DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Primacor (Milrinone Lactate) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Cardiovascular Effects

In patients receiving PRIMACOR in Phase II and III clinical trials, ventricular arrhythmias were reported in 12.1%: Ventricular ectopic activity, 8.5%; nonsustained ventricular tachycardia, 2.8%; sustained ventricular tachycardia, 1% and ventricular fibrillation, 0.2% (2 patients experienced more than one type of arrhythmia). Holter recordings demonstrated that in some patients injection of PRIMACOR increased ventricular ectopy, including nonsustained ventricular tachycardia. Life-threatening arrhythmias were infrequent and when present have been associated with certain underlying factors such as preexisting arrhythmias, metabolic abnormalities (e.g. hypokalemia), abnormal digoxin levels and catheter insertion. PRIMACOR was not shown to be arrhythmogenic in an electrophysiology study. Supraventricular arrhythmias were reported in 3.8% of the patients receiving PRIMACOR. The incidence of both supraventricular and ventricular arrhythmias has not been related to the dose or plasma milrinone concentration.

Other cardiovascular adverse reactions include hypotension, 2.9% and angina/chest pain, 1.2%.

In the post marketing experience, there have been rare cases of "torsades de pointes" reported.

CNS Effects

Headaches, usually mild to moderate in severity, have been reported in 2.9% of patients receiving PRIMACOR.

Other Effects

Other adverse reactions reported, but not definitely related to the administration of PRIMACOR include hypokalemia, 0.6%; tremor, 0.4%; and thrombocytopenia, 0.4%.

Post-Marketing Adverse Event Reports

In addition to adverse events reported from clinical trials, the following events have been reported from worldwide post-marketing experience with PRIMACOR:

Isolated spontaneous reports of bronchospasm and anaphylactic shock.

Liver function test abnormalities and skin reactions such as rash.

Administration site conditions: Infusion site reaction.



REPORTS OF SUSPECTED PRIMACOR SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Primacor. The information is not vetted and should not be considered as verified clinical evidence.

Possible Primacor side effects / adverse reactions in 3 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-23

Patient: 3 year old female weighing 10.0 kg (22.0 pounds)

Reactions: Death

Adverse event resulted in: death

Suspect drug(s):
Primacor

Remodulin
    Start date: 2009-07-24
    End date: 2012-04-01

Other drugs received by patient: Sildenafil Citrate; Aspirin; Diuretics



Possible Primacor side effects / adverse reactions in 3 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-04

Patient: 3 year old female weighing 10.0 kg (22.0 pounds)

Reactions: Cardiac Failure, Tachypnoea, Respiratory Distress, Cardiac Arrest

Adverse event resulted in: death

Suspect drug(s):
Remodulin
    Start date: 2009-07-24
    End date: 2012-04-01

Primacor
    Dosage: 0.5mg/kg/min
    Start date: 2010-03-03
    End date: 2012-04-01

Other drugs received by patient: Sildenafil Citrate; Aldactone; Lasix; Aspirin; Diuril; Potassium Chloride



Possible Primacor side effects / adverse reactions in 62 year old female

Reported by a physician from United States on 2012-05-25

Patient: 62 year old female

Reactions: Hypotension, Cardiopulmonary Failure, Leukaemoid Reaction, Cardiogenic Shock, Septic Shock, Shock

Adverse event resulted in: death

Suspect drug(s):
Flolan
    Start date: 2011-12-01
    End date: 2011-12-01

Primacor
    Indication: Cardiac Output
    Start date: 2011-12-01
    End date: 2011-12-01

Sildenafil Citrate
    Administration route: Oral
    Indication: Pulmonary Hypertension
    Start date: 2011-08-24
    End date: 2011-12-14



See index of all Primacor side effect reports >>

Drug label data at the top of this Page last updated: 2008-02-29

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017