... 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-Nizoral (ketoconazole) 2 &# 37 shampoo Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)-August 2009 Summary View PRECAUTIONS Severe hypersensitivity reactions, including anaphylaxis, have been reported during post-marketing use of Nizoral (ketoconazole) 2 %shampoo. Patients who develop allergic reactions, such as generalized rash, skin reactions, severe swelling, or shortness of breath should discontinue Nizoral and contact their physician immediately. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies to assess the carcinogenic potential of Nizoral (ketoconazole) 2 %shampoo have ...

... 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-Lariam (mefloquine hydrochloride) 250 mg tablets Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)-August 2009 Summary View WARNINGS Halofantrine should not be administered with Lariam or within 15 weeks of the last dose of Lariam due to the risk of a potentially fatal prolongation of the QTc interval. Ketoconazole should not be administered with Lariam or within 15 weeks of the last dose of Lariam due to the risk of a potentially fatal prolongation of the QTc interval. Ketoconazole increases plasma concentrations and elimination half-life of mefloquine following coadministration PRECAUTIONS Central and Peripheral Nervous System Effects vertigo Information for Patients that in a small percentage of cases, patients are unable to take this medication because of side effects, including vertigo Drug Interactions Halofantrine and Other Antimalarials Halofantrine should not be administered with Lariam or within 15 weeks of the last dose of Lariam Ketoconazole (potent ...

... failure that can be life-threatening. And tell patients to promptly report muscle pain and weakness, malaise, fever, dark urine, nausea or vomiting. Additional Information: MedWatch 2004 Safety Summary: Crestor (rosuvastatin). http :// www.fda.gov / Safety / MedWatch / SafetyInformation / SafetyAlertsforHumanMedicalProduct / ucm151070.htm Drug Interactions with Desyrel Bristol-Myers Squibb has notified healthcare professionals about important drug interactions that can increase or decrease plasma concentrations of the antidepressant drug Desyrel (trazodone hydrochloride). One type of interaction occurs when Desyrel is given with CYP3A4 inhibitors such as ketoconazole, indinavir, and ritonavir. In these cases, the plasma concentration of trazodone may increase substantially, and patients could experience adverse effects such as nausea, hypotension and syncope. So if Desyrel is used with one of these CYP3A4 inhibitors, a lower dose of Desyrel should be considered. Conversely, the plasma concentration of Desyrel may decrease when it's given with the anti-seizure drug carbamazapine. So patients who are taking both of these drugs should be closely monitored to see if their doses of Desyrel need to be increased. Additional Information: ...

... Drug Interactions with Desyrel FDA Patient Safety News: Show #30, August 2004 Bristol-Myers Squibb has notified healthcare professionals about important drug interactions that can increase or decrease plasma concentrations of the antidepressant drug Desyrel (trazodone hydrochloride). One type of interaction occurs when Desyrel is given with CYP3A4 inhibitors such as ketoconazole, indinavir, and ritonavir. In these cases, the plasma concentration of trazodone may increase substantially, and patients could experience adverse effects such as nausea, hypotension and syncope. So if Desyrel is used with one of these CYP3A4 inhibitors, a lower dose of Desyrel should be considered. Conversely, the plasma concentration of Desyrel may decrease when it's given with the anti-seizure drug carbamazapine. So patients who are taking both of these drugs should be closely monitored to see if their doses of Desyrel need to be increased. Additional Information: MedWatch 2004 Medical Product Safety Alerts. http :// www.fda.gov / Safety / MedWatch / SafetyInformation / SafetyAlertsforHumanMedicalProduct / ucm154912.htm FDA Patient Safety News is available at www.fda.gov / psn ...

... Drug Name Confusion Between Kuric and Carac FDA Patient Safety News: Show #83, February 2009 The Institute for Safe Medication Practices (ISMP) recently reported on the potential for mix-ups between two topical creams: Kuric (ketoconazole) and Carac (fluorouracil). Kuric is used to treat fungal infections and seborrheic dermatitis. Carac is used to treat multiple actinic or solar keratoses of the face and anterior scalp. Sanofi-Aventis, the maker of Carac, recently sent a letter to pharmacists describing how one mix-up occurred. In this case, a verbal prescription for Kuric was mistakenly heard and transcribed as Carac, which was then dispensed. The patient developed severe rash with erythema, irritation, and peeling of the skin and secondary infection at the application site and surrounding areas. The letter gave several ways to help avoid these kinds of errors. For example, clarify oral and written orders with the prescriber by verifying both the brand and generic name, as well as the spelling of the product; match the product's indication to the patient's condition; and create electronic alerts ...

... Reporting Program Safety Information Drug Safety Labeling Changes-Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)-January 2008 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. Summary View Sections Modified PRECAUTIONS Drug Interactions Drugs that Inhibit Cytochrome P450 Isoenzymes Ketoconazole: A pharmacokinetic study with ketoconazole 100 mg b.i.d. with a single dose of venlafaxine 50 mg in extensive metabolizers (EM; n = 14) and 25 mg in poor metabolizers (PM; n = 6) of CYP2D6 resulted in higher plasma concentrations of both venlafaxine and O-desmethylvenlafaxine (ODV) in most subjects following administration of ketoconazole. Venlafaxine Cmax increased by 26 %in EM subjects and 48 %in PM subjects. Cmax values for ODV increased by 14 %and 29 %in EM and PM subjects, respectively. Venlafaxine ...

