The MedWatch February 2012 Safety Labeling Changes posting includes 65 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:

The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections:

  • Abilify (aripiprazole) Tablets, Orally Disintegrating Tablets, Oral Solution, and Injection
  • Amturnide (amlodipine/aliskiren/hydrochlorothiazide) tablets
  • Angeliq (drospirenone and estradiol) tablets
  • Aptivus (tipranavir) Capsules and Oral Solution
  • Avalide (irbesartan/hydrochlorothiazide) tablets
  • Benicar (olmesartan medoxomil) Tablets
  • Beyaz (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium) tablets
  • Cardiogen-82 (Rubidium Rb 82 Generator)
  • Crestor (rosuvastatin calcium) Tablets
  • Crixivan (indinavir sulfate) Capsules
  • Diovan HCT (valsartan/hydrochlorothiazide) Tablets
  • EES (erythromycin ethylsuccinate) Granules for oral suspension, Eryc (erythromycin delayed-release) capsules, Ery-Ped liquid and
  • PCE (erythromycin particles in tablets) 333 mg and 500 mg film coated tablets
  • Elestrin (estradiol gel)
  • Exforge HCT (amlodipine/valsartan/hydrochlorothiazide) tablets
  • Famvir (famciclovir) Tablets
  • Hepsera (adefovir dipivoxil) tablets
  • Invirase (saquinavir mesylate) Capsules and Tablets
  • Kaletra (lopinavir/ritonavir) Tablets and Oral Solution
  • Lescol (fluvastatin sodium) Capsules
  • Lescol XL (fluvastatin sodium) Extended-Release Tablets
  • Letairis (ambrisentan) Tablets
  • Lexiva (fosamprenavir calcium) tablets and oral suspension
  • Lipitor (atorvastatin calcium) Tablets
  • Livalo (pitavastatin) tablets
  • Lotensin HCT (benazepril HCl and hydrochlorothiazide) Tablets
  • Mevacor (lovastatin) Tablets
  • Natazia (estradiol valerate and estradiol valerate/dienogest) tablets
  • Norvir (ritonavir) oral solution and tablets
  • Orencia (abatacept) for injection
  • Ozurdex (dexamethasone intravitreal) implant
  • Patanase (olopatadine hydrochloride) Nasal Spray
  • Phendimetrazine tartrate SR 105 mg capsules
  • Pravachol (pravastatin sodium) Tablets
  • Premarin (conjugated estrogens) Vaginal Cream
  • Prempro (conjugated estrogens/medroxyprogesterone acetate tablets) and Premphase (conjugated estrogens plus medroxyprogesterone acetate) tablets
  • Prezista (darunavir), Oral suspension
  • Reyataz (atazanavir sulfate) Capsules
  • Rituxan (rituximab) Intravenous Injection
  • Safyral (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium) tablets
  • Simcor (niacin ER/simvastatin) Tablets
  • Tekamlo (aliskiren/amlodipine) tablets
  • Tekturna (aliskiren) and Tekturna HCT (aliskiren/hydrochlorothiazide) Tablets
  • Valturna (aliskiren/valsartan) tablets
  • Vaseretic (enalapril maleate/hydrochlorothiazide) Tablets
  • Vasotec (enalapril maleate) Tablets
  • Viracept (nelfinavir mesylate) Oral Powder
  • Vytorin (ezetimibe/simvastatin) Tablets
  • Xalkori (crizotinib) Capsules
  • Yasmin (drospirenone/ethinyl estradiol) tablets
  • Zocor (simvastatin) Tablets
  • Zyvox (linezoid) Tablets and Oral Suspension

Language is interesting. The FDA calls them “Safety Labels” which inspires trust. The truth is, they would much more aptly be called “Danger Labels” and you would do well to regard them as such. Remember, all drugs are dangerous. Consume only what you absolutely must and then do so with the utmost care.

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