... Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links Enter Search terms A-Z Index Home Food Drugs Medical Devices Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Tobacco Products-Safety Home >Safety >MedWatch The FDA Safety Information and Adverse Event Reporting Program >Safety Information Section Contents Menu MedWatch The FDA Safety Information and Adverse Event Reporting Program Safety Information Safety Alerts for Human Medical Products Drug Safety Labeling Changes-Altace (ramipril) tablets Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) â €“ November 2009 Summary View PRECAUTIONS Dual Blockade of the Renin-angiotensin-aldosterone System The ONTARGET trial enrolled 25, 620 patients >55 years old with atherosclerotic disease or diabetes with end-organ damage, randomized them to telmisartan only, ramipril only, or the combination, and followed them for a median of 56 months. Patients receiving the combination of telmisartan and ramipril did not obtain any benefit in the composite endpoint of cardiovascular death, MI, stroke and heart failure ...

... Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links Enter Search terms A-Z Index Home Food Drugs Medical Devices Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Tobacco Products-Safety Home >Safety >MedWatch The FDA Safety Information and Adverse Event Reporting Program >Safety Information Section Contents Menu MedWatch The FDA Safety Information and Adverse Event Reporting Program Safety Information Drug Safety Labeling Changes-Altace (ramipril) 1.25, 2.5, 5 and 10 mg Tablets March 2009 Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)-March 2009 The detailed view includes drug products with safety labeling changes to the BOXED 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 Sections Modified Summary of Changes to Contraindications and Warnings WARNINGS Fetal / Neonatal Morbidity and Mortality PRECAUTIONS ...

... Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links Enter Search terms A-Z Index Home Food Drugs Medical Devices Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Tobacco Products-Safety Home >Safety >MedWatch The FDA Safety Information and Adverse Event Reporting Program >Safety Information Section Contents Menu MedWatch The FDA Safety Information and Adverse Event Reporting Program Safety Information Drug Safety Labeling Changes-Resources for You Prescribing Information-- Altace (ramipril) 1.25, 2.5, 5 and 10 mg Tablets February 2009 Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)-February 2009 The detailed view includes drug products with safety labeling changes to the BOXED 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 Gold: Nitritoid reactions (symptoms include ...

... Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links Enter Search terms A-Z Index Home Food Drugs Medical Devices Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Tobacco Products-Safety Home >Safety >MedWatch The FDA Safety Information and Adverse Event Reporting Program >Safety Information Section Contents Menu MedWatch The FDA Safety Information and Adverse Event Reporting Program Safety Information Drug Safety Labeling Changes-Altace (ramipril) 1.25, 2.5, 5, and 10 mg Capsules March 2009 Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)-March 2009 The detailed view includes drug products with safety labeling changes to the BOXED 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 Sections Modified Summary of Changes to Contraindications and Warnings WARNINGS Fetal / Neonatal Morbidity and Mortality ...

... Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links Enter Search terms A-Z Index Home Food Drugs Medical Devices Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Tobacco Products-Safety Home >Safety >MedWatch The FDA Safety Information and Adverse Event Reporting Program >Safety Information Section Contents Menu MedWatch The FDA Safety Information and Adverse Event Reporting Program Safety Information Drug Safety Labeling Changes-Resources for You Prescribing Information-- Altace (ramipril) 1.25, 2.5, 5, and 10 Capsules February 2009 Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)-February 2009 The detailed view includes drug products with safety labeling changes to the BOXED 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 Gold: Nitritoid reactions (symptoms include ...

... Women who are taking these drugs, or a combination product containing ACE inhibitors, to tell their practitioner if they're planning a pregnancy or think they might be pregnant. And they should be counseled about the potential risks throughout pregnancy, especially during the second and third trimesters. ACE inhibitor drugs include: Lotensin (benazepril ), Capoten (captopril ), Vasotec oral and injectable (enalapril / enalaprilat ), Monopril (fosinopril ), Zestril (lisinopril ), Prinivil (lisinopril ), Univasc (moexipril ), Aceon (perindopril ), Accupril (quinapril ), Altace (ramipril ), Mavik (trandolapril) ACE inhibitors combined with other antihypertensive drugs include: Capozide (captopril / hydrochlorothiazide ), Lotrel (benazepril, amlodipine ), Vaseretic (enalopril / hydrochlorothiazide ), Prinzide (lisinopril / hydrochlorothiazide ), Accuretic (Accupril / hydrochlorothiazide) Additional Information: FDA MedWatch Safety Alert 2006-Angiotensin-converting enzyme inhibitors (ACE inhibitors) drug class. June 7, 2006. http :// www.fda.gov / Safety / MedWatch / SafetyInformation / SafetyAlertsforHumanMedicalProduct / ucm150412.htm FDA Patient Safety News is available at www.fda.gov / psn ...

