Ridaura Side Effects

Generic Name: auranofin

Please note - some side effects for Ridaura may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Ridaura - for the Consumer

Ridaura

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ridaura:

Abdominal pain; constipation; diarrhea; gas; inflammation of the eye, mouth, or skin; itching; loose stools; nausea; stomach pain; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bleeding disorder; blood in the urine; fainting; indigestion; itching; metallic taste; mouth sores; peeling skin; persistent diarrhea; purple blotches or other unusual skin spots; rash; shortness of breath; sore throat; unusual bleeding or bruising; unusual weakness.

Ridaura Side Effects - for the Professional

Ridaura

The adverse reactions incidences listed below are based on observations of 1) 4,784 Ridaura treated patients in clinical trials (2,474 U.S., 2,310 foreign), of whom 2,729 were treated more than one year and 573 for more than three years; and 2) postmarketing experience. The highest incidence is during the first six months of treatment; however, reactions can occur after many months of therapy. With rare exceptions, all patients were on concomitant nonsteroidal anti-inflammatory therapy; some of them were also taking low dosages of corticosteroids.

Reactions occurring in more than 1% of Ridaura-treated patients

Gastrointestinal: loose stools or diarrhea (47%); abdominal pain (14%); nausea with or without vomiting (10%); constipation; anorexia*; flatulence*; dyspepsia*; dysgeusia.

Dermatological: rash (24%); pruritus (17%); hair loss; urticaria.

Mucous Membrane: stomatitis (13%); conjunctivitis*; glossitis.

Hematological: anemia; leukopenia; thrombocytopenia; eosinophilia.

Renal: proteinuria*; hematuria.

Hepatic: elevated liver enzymes.

*Reactions marked with an asterisk occurred in 3-9% of the patients. The other reactions listed occurred in 1-3%.

Reactions occurring in less than 1% of Ridaura-treated patients

Gastrointestinal: dysphagia; gastrointestinal bleeding†; melena†; positive stool for occult blood†; ulcerative enterocolitis.

Dermatological: angioedema.

Mucous Membrane: gingivitis†.

Hematological: aplastic anemia; neutropenia†; agranulocytosis; pure red cell aplasia; pancytopenia.

Hepatic: jaundice.

Respiratory: interstitial pneumonitis.

Neurological: peripheral neuropathy

Ocular: gold deposits in the lens or cornea unassociated clinically with eye disorders or visual impairment.

† Reactions marked with a dagger occurred in 0.1-1% of the patients. The other reactions listed occurred in less than 0.1%.

Reactions reported with injectable gold preparations, but not with Ridaura (auranofin) (based on clinical trials and on postmarketing experience)

Cutaneous Reactions: generalized exfoliative dermatitis.

Side Effects by Body System

Gastrointestinal

Gastrointestinal side effects are among the most common complaints in patients treated with auranofin. Diarrhea or loose stools may occur in 50% to 74% of patients. Abdominal pain (14%), nausea/vomiting (10%), anorexia (3% to 9%), flatulence (3% to 9%), dyspepsia (3% to 9%), stomatitis, constipation, and dysgeusia have also been reported. More serious gastrointestinal effects include gastrointestinal bleeding (0.1% to 1%), enterocolitis and toxic megacolon, as well as aphthous ulcerations of the gastric and intestinal mucosa.

In one study evaluating the incidence of diarrhea during auranofin therapy, diarrhea occurred in 74% of patients during the first month of treatment. The diarrhea was categorized as mild in 64% of cases, moderate in 28% of cases, and severe in 8% of cases. These symptoms may be reduced by the use of antidiarrheals or bulk-forming agents. Approximately 11% of patients required discontinuation of therapy.

Diarrhea is often dose-related as it increases in incidence with higher doses (for example, 9 mg per day). Initiating therapy at lower doses, or reducing the dose if diarrhea develops, may help to prevent or alleviate symptoms.

While diarrhea is generally mild and self-limiting, the possibility of more serious gastrointestinal pathology should be kept in mind. Enterocolitis and toxic megacolon have been reported. Diarrhea may be accompanied by nausea and/or vomiting, abdominal pain, and fever as well as bloody stools in cases of auranofin-induced enterocolitis.

