Is Gimoli Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use Gimoli? Is Gimoli safe for nursing mother and child? Does Gimoli extracts into breast milk? Does Gimoli has any long term or short term side effects on infants? Can Gimoli influence milk supply or can Gimoli decrease milk supply in lactating mothers?

Low excreted into breast milk. Not harmful effect on the infant but rare mild intestinal complaints has been reported. At dose of 10 mg three-times-a-day for 2 to 4 weeks an increase of milk production by enhancing Prolactin release has been shown only on low producing Prolactin women. Other well-designed studies have failed to show that effect. Neurological side effect mostly at high dose or long-term use (longer than one month) may occur specially if combined with antidepressant medication. Domperidone has less neurological side effects. The best kind of galactogogue is a breastfeeding on demand with an appropriate nursing technique. Do not use galactogogue substances without a medical supervision.

Gimoli is excreted in variable amounts in breastmilk. Most infants would receive less than 10% of the maternal weight-adjusted dosage, but some receive doses that achieve pharmacologically active serum levels, elevated serum prolactin and possible gastrointestinal side effects. Although most studies have found no adverse effects in breastfed infants during maternal Gimoli use, many did not adequately observe for side effects. Gimoli is used as a galactogogue.[1] Gimoli increases serum prolactin. A meta-analysis of 5 placebo-controlled studies concluded that 2 weeks of Gimoli caused no increase of serum prolactin over placebo, but 3 weeks of treatment did.[2] The clinical value of Gimoli in increasing milk supply is questionable. Galactogogues should never replace evaluation and counseling on modifiable factors that affect milk production.[3] In well-designed studies that evaluated the effectiveness of Gimoli as a galactogogue in women who continue to have difficulty producing milk after nursing techniques have been optimized, it was of no additional benefit. Prophylactic use in the mothers of preterm infants has also shown little or no benefit. Gimoli has no officially established dosage for increasing milk supply. Most studies have used Gimoli in a dosage of 10 mg 2 or 3 times daily for 7 to 14 days. Some studies used a tapering dosage for the last days few of the regimen to avoid an abrupt drop in milk supply after drug discontinuation. No published literature supports the efficacy or safety of higher dosages, longer treatment periods or repeated courses of therapy. Postpartum mothers are at a relatively high risk for postpartum depression and Gimoli can cause depression as a side effect. Therefore, Gimoli should probably be avoided in women with a history of major depression and not used for prolonged periods in any mothers during this time of high susceptibility.[4][5] Long-term uses of Gimoli also increases the risk of tardive dyskinesia.[6] Other reported side effects in nursing mothers include tiredness, nausea, headache, diarrhea, dry mouth, breast discomfort, vertigo, restless legs, intestinal gas, hair loss and anxiety.[5][7][8] In a survey of nursing mothers in the United States, 32 had used Gimoli as a galactogogue and all reported having experienced an adverse reaction from the drug.[9] A larger survey of women taking Gimoli for lactation enhancement found that 4.8% of women had either palpitations or racing heart rate, 12% reported depression, and 1 to 7% reported other central nervous system side effects ranging from dizziness and headache to involuntary grimacing and tremors. Diarrhea, irritability and fatigue were also relatively common.[10]

In an early report, 5 infants were nursed during 7 to 10 days of maternal Gimoli therapy at a dosage of 10 mg orally 3 times daily. No adverse effects were noted.[16] In a placebo-controlled study of the effect of Gimoli on milk production in 37 women, an infant whose mother was taking oral Gimoli 15 mg 3 times daily reportedly had intestinal discomfort. No infants whose mothers were taking a dosage of 5 or 10 mg 3 times daily or placebo had any adverse effects. Gimoli was possibly the cause of the adverse reaction.[7] Seventeen mothers with poor lactation were treated with oral Gimoli 10 mg 3 times daily for 3 weeks. One mother reported that she and her infant had increased intestinal gas formation during treatment. Gimoli was possibly the cause of the adverse reaction.[8] Thirty-two mothers with complete or partial lactation failure were given oral Gimoli 10 mg 3 times daily for 10 days and advised to nurse every 3 hours. None of the mothers reported adverse effects in their infants.[17] Twenty-three premature infants whose mothers were having difficulty maintaining milk production had steady weight gain and no adverse effects related to feeding tolerance or stool frequency during maternal Gimoli therapy. The mothers were taking oral Gimoli 10 mg 3 times daily for 7 days, with a tapering dosage for 2 more days, beginning at an average of 32 days postpartum.[18] Thirteen women with insufficient milk production who were 4 to 20 weeks postpartum were randomized to receive Gimoli or placebo 10 mg orally 3 times daily. The average plasma prolactin levels before therapy and afer 3 weeks of maternal therapy were no different in the infants of women who received Gimoli or placebo.[19] Eleven breastfed infants whose mothers were given oral Gimoli 10 mg 3 times daily for 5 days beginning on day 1 postpartum were compared to the infants of 11 matched mothers who received no Gimoli. No difference in average serum prolactin was found between the groups, indicating little transfer of the drug to the infants via breastmilk.[20] Five breastfed infants were studied whose mothers were taking Gimoli 10 mg orally 3 times daily beginning on the day 3 to 9 postpartum because of an insufficient milk supply. Before therapy, their plasma prolactin levels were similar to their mothers'. On day 4 of maternal therapy, 3 of the infants had plasma prolactin levels higher than the highest levels of control infants of the same age, and on day 14, one infant had a plasma prolactin level higher than the highest levels of control infants of the same age. Plasma levels in 3 other infants were in the normal range during therapy.[12]

