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Newsletter
Vol 58 - June 2009
Featured News
A Side Effect of Michael Jackson’s Tragic Death – Consumer Health Education
June 2009
Drugs.com reported a massive 20,900% increase (yes, you read that correctly – twenty thousand, nine hundred percent) in interest for information on the prescription medication Demerol – allegedly prescribed for the legendary entertainer Michael Jackson. Read more...
New Drug Approvals
The following drugs have recently been approved by the FDA.
Date of Approval: June 30, 2009
Treatment for: Anemia Associated with Chronic Renal Failure
Feraheme Drug Information | Press Release
Date of Approval: June 17, 2009
Treatment for: Migraine
Cambia Drug Information | Press Release
Date of Approval: June 17, 2009
Treatment for: Cryopyrin-Associated Periodic Syndrome
Ilaris Drug Information | Press Release
Date of Approval: June 17, 2009
Treatment for: Macular Edema, Uveitis
Ozurdex Drug Information | Press Release
Date of Approval: June 16, 2009
Treatment for: Pain
Zipsor Drug Information | Press Release
Date of Approval: June 11, 2009
Treatment for: Pain, Fever
Caldolor Drug Information | Press Release
Date of Approval: May 28, 2009
Treatment for: Bacterial Conjunctivitis
Besivance Drug Information | Press Release
FDA Drug Safety Labeling Changes
This is a summary of the FDA drug labeling changes for September 2012. Click on a drug name to view the changes in more detail.
Key to Label Sections:
BW - Boxed Warning C - Contraindications
W - Warnings P - Precautions
AR - Adverse Reactions PPI - Patient Package Insert
MG - Medication Guide PCI - Patient Counseling Information

  Sections Modified
Drug Name BW C W P AR PPI MG PCI
Exjade
(deferasirox) Tablets
x x x x x - - -
Accupril
(quinapril hydrochloride) 5 mg, 10 mg, 20 mg and 40 mg Tablets
- x - x - - - -
Accuretic
(quinapril HCL/hydrochlorothiazide) 10/12.5 mg, 20/12.5 mg and 20/25 mg Tablets
- x - x - - - -
Arcapta Neohaler
(indacaterol maleate) Inhalation Powder 75 mcg
- x x x x - - -
Avapro
(irbesartan) 75 mg, 150 mg, and 300 mg tablets
- x - x - - - -
Azor
(amlodipine/olmesartan medoxomil) 5/20 mg, 5/40 mg, 10/20 mg and 10/40 mg Tablets
- x - x - - - -
Benicar
(olmesartan medoxomil) 5 mg 20 mg and 40 mg Tablets
- x - x - - - -
Benicar HCT
(olmesartan medoxomil/hydrochlorothiazide) 20/12.5 mg, 40/12.5 mg and 40/25 mg Tablets
- x - x - - - -
Cozaar
(losartan potassium) 25 mg, 50 mg and 100 mg Tablets
- x - x - - - -
Doxil
(doxorubicin HCl liposome injection) for intravenous infusion, single dose vial: 20 mg/10 mL and 50 mg/25 mL
- x - - - - - -
Exforge
(amlodipine/valsartan) 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg Tablets
- x x x x x - -
Exforge HCT
(amlodipine/valsartan/hydrochlorothiazide) Tablets
- x x x x - - -
Hyzaar
(losartan potassium/HCTZ) 50/12.5 mg, 100/25 mg, and 100/12.5 mg Tablets
- x - x - - - -
Juvisync
(sitagliptin/simvastatin) Tablets, 100mg/10mg, 100 mg/20 mg, 100mg/40mg, 50mg/10mg, 50 mg/20 mg, and 50mg/40mg
- x x x x - - -
Lotensin
(benazepril HCl) 5 mg, 10 mg 20 mg and 40 mg Tablets
- x - x - - - -
Lotensin HCT
(benazepril HCl and hydrochlorothiazide) 5/6.25 mg, 10/12.5 mg 20/12.5 mg and 20/25 mg Tablets
- x - x - - - -
Mavik
(trandolapril) 1 mg, 2 mg and 4 mg Tablets
- x - x - - - -
Multaq
(dronedarone hydrochloride) 400 mg Tablets
- x x x x - - -
Ozurdex
(dexamethasone intravitreal implant) 0.7 mg
- x - - x - - -
Tarka
(trandolapril/verapamil hydrochloride) 2/180 mg, 1/240 mg, and 4/240 mg Tablets
- x - x - - - -
Teveten
(Eprosartan Mesylate) 400 mg and 600 mg Tablets
- x - x - - - -
Teveten HCT
(eprosartan mesylate hydrochlorothiazide) 600/12.5 mg and 600/25 mg Tablets
- x - x - - - -
Tribenzor
(olmesartan medoxomil amlodipine/hydrochlorothiazide) 20/5/12.5 mg, 40/5/12.5 mg, 40/5/25 mg 40/10/12.5 and 40/10/25 mg Tablets
- x - x - - - -
Uniretic
(moexipril hydrochloride/hydrochlorothiazide) 7.5/12.5 mg, 15/12.5 mg and 15/25 mg Tablets
- x - x - - - -
Vaseretic
(enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets
- x - x - - - -
Vasotec
(enalapril maleate) 2.5 mg, 5 mg, 10 mg, and 20 mg Tablets 
- x - x - - - -
Univasc
(moexipril hydrochloride) 7.5 mg and 15 mg Tablets
- x - x - - - -
Abraxane for Injectable Suspension
(paclitaxel protein-bound particles for injectable suspension) (albumin-bound), 100 milligram vial
- - x x x - - -
Aggrenox
(aspirin/extended release dipyridamole) 25 mg/200 mg Capsules
- - x x x - - -
Cefepime for Injection USP and Dextrose Injection USP in the Duplex ContainerCefepime Injection in the GALAXY Container for intravenous use
- - x x x - - -
Dexilant
(dexlansoprazole) Delayed-release Capsules
- - x x - - - -
Foradil Aerolizer
(formoterol fumarate inhalation powder) 12 mcg
- - x x x - - -
Lovaza
(omega 3-acid ethyl esters) Capsules
- - x x - x - -
Maxipime
(cefepime hydrochloride) for Injection
- - x x x - - -
Nexium
(esomeprazole magnesium) Delayed-Release Capsules, 20 mg and 40 mg; For Delayed-Release Oral Suspension, 10 mg, 20 mg, and 40 mg
- - x x - - - -
Nexium I.V.