Dermatologic

Dermatologic reactions are relatively common and include rash (24%) and pruritus (17%). Pityriasis rosea and discoid eczema as well as skin pigmentation, known as chrysiasis, have also been reported. While not associated with auranofin, per se, exfoliative dermatitis has been associated with parenteral gold therapy. Topical use of 0.1% to 0.6% products may produce contact dermatitis.

Pruritus and rash may be early warning signs of gold toxicity. Any eruption during auranofin therapy should be considered a drug-related side effect until proven otherwise. Serious dermatologic toxicity, including exfoliative dermatitis, has been associated with parenteral gold.

Skin pigmentation--known as chrysiasis--characterized by a gray or blue discoloration of sun-exposed skin, has been reported following the use of parenteral gold salts.

Ocular

Ocular side effects include gold deposits in the cornea and, occasionally, the lens. Vision is not usually affected. Conjunctivitis is also reported.

Gold deposits in either the lens or cornea are not usually associated with visual disturbances. Deposits typically disappear within months following discontinuation of gold therapy.

Hematologic

Decreases in hemoglobin as well as leukopenia, granulocytopenia, and thrombocytopenia may be warning signs of gold toxicity. Any rapid decline in platelet counts or a platelet count of less than 100,000/mm3 necessitates discontinuation of auranofin. Gold therapy should not be reinstituted unless the thrombocytopenia is shown to be unrelated to gold.

Auranofin-induced thrombocytopenia appears to be due to an immune-mediated peripheral destruction of platelets. Bone marrow aspirates in cases of auranofin thrombocytopenia revealed an increased number of megakaryocytes. In addition, platelet reactive antibodies were detectable only in the presence of gold. In one case report, increased uptake of platelets by the spleen with subsequent platelet destruction was demonstrated.

Hematologic abnormalities associated with auranofin include thrombocytopenia (>1%), eosinophilia (>1%), leukopenia (>1%), neutropenia (0.1% to 1%), agranulocytosis, aplastic anemia, pure red cell aplasia, and pancytopenia.

Renal

Proteinuria occurs in 3% to 9% of patients treated with auranofin. Clinically significant proteinuria and/or hematuria may require cessation of auranofin therapy. Renal toxicity is usually reversible if recognized early and auranofin is discontinued.

Renal side effects include hematuria, proteinuria, and nephropathy. Parenteral gold salts are associated with glomerulonephritis as well as nephrotic syndrome.

Hepatic

Hepatic side effects include elevations in liver function tests (>1%) and jaundice. These effects are usually reversible and may be more common in patients with preexisting liver disease. Cholestatic jaundice has been associated with the use of parenteral gold salts.

Cardiovascular

Vasomotor, or nitritoid, symptoms typically include faintness, palpitations, and flushing and occur most often following injection of gold sodium thiomalate. In the elderly, this may result in myocardial infarction or central nervous system injury.

A 37-year-old female with a history of a nitritoid reaction to gold sodium thiomalate, developed similar symptoms during oral therapy with auranofin. Onset of symptoms (i.e. nausea, palpitations, and presyncope) occurred after 18 months of auranofin (6 mg/day) therapy.

Several case reports suggest that concomitant therapy with angiotensin converting enzyme inhibitors may increase the risk of nitritoid reactions in some patients.

Cardiovascular side effects are limited to a case report of a vasomotor or nitritoid reaction. While not usually seen with auranofin or aurothioglucose therapy, this reaction is not uncommon in patients treated with gold sodium thiomalate.

Respiratory

Respiratory side effects are uncommon although rare cases of bronchiolitis and interstitial pneumonitis have been reported.

Irreversible bronchiolitis developed in a 44-year-old female with seropositive rheumatoid arthritis treated with auranofin (6 mg/day) for five months. A lung biopsy revealed a dense, cellular infiltrate around the bronchioles, with mucous plugging and macrophage infiltration of the bronchiole lumens. The extent to which auranofin versus rheumatoid arthritis contributed to the pathology is uncertain.

Nervous system

Nervous system side effects are rare. Peripheral neuropathy after long-term use has been reported. Serious nervous system toxicity, including Guillain Barre-type syndrome and acute disseminated encephalomyelitis, has been associated with parenteral gold salts.

Endocrine

Endocrine side effects are limited to a single case report of gynecomastia.

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