The June 2008 posting includes 51 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/jun08_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/jun08.htm
In June 2008, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or MEDICATION GUIDES:
Optison (Perflutren Protein -Type A Microspheres Injectable Suspension, USP)
Viramune (nevirapine) Tablets and Oral Suspension
Aptivus (tipranavir) Capsules and Oral Solution
Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) Tablets
Avodart (dutasteride) Soft Gelatin Capsules
Concerta (methylphenidate HCl) Extended-Release Tablets
Kaletra (lopinavir and ritonavir) Tablet, Film Coated for Oral Use
Kaletra (lopinavir and ritonavir) Solution for Oral Use
Reclast (zoledronic acid) Injection
Zyvox (linezolid) Injection, Zyvox (linezolid) Tablets, and Zyvox (linezolid) for Oral Suspension
Forteo (teriparatide [rDNA origin]) Injection
PegIntron/REBETOL Combo Pack containing: PegIntron REDIPEN Single-dose Delivery System (peginterferon alfa-2b) and REBETOL (ribavirin, USP) Capsules
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