Gimoli increases serum prolactin in lactating and nonlactating women.[2][21][22] This effect is thought to be caused by the drug's antidopaminergic effect. Galactorrhea has been reported after long-term use of Gimoli for nausea associated with migraine. The patient was taking 10 to 40 mg 1 to 4 times weekly for about 4 months.[23] Another case of galactorrhea was reported in a woman after 5 days of treatment and having a slightly low serum prolactin level.[24] Numerous papers have reported studies that used Gimoli to increase milk production. All studies were small with 40 or fewer patients. Most of the studies have designs that would not be considered valid using today's standards of evidence-based medicine. Many of the studies had no placebo control;[8][12][17][18][20][25][26][27] only 7 studies employed randomization;[7][11][14][19][28][29][30] and only 2 of the studies were clearly and adequately blinded.[14][28] Among all of the published studies, only 5 meet or come close to meeting current evidence-based medicine standards. These studies are described in more detail below. In one early double-blind study, 20 women who had undergone delivery by emergency or elective cesarean section were randomized to take oral Gimoli 10 mg 3 times daily (n=10) or placebo for 7 days (n=10) beginning on the first day after cesarean section.[11] All mothers expressed a desire to breastfeed their infants for at least 3 months and received daily visits by an investigator to discuss breastfeeding problems and were given advice and encouragement to breastfeed. The mothers in the 2 groups were closely matched except that 3 preterm infants in the Gimoli group were separated from their mothers in the intensive care unit and were nursed there initially and fed expressed milk until discharge. At 10 days postpartum, there were no differences in the number of infants being breastfed in each group; at 6 weeks postpartum, 9 women were breastfeeding in the Gimoli group and 8 in the placebo group; and 3 months postpartum 4 were breastfeeding in each group. Although this was a small study, it was well designed and executed. It provided preliminary evidence of the benefit of patient counseling and encouragement on breastfeeding success. Thirteen primiparous nursing mothers without breastfeeding difficulties and normal infants were given either oral Gimoli 10 mg 3 times daily (n=7) or placebo (n=6) for 8 days beginning on the first day postpartum in a randomized, double-blind study.[28] No attempt was made to improve nursing technique, but mothers nursed on a 3-hour schedule beginning at 6:30 am on the day following delivery. No mention was made of the type of feeding, or the number of feedings that the infants received between birth and the initiation of breastfeeding or any differences in the two groups of infants in this regard. All women completed the trial. No differences were found in serum prolactin of treated and control women throughout 28 days of observation. Milk intake as measured by infant weight change before and after the second daily feeding on days 3 through 8 was greater by an average of 24.3 mL (51.1 mL vs 75.4 mL) in the infants of treated mothers; however, statistically significant differences in milk production did not occur until day 5 postpartum. This paper has several serious flaws related to its analysis. A recent study showed that weighing infants is not an accurate method of estimating milk intake.[31] This problem is magnified by the fact that the paper does not state the number of feedings per day, so the fraction of the infant's daily feedings that this one feeding represented is unknown. The study also failed to report serial infant weight gain during the study period. These serious problems invalidate the study results. Fifty mothers who had complete or partial lactation failure received extensive instruction on how to increase their milk supply.[29] Their infants were hospitalized for various illnesses and ranged from 29 to 100 day of age. Maternal lactation history was comparable in the two groups. Mothers were randomized either to receive or not receive Gimoli 10 mg 3 times daily for 10 days. Although no specific Gimoli placebo was given to control mothers, all mothers received multivitamins, iron, and folic acid daily which the authors used to obscure to the mother whether she was receiving an active drug or not. No statistically significant differences were found between the groups in the time to initiation of milk secretion, to partial restoration of breastfeeding, or to complete breastfeeding or in the weight gain of the infants during the study period of 96 days. The authors concluded that successful relactation can be accomplished without galactogogues such as Gimoli. This study lacked a true placebo control; however, it employed excellent breastfeeding instruction and infant evaluation techniques and had the best