FLOLAN SIDE EFFECTS

  • Generic Name: epoprostenol sodium
  • Brand Name: Flolan
  • Drug Class: PAH, Prostacyclin Analogs
Last updated on MDtodate: 10/5/2022

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adverse reactions are shown in Table 1 and are generally related to vasodilatory effects.

Table 1. Adverse Reactions Occurring in Patients with Idiopathic or Heritable PAH and with PAH Associated with Scleroderma Spectrum of Diseases (PAH/SSD) Occurring ≥10% More Frequently on FLOLAN than Conventional Therapy

Adverse Reaction Idiopathic or Heritable PAH PAH/SSD
FLOLAN Conventional Therapy FLOLAN Conventional Therapy
(n = 52) (n = 54) (n = 56) (n = 55)
Body as a whole
Jaw pain 54% 0% 75% 0%
Nonspecific musculoskeletal pain 35% 15% 84% 65%
Headache 83% 33% 46% 5%
Chills/fever/sepsis/flu-like symptoms 25% 11% 13% 11%
Cardiovascular system
Flushing 42% 2% 23% 0%
Hypotension 27% 31% 13% 0%
Tachycardia 35% 24% 43% 42%
Digestive system
Anorexia 25% 30% 66% 47%
Nausea/Vomiting 67% 48% 41% 16%
Diarrhea 37% 6% 50% 5%
Skin and Appendages
Skin ulcer 39% 24%
Eczema/rash/urticaria `10% 13% 25% 4%
Musculoskeletal System
Myalgia 44% 31%
Nervous system
Anxiety/hyperkinesias/nervousness/tremor 21% 9% 7% 5%
Hyperesthesia/hypesthesia/paresthesia 12% 2% 5% 0%
Dizziness 83% 70% 59% 76%

 

Adverse Events Attributable To The Drug Delivery System

Chronic infusions of FLOLAN are delivered using a small, portable infusion pump through an indwelling central venous catheter. During controlled PAH trials of up to 12 weeks’ duration, the local infection rate was about 18% and the rate for pain was about 11%. During long-term follow-up, sepsis was reported at a rate of 0.3 infections/patient per year in patients treated with FLOLAN.

Postmarketing Experience

The following events have been identified during postapproval use of FLOLAN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure.

Blood And Lymphatic

Anemia, hypersplenism, pancytopenia, splenomegaly, thrombocytopenia.

Cardiac

High output cardiac failure.

Endocrine And Metabolic

Hyperthyroidism.

Gastrointestinal

Hepatic failure.

Respiratory, Thoracic, And Mediastinal

Pulmonary embolism.

 

SRC: NLM .