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WARNINGS The ingestion of Gastromark may cause abdominal pain, diarrhea, nausea and vomiting. In 78/256 (30%) of patients and normal volunteers, gastrointestinal adverse events occurred within the first 2 hours after ingestion of Gastromark. In 30/256 (12%), gastrointestinal events had their onset within 30 minutes. In 63/256 (24%), diarrhea occurred within 24 hours. Vomiting can be associated with aspiration. Precautions should be taken to avoid aspiration. The effects of Gastromark on human peritoneal tissues are not known. In animal studies, intraperitoneal injection of Gastromark was associated with a foreign body reaction that persisted for at least 30 days.
ADVERSE REACTIONS Gastromark was evaluated in 256 patients and normal volunteers in clinical trials. Of these, 147 (57%) had at least one adverse event. Deaths did not occur during the study period of 7 days. In 15/256 (6%) patients, the ingestion of Gastromark was either interrupted or stopped because of vomiting or because they could not ingest any more fluid. One normal volunteer had prolonged abdominal cramping for 4 hours. One patient had post-operative ileus 2 days after ingesting Gastromark. There is a suggestion of differences in rates of adverse experiences in patients who have or do not have pancreatic or gastric masses. In patients with gastric or pancreatic masses, vomiting was reported in 4/35 (11%); in patients without gastric or pancreatic masses, vomiting was reported in 10/221 (5%) (p = 0.07). Abdominal pain was reported in 1/35 (3%) of patients with pancreatic or gastric masses and in 22/221 (10%) of patients without these lesions. The clinical relevance of these findings is not known. The following table of adverse events is based upon clinical trials with Gastromark in 256 subjects. ADVERSE EVENTS REPORTED IN ≥ 0.5% OF PATIENTS WHO RECEIVED GASTROMARK IN CONTROLLED TRIALS * Adverse Event Before Gastromark N = 241 After Gastromark N = 256 * The mean volume of Gastromark administered was 701 mL (122.7 mg of iron). ** Includes bloating and gas. Patients with Any Adverse Event 83 (34%) 147 (57%) Body as a Whole 0 (0%) 25 (10%) Headache 0 (0%) 3 (1%) Digestive System 80 (33%) 130 (51%) Abdominal Pain/Cramps 18 (8%) 23 (9%) Diarrhea 38 (16%) 67 (26%) Dyspepsia 14 (6%) 16 (6%) Flatulence ** 41 (17%) 55 (21%) Nausea 18 (8%) 43 (17%) Vomiting 5 (2%) 14 (6%) Nervous System 0 (0%) 44 (17%) Paresthesia, Oral 0 (0%) 44 (17%) Skin & Appendages 0 (0%) 3 (1%) Pruritus 0 (0%) 2 (0.8%) In the safety database of 256 people, the type of events was similar in people of each gender and in patients and healthy volunteers. The sample size was too small to determine whether there is any association of adverse events to body weight. However, for nausea and diarrhea, as shown in the following table, the rate of adverse events was much higher in women, both in patients and in volunteers. GENDER DIFFERENCES IN THE RATE OF NAUSEA AND DIARRHEA AFTER GASTROMARK REPORTED BY PATIENTS AND HEALTHY VOLUNTEERS IN CONTROLLED TRIALS Adverse Event Men Women Healthy Volunteers (N = 42) Patients (N = 99) Healthy Volunteers (N = 21) Patients (N = 94) Nausea 4 (10%) 9 (9%) 10 (48%) 20 (21%) Diarrhea 9 (21%) 23 (23%) 12 (57%) 23 (25%) Other events reported in less than 0.5% of 256 healthy volunteers and patients who received Gastromark are: chills, fever, post-operative ileus, eructation, itching, urticarial rash, pustular rash, stomatitis, taste alteration, and edema of extremities. One healthy volunteer had prolonged abdominal cramping for 4 hours.