The Health Gazette» Announcement http://the-health-gazette.com Your interactive source for health news, views and reviews Mon, 21 May 2012 09:27:29 +0000 en hourly 1 http://wordpress.org/?v=3.3.2 FDA MedWatch – Safety Labeling Changes for April 2012 http://the-health-gazette.com/1364/fda-medwatch-safety-labeling-changes-for-april-2012/ http://the-health-gazette.com/1364/fda-medwatch-safety-labeling-changes-for-april-2012/#comments Mon, 21 May 2012 09:27:29 +0000 Editor http://the-health-gazette.com/?p=1364 The MedWatch April 2012 Safety Labeling Changes posting includes 43 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.

The “Summary Page” accessible via the link below provides a listing of drug names and safety labeling sections revised:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm302285.htm

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

  • Aceon (Perindopril Erbumine)
  • Altace (Ramipril)
  • Atacand (Candesartan Cilexetil)
  • Sporanox (Itraconazole)
  • Zortress (Everolimus)
  • Advicor (Niacin Extended-release/Lovastatin)
  • Altoprev (Lovastatin Extended-release)
  • Amturnide (Aliskiren, Amlodipine and Hydrochlorothiazide)
  • Premarin (Conjugated Estrogens,USP)
  • Tekamlo (Aliskiren and Amlodipine)
  • Tekturna (Aliskiren)
  • Tekturna HCT (Aliskiren and Hydrochlorothiazide)
  • Vagifem (Estradiol)
  • Valturna (Aliskiren and Valsartan)
  • Viracept (nelfinavir mesylate)
  • Beyaz (Drospirenone and Ethinyl Estradiol and Levomefolate Calcium)
  • Cimzia (Certolizumab Pegol)
  • Krystexxa (Pegloticase)
  • Levaquin (Levofloxacin)
  • Levemir (Insulin Detemir [rDNA origin])
  • Neupro (Rotigotine)
  • Nutropin (Somatropin [rDNA origin])
  • Prandimet (Repaglinide and Metformin HCL)
  • Safyral (Drospirenone and Ethinyl Estradiol and Levomefolate Calcium)
  • Sutent (Sunitinib Malate)
  • Synagis (palivizumab)
  • Tarceva (Erlotinib)
  • Victoza (liraglutide [rDNA])
  • Votrient (Pazopanib)
  • Xgeva (Denosumab)
  • Yasmin (Drospirenone and Ethinyl Estradiol)
  • Yaz (Drospirinenone and Ethinyl Estradiol)
  • Zegerid (Omeprazole and Sodium Bicarbonate)

 

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Plugin by Taragana]]> http://the-health-gazette.com/1364/fda-medwatch-safety-labeling-changes-for-april-2012/feed/ 0 May 2012 Edition of The Health Gazette Ezine http://the-health-gazette.com/1354/may-2012-edition-of-the-health-gazette-ezine/ http://the-health-gazette.com/1354/may-2012-edition-of-the-health-gazette-ezine/#comments Tue, 01 May 2012 05:11:36 +0000 Editor http://the-health-gazette.com/?p=1354 The May 2012 edition of The Health Gazette Ezine will be published as scheduled on May 1st.

This month’s edition concludes a brief series on aging. In part four we briefly discuss the reality of anti-aging prospects and methods.

Subscribers will find the ezine in their mailbox on publication. It will be posted in the subscribers’ archive around the same time.

Copyright © 2012 The Health Gazette. This Feed is for personal non-commercial use only. If you are not reading this material in your own news aggregator, the site you are looking at may be guilty of copyright infringement. Please contact legal@the-health-gazette.com so we can take appropriate action immediately.
Plugin by Taragana]]> http://the-health-gazette.com/1354/may-2012-edition-of-the-health-gazette-ezine/feed/ 0 FDA MedWatch – 39 Products Safety Labeling Changes March 2012 http://the-health-gazette.com/1348/fda-medwatch-39-products-safety-labeling-changes-march-2012/ http://the-health-gazette.com/1348/fda-medwatch-39-products-safety-labeling-changes-march-2012/#comments Fri, 13 Apr 2012 11:19:13 +0000 Editor http://the-health-gazette.com/?p=1348 The MedWatch March 2012 Safety Labeling Changes posting includes 39 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/ucm299284.htm

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

  • Atacand HCT (candesartan cilextetil/hydrochlorothiazide)
  • Benicar (olmesartan medoxomil)
  • Sporanox (itraconazole)
  • Twynsta (telmisartan/amlodipine)
  • Zestoretic (lisinopril/hydrochlorothiazide)
  • Zestril (lisinopril)
  • Benlysta (belimumab)
  • Celexa (citalopram hydrobromide)
  • Enablex (darifenacin)
  • Incivek (telaprevir)
  • Janumet (sitagliptin and metformin fixed-dose combination)
  • Januvia (sitagliptin)
  • Kombiglyze XR (saxagliptin/metformin hydrochloride extended-release)
  • Lidocaine in 5% Dextrose Injection
  • Magnevist (brand of gadopentetate dimeglumine)
  • Revlimid (lenalidomide)
  • Reyataz (atazanavir sulfate)
  • Treximet (sumatriptan and naproxen sodium)
  • Votrient (pazopanib)
  • Zometa (zoledronic acid)
  • Zmax (azithromycin extended release)

Do not be fooled. 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.

Copyright © 2012 The Health Gazette. This Feed is for personal non-commercial use only. If you are not reading this material in your own news aggregator, the site you are looking at may be guilty of copyright infringement. Please contact legal@the-health-gazette.com so we can take appropriate action immediately.
Plugin by Taragana]]> http://the-health-gazette.com/1348/fda-medwatch-39-products-safety-labeling-changes-march-2012/feed/ 0 April 2012 Edition of The Health Gazette Ezine http://the-health-gazette.com/1343/april-2012-edition-of-the-health-gazette-ezine/ http://the-health-gazette.com/1343/april-2012-edition-of-the-health-gazette-ezine/#comments Sun, 01 Apr 2012 06:17:00 +0000 Editor http://the-health-gazette.com/?p=1343 The April 2012 edition of The Health Gazette Ezine will be published as scheduled on April 1st.

This month’s edition continues a brief series on aging. In part three we consider a prescription for anti-aging. Most people are looking for a “magic bullet” approach that ideally comes as something like a daily pill or potion. Many companies would love to supply just such a product but the reality is that no such thing exists or ever will. While people wait in futility for such a pipe dream they could actually implement proven approaches that work. Why don’t they? Well, to be fair, some do and they reap the benefits but most don’t simply because it requires effort. What about you?

Subscribers will find the ezine in their mailbox on publication. It will be posted in the subscribers’ archive around the same time.

Copyright © 2012 The Health Gazette. This Feed is for personal non-commercial use only. If you are not reading this material in your own news aggregator, the site you are looking at may be guilty of copyright infringement. Please contact legal@the-health-gazette.com so we can take appropriate action immediately.
Plugin by Taragana]]> http://the-health-gazette.com/1343/april-2012-edition-of-the-health-gazette-ezine/feed/ 0 FDA MedWatch – 65 Products Safety Labeling Changes Febrary 2012 http://the-health-gazette.com/1338/fda-medwatch-65-products-safety-labeling-changes-febrary-2012/ http://the-health-gazette.com/1338/fda-medwatch-65-products-safety-labeling-changes-febrary-2012/#comments Fri, 16 Mar 2012 00:33:04 +0000 Editor http://the-health-gazette.com/?p=1338 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:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm294217.htm

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.

Copyright © 2012 The Health Gazette. This Feed is for personal non-commercial use only. If you are not reading this material in your own news aggregator, the site you are looking at may be guilty of copyright infringement. Please contact legal@the-health-gazette.com so we can take appropriate action immediately.
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