7 results found.
FDA and AstraZeneca added a boxed warning and strengthened the WARNINGS section of the label to inform healthcare professionals about new risk inf...
... MedWatch The FDA Safety Information and Adverse Event Reporting Program Safety Information Safety Alerts for Human Medical Products 2010 Safety Alerts for Human Medical Products 2009 Safety Alerts for Human Medical Products 2008 Safety Alerts for Human Medical Products 2007 Safety Alerts for Human Medical Products 2006 Safety Alerts for Human Medical Products 2005 Safety Alerts for Human Medical Products 2004 Safety Alerts for Human Medical Products 2003 Safety Alerts for Human Medical Products 2002 Safety Alerts for Human Medical Products 2001 Safety Alerts for Human Medical Products 2000 Safety Alerts for Human Medical Products-Nolvadex (tamoxifen citrate) Audience: Oncologists and other healthcare professionals caring for women with breast cancer FDA and AstraZeneca added a boxed warning and strengthened the WARNINGS section of the label to inform healthcare professionals about new risk information of particular relevance to women with ductal carcinoma in situ [DCIS] and women at high risk for developing breast cancer and are receiving or considering Nolvadex therapy to reduce their risk of developing invasive breast cancer. Serious, life-threatening or fatal events associated with Nolvadex in the risk reduction setting [women at high risk for cancer and women with ...
URL: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm154510.htm
... [2005 version] Mircera*( methoxy polyethylene glycol-epoetin beta) [2007 version] Mobic (meloxicam) [2010 version] Morphine Sulfate (morphine sulfate oral solution) [2010 version] Motrin (ibuprofen) [2007 version] Multaq (dronedarone) [2009 version] Myfortic (mycophenolic acid) [2009 version] Myobloc*( rimabotulinumtoxinB) [2009 version] Nalfon (fenoprofen calcium) [2009 version] Naprosyn (naproxen) [2008 version] Nardil (phenelzine sulfate) [2007 version] Nolvadex (tamoxifen) [2006 version] Noroxin (norfloxacin) [2008 version] Norpramin (desipramine hydrochloride) [2009 version] Nplate (romiplostim) [2008 version] Nucynta (tapentadol hydrochloride) [2009 version] Oleptro (trazadone hydrochloride) [2010 version] Onsolis (fentanyl buccal soluble film) [2009 version] Osmoprep (sodium phosphate dibasic anhydrous and sodium phosphate monobasic monohydrate) [2009 version] OxyContin (oxycodone hydrochloride) [2010 version] Pacerone (amiodarone hydrochloride) [2008 version] Palladone (hydromorphone hydrochloride) [2004 version ...
URL: http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm
... , CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT / MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format. Summary View Sections Modified PRECAUTIONS Drug Interactions Drug Metabolized by CYP2D6 Therefore, coadministration of Paxil CR with other drugs that are metabolized by this isozyme, including certain drugs effective in the treatment of major depressive disorder (e.g, nortriptyline, amitriptyline, imipramine, desipramine, and fluoxetine ), phenothiazines, risperidone, tamoxifen, and Type 1C antiarrhythmics (e.g, propafenone, flecainide, and encainide ), or that inhibit this enzyme (e.g, quinidine ), should be approached with caution .Tamoxifen is a pro-drug requiring metabolic activation by CYP2D6. Inhibition of CYP2D6 by paroxetine may lead to reduced plasma concentrations of an active metabolite and hence reduced efficacy of tamoxifen.-- Links on this page: Page Last Updated: 06 / 19 / 2009 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Home About ...
URL: http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-RelatedDrugLabelingChanges/ucm122147.htm
... WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT / MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format. Summary View Sections Modified PRECAUTIONS Drug Interactions Drug Metabolized by CYP2D6 Therefore, coadministration of Paxil with other drugs that are metabolized by this isozyme, including certain drugs effective in the treatment of major depressive disorder (e.g, nortriptyline, amitriptyline, imipramine, desipramine, and fluoxetine ), phenothiazines, risperidone, tamoxifen, and Type 1C antiarrhythmics (e.g, propafenone, flecainide, and encainide ), or that inhibit this enzyme (e.g, quinidine ), should be approached with caution .Tamoxifen is a pro-drug requiring metabolic activation by CYP2D6. Inhibition of CYP2D6 by paroxetine may lead to reduced plasma concentrations of an active metabolite and hence reduced efficacy of tamoxifen.-- Links on this page: Page Last Updated: 06 / 19 / 2009 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Home About ...
