mom2lillian
New member
As part of my job I get updates on all sorts FDA stuff so I figured I would start fishing through some of the stuff that is normally in my 'dont care' about pile to see if it relates to CF and post it. Hopefully some find it helpful.
Today 33 drugs had updates to their safety profiles. This often comes after additional adverse reactions were reproted and confirmed or after longer safety studies were completed or larger populations have been on teh drug for a while and reports were generated.
These come in table format and so are hard to read here, please visit <a target=_blank class=ftalternatingbarlinklarge href="http://www.fda.gov/default.htm">http://www.fda.gov/default.htm</a> for full details.
Advair Diskus
(fluticasone propionate and salmeterol xinafoate inhalation powder)
WARNINGS AND PRECAUTIONS
. Reduction in Bone Mineral Density
WARNINGS and PRECAUTIONS
. Reduction in Bone Mineral Density
o 2-Year Fluticasone Propionate Study
o 3-Year Bone Mineral Density Study
o 3-Year Survival Study
Spiriva HandiHaler inhalation powder
Prescribing Information and New Patient Package Insert
WARNINGS
ADVERSE REACTIONS
. added "(new onset or worsening)" to glaucoma
PATIENT PACKAGE INSERT
. New WARNINGS
. section updated symptoms of angioedema: (including swelling of the lips, tongue or throat), itching, and rash
Zithromax (azithromcyin) for Oral Suspension, 200 mg, 500 mg, Single Dose Packet, 600 mg, IV
Prescribing Information
PRECAUTIONS
. General
o Exacerbation of symptoms of myasthenia gravis and new onset of myasthenic syndrome have been reported in patients receiving azithromycin therapy.
. Precautions -Drug Interactions
o Although, in a study of 22 healthy men, a 5-day course of azithromycin did not affect the prothrombin time from a subsequently administered dose of warfarin, spontaneous post-marketing reports suggest that concomitant administration of azithromycin may potentiate the effects of oral anticoagulants. Prothrombin times should be carefully monitored while patients are receiving azithromycin and oral anticoagulants concomitantly.
Sporanox (itraconazole) Capsules, 100 mg
Sections
BOXED WARNING
. Drug Interactions
CONTRAINDICATIONS
. Congestive Heart Failure
. Drug Interactions
WARNINGS
. Cardiac Dysrhythmias
. Cardiac Disease
. Treatment of Severely Neutropenic Patients
PRECAUTIONS
. Hearing Loss
o Transient or permanent hearing loss has been reported .....
. Information for Patients
o Instruct patients that hearing loss can occur...
. Drug Interactions Table additions
o ...disopyramide..(including nisoldipine)..levacetylmethadol (levomethadyl), ergot alkaloids, halofantrine..budesonide,
dexamethasone, fluticasone..warfarin, cilostazol, eletriptan, fentanyl...
. Antiarrhythmics
o The class IA antiarrhythmic disopyramide has the potential to increase the QT interval...
o ...via inhibition of P glycoprotein.
. Calcium Channel Blockers
o ...due to an increased risk of CHF. Concomitant administration of Sporanox and nisoldipine results in...
. Other
o Levacetylmethadol (levomethadyl) is known to prolong the QT...
o Elevated concentrations of ergot alkaloids can cause ergotism...
o Halofantrine has the potential to prolong the QT interval...
o Sporanox may..."glucocorticosteroids such as budesonide, dexamethasone, fluticasone and"...
o Cilostazol and eletriptan are CYP3A4 metabolized...
o Fentanyl plasma concentrations could...
. Pregnancy:Teratogenic Effects, Pregnancy Category C
o During post-marketing experience, cases of congenital abnormalities have been reported.
. Geriatric Use (new section)
. Renal Impairment (new section)
. Hepatic Impairment (new section)
ADVERSE REACTIONS
. Postmarketing Experience
o Revised and table updated
? Transient or permanent hearing loss BOXED WARNING
. Drug Interactions
o Coadministration of "levacetylmethadol (levomethadyl)" addition
o ..sudden death have occurred in patients using "levacetylmethadol (levomethadyl)"...
CONTRAINDICATIONS
. Congestive Heart Failure (new section)
. Drug Interactions
o nisoldipine
o levacetylmethadol
(levomethadyl)
o Ergot alkaloids metabolized...
