The MedWatch June 2012 Safety Labeling Changes posting includes 35 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.
The “Summary Page” available via the link below provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm309380.htm
The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and/or WARNINGS sections:
- Avodart (dutasteride)
- Bepreve (bepotastine besilate) 1.5% ophthalmic
- CellCept (mycophenolate mofetil)
- CellCept (mycophenolate mofetil hydrochloride)
- Estraderm (estradiol) transdermal
- Helidac Therapy (bismuth subsalicylate, metronidazole and tetracycline hydrochloride)
- Incivek (telaprevir)
- Jalyn (dutasteride and tamsulosin HCL)
- Methergine (methylergonovine maleate)
- Myfortic (mycophenolic acid)
- Noxafil (posaconazole)
- Prezista (darunavir)
- Prinivil (lisinopril) tablets and
- Prinzide(lisinopril/hydrochlorothiazide)
- Privigen Immune Globulin Intravenous (Human) 10%
- Stelara (ustekinumab)
- Strattera (atomoxetine hydrochloride)
- Sustiva (efavirenz)
- Vesicare (solifenacin succinate)
- Zithromax (azithromycin)
Remember, only prescribe or consume the above if they are genuinely essential. All medication is dangerous and all do cause some harm. Always! What is your honest harm-benefit analysis? Is it honestly and soundly informed or are you someone’s fool? Think about it.
Tags: FDA MedWatch