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Octreotide Pregnancy and Breastfeeding Warnings

Octreotide is also known as: Sandostatin, Sandostatin LAR Depot

Octreotide Pregnancy Warnings

Octreotide has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of fetotoxicity or teratogenicity. There are no controlled data from human pregnancy. Octreotide should only be given during pregnancy when benefit outweighs risk.

Although acromegaly may lead to infertility, there are reports of pregnancy in acromegalic women. In women with active acromegaly who have been unable to become pregnant, normalization of growth hormone (GH) and insulin-like growth factor (IGF-1) may restore fertility. Female patients of childbearing potential should be advised to use adequate contraception during treatment with octreotide. There are no reports of adverse effects or teratogenicity associated with octreotide during human pregnancy. Preliminary data (based on six case reports) suggest that octreotide during could be safe and effective. Below are some details on four of those case reports. A 37-year-old woman with acromegaly and infertility became pregnant within 60 to 84 hours after the first injection of octreotide, which had been given in preparation for surgical excision of a pituitary adenoma. The pregnancy was discovered coincidentally during a routine preoperative ultrasound examination for suspected octreotide-induced gallstones. Once pregnancy was diagnosed, octreotide was discontinued. The pregnancy was only complicated by imminent foetal asphyxia at term, prompting Cesarean section delivery. The newborn, weighing 2,530 grams and measuring 46.0 cm in length, had no malformations and developed normally. A 36-year-old woman with acromegaly and amenorrhea secondary to pituitary macroadenoma became pregnant 14 months after starting octreotide therapy and 9 months after starting bromocriptine therapy. Once the pregnancy was diagnosed, all medications were discontinued. The pregnancy was complicated by impaired glucose tolerance and, near gestation week 40, signs of acute maternal intracranial hypertension and foetal distress. A newborn, weighing 3,540 grams and measuring 50 cm in length, was born by emergency Cesarean section. The infant required mechanical ventilation for three days, but showed no malformations, and developed normally. A 31-year-old woman with infertility secondary to pituitary macroadenoma became pregnant 4 months after starting octreotide therapy. One month after the pregnancy was diagnosed, octreotide therapy was discontinued. After withdrawal of octreotide therapy, serum TSH levels and thyroid hormone levels returned to elevated pretreatment values. At six months of pregnancy, a large pituitary macroadenoma with marked suprasellar extension was shown on MRI. Octreotide was restarted during the seventh month of pregnancy and was continued until time of delivery by Cesarean section. The newborn, weighing 3300 grams and measuring 51 cm in length, had no malformations and developed normally. Additionally, a successful pregnancy in a 36-year-old woman treated with octreotide during the second and third trimesters has also been reported.

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Octreotide Breastfeeding Warnings

There are no data on the excretion of octreotide into human milk.

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References for pregnancy information

  1. Montini M, Pagani G, Gianola D, Pagani MD, Piolini R, Camboni MG "Acromegaly and primary amenorrhea: ovulation and pregnancy induced by SMS 201-995 and bromocriptine." J Endocrinol Invest 13 (1990): 193
  2. Landolt AM, Schmid J, Wimpfheimer C, Karlsson ER, Boerlin V "Successful pregnancy in a previously infertile woman treated with SMS- 201-995 for acromegaly." N Engl J Med 320 (1989): 671-2
  3. Caron P, Gerbeau C, Pradayrol L, Simonetta C, Bayard F "Successful pregnancy in an infertile woman with a thyrotropin-secreting macroadenoma treated with somatostatin analog (octreotide)." J Clin Endocrinol Metab 81 (1996): 1164-8
  4. Mikhail N "Octreotide treatment of acromegaly during pregnancy." Mayo Clin Proc 77 (2002): 297-8
  5. "Product Information. Sandostatin (octreotide)." Sandoz Pharmaceuticals Corporation, East Hanover, NJ.

References for breastfeeding information

  1. "Product Information. Sandostatin (octreotide)." Sandoz Pharmaceuticals Corporation, East Hanover, NJ.

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