Angiomax (Bivalirudin) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

BLEEDING:

In 4312 patients undergoing PTCA for treatment of unstable angina in 2 randomized, double-blind studies comparing Angiomax to heparin, Angiomax patients exhibited lower rates of major bleeding and lower requirements for blood transfusions. The incidence of major bleeding is presented in Table 3. The incidence of major bleeding was lower in the Angiomax group than in the heparin group.

OTHER ADVERSE EVENTS:

In the 2 randomized double-blind clinical trials of Angiomax in patients undergoing PTCA, 82% of 2161 Angiomax-treated patients and 83% of 2151 heparin-treated patients experienced at least one treatment-emergent adverse event. The most frequent treatment-emergent events were back pain (42%), pain (15%), nausea (15%), headache (12%), and hypotension (12%) in the Angiomax-treated group. Treatment-emergent adverse events other than bleeding reported for >/=5% of patients in either treatment group are shown in Table 4.

Serious, non-bleeding adverse events were experienced in 2% of 2161 Angiomax-treated patients and 2% of 2151 heparin-treated patients. The following individual serious non-bleeding adverse events were rare (>0.1% to <1%) and similar in incidence between Angiomax- and heparin-treated patients. These events are listed by body system: Body as a Whole: fever, infection, sepsis: Cardiovascular: hypotension, syncope, vascular anomaly, ventricular fibrillation; Nervous: cerebral ischemia, confusion, facial paralysis; Respiratory: lung edema; Urogenital: kidney failure, oliguria.

POSTMARKETING EVENTS:

There have been reports of thrombus formation with the use of Angiomax during percutaneous coronary intervention (PCI), including intracoronary brachytherapy. Fatal outcomes have been reported.

REPORTS OF SUSPECTED ANGIOMAX SIDE EFFECTS / ADVERSE REACTIONS

Possible Angiomax side effects / adverse reactions in 55 year old male

Reported by a physician from United States on 2011-10-18

Patient: 55 year old male weighing 95.0 kg (209.0 pounds)

Reactions: Medical Device Complication, Surgical Procedure Repeated, Incorrect Drug Administration Duration, Coronary Artery Thrombosis, NO Therapeutic Response, Coagulation Time Abnormal, Myocardial Infarction

Adverse event resulted in: death

Suspect drug(s):
Angiomax

Other drugs received by patient: Plavix; Integrilin

Possible Angiomax side effects / adverse reactions in 74 year old male

Reported by a individual with unspecified qualification from Spain on 2011-10-20

Patient: 74 year old male

Reactions: Anaemia, Coagulopathy

Suspect drug(s):
Aspirin
    Dosage: 100 mg
    Indication: Acute Coronary Syndrome
    Start date: 2011-05-11
    End date: 2011-05-11

Angiomax
    Dosage: 250 mg, intravenous
    Start date: 2011-05-11
    End date: 2011-05-11

Arixtra
    Dosage: 2.5 mg, qd, subcutaneous
    Start date: 2011-05-11
    End date: 2011-05-11

Plavix
    Dosage: 300 mg, qd, oral
    Administration route: Oral
    Indication: Acute Coronary Syndrome
    Start date: 2011-05-11
    End date: 2011-05-11

Other drugs received by patient: Pantoprazole

Possible Angiomax side effects / adverse reactions in 80 year old male

Reported by a physician from United Kingdom on 2011-11-02

Patient: 80 year old male

Reactions: Death

Adverse event resulted in: death

Suspect drug(s):
Angiomax

Other drugs received by patient: Aspirin; Clopidogrel