February 2011 Safety Labeling Changes: 53 Medical Product Labels with changes to Prescribing Information

The MedWatch February 2011 Safety Labeling Changes posting includes 53 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.

Mar 25, 2011

The "Summary Page" provides a listing of drug names and safety labeling sections revised.

Clicking on a drug product name in the Summary View will take you to the "detailed view" page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information.

The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections:

Avandia (rosiglitazone maleate) Avandamet (rosiglitazone maleate/metformin hydrochloride) and Avandaryl (rosiglitazone maleate/glimepiride) Tablets
Avelox (moxifloxacin hydrochloride) tablets and Avelox (moxifloxacin hydrochloride in NaCl injection) I.V.
Cipro (ciprofloxacin hydrochloride) Tablets, Oral Suspension, IV and Cipro XR (ciprofloxacin extended-release tablets)
Factive (gemifloxacin mesylate) Tablets
Floxin (ofloxacin) Tablets
Heparin Sodium Injection, USP
Humatrope (somatropin [rDNA origin]) for injection
Increlex (mecasermin [rDNA origin] injection
Kaletra (lopinavir/ritonavir) Tablets and Oral Solution
Levaquin (levofloxacin) Tablets, Oral Solution and Injection
Multaq (dronedarone hydrochloride) Tablets
Noroxin (norfloxacin) Tablets
Prilosec OTC (omeprazole magnesium) delayed-release tablets
Promacta (eltrombopag) Tablets
Proquin XR (ciprofloxacin) Extended-Release Tablets
Remicade (Infliximab)
Tekturna (aliskiren) and Tekturna HCT (aliskiren/hydrochlorothiazide) Tablets
Toviaz (fesoterodine fumarate) Extended Release Tablets
Valturna (aliskiren/valsartan) Tablets
Zebeta (bisoprolol fumarate) Tablets

Our List of Cobot Palletizing Solutions

Researched List: Blister Machines for Life Sciences

List: Digitalization Companies From PACK EXPO

Claire Lageat, BD Clinical and Human Factors Specialist shared expert insights into how needle choice can impact the self-injection experience.

Improving Self-Injection Delivery of Biologics Through Better Needle Choices

A recent webinar from BD shared important insights into patient fear and anxiety over self-injection and how the right device can ease it.

Through the Line: Packaging and Processing

Through the Line: Patient Centric Autoinjector Pen

Are Take-back Programs The Future of Pharma Packaging or a Miss?

To address the new and evolving regulations within the industry, and streamline packaging development, RegASK recently partnered with Esko, a global leader in integrated software and hardware solutions for packaging and labeling.

How AI Will Help Brands Transform Packaging Compliance and Speed to Market

Through the Line: Advanced Recycling in Medical Packaging

Medical Device Innovations Report

Cutting-edge packaging technologies are transforming the medical device sector in PMMI’s “Innovation in Medical Device” report, featuring advanced materials, smart solutions, and evolving regulations. Editors share insights from nearly 300 PACK EXPO booth visits—each product deemed new and truly innovative—alongside video demonstrations of the equipment and materials on display.

Learn More

Break out of the ordinary: see what’s new in life sciences packaging

<strong>At PACK EXPO Las Vegas, you’ll see machinery in action and new tech from 2,300 suppliers, collaborate with experts and explore transformative solutions. Join us in September to experience a breakthrough for life sciences products.</strong>