  |
The MedWatch February 2015 Safety Labeling Changes posting includes 45 products with safety labeling changes to the following sections: CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.
The "Summary Page" table provides a listing of product names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm436827.htm
The following drugs had modifications to the CONTRAINDICATIONS, or WARNINGS and PRECAUTIONS sections:
Apidra (insulin glulisine [rDNA origin]) injection
Byetta (exenatide) injection
Dianeal Peritoneal Dialysis Solution in Plastic Container, Low Calcium Peritoneal Dialysis Solution in ULTRABAG Plastic Container, and Dianeal PD-2 Peritoneal Dialysis Solution in ULTRABAG Plastic Container
Ditropan XL (oxybutynin chloride) Extended Release Tablets
Epivir (lamivudine) Tablets and Oral Solution
Exelon (rivastigmine tartrate) Capsule and Oral Solution
Exelon Patch (rivastigmine) transdermal system
Firmagon (degarelix for injection) Lyophilized Powder for Injection
Gablofen (baclofen) Injection
Humalog (insulin lispro [rDNA origin]) injection
Humalog Mix 75/25 (75% insulin lispro protamine suspension /25% insulin lispro [rDNA origin]) injection
Humalog Mix 50/50 (50% insulin lispro protamine suspension /50% insulin lispro [rDNA origin]) injection
Humulin 70/30 (70% human insulin isophane suspension/30% insulin human injection, rDNA origin)
Humulin N NPH (human insulin isophane suspension [rNDA origin])
Humulin R (insulin human injection, USP [rDNA origin])
Lantus (insulin glargine [rDNA origin]) injection
Levemir (insulin detemir [rDNA origin]) injection
Minipress (prazosin hydrochloride) Capsules
Minocin (minocycline hydrochloride) Oral Suspension
Neupro Patch (rotigotine) Transdermal System
NovoLog (insulin aspart [rDNA origin]) injection
NovoLog Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart [rDNA origin]) injection
NovoLog Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart [rDNA origin]) injection
Novolin N (NPH, human insulin isophane suspension [rDNA origin]) injection
Osphena (ospemifene) Oral Tablets
Razadyne (galantamine HBr) Tablets, Oral Solution
Razadyne ER (galantamine HBr) Extended-Release Capsules
Suprane (desflurane, USP) Volatile Liquid for Inhalation
Symlin (pramlintide acetate) injection
VFEND (voriconazole) Tablets, for Oral Suspension, and for Injection
Victoza (liraglutide [rDNA origin]) injection
Zoladex (goserelin acetate) Implant
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your email address to log in. If you have questions or problems with the subscription service, please visit subscriberhelp.govdelivery.com.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
| This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
