June 2010 Drug Safety Labeling Changes: 28 Medical Product Labels with changes

The MedWatch June 2010 Drug Safety Labeling Changes posting includes 28 products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.

This content was submitted directly to this website by the supplier.

Aug 4th, 2010

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

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm218813.htm

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

Advair Diskus (fluticasone propionate and salmeterol xinafoate) inhalation powder
Advair HFA Inhalation Aerosol (fluticasone propionate and salmeterol xinafoate)
Avodart (dutasteride) soft gelatin capsules
Brovana Inhalation Solution (arformoterol tartrate)
Ceftriaxone for Injection and Dextrose Injection in the Duplex Container
Copegus (ribavirin) tablets
Foradil Aerolizer (formoterol fumarate inhalation powder)
Heparin Sodium injection
Hycamtin (topotecan hydrochloride) capsules
Kaletra (lopinavir/ritonavir) tablets and oral solution
Novantrone (mitoxantrone HCl) injection
Ovidrel (choriogonadotropin alfa injection) prefilled syringe
Rybix ODT (tramadol hydrochloride) orally disintegrating tablet
Serevent Diskus (salmeterol xinafoate) inhalation powder
Solu-Medrol (methylprednisolone sodium succinate) for injection
Symbicort Inhalation Aerosol (budesonide and formoterol)

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