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Newsletter
Vol 85 - September 2011
Featured News
Monthly Roundup - September 2011
September 2011
JAMA Study: Atypical Antipsychotics Have Variable Efficacy, Safety Risk in Off-Label Uses First, as an important reminder, the atypical antipsychotic class already has a black box warning for increased mortality risk in off-label use in dementia-related psychosis. Read more...
New Drug Approvals
The following drugs have recently been approved by the FDA.
New Indications and Dosage Forms
Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens.
New Indication Approved: September 16, 2011
Now Approved for: Cancer Treatment-Induced Bone Loss
Prolia Drug Information | Press Release
New Indication Approved: September 23, 2011
Now Approved for: Atypical Hemolytic Uremic Syndrome
Soliris Drug Information | Press Release
Patient Population Altered: September 26, 2011
Now Approved for: Ulcerative Colitis in Children Older than 6 Years
Remicade Drug Information | Press Release
First-Time Generic Approvals
First Time Generics are those drug products that have never been approved before as generic drug products and are new generic products to the marketplace.
Tranexamic Acid Injection
100 mg/mL; packaged in 1000 mg/10 mL single-dose vials
Approved: August 10, 2011 - Pharmaforce Inc.
Generic for: Cyklokapron Injection
Gatifloxacin Ophthalmic Solution
0.3%
Approved: August 19, 2011 - Apotex Corp.
Generic for: Zymar Ophthalmic Solution
Ketoconazole Foam
2%
Approved: August 25, 2011 - Perrigo Israel Pharmaceuticals Ltd.
Generic for: Extina Foam, 2%
Cevimeline Hydrochloride Capsules
30 mg
Approved: August 25, 2011 - Apotex Inc.
Generic for: Evoxac Capsules, 30 mg
Prilocaine Hydrochloride with Epinephrine Injection
USP, 4%/1:200,000; packaged in cartridges for dental use
Approved: August 30, 2011 - Septodont Inc.
Generic for: Citanest Forte Dental
FDA Drug Safety Labeling Changes
This is a summary of the FDA drug labeling changes for August 2011. 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
Accolate
(zafirlukast) tablets
- x - - - x - -
Celexa
(citalopram hydrobromide) Tablets and  Oral Solution
- x x x x - - -
Reclast
(zoledronic acid) Injection
- x x x - - - -
Saphris
(asenapine)  Sublingual Tablets
- x x x x - - -
Bentyl
(dicyclomine hydrochloride, USP) Capsules/Tablets, Oral Syrup and Injection
- - x x - - - -
Betapace and Betapace AF
(sotalol HCl) Tablets
- - x - - - - -
BiCNU
(carmustine for injection)
- - x - x - - -
DepoCyt
(cytarabine liposome injection)
- - x - - - - -
Ditropan
(Oxybutynin chloride) Tablets
- - x x x - - -
Dostinex
(cabergoline) Tablets
- - x - - - - -
Exjade
(deferasirox) Tablets for Oral Suspension
- - x x - - - -
Haldol
(haloperidol) Injection and Haldol Decanoate IM Injection
- - x x - - - -
Hyzaar
(losartan/hydrochlorothiazide) and Hyzaar (losartan potassium/HCTZ) Tablets
- - x x - x - -
Kerledex
(betaxolol hydrochloride/chlorthalidone) Tablets
- - x x - - - -
Kerlone
(betaxolol hydrochloride) Tablets
- - x x - - - -
Lamictal
(lamotrigine) Tablets, Chewable Dispersible Tablets, Lamictal Orally Disintegrating Tablets, and Lamictal XR Extended-Release Tablets
- - x x - - - -
Mobic
(meloxicam) Tablets and Oral Suspension
- - x x - - - -
Multaq
(dronedarone hydrochloride) Tablets
- - x x - - - -
Neurontin
(gabapentin) Capsules, Tablets, and Oral Solution
- - x - - - - -
Platinol
(cisplatin for injection, USP)
- - x - x - - -
Prinzide
(lisinopril/hydrochlorothiazide) Tablets
- - x - x - - -
Sensipar
(cinacalcet) Tablets
- - x x x - - -
Tenoretic
(atenolol/chlorthalidone) Tablets
- - x - - - - -
Tenormin
(atenolol) Tablets
- - x - - - - -
Thallous Chloride [Tl-201] Injection
- - x - - - - -
Zoloft
(sertraline hydrochloride) Tablets and Oral Concentrate
- - x x - - - -
Aceon
(perindopril erbumine) Tablets
- - - x - - - -
Augmentin ES-600
(amoxicillin/clavulanate potassium) Powder for Oral Suspension and Extended Release Tablets
- - - x - - - -
Duetact
(pioglitazone hydrochloride and glimepiride) fixed-dose combination Tablets
- - - x - - - -
Starlix
(nateglinide) tablets
- - - x - - - -
Tarka
(trandolapril/verapamil hydrochloride) Tablets
- - - x x - - -
Tykerb
(lapatinib) Tablets
- - - x - - - -
Uniretic
(moexipril hydrochloride/hydrochlorothiazide) Tablets
- - - x - - - -
Univasc
(moexipril hydrochloride) Tablets
- - - x - - - -
Zestril
(lisinopril) Tablets
- - - x - - - -
Zyban
(bupropion hydrochloride) Sustained-Release Tablets 
- - - x - - - -
Dulera
(mometasone furoate and formoterol fumarate) Inhalation Aerosol
- - - - x - - -
Lyrica
(pregabalin) Capsules and Oral Solution
- - - - x - - -
Xanax
(alprazolam) and Xanax XR
- - - - x - - -
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
Number of U.S. Kids on ADHD Meds Keeps Rising
September 28, 2011
The use of stimulant medications such as Ritalin or Adderall in children with attention-deficit/hyperactivity disorder (ADHD) is continuing to climb, although at a slower pace than in decades past, a new study finds.
