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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.
New Indications and Dosage Forms
Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens.
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.
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
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.
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.
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.
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.
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.
'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. |
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FDA MedWatch Alerts
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About This Newsletter
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This information is not intended to be medical advice. You should contact your physician before making any changes to your health care. Drugs.com is not responsible for content provided by third-party web sites.
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