Changes made by FDA to safety labels on 65 products

March 19, 2012

The FDA announced on Friday, March 15, that changes have been made to the safety labels of 65 products. This follows the recent release of the side effects caused by the drug class of Statins, used to lower cholesterol. Thankfully, the FDA is changing the safety labels to allow the consumers to be aware of such reactions. This change may stem from a petition filed by Public Citizen , a consumer rights advocacy group. The petition was filed back in August 2011, requesting the FDA to amend regulations that prevent generic drug manufacturers from updating product labels with important product safety information. These changes range from boxed warnings, contraindications, warnings, precautions, adverse reactions and patient package insert. A complete list of the medications associated with this announcement is below. If you are taking any of these medications please read the new labels and discuss with your doctor any impact these changes may have.

List of Products with Safety Label Changes from the FDA:

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

{Sources: UT San Diego,   UPenn Law Blog,  Photo: Stock Photo by Sean Locke}