FDA label 641599e9-1db0-4ffa-a651-b37a13dd9077

Physicians planning to use Gold Sodium Thiomalate should thoroughly familiarize themselves with its toxicity and its benefits. The possibility of toxic reactions should always be explained to the patient before starting therapy. Patients should be warned to report promptly any symptoms suggesting toxicity. Before each injection of Gold Sodium Thiomalate , the physician should review the results of laboratory work, and see the patient to determine the presence or absence of adverse reactions since some of these can be severe or even fatal.

WARNINGS Before treatment is started, the patient's hemoglobin, erythrocyte, white blood cell, differential and platelet counts should be determined, and urinalysis should be done to serve as basic reference. Urine should be analyzed for protein and sediment changes prior to each injection. Complete blood counts including platelet estimation should be made before every second injection throughout treatment. The occurrence of purpura or ecchymoses at any time always requires a platelet count. Danger signals of possible gold toxicity include: rapid reduction of hemoglobin, leukopenia below 4000 WBC/mm 3 , eosinophilia above 5 percent, platelet decrease below 100,000/mm 3 , albuminuria, hematuria, pruritus, skin eruption, stomatitis, or persistent diarrhea. No additional injections of Gold Sodium Thiomalate should be given unless further studies show these abnormalities to be caused by conditions other than gold toxicity.

ADVERSE REACTIONS A variety of adverse reactions may develop during the initial phase (weekly injections) of therapy or during maintenance treatment. Adverse reactions are observed most frequently when the cumulative dose of Gold Sodium Thiomalate administered is between 400 and 800 mg. Very uncommonly, complications occur days to months after cessation of treatment. Cutaneous reactions: Dermatitis is the most common reaction. Any eruption, especially if pruritic, that develops during treatment with Gold Sodium Thiomalate should be considered a reaction to gold until proven otherwise. Pruritus often exists before dermatitis becomes apparent, and therefore should be considered a warning signal of impending cutaneous reaction. The most serious form of cutaneous reaction is generalized exfoliative dermatitis which may lead to alopecia and shedding of nails. Gold dermatitis may be aggravated by exposure to sun light or an actinic rash may develop. Mucous membrane reactions: Stomatitis is the second most common adverse reaction. Shallow ulcers on the buccal membranes, on the borders of the tongue, and on the palate or in the pharynx may occur as the only adverse reaction, or along with dermatitis. Sometimes diffuse glossitis or gingivitis develops. A metallic taste may precede these oral mucous membrane reactions and should be considered a warning signal. Conjunctivitis is a rare reaction. Renal reactions: Gold may be toxic to the kidney and produce a nephrotic syndrome or glomerulitis with hematuria. These renal reactions are usually relatively mild and subside completely if recognized early and treatment is discontinued. They may be come severe and chronic if treatment is continued after onset of the reaction. Therefore, it is important to perform a urinalysis before every injection , and to discontinue treatment promptly if proteinuria or hematuria develops. Hematologic reactions: Blood dyscrasia due to gold toxicity is rare, but because of the potential serious consequences it must be constantly watched for and recognized early by frequent blood examinations done throughout treatment. Granulocytopenia; thrombocytopenia, with or without purpura; hypoplastic and aplastic anemia; and eosinophilia have all been reported. These hematologic disorders may occur separately or in combinations. Nitritoid and allergic reactions: Reactions of the “nitritoid type” which may resemble anaphylactoid effects have been reported. Flushing, fainting, dizziness and sweating are most frequently reported. Other symptoms that may occur include: nausea, vomiting, malaise, headache, and weakness. More severe, but less common effects include: anaphylactic shock, syncope, bradycardia, thickening of the tongue, difficulty in swallowing and breathing, and angioneurotic edema. These effects may occur almost immediately after injection or as late as 10 minutes of following injection. They may occur at any time during the course of therapy and if observed, treatment with Gold Sodium Thiomalate should be discontinued. Miscellaneous reactions: Gastrointestinal reactions have been reported, including nausea, vomiting, anorexia, abdominal cramps and diarrhea. Ulcerative enterocolitis, which can be severe or even fatal, has been reported rarely. There have been rare reports of reactions involving the eye such as iritis, corneal ulcers, and gold deposits in ocular tissues. Peripheral and central nervous system complications have been reported rarely. Peripheral neuropathy, with or without, fasciculations, sensorimotor effects (including Guillain-Barré syndrome) and elevated spinal fluid protein have been reported. Central nervous system complications have included confusion, hallucinations and seizures. Usually these signs and symptoms cleared upon discontinuation of gold therapy. Hepatitis, jaundice, with or without cholestasis, gold bronchitis, pulmonary injury manifested by interstitial pneumonitis and fibrosis, partial or complete hair loss and fever have also been reported. Sometimes arthralgia occurs for a day or two after an injection of Gold Sodium Thiomalate; this reaction usually subsides after the first few injections.