50 Ways To Lose Your Label -- In Pharma

50 Drugs Get New Safety Labels

50 products have recently undergone safety labeling changes.  The changes affect the following sections:

1. BOXED WARNINGS

2. CONTRAINDICATIONS

3. WARNINGS

4. PRECAUTIONS

5. ADVERSE REACTIONS

6. PATIENT PACKAGE INSERT

7. MEDICATION GUIDE

This strikes me as a good list to review.  If you use, manufacture or sell any of these products, see below for instructions on how to dig deeper.

Recent changes affect:

Avalide (irbesartan/hydrochlorothiazide) tablets

Avodart (dutasteride) soft gelatin capsules    

Corgard (nadolol) tablets    

Corzide (nadolol and bendroflumethiazide) tablets  

Diflucan (fluconazole) tablets, I.V, and oral suspension      

Diovan (valsartan) tablets

Ditropan XL (oxybutynin chloride) tablets  

Exforge HCT (amlodipine/valsartan/hydrochlorothiazide) tablets

Feraheme (ferumoxytol) injection

Fioricet with Codeine (butalbital, acetaminophen, caffeine, and codeine phosphate) Capsules

Jalyn (dutasteride and tamsulosin) capsules  

Kenalog-10 (triamcinolone acetonide) injection and Kenalog-40 (triamcinolone acetonide) injection  

Nexium (esomeprazole magnesium) for delayed-release oral suspension, delayed-release capsules and (esomeprazole sodium) for injection    

Photofrin (porfimer sodium) for injection

Prilosec (omeprazole magnesium) for delayed-release oral suspension and delayed-release capsules

Proscar (finasteride) tablets    

Prozac Pulvules (fluoxetine hydrochloride) capsules for oral use and Prozac Weekly (fluoxetine hydrochloride) delayed-release capsules

Renagel (sevelamer hydrochloride) tablets and Renvela (sevelamer carbonate) powder for oral suspension and tablets      

Simcor (niacin extended-release/simvastatin) tablets  

Sumavel DosePro (sumatriptan) injection for subcutaneous use

Talacen (pentazocine hydrochloride and acetaminophen) tablets

Tekturna HCT (aliskiren/hydrochlorothiazide) tablets

Torisel (temsirolimus) injection        

Ultracet (tramadol HCl/acetaminophen) tablets

Venofer (iron sucrose) injection

Vimovo (naproxen/esomeprazole magnesium) tablets

Vytorin (ezetimibe/simvastatin) tablets

Zmax (azithromycin extended release) for oral suspension  

Zocor (simvastatin) tablets

Are you -- or is your business -- affected by such changes?  If so, go to the "

Summary Page

" on the FDA site, which provides a list of drug names and safety labeling sections revised.  Here is text version of URL: 

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm261325.htm

For more about safety labeling in pharmaceutical manufacturing and about chemical labels used across all industries. The product page will help you get a perspective on how an automation tool in industrial labeling can work, what the features and benefits are, etc.

Otherwise, you can slip out the back, Jack.  Or make a new plan, Stan.