Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS Experience with AHA is limited.
About 150 patients have been treated, most for periods of more than a year.
Adverse reactions have occurred in up to thirty percent (30%) of the patients receiving AHA.
In some instances the reactions were symptomatic;
in others only changes in laboratory parameters were noted.
Adverse reactions seem to be more prevalent in patients with preexisting thrombophlebitis or phlebothrombosis and/or in patients with advanced degrees of renal insufficiency.
The risk of adverse reactions is highest during the first year of treatment.
Chronic treatment does not seem to increase the risk nor the severity of adverse reactions.
The following reactions have been reported: NEUROLOGICAL: Mild headaches are commonly reported (about 30%) during the first 48 hours of treatment.
These headaches are mild, responsive to oral salicylate-type analgesics, and usually disappear spontaneously.
WARNINGS A Coombs negative hemolytic anemia has occurred in patients receiving AHA.
Gastrointestinal upset characterized by nausea, vomiting, anorexia and generalized malaise have accompanied the most severe forms of hemolytic anemia.
Approximately 15% of patients receiving AHA have had only laboratory findings of an anemia.
However, most patients developed a mild reticulocytosis.
The untoward reactions have reverted to normal following cessation of treatment.
Like all medications, Lithostat can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: