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Newsletter
Vol 78 - February 2011
Featured News
Confusion Over Drug Dosing Common for Seniors
February 2011
Instructions for taking medications are often so vague that older patients, sometimes taking an average of seven pills a day, may take their drugs incorrectly, a new study finds. Read more...
New Drug Approvals
The following drugs have recently been approved by the FDA.
Date of Approval: February 25, 2011
Treatment for: Hypertension
Edarbi Drug Information | Press Release
Date of Approval: February 17, 2011
Treatment for: Factor XIII Deficiency
Corifact Drug Information | Press Release
Date of Approval: February 3, 2011
Treatment for: Premature Labor
Makena Drug Information | Press Release
New Indications and Dosage Forms
Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens.
Labeling Revision Approved: February 4, 2011
Now Approved: Dosing Recommendations for Pregnancy
Reyataz 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.
Fentanyl Citrate Buccal Tablets, USP
0.1 mg, 0.2 mg, 0.4 mg, 0.6 mg and 0.8 mg
Approved: January 7, 2011 - Watson Pharmaceuticals, Inc.
Generic for: Fentora
Atovaquone and Proguanil Hydrochloride Tablets
250 mg/100 mg
Approved: January 12, 2011 - Glenmark Generics Inc.
Generic for: Malarone
FDA Drug Safety Labeling Changes
This is a summary of the FDA drug labeling changes for January 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
Carbatrol
(carbamazepine) Extended-Release Capsules
- x - x - - - -
Ery-Ped
(erythromycin ethylsuccinate) Liquids
- x x x x - - -
PCE
(erythromycin particles in tablets) Dispertab Tablet
- x x x x - - -
Gelnique
(oxybutynin chloride) 10% gel
- x x - - - - -
Uloric
(febuxostat tablets)
- x - x x - - -
Zithromax
(azithromycin) tablet, single-dose packet, IV for injection, and oral suspension
- x x - x - - -
Cyklokapron
(tranexamic acid) Injection
- - x - - - - -
Folotyn
(pralatrexate) Injection
- - x x - x - -
Kayexalate
(sodium polystyrene sulfonate) powder
- - x x x - - -
Oxytrol
(oxybutynin transdermal system)
- - x x - - - -
Prilosec
(omeprazole) Delayed-Release Capsules,  Prilosec (omeprazole magnesium) For Delayed Release Oral Suspension
- - x x - - - -
Reclast
(zoledronic acid) Injection
- - x x - - - -
Rituxan
(rituximab)
- - x x - - - -
Sanctura
(trospium chloride) tablets
- - x x - - - -
Sanctura XR
(trospium chloride extended release capsules)
- - x x - - - -
Tasigna
(nilotinib) Capsules
- - x x - - - -
Tessalon
(benzonatate) Perles and Capsules
- - x x x - - -
Trelstar
(triptorelin palmoate) Depot
- - x x - - - -
ZOLADEX
(goserelin acetate) implant, 3.6 mgZOLADEX (goserelin acetate) implant, 10.8 mg
- - x x - - - -
Eligard
(leuprolide acetate) for Injectable Suspension
- - - x - - - -
Famvir
(famciclovir) Tablets
- - - x - - - -
Multaq
(dronedarone hydrochloride) Tablets
- - - x - - - -
Lupron Depot 
(leuprolide acetate for depot suspension) 
- - - x - - - -
Vantas
(histrelin acetate) Subcutaneous Implant
- - - x - - - -
Viadur
(leuprolide acetate implant)
- - - x - - - -
Advicor
(niacin extended release/lovastatin) Tablets
- - - - x - - -
Agrylin
(anagrelide hydrochloride) Capsules
- - - - x - - -
Astepro
(azelastine hydrochloride) Nasal Spray
- - - - x - - -
Lotrel
(amlodipine besylate/benazapril hydrochloride) Capsules
- - - - x - - -
Pristiq
(desvenlafaxine) Extended-Release Tablet
- - - - x - - -
Synarel
(nafarelin acetate) Nasal Solution 2mg/mL
- - - - x - - -
Advair HFA
(fluticasone propionate and salmeterol xinafoate) Inhalation Aerosol
- - - - - - - -
Dilantin
(phenytoin)
- - - - - - - -
Viramune
(nevirapine) tablets and oral suspension
- - - - - - - -
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
Kids' Fevers May Not Always Need Treatment
February 28, 2011
Few things send a parent's fears soaring as quickly as a child's rapidly rising temperature.
