"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Because of a potential allergic reaction to secretin, patients should receive an intravenous test dose of 0.2 mcg (0.1 mL). If no allergic reaction is noted after one minute, the recommended dose for the specific indication (see DOSAGE AND ADMINISTRATION) may be injected slowly over 1 minute. A test dose is especially important in patients with a history of atopic allergy and/or asthma. Appropriate measures for the treatment of acute hypersensitivity reactions should be immediately available. No allergic reactions were observed after the test dose or full dose of SecreFlo™ (secretin) in over 981 patients.
Patients who have undergone vagotomy, or are receiving anticholinergic agents at the time of secretin stimulation testing, or who have inflammatory bowel disease may be hyporesponsive to secretin stimulation. This response does not indicate pancreatic disease. A greater than normal volume response to secretin stimulation, which may mask coexisting pancreatic disease, is occasionally encountered in patients with alcoholic or other liver disease.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been performed to evaluate the carcinogenic potential of secretin. Studies to evaluate its potential for impairment of fertility or its mutagenic potential have not been performed.
Teratogenic Effects, Pregnancy Category C: Animal reproduction studies have not been conducted with secretin. It is also not known whether secretin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Secretin should be given to a pregnant woman only if clearly needed.
It is not known whether secretin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when secretin is administered to a nursing woman.
Safety and effectiveness in pediatric patients have not been established.
Among the 981 patients who have received SecreFlo™ (secretin) in clinical trials 16% were 65 years of age or older and 11% were 75 years of age or older. Dosing was identical to the overall population of patients. No overall differences in safety, pharmacological response, or diagnostic effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and the younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Last reviewed on RxList: 11/21/2008
This monograph has been modified to include the generic and brand name in many instances.
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