"The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
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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
Additional Flolan Information
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Report Problems to the Food and Drug Administration
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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