Your Medicine Cabinet May Be Your Pet's Worst Enemy
February 27, 2011
Giving medications meant for humans to pets can be dangerous, a veterinarian warns.
Higher Vitamin D Intake Could Cut Cancer Risk
February 27, 2011
A new study says it takes far more vitamin D than initially thought to dramatically cut the risk of several major diseases, including breast cancer.
Depression May Worsen Over Time in Addiction-Prone Women
February 25, 2011
Depression symptoms increase over time for women in their 30s and 40s who are prone to addiction problems and antisocial behavior, researchers report.
Newer Drug May Help Prevent Fracture in Men With Prostate Cancer
February 24, 2011
A new drug called denosumab (Xgeva) performed somewhat better than the current standard treatment of zoledronic acid (Zometa) for preventing fractures and other bone problems in men with hormone-resistant prostate cancer, a new study suggests.
Statins Might Help HIV Patients, Study Suggests
February 24, 2011
Preliminary research suggests that statins restrain the immune systems of HIV patients and may stave off progression of the AIDS-causing virus.
Pot Ingredient May Restore Appetite After Chemo
February 23, 2011
The main active ingredient in marijuana seems to allow chemotherapy patients to regain their ability to taste and enjoy food, according to the results of a small new study.
More Evidence Ties Moderate Drinking to Heart Health
February 22, 2011
Moderate alcohol consumption may help protect against heart disease, according to two new papers by Canadian researchers.
Nitroglycerin Ointment Might Strengthen Bones
February 22, 2011
Nitroglycerin ointment, usually prescribed to relieve chest pain, may also counter bone loss, a new study suggests.
Induced Labor Linked to Raised Risks for First-Time Moms
February 22, 2011
The increasingly commonplace decision by pregnant women and their doctors to induce labor for convenience rather than for medical necessity entails some health risks to both mother and child, research suggests.
Antipsychotic Drugs Raise Heart Risks, Experts Warn
February 18, 2011
Doctors must not forget about the physical health of people with serious mental health disorders who take antipsychotic drugs, experts warn.
Many Kids Who Drink Get Liquor From Home: Report
February 17, 2011
Some 709,000 youngsters aged 12 to 14 in the United States are drinking beer, liquor and other alcoholic beverages, a new federal study found.
Parents Still Giving Cough, Cold Meds to Kids Under 2: Poll
February 16, 2011
Many American parents of children aged 2 and younger still give over-the-counter cough and cold medicines to their kids despite United States Food and Drug Administration warnings to the contrary, researchers have found.
Placebo Effect May Work in Reverse
February 16, 2011
Everyone's heard of the placebo effect: when you take a sugar pill but believe it is medicine, it tends to work.
Zinc May Help Ease Common Cold: Analysis
February 15, 2011
A review of data from 15 trials suggests that the zinc supplements so many Americans pop at the first sign of a cold may, in fact, cut the length and severity of illness.
Popular Bone Drugs Linked to Reduced Colon Cancer Risk
February 15, 2011
People who take drugs called bisphosphonates to prevent bone loss may also reduce their risk of developing colorectal cancer by almost 60 percent compared to those not on the drugs, a new study suggests.
Few Stroke Patients Given Clot-Buster Quickly Enough: Study
February 10, 2011
Few eligible stroke patients get an injectable clot-busting drug within the recommended 60-minute window after their hospital arrival, new research finds.
New Drug May Help Patients With Irregular Heartbeat Avoid Stroke
February 10, 2011
A new anti-clotting drug works better than aspirin for stroke prevention in some patients with the common, sometimes lethal, heart rhythm problem known as atrial fibrillation, according to research presented Thursday.
Warming Injections May Take Out the Sting
February 8, 2011
An injection of local anesthetic can be made much less painful if it is warmed beforehand, Canadian researchers report.
'Universal' Flu Vaccine Shows Promise in Early Trial
February 8, 2011
A small group of 22 British volunteers is testing out a new "universal" influenza vaccine: one that one day might be effective against all strains of flu and wouldn't have to be reformulated each year, as now happens.
Hallucinogens Legally Sold as 'Bath Salts' a New Threat
February 4, 2011
fully legal drugs sold as "bath salts" has law enforcement and drug abuse experts very concerned.
Look-and-Sound-Alike Names Account for Many Painkiller Prescription Errors
February 1, 2011
Confusion caused by look-alike and sound-alike names contributes to a large number of the painkiller prescription errors that occur in hospitals, United States researchers report.
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