... Adverse Event Reporting Program Safety Information Drug Safety Labeling Changes-Effexor (venlafaxine hydrochloride) Tablets Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)-January 2008 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. Summary View Sections Modified PRECAUTIONS Drug Interactions Drugs that Inhibit Cytochrome P450 Isoenzymes Ketoconazole: A pharmacokinetic study with ketoconazole 100 mg b.i.d. with a single dose of venlafaxine 50 mg in extensive metabolizers (EM; n = 14) and 25 mg in poor metabolizers (PM; n = 6) of CYP2D6 resulted in higher plasma concentrations of both venlafaxine and O-desmethylvenlafaxine (ODV) in most subjects following administration of ketoconazole. Venlafaxine Cmax increased by 26 %in EM subjects and 48 %in PM subjects. Cmax values for ODV increased by 14 %and 29 %in EM and PM subjects, respectively. Venlafaxine ...

... and Warnings CONTRAINDICATIONS WARNINGS AND PRECAUTIONS Deterioration of Disease and Acute Episodes Pneumonia Drug Interactions With Strong Cytochrome P450 3A4 Inhibitors ADVERSE REACTIONS Clinical Trials Experience in Asthma Adult and Adolescent Patients 12 Years of Age and Older Table 2 Clinical Trials Experience in Chronic Obstructive Pulmonary Disease Short-Term (6 Months to 1 Year) Trials Table 3 Postmarketing Experience Musculoskeletal, Connective Tissue, and Bone Disorders Arthralgia Psychiatric Disorders Behavioral changes, including hyperactivity and irritability, have been reported very rarely and primarily in children. DRUG INTERACTIONS Inhibitors of Cytochrome P450 3A4 Initial Paragraph Ketoconazole: Salmeterol Beta-Adrenergic Receptor Blocking Agents USE IN SPECIFIC POPULATIONS Pregnancy Pediatric Use Geriatric Use Hepatic Impairment Renal Impairment PATIENT COUNSELING INFORMATION Pneumonia MEDICATION GUIDE What is Advair Diskus Chronic Obstructive Pulmonary Disease Who should not use Advair Diskus? What should I tell my healthcare provider before using Advair Diskus? .are allergic to any of the ingredients in Advair Diskus. How do I use Advair Diskus? What are the possible side effects with Advair Diskus? The most common side effects with Advair Diskus include. CONTRAINDICATIONS Severe hypersensitivity to milk proteins. WARNINGS AND PRECAUTIONS ...

... in active metabolite levels of about 45 %was found in people who received clopidogrel with omeprazole compared to those taking clopidogrel alone. The effect of clopidogrel on platelets was reduced by as much as 47 %in people receiving clopidogrel and omeprazole together. These reductions were seen whether the drugs were given at the same time or 12 hours apart. Other drugs that are potent inhibitors of the CYP 2C19 enzyme would be expected to have a similar effect and should be avoided in combination with clopidogrel. These include: cimetidine, fluconazole, ketoconazole, voriconazole, etravirine, felbamate, fluoxetine, fluvoxamine, and ticlopidine. Since the level of inhibition among other PPIs varies, it is unknown to what amount other PPIs may interfere with clopidogrel. However, esomeprazole, a PPI that is a component of omeprazole, inhibits CYP2C19 and should also be avoided in combination with clopidogrel. FDA is aware there are studies, such as the Clopidogrel and Optimization of Gastrointestinal Events (COGENT) study, that might provide information about the effect of this interaction on clinical outcome. Although the FDA ...

... GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Summary View Sections Modified Summary of Changes to Contraindications and Warnings WARNINGS AND PRECAUTIONS Use in Pregnancy Peripheral Neuropathy Cardiac Disorders Gastrointestinal Adverse Events Thrombocytopenia / Neutropenia Table 4 ADVERSE REACTIONS Clinical Trials Safety Experience Summary of Clinical Trial in Patients with Previously Untreated Multiple Myeloma (new subsection) Table 5 (new) Description of Selected Adverse Events from the Phase 2 and 3 Relapsed Multiple Myeloma and Phase 2 Mantle Cell Lymphoma Studies Herpes Virus Infection DRUG INTERACTIONS Ketoconazole Melphalan-Prednisone Omeprazole USE IN SPECIFIC POPULATIONS Pregnancy Patients with Renal Impairment PATIENT COUNSELING INFORMATION Dehydration / Hypotension Pregnancy / Nursing Concomitant Medications Diabetic Patients Peripheral Neuropathy Other WARNINGS AND PRECAUTIONS Use in Pregnancy .Bortezomib administered to rabbits during organogenesis caused post-implantation loss and a decreased number of live fetuses. Peripheral Neuropathy .Following dose adjustments, improvement in or resolution of peripheral neuropathy was reported in 51 %of patients with >Grade 2 peripheral neuropathy in the relapsed multiple myeloma study. Cardiac Disorders .In the relapsed multiple myeloma study, the incidence of any treatment-emergent cardiac disorder was ...