... Section Contents Menu Drug Safety and Availability Postmarket Drug Safety Information for Patients and Providers Index to Drug-Specific Information Approved Risk Evaluation and Mitigation Strategies (REMS) Postmarketing Safety Evaluation of New Molecular Entities: Final Report Drug Safety Information for Healthcare Professionals-Angiotensin-Converting Enzyme Inhibitor (ACE inhibitor) Drugs and Pregnancy [ACE inhibitor drugs include Benazepril (Lotensin ), Captopril (Capoten ), Enalapril / Enalaprilat (Vasotec oral and injectable ), Fosinopril (Monopril ), Lisinopril (Zestril and Prinivil ), Moexipril (Univasc ), Perindopril (Aceon ), Quinapril (Accupril ), Ramipril (Altace ), and Trandolapril (Mavik )] FDA ALERT [06 / 2006 ]: On June 8, 2006, the New England Journal of Medicine published an article reporting that infants whose mothers had taken an angiotensin-converting enzyme inhibitor (ACE inhibitors) drug during the first trimester of pregnancy had an increased risk of major congenital malformations, compared with infants who had not undergone first trimester exposure to ACE inhibitor drugs. The number of cases of birth defects is small and the findings of this study have not yet been repeated (see below for ...

... , 1 g and 2 g X X X Sporanox (itraconazole) Capsules, 100 mg X X X X PPI Sporanox (itraconazole) Injection, 10 mg / mL X X X X PPI Theophylline in 5 %Dextrose injection, USP, Flexible Plastic Container X X X X Tracleer (bosentan) 62.5 and 125 mg Tablets X X MG (Click on drug name to go to detailed view) BW C W P AR PPI / MG Advair Diskus (fluticasone propionate and salmeterol xinafoate inhalation powder) X X Altace (ramipril) 1.25, 2.5, 5, and 10 mg Capsules Altace (ramipril) 1.25, 2.5, 5 and 10 mg Tablets X X Axert (almotriptan malate) Tablets 6.25 and 12.5 mg X X X PPI Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules 20, 30 and 60 mg X X X MG Frova (frovatriptan succinate) Tablets 2.5 mg X X X X Lexiscan (regadenoson) Injection X X X Spiriva HandiHaler inhalation powder X X X (Click on drug name to go to detailed view) BW C W P AR ...

... (tacrolimus) Injection, 5 mg / ml X X X Toprol XL (metoprolol succinate) 25 mg, 50 mg, 100 mg, and 200 mg Extended Release Tablets X Tracleer (bosentan) 62.5 and 125 mg Tablets X X MG Zerit (stavudine) Capsules, 15 mg, 20 mg, 30 mg and 40 mg Zerit (stavudine) Powder for Oral Solution, 1mg / mL X X PPI (Click on drug name to go to detailed view) BW C W P AR PPI / MG Altace (ramipril) 1.25, 2.5, 5, and 10 Capsules Altace (ramipril) 1.25, 2.5, 5 and 10 mg Tablets X Amaryl (glimepiride) Tablets X Capozide (captopril / hydrochlorothiazide) 25 / 15, 50 / 15, 25 / 25, 50 / 25 mg Tablets X Casodex (bicalutamide) Tablets X X Comtan (entacapone) Tablets X Monopril (fosinopril sodium) 10, 20, and 40 mg Tablets Monopril HCT (fosinopril / hydrochlorothiazide) 20 / 12.5mg and 10 / 12.5mg Tablets X Noxafil (posaconazole) ...

... 2008 Public Health Advisories 2007 Public Health Advisories 2006 Public Health Advisories 2005 Public Health Advisories 2004 Public Health Advisories 2003 Public Health Advisories 2002 Public Health Advisory 2001 Public Health Advisories 2000 Public Health Advisories Pre-2000 Public Health Advisories-Public Health Advisory: Angiotensin-Converting Enzyme Inhibitor (ACE inhibitor) Drugs and Pregnancy [ACE inhibitor drugs include Benazepril (Lotensin ), Captopril (Capoten ), Enalapril / Enalaprilat (Vasotec oral and injectable ), Fosinopril (Monopril ), Lisinopril (Zestril and Prinivil ), Moexipril (Univasc ), Perindopril (Aceon ), Quinapril (Accupril ), Ramipril (Altace ), and Trandolapril (Mavik )] 6 / 7 / 2006 A new study in the New England Journal of Medicine suggests that angiotensin-converting enzyme inhibitor drugs (ACE inhibitors or ACEIs) may be associated with increased risk of birth defects when used in the first three months of pregnancy. While the results of this single study do not establish a causal relationship between exposure to the drugs early in pregnancy and birth defects, they are concerning. ACE inhibitors are already known to have risks to the developing infant when used in the last ...