Sincalide is temporarily unavailable--again.

Bracco Diagnostics, Inc. announced in June that Kinevac (sincalide) production had been halted and that the product will not be available for at least 2 months. Kinevac is the only intravenous cholecystogogue drug approved by the U.S. Food and Drug Administration (FDA) to stimulate gallbladder contraction. It is thus useful for calculation of gallbladder ejection fraction (GBEF) to diagnose chronic acalculous gallbladder disease. Sincalide was last unavailable in 2002 (1) and remained unavailable for about 6 months. During Kinevac shortages pharmacy-compounded sincalide preparations have been employed as an alternative. Compounding pharmacies are regulated by states, and their regulation is based on the practice of pharmacy. These compounded drugs are not FDA approved. Some states or hospitals may no longer support this alternative method of obtaining drugs because of recent deaths reported from fungal sepsis after intrathecal administration of methylprednisolone preparations obtained from a state-regulated compounding pharmacy in Massachusetts (2). Quality control is a potential issue. In hospital settings, caution should be employed when considering the use of compounded sincalide preparations obtained from outside compounding pharmacies (3). Given these new concerns, the following options may be more appropriate. Fatty meals can serve as an alternative method to stimulate gallbladder contraction. Although " physiologic, " their effectiveness and accurate quantification are dependent on normal gastric emptying. Fatty meals stimulate endogenous cholecystokinin in the proximal small bowel. A delay in gastric emptying will result in a delay in gallbladder emptying and inaccurate quantification of GBEF during the 60-minute study. In patients who have been fasting for more than 24 hours, fatty meals do not solve the problem of emptying the gallbladder to expel the viscous bile that might prevent HIDA radiotracer entry. However, fatty meals can be used as an alternative approach, particularly in patients referred for evaluation of possible chronic acalculous gallbladder disease and for calculating GBEF. Most fatty meals (e.g., French fries) have not been standardized and do not have validated normal values. A few publications have investigated orally administered foods with standardized protocols and established normal values. These include whole milk (250 cc), Ensure Plus (8 oz), and corn oil emulsion (30 mL) (4–6). The lower ranges of normal for GBEF at 60 minutes for the 3 different methods were reported to be 44 %, 33%, and 20%, respectively. It is hoped that Kinevac will again be available in the near future.