Fw: FDA MedWatch - July 2008 Drug Safety-Related Labeling Changes for 35 Drugs Now Available on Web

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FDA MedWatch - July 2008 Drug Safety-Related Labeling Changes for 35 Drugs Now Available on Web

The July 2008 posting includes 35 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT PACKAGE INSERTS, and MEDICATION GUIDES.

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

http://www.fda.gov/medwatch/safety/2008/jul08_quickview.htm

The "Detailed View Page" identifies safety labeling sections and subsections revised along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:

http://www.fda.gov/medwatch/safety/2008/jul08.htm

In July 2008, the following drugs had modifications to the BOXED WARNING section:

Baraclude (entecavir) Tablets and Oral Solution

Exforge (amlodipine and valsartan) Tablets

Strattera (atomoxetine hydrochloride) Capsules

Tykerb (lapatinib) Tablets

Ziagen (abacavir sulfate) Tablets and Oral Solution

In addition, the following products in July 2008 had changes to MEDICATION GUIDES:

Advair HFA (fluticasone propionate and salmeterol) Inhalation Aerosol for Oral Inhalation Only

Enbrel (etanercept) for Subcutaneous Injection

EC-Naprosyn (naproxen delayed-release tablets), Naprosyn (naproxen tablets), Anaprox/Anaprox DS (naproxen sodium tablets), and Naprosyn (naproxen suspension)

Strattera (atomoxetine hydrochloride) Capsules

Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol for Oral Inhalation Only

Vicoprofen (hydrocodone bitartrate/ibuprofen) Tablets

Ziagen (abacavir sulfate) Tablets and Oral Solution

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