WARNINGS
. Cardiac Dysrhythmias
o levacetylmethadol (levomethadyl)
. Cardiac Disease
o Itraconazole has been shown to have a negative inotropic effect.
o Sporanox has been associated with reports of congestive heart failure. In post-marketing...
o Calcium channel blockers can have negative inotropic effects
. Treatment of Severely Neutropenic Patients (new section)
Today 33 drugs had updates to their safety profiles. This often comes after additional adverse reactions were reproted and confirmed or after longer safety studies were completed or larger populations have been on teh drug for a while and reports were generated.
These come in table format and so are hard to read here, please visit <a target=_blank class=ftalternatingbarlinklarge href="http://www.fda.gov/default.htm">http://www.fda.gov/default.htm</a> for full details.
Advair Diskus
(fluticasone propionate and salmeterol xinafoate inhalation powder)
WARNINGS AND PRECAUTIONS
. Reduction in Bone Mineral Density
WARNINGS and PRECAUTIONS
. Reduction in Bone Mineral Density
o 2-Year Fluticasone Propionate Study
o 3-Year Bone Mineral Density Study
o 3-Year Survival Study
Spiriva HandiHaler inhalation powder
Prescribing Information and New Patient Package Insert
WARNINGS
ADVERSE REACTIONS
. added "(new onset or worsening)" to glaucoma
PATIENT PACKAGE INSERT
. New WARNINGS
. section updated symptoms of angioedema: (including swelling of the lips, tongue or throat), itching, and rash
Zithromax (azithromcyin) for Oral Suspension, 200 mg, 500 mg, Single Dose Packet, 600 mg, IV
Prescribing Information
PRECAUTIONS
. General
o Exacerbation of symptoms of myasthenia gravis and new onset of myasthenic syndrome have been reported in patients receiving azithromycin therapy.
. Precautions -Drug Interactions
o Although, in a study of 22 healthy men, a 5-day course of azithromycin did not affect the prothrombin time from a subsequently administered dose of warfarin, spontaneous post-marketing reports suggest that concomitant administration of azithromycin may potentiate the effects of oral anticoagulants. Prothrombin times should be carefully monitored while patients are receiving azithromycin and oral anticoagulants concomitantly.
Sporanox (itraconazole) Capsules, 100 mg
Sections
BOXED WARNING
. Drug Interactions
CONTRAINDICATIONS
. Congestive Heart Failure
. Drug Interactions
WARNINGS
. Cardiac Dysrhythmias
. Cardiac Disease
. Treatment of Severely Neutropenic Patients
PRECAUTIONS
. Hearing Loss
o Transient or permanent hearing loss has been reported .....
. Information for Patients
o Instruct patients that hearing loss can occur...
. Drug Interactions Table additions
o ...disopyramide..(including nisoldipine)..levacetylmethadol (levomethadyl), ergot alkaloids, halofantrine..budesonide,
dexamethasone, fluticasone..warfarin, cilostazol, eletriptan, fentanyl...
. Antiarrhythmics
o The class IA antiarrhythmic disopyramide has the potential to increase the QT interval...
o ...via inhibition of P glycoprotein.
. Calcium Channel Blockers
o ...due to an increased risk of CHF. Concomitant administration of Sporanox and nisoldipine results in...
. Other
o Levacetylmethadol (levomethadyl) is known to prolong the QT...
o Elevated concentrations of ergot alkaloids can cause ergotism...
o Halofantrine has the potential to prolong the QT interval...
o Sporanox may..."glucocorticosteroids such as budesonide, dexamethasone, fluticasone and"...
o Cilostazol and eletriptan are CYP3A4 metabolized...
o Fentanyl plasma concentrations could...
. Pregnancy:Teratogenic Effects, Pregnancy Category C
o During post-marketing experience, cases of congenital abnormalities have been reported.
. Geriatric Use (new section)
. Renal Impairment (new section)
. Hepatic Impairment (new section)
ADVERSE REACTIONS
. Postmarketing Experience
o Revised and table updated
? Transient or permanent hearing loss BOXED WARNING
. Drug Interactions
o Coadministration of "levacetylmethadol (levomethadyl)" addition
o ..sudden death have occurred in patients using "levacetylmethadol (levomethadyl)"...
CONTRAINDICATIONS
. Congestive Heart Failure (new section)
. Drug Interactions
o nisoldipine
o levacetylmethadol
(levomethadyl)
o Ergot alkaloids metabolized...
WARNINGS
. Cardiac Dysrhythmias
o levacetylmethadol (levomethadyl)
. Cardiac Disease
o Itraconazole has been shown to have a negative inotropic effect.
o Sporanox has been associated with reports of congestive heart failure. In post-marketing...
o Calcium channel blockers can have negative inotropic effects
. Treatment of Severely Neutropenic Patients (new section)