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asks: “I am a psychiatrist treating a patient with Bipolar Disorder on Seroquel and Topamax. I would like to know what information is available regarding the safety of these medications to the infant if used during breastfeeding.” With regard to topiramate (Topamax), there is relatively little information on breastfeeding. One case series included five women with epilepsy treated with topiramate during pregnancy and lactation. Breastfed infants had very low topiramate concentrations, and no adverse effects were observed in the infants. The literature includes a handful of case reports assessing the use of quetiapine (Seroquel) in breastfeeding women. The largest series included six women treated with multiple medications, including quetiapine. Levels of quetiapine were typically low in the breast milk and infant serum. Four of the six infants showed normal development; two of the children had mild developmental delays. It is not clear if these delays were a result of exposure; however, it is reassuring to note that in the two children showing mild delays, estimated levels of quetiapine exposure through breast milk were not higher than in the children with no delays. Based on the limited number of case reported in the literature (a total of 8 mother-infant pairs), there appears to be low levels of infant exposure to quetiapine through the breast milk, and no clear association between adverse outcome and exposure has been observed. Clearly more research is required to assess the safety of these drugs in nursing infants, and decisions regarding the use of these drugs in breastfeeding women involve a careful consideration of the risks and benefits. For women with bipolar disorder, breastfeeding raises concerns for another reason. The sleep deprivation associated with exclusively breastfeeding a new infant may be destabilizing for those with bipolar disorder and may precipitate a relapse during this vulnerable time. Ruta Nonacs, MD PhD
Published: August 10, 2009 Many patients ask questions about generic medications, wondering how they differ and if they’re as safe and as effective as the more expensive brand name versions. To better understand this concept, we’ll discuss an example. Many patients have heard of the medication, Prozac, a selective serotonin reuptake inhibitor antidepressant, generically known as fluoxetine. The company, Eli Lilly & Co., researched and developed this medication, which received Food and Drug Administration (FDA) approval in 1987. Eli Lilly was allowed to be the sole manufacturer until the patent for Prozac expired in 2001, at which point other drug manufacturers were able to apply to the FDA to be able to sell generic versions of this medication. Because the manufacturers of generic medications did not have the initial start up costs of researching, developing, and marketing the medication, they are able to sell fluoxetine more cheaply. One example of a company which produces generic fluoxetine is Teva Pharmaceuticals Industries, which was granted FDA approval for fluoxetine in January of 2002. Companies producing generic versions of medication, such as Teva, must demonstrate to the FDA that their product has the same active ingredient, in this case fluoxetine hydrochloride, dosage, efficacy, performance, and strength of Prozac. The fluoxetine hydrochloride product they produce must also be cleared by the body in the same method and time frame as the brand name product; the risks and benefits also need to be the same. While the active ingredient is the same, generic medications may have different inactive ingredients. Generic fluoxetine will look different from brand-name Prozac because the FDA does not allow generic medications to look identical to brand-name versions. For example, the 20mg pulvule (capsule) by Eli Lilly has an opaque green cap and off-white body, while generic fluoxetine capsules comes in various colors including blue, green and white, green and purple, and blue and turquoise, for example. The vast majority of patients will be able to take generic medications without difficulty and without any noticeable change in effectiveness or side effects. Occasionally, patients notice a difference between a generic version and a brand name version or sometimes between generic medications by different manufacturers. These may be due to differences in the inactive ingredients, fillers, or binders. All generic medications must meet the same manufacturing standards as brand-name medications and the FDA makes thousands of inspections per year to manufacturing companies producing brand-name and/ or generic medications to ensure that guide lines are being met. Generic medications are a safe and cost effective treatment option and should be considered first line, when a generic version of the medication is available. Betty Wang, MD http://www.fda.gov/Drugs/EmergencyPreparedness/BioterrorismandDrugPreparedness/ucm1344 51.htm Depression and Menopausal Symptoms Go Together
Published: August 17, 2009 It is well established that women are at increased risk for developing depression compared to men. It has been hypothesized that this vulnerability to depression may be hormonally mediated, and several longitudinal studies have documented an increased risk of depressive symptoms during perimenopause or the menopausal transition. Based on the results of two prospective cohort studies, approximately one-third of women will develop their first episode of depression during the menopausal transition. (Cohen LS et al 2006, Freeman EW et al 2006). Studies investigating the relationship between hot flashes, a hallmark vasomotor symptom of the menopause transition, and depression have indicated that hot flushes and night sweats are associated with depression in perimenopausal women. A recent large cross-sectional populationbased survey of midlife women has attempted to better understand the impact of depression on menopausal symptoms. This study included a sample of women (ages 45-70), who were obtained randomly from two large health plans, one in Washington State and the other in Massachusetts. The majority of the 2530 eligible women had previously taken hormone replacement therapy and had since discontinued it. Women who were taking SSRI or SNRI antidepressants were included. Of the 2530 eligible women, 1358 women completed the telephone survey examining depressive symptoms using the Patient Health Questionnaire (PHQ-8) and the Wiklund Menopause Symptom Checklist. 580 of these women were taking hormone replacement therapy and were excluded from the analysis, as were another 8 women with unknown menopausal status. A total of 770 women were included in the analysis, and it was observed that 98 (12.7%) of the women reported moderate to severe depressive symptoms. After adjusting for age and body mass index, those women with moderate to severe depressive symptoms were almost twice as likely to report recent vasomotor symptoms (hot flashes or night sweats) than the women with no or mild depressive symptoms. Women with severe depression were also more likely to report their vasomotor symptoms as severe, despite the fact that 20% of those women were also taking either an SSRI or SNRI, agents which have been shown to improve vasomotor symptoms. The women who experienced moderate to severe depression were also more likely to experience feeling anxious at least 50% of the time. This study is the first to demonstrate a correlation between the severity of depressive symptoms and the intensity of menopausal symptoms. The authors concluded that depressive symptoms “amplified” or were associated with more severe vasomotor symptoms, but they also noted that this study could not rule out the possibility that more severe vasomotor symptoms were in fact worsening the depressive symptoms. This study has a few limitations including the fact that all the information was based on self report and some women were taking SSRI or SNRI antidepressants. (The brands and dosages were not included in the results). Also because women who were on hormone therapy were excluded, it is not known what impact hormonal replacement therapy may have on depressive symptoms. Longitudinal studies comparing depressed and