mg tablets, USP)  

X

 X X X
(Click on drug name to go to detailed view)

BW

C

W

P

AR
Cordarone (amiodarone hydrochloride) Intravenous     X X  
Cordarone (amiodarone hydrochloride) Tablets     X X  
Coreg (carvedilol) Tablets     X X  
Epzicom (abacavir sulfate and lamivudine) Tablets     X X  
Focalin (dexmethylphenidate hydrochloride tablets)     X    
Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules     X    
Forane (isoflurane, USP) Liquid for Inhalation     X X X
Keppra (levetiracetam) Tablets and Oral Solution     X X X
Metadate CD (methylphenidate hydrochloride, USP) Extended-Release Capsules     X    
Methylin (methylphenidate hydrochloride chewable tablets)     X    
Methylin (methylphenidate hydrochloride oral solution)     X    
Naropin (ropivacaine HCl) Injection     X    
Paxil (paroxetine hydrochloride) Tablets and Oral Suspension     X X X
Paxil CR (paroxetine hydrochloride) Controlled-Release Tablets     X X X
Plavix (clopidogrel bisulfate tablets)     X X X
Rebetol (ribavirin, USP) Capsules and Oral Solution     X    
Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules     X    

Ritalin (methylphenidate hydrochloride tablets, USP)

Ritalin SR (methylphenidate hydrochloride, USP) Sustained-Release Tablets

     X    
Roferon-A (interferon alfa-2a, recombinant)     X   X
Suprane (desflurane, USP) Liquid for Inhalation     X X X
Trizivir (abacavir sulfate/ lamivudine/zidovudine) Tablets     X    

Videx (didanosine) Chewable/Dispersible Buffered Tablets

Videx (didanosine) Pediatric Powder for Oral Solution

     X X X
Videx EC (didanosine) Delayed-Release Capsules [Enteric-Coated Beadlets]     X X X
(Click on drug name to go to detailed view)

BW

C

W

P

AR
Actonel (risedronate sodium tablets)       X X
Actoplus Met (pioglitazone hydrochloride and metformin hydrochloride tablets)       X X
Actos (pioglitazone hydrochloride) Tablets       X X

Atacand (candesartan cilexetil) Tablets

       X  
Atacand HCT (candesartan cilexetil and hydrochlorothiazide) Tablets       X  
Boniva (ibandronate sodium) Injection       X  
Cozaar (losartan potassium tablets)       X X
Diprolene (augmented betamethasone dipropionate) AF Cream, 0.05%       X  
Diprolene (augmented betamethasone dipropionate) Lotion, 0.05%       X  
Diprolene (augmented betamethasone dipropionate) Ointment, 0.05%       X  
E.E.S. (erythromycin ethylsuccinate)       X  
Hyzaar (losartan potassium/ hydrochlorothiazide tablets)       X X
Lexiva (fosamprenavir calcium) Tablets       X  
OptiMARK (gadoversetamide injection) for Intravenous Injection Only       X  
PCE Dispertab Tablets (erythromycin particles in tablets)       X  
Plavix (clopidogrel bisulfate tablets)       X X
Remicade (infliximab) for IV Injection       X X
Ultram ER (tramadol hydrochloride) Extended-Release Tablets       X  
Ziagen (abacavir sulfate) Tablets and Oral Solution       X X

Zofran (ondansetron hydrochloride) Injection

Zofran (ondansetron hydrochloride) Injection Premixed

       X X

Zofran (ondansetron hydrochloride) Tablets and Oral Solution

Zofran ODT (ondansetron hydrochloride) Orally Disintegrating Tablets

       X X

Zyprexa (olanzapine tablets)

Zyprexa Zydis (olanzapine orally disintegrating tablets)

Zyprexa IntraMuscular (olanzapine for injection)

       X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR
Actonel with Calcium (risedronate sodium tablets with calcium carbonate tablets, USP)         X
Aloxi (palonosetron HCl injection)         X
Crixivan (indinavir sulfate) Capsules         X
Humira (adalimumab)         X
Invanz (ertapenem for injection)         X
Primaxin I.M. (imipenem and cilastatin for injectable suspension)         X
Primaxin I.V. (imipenem and cilastatin for Injection)         X
Reyataz (atazanavir) Capsules         X

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