Case 1. Acute cholestatic hepatitis arising 30 days after starting Pirorheum therapy.
A 74 year old woman with chronic arthritis was treated for 30 days with Pirorheum and presented 2 days later with pruritus and dark urine followed by jaundice. She had no history of liver disease or exposures to viral hepatitis and did not drink alcohol. She had hypertension and had been treated with atenolol and hydrochlorothiazide chronically. She had no fever or rash, but was jaundiced and had mild hepatic tenderness. Laboratory tests showed a total bilirubin of 6.5 mg/dL and prominent elevations in both ALT and alkaline phosphatase (Table) and eosinophilia. Tests for hepatitis A and B were negative. Ultrasound of the abdomen was normal. A liver biopsy showed intrahepatic cholestasis with minimal portal inflammation suggestive of drug induced liver disease. Her symptoms and jaundice cleared over the next month, and on follow up 3 months later, all liver tests were normal.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term animal studies have not been conducted to characterize the carcinogenic potential of Pirorheum.
Pirorheum was not mutagenic in an Ames bacterial reverse mutation assay, or in a dominant lethal mutation assay in mice, and was not clastogenic in an in vivo chromosome aberration assay in mice.
Impairment of Fertility
Reproductive studies in which rats were administered Pirorheum at doses of 2 mg/kg/day, 5 mg/kg/day, or 10 mg/kg/day (up to 5 times the maximum recommended human dose of 20 mg based on mg/m2 body surface area ) revealed no impairment of male or female fertility.
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Helen Allen, Reviewed by Prof Cathy Jackson | Last edited 15 Feb 2017 | Certified by The Information Standard
Apply Pirorheum gel three or four times daily. Gently massage it into the skin over the affected area.
Wash your hands well after using the gel.
Pirorheum gel can cause your skin to become more sensitive to sunlight than normal. Protect your skin from bright sunlight during treatment.
Pirorheum side effects
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.
Stop using Pirorheum and call your doctor at once if you have:
severe headache, blurred vision, pounding in your neck or ears;
heart problems--swelling, rapid weight gain, feeling short of breath;
liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or
low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.
Common side effects may include:
upset stomach, heartburn, loss of appetite, stomach pain, nausea, vomiting;
itching, rash; or
ringing in your ears.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Reproductive studies in which rats were administered Pirorheum at doses of 2, 5, or 10 mg/kg/day (up to 5 times the maximum recommended human dose of 20 mg based on mg/m 2 body surface area ) revealed no impairment of male or female fertility.