amiodarone case safety report
TRANSCRIPT
Case safety report
Drug : amiodarone
Improved REMS
D. Ibrahim Mahamoud
Presented at : AAPS ,Toronto ,Canada
21/ March /2014
2 1 / 3 / 2 0 1 3
Amiodarone Adverse Reaction
Adverse reaction report number :000168147Health Canada
78 years old male patient
Outcome : Death
Date : 24/2/2004
Reporter type : non health professional
Suspect :
amiodarone 400 mg once daily
Concomitant :
colace (Docusate sodium) (stool softeners)
dulcolax
morphine
warfarin
Adverse reaction
Cerebral haemorrhage
Epistaxis
Mouth haemorrhage
Pyrexia
Interactions between your selected drugs
amiodarone ↔ warfarin ...............major Applies to: amiodarone, warfarin MONITOR CLOSELY: Amiodarone may increase the pharmacologic effects of
warfarin by inhibiting CYP450 2C9 hepatic metabolism of S-warfarin. Similar effects may also occur with other oral anticoagulants, resulting in significant hypo prothrombinemia and bleeding.
When amiodarone is added to an anticoagulant regimen, increased anticoagulant effects may become apparent within one to several weeks and may persist for months after the amiodarone is discontinued.
The effects of this interaction are highly variable - while some patients are asymptomatic, serious and life-threatening bleeding complications have been reported in others.
MANAGEMENT: An empiric 30% to 50% reduction in anticoagulant dosage has been recommended, in addition to frequent monitoring of the patient and the prothrombin time or International Normalized Ratio (INR).
Patients should be advised to notify their physician promptly if they experience any signs of excessive anticoagulation such as unusual or prolonged bleeding, bruising, vomiting, change in stool or urine color, headache, dizziness, or weakness.
amiodarone ↔ bisacodyl ................... moderate Applies to: amiodarone, Dulcolax (bisacodyl) MONITOR: Bowel cleansing as well as overuse of certain laxatives may cause
electrolyte loss and increase the risk of torsade de pointes ventricular arrhythmia in patients treated with drugs that prolong the QT interval.
Electrolyte disturbances including hypokalemia and hypomagnesemia have been reported with laxative abuse and are known risk factors for torsade de pointes associated with QT interval prolongation.
MANAGEMENT: Patients treated with drugs that prolong the QT interval should exercise caution when self-medicating with laxatives.
The recommended dosage and duration of use should not be exceeded. Patients treated with lactulose for more than six months should be monitored
periodically for electrolyte imbalance. Patients should be advised to seek prompt medical attention if they experience symptoms that could indicate the occurrence of torsade de pointes such as dizziness, lightheadedness, fainting, palpitation, irregular heart rhythm, shortness of breath, or syncope.
warfarin
Monitoring INR
Diet
Interaction
Dabigatran
first oral direct thrombin inhibitor
Morphine Side Effects
Gastrointestinal side effects - These include nausea, vomiting, abdominal cramps and constipation.
Opioid receptors for morphine are present in the gastrointestinal tract and their activation may lead to a slowing of gut movement, leading to constipation. Long-term use leads to severe constipation.
Sedation –
Respiratory depression –
Pyrexia
Sepsis
Disseminated intravascular coagulation (DIC)
summery
Drug- drug Interaction
Education ( medical staff, patient, care giver )
To choose safer medication if possible
Proper (clinical , Lab. Test) follow up of the patient.
Other possibility ( sepses, DIC)
Morphine ?
Thank you