"A unique type of poster placed in exam rooms helped reduce unnecessary antibiotic prescriptions for respiratory infections during flu season. The approach could help reduce costs and extend the usefulness of these drugs.
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 3 and are generally related to vasodilatory effects.
Table 3: 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
|Adverse Reaction||Idiopathic or Heritable PAH||PAH/SSD|
(n = 52)
(n = 54)
(n = 56)
(n = 55)
|Body as a whole|
|Nonspecific musculoskeletal pain||35%||15%||84%||65%|
|Chills/ fever/ sepsis/ flu-like symptoms||25%||11%||13%||11%|
|Skin and Appendages|
|Eczema/ rash/ urticaria||10%||13%||25%||4%|
|Anxiety/ hyperkinesias / nervousness/ tremor||21%||9%||7%||5%|
|Hyperesthesia/ hypesthesia / paresthesia||12%||2%||5%||0%|
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.
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
Endocrine and Metabolic
Respiratory, Thoracic, and Mediastinal
Read the Flolan (epoprostenol sodium) Side Effects Center for a complete guide to possible side effects
Last reviewed on RxList: 5/6/2015
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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