Vaniqa (Eflornithine) Adverse Reactions
- abdominal pain
- alopecia
- anemia
- anorexia
- asthenia
- diarrhea
- dizziness
- edema
- eosinophilia
- erythema
- headache
- hearing loss
- leukopenia
- nausea/vomiting
- pancytopenia
- rash (unspecified)
- seizures
- skin irritation
- thrombocytopenia
Vaniqa (Eflornithine) Adverse Reactions
Most adverse events occurring with topical eflornithine have occurred at a similar rate as with the vehicle control and have involved skin irritation. Most adverse events are mild and resolve without medical treatment or discontinuation of eflornithine. Reactions occurring at a greater percentage than the vehicle include stinging skin (7.9% eflornithine vs. 2.5% vehicle), burning skin (4.3% vs. 2%), erythema (1.3% vs 0%), tingling skin (3.6% vs. 1.5%) and rash (unspecified), (2.8% vs 0%). Notable reactions occurring at a rate similar to vehicle include acne (21.3% vs. 21.4%) and pseudofolliculitis barbae (16.3% vs. 15.4%). Skin-related adverse events occurring in less than 1% of patients include: bleeding skin, cheilitis, contact dermatitis, swelling of the lips, herpes simplex, numbness and rosacea.
In studies evaluating treatment of trypanosomiasis with systemic eflornithine, anemia (55%), eosinophilia (2%), leukopenia (37%), and thrombocytopenia (48%) were common and serious adverse effects. Pancytopenia and neutropenia were reported in AIDS patients receiving eflornithine for PCP. Upon discontinuation of the drug, these effects are reversible and may not recur if eflornithine is started at a lower dose. However, there have been reports of patients requiring transfusions to reverse these effects.
Seizures have been reported in up to 8% of patients receiving systemic eflornithine. Seizure activity may be a direct result of CNS penetration and neurotoxicity of systemic eflornithine as well as a manifestation of the disease. A 14 day course of therapy resulted in higher rates of seizures than a 7 day course of therapy. Seizures were shown to be more common among relapsing than new cases of trypanosomiasis. In one study, seizures associated with eflornithine were characterized as generalized, occurring 30-60 minutes after the first or second dose of IV eflornithine, and were followed by post-ictal stupor. Eflornithine was resumed 1-2 days after the seizure with a recurrence in only 1/9 patients. Other CNS adverse effects of eflornithine include dizziness (1 %) and headache (2%).
Nausea/vomiting (5%), anorexia (2%), abdominal pain (2%) and diarrhea (9%) have all been reported in clinical trials with systemic eflornithine. In one study, GI adverse events were more common with a 14 day vs a 7 day regimen. GI adverse events may be more common with oral use of eflornithine. One study recommends halving the dose of oral eflornithine if serious diarrhea occurs.
Hearing loss with eflornithine appears to be associated with cumulative dose, length of therapy, and/or pre-existing hearing deficit. The manufacturer reports that hearing impairment may occur in up to 5% of patients. In one study, up to 75% of patients who received more than 250 g/m2 developed reversible hearing loss. Animal data suggest that the hearing loss may be due to ODC inhibition of polyamine biosynthesis in the cochlea.
Other reported adverse events with systemic eflornithine include anorexia (2%), alopecia (3%), asthenia (2%), and facial edema (2%).
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