(esomeprazole sodium) For Injection
- - x x - - - -
Prevacid
(lansoprazole) Delayed-Release Capsules, 15 mg and 30 mg and Delayed-Release Orally Disintegrating Tablets, 15 mg and 30 mg
- - x x - - - -
Prilosec
(omeprazole) Delayed-Release Capsules, 10 mg, 20 mg and 40 mg; For Delayed-Release Oral Suspension, 2.5 mg and 10 mg
- - x x - - - -
Protonix
(pantoprazole sodium) For Injection
- - x x - - - -
Rotarix
(Rotavirus Vaccine, Live, Oral)
- - x x x - - -
Trilipix
(fenofibric acid) Delayed Release Capsules
- - x x x - - -
Vimovo
(naproxen/esomeprazole magnesium) Delayed Release Tablets
- - x x - - - -
Xgeva
(denosumab)
- - x x - - - -
Xyzal 
(levocetirizine dihydrochloride) 5mg tablets and 2.5mg/5ml solution
- - x x x - - -
Zomig
(zolmitriptan) tabletsZomig-ZMT (zolmitriptan) orally disintegrating tablets
- - x x - - - -
Glyset
(miglitol) Tablets, 25 mg, 50 mg and 100 mg
- - - x x - - -
Voltaren Opthalmic
(diclofenac sodium ophthalmic solution) 0.1%
- - - x x - - -
Cayston
(aztreonam for inhalation solution)
- - - - x - - -
Singulair
(Montelukast Sodium) 10 mg Tablets, 5 mg and 4 mg Chewable Tablets, and 4mg Oral Granules
- - - - x - - -
Tradjenta
(linagliptin) tablets, 5 mg
- - - - x - - -
Ventolin HFA
(albuterol sulfate) Inhalation Aerosol
- - - - x - - -
Xopenex
(levalbuterol HCl) Inhalation Solution Concentrate, 1.25 mg/0.5 mL
- - - - x - - -
Zytiga
(abiraterone acetate) Tablets
- - - - x - - -
AndroGel
(testosterone gel) 1.62%
- - - - - - - -
CellCept
(mycophenolate mofetil) Capsules, Tablets, Oral Suspension and CellCept (mycophenolate mofetil hydrochloride) for Injection
- - - - - - - -
Clobex
(clobetasol propionate) Spray, 0.05%
- - - - - x - -
Micardis
(telmisartan) 20, 40, and 80 mg Tablets
- - - - - x - -
Myfortic
(mycophenolic acid) delayed-release tablets
- - - - - - - -
Prolia
(denosumab)
- - - - - - - -
Note: the drug safety labeling changes listed above may not be a complete list. Please visit the link below for the entire current list and historical archive.
Other Drug News
U.S. Considers Massive Swine Flu Vaccination Program
June 26, 2009
United States health officials said Friday that they are considering a swine flu immunization campaign that could involve an unprecedented 600 million doses of vaccine.
Alcohol-Related Ills Increasing Worldwide
June 25, 2009
Consumption of alcohol is up, and so it seems are the ills associated with it.
Global Efforts to Lower 'Bad' Cholesterol Working
June 22, 2009
People in the United States and around the world who are trying to lower their "bad" cholesterol have been succeeding more often in the past decade, new research suggests.
Obama Signs Tough New Anti-Smoking Law
June 22, 2009
President Barack Obama signed into law Monday the nation's toughest anti-smoking law that gives the United States Food and Drug Administration unprecedented powers to regulate tobacco products.
Painkillers May Be Good for the Prostate
June 20, 2009
Taking over-the-counter painkillers such as aspirin and ibuprofen might help men avoid prostate problems.
Health Tip: Taking an Herbal Supplement
June 15, 2009
Any product labeled "herbal" doesn't automatically make it safe.
61% of American Adults Look Online for Health Information
June 12, 2009
A majority of American adults look online for health information and most are accessing reviews and comments posted by fellow consumers.
Morning Sickness Drug Gets Green Light in Study
June 10, 2009
A new study suggests that women who experience morning sickness early in pregnancy can safely take the medication metoclopramide to relieve their symptoms.
Heart Drug Combos Raise Risk of Gastrointestinal Bleeding
June 2, 2009
Common drug combinations used to treat heart disease raise the risk of bleeding or perforation of the upper gastrointestinal tract, new research shows.
Cervical Cancer Vaccine Not Just for Teens
June 2, 2009
The human papillomavirus (HPV) vaccine works for women aged 24 to 45 who aren't already infected by HPV, the virus that has been linked to cervical cancer and other cervical diseases.
Depression Treatment Wanes Following FDA Warnings
June 1, 2009
Newly diagnosed cases of depression in America have dropped sharply since the government's warning of an increased risk of suicidal behavior among children and teens taking antidepressants, a new analysis finds.
FDA MedWatch Alerts
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