URL: http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-RelatedDrugLabelingChanges/ucm122144.htm
Femara (letrozole) 2.5 mg tablets Drug Safety Labeling CHanges March 2010
... 3.8 %in hip BMD compared to a median decrease of 2.0 %in the placebo group. The changes from baseline in lumbar spine BMD in letrozole and placebo treated groups were not statistically different. Cholesterol Consideration should be given to monitoring serum cholesterol. In the adjuvant setting, an increase of â ‰¥ 1.5 X ULN in total cholesterol (generally non-fasting) was observed in patients who had baseline total serum cholesterol within the normal range in 151 / 1843 (8.2 %) on letrozole vs 57 / 1840 (3.2 %) on tamoxifen. Lipid lowering medications were required for 25 %of patients on letrozole and 16 %on tamoxifen. ADVERSE REACTIONS Updated Analysis, Extended Adjuvant Treatment of Early Breast Cancer, Median Treatment Duration of 60 Months The extended adjuvant treatment trial was unblinded early. At the updated (final analysis ), overall the side effects seen were consistent to those seen at a median treatment duration of 24 months.-- Links on this page: Page Last Updated: 04 / 15 / 2010 Note: If you need help accessing information in different file formats ...
URL: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm208703.htm
... studies in pregnant women using Arimidex. If Arimidex is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus or potential risk for loss of the pregnancy. [see Use in Specific Populations (8.1 )] WARNINGS AND PRECAUTIONS Ischemic Cardiovascular Events: In women with pre-existing ischemic heart disease, an increased incidence of ischemic cardiovascular events was observed with Arimidex in the ATAC trial (17 %of patients on Arimidex and 10 %of patients on tamoxifen). Consider risk and benefits of Arimidex therapy in patients with pre-existing ischemic heart disease. [see Adverse Reactions (6.1 )]-- Links on this page: Page Last Updated: 06 / 19 / 2009 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Home About FDA Contact Us A to Z Subject Index Site Map Web Site Policies FOIA Accessibility No FEAR Act Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency Preparedness International Programs News & Events Training and Continuing ...
URL: http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-RelatedDrugLabelingChanges/ucm125179.htm
2002 Safety Alerts for Human Medical Products
... Sodium Injection, USP 05 / 01 / 2002 Injectable drugs prepared by Urgent Care Pharmacy 11 / 18 / 2002 Lariam (mefloquine hydrochloride) October 2002 10 / 04 / 2002 Lioresal Intrathecal (baclofen injection) 05 / 23 / 2002 Lovenox (enoxaparin sodium) 04 / 03 / 2002 Lunelle Monthly Contraceptive Injection (medroxyprogesterone acetate and estradiol cypionate injectable suspension) 10 / 11 / 2002 Maxair Inhaler (pirbuterol acetate inhalation aerosol) 05 / 07 / 2002 Mifeprex (mifepristone) April 2002 04 / 17 / 2002 Nolvadex (tamoxifen citrate) 06 / 27 / 2002 Norplant (levonorgestrel implants) 07 / 29 / 2002 Premarin (conjugated estrogens) 09 / 26 / 2002 Prempro / Premphase (conjugated estrogens / medroxyprogesterone acetate tablets) August 2002 09 / 26 / 2002 Rapamune (sirolimus) April 2002 04 / 24 / 2002 Serostim [somatropin (rDNA origin) for injection] 05 / 17 / 2002 Seroquel (quetiapine fumarate) 06 / 12 / 2002 Serzone (nefazodone HCL) 01 / 09 / 2002 Thiazolidinediones [Actos (pioglitazone HCl ), Avandia (rosiglitazone ...
URL: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm154450.htm
