Proceptin Warnings

In long term [2 years] studies in rats, omeprazole produced a dose-related increase in gastric carcinoid tumours. While available endoscopic evaluations and histologic examinations of biopsy specimens from human stomach have not detected a risk from short-term exposure to omeprazole, further human data on the effects of sustained hypochlorhydria and hypergastinemia are needed to rule out the possibility of an increased risk for the development of tumours in humans receiving long term therapy with Omeprazole.
Clostridium difficile-associated diarrhea: Published observational studies suggest that proton pump inhibitor [PPI] therapy like Proceptin may be associated with an increased risk of Clostridium difficile-associated diarrhea [CDAD], especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve (see Adverse Reactions). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
Bone Fracture: Several published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy [a year or longer]. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines (see Dosage & Administration and Adverse Reactions).
Hypomagnesaemia: Hypomagnesaemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesaemia required magnesium replacement and discontinuation of the PPI.
For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesaemia [e.g., diuretics], health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.
Concomitant use of Proceptin with Methotrexate: Literature suggests that concomitant use of PPIs with methotrexate [primarily at high dose] may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration a temporary withdrawal of PPI may be considered in some patients (see Interactions).