Mixed Results Seen With 'Off-Label' Use of Antipsychotics
September 27, 2011
Even though off-label use of atypical antipsychotic drugs is common, a new review finds that such use is only effective in a few conditions and can be harmful in others.
Certain Antidepressants With Blood Thinners May Pose Risk for Heart Patients
September 26, 2011
Heart attack patients who take both selective serotonin reuptake inhibitor (SSRI) antidepressants and antiplatelet drugs such as aspirin or Plavix have a higher risk for bleeding than those who take anti-clotting drugs only, a new study finds.
CDC Considers Vaccinating Boys, Not Just Girls, for HPV
September 23, 2011
U.S. health authorities now recommend that girls and young women be vaccinated against human papillomavirus, a sexually transmitted disease that is a known cause of cervical cancer, but that recommendation does not extend to boys and young men.
FDA: Over-the-counter Asthma Inhalers Containing chloroflouorocarbons (CFCs) Will no Longer be Made or Sold After Dec. 31, 2011
September 23, 2011
The U.S. Food and Drug Administration says users of epinephrine inhalers containing chlorofluorocarbons (CFCs) should plan now to get a prescription for a replacement product because these inhalers will not be made or sold after December 31, 2011.
Popular Diabetes Drugs May Raise Pancreatic Cancer Risk, Study Suggests
September 22, 2011
People with type 2 diabetes taking the drugs Januvia or Byetta might have an increased risk of developing pancreatitis and pancreatic cancer, a preliminary study suggests.
CDC Urges Americans: Get Your Flu Shot
September 21, 2011
With plenty of influenza vaccine available, United States health officials have urged Americans to get a flu shot.
The War on Cancer Continues
September 20, 2011
Forty years after President Nixon signed the National Cancer Act into law and pledged to put the country's resources to work to find better treatments for cancer, substantial victories have been scored against some, but not all, cancers.
Vaccinations Aren't Just for Kids
September 16, 2011
Public health experts often focus immunization awareness efforts toward protecting children, and with good reason: Facing a potentially bewildering schedule of vaccinations for their young ones, parents usually need all the help they can get.
Accidental Medication Poisonings in Kids on the Rise
September 16, 2011
Despite ongoing prevention efforts, a growing number of young children are being accidentally poisoned with medications, according to new research.
Fear of Antidepressants Keep Many From Disclosing Depression
September 13, 2011
For a nation that seems ready to pop a pill for any ill, a new study suggests that the opposite seems true for some people with symptoms of depression, whose concerns about the side effects of antidepressants were the top reason they wouldn't disclose warning signs to their doctors.
Public Often Unaware of a Drug's Safety Record -- Or Lack of One
September 12, 2011
Many patients mistakenly believe that medications approved by the Food and Drug Administration (FDA) are foolproof and free of harmful side effects, a new study finds.
Insulin Spray May Improve Alzheimer's Symptoms
September 12, 2011
A nasal insulin spray may someday help people with mild memory problems or early Alzheimer's disease improve or preserve their mental functioning, a new small study suggests.
Over Half of Adverse Drug Reactions in Hospitals Are Preventable: Study
September 9, 2011
More than one-half of all adverse drug reactions treated in hospitals and emergency care are preventable, according to a new study.
FDA MedWatch Alerts
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