From the FDA Drug Label
The complete spectrum of side effects induced by LITHOSTAT ® (acetohydroxamic acid) is unknown. However, some side effects which have been reported to date have been headaches, abdominal discomfort, nausea, loss of hair, shakiness, and anemia. Lifethreatening problems (blood clot in the legs) occurred in several patients with advanced disease in early investigation. A flushing skin reaction (i.e., redness, warmth, and tingling) has occurred in several patients who consumed alcohol during treatment with LITHOSTAT ®. In animal studies doses of LITHOSTAT ®about 20 times the maximum human dose have caused fetal abnormalities (birth defects) indicating a potential for such an adverse effect in an exposed human fetus. An acceptable long-term study of the cancer causing potential of LITHOSTAT ®has not been conducted, but a known metabolite of LITHOSTAT ®, acetamide, is carcinogenic (cancer-causing) to the liver in rats at doses about 80 times the maximum human dose of LITHOSTAT ®. LITHOSTAT ®thus must be considered a potential human carcinogen. LITHOSTAT ®kills tissue cells grown in tissue culture and alters genetic material in cells grown in culture. LITHOSTAT ® may induce other adverse reactions which have not yet been recognized.
The side effects of acetohydroxamic acid (AHA) include:
- Headaches
- Abdominal discomfort
- Nausea
- Loss of hair
- Shakiness
- Anemia
- Blood clots in the legs (in patients with advanced disease)
- Flushing skin reaction (when consuming alcohol during treatment)
- Fetal abnormalities (in animal studies, at high doses)
- Potential human carcinogen (based on animal studies and metabolite data) 1 1
From the Research
Acetohydroxamic acid (AHA) is expected to be relatively safe with potential side effects including gastrointestinal tract and hematopoietic system toxicity, although its toxicity in human beings has not been extensively studied 2. The most relevant information regarding the side effects of AHA comes from a 1975 study published in Urology, which suggests that AHA may cause reversible toxicity involving the gastrointestinal tract and the hematopoietic systems when high doses are administered 2. Some potential side effects of AHA include:
- Gastrointestinal disturbances
- Hematopoietic system toxicity
- Other possible side effects may include headache, nausea, vomiting, rash, and anemia, although these are not directly mentioned in the provided evidence It is essential to note that the evidence provided does not extensively discuss the side effects of AHA, and most of the studies are not directly related to the question. However, based on the available information, it is crucial for patients to be aware of the potential side effects of AHA and report any unusual symptoms to their healthcare provider immediately, especially signs of blood disorders like unusual bleeding or bruising 2.