FLOLAN SIDE EFFECTS
- Generic Name: epoprostenol sodium
- Brand Name: Flolan
- Drug Class: PAH, Prostacyclin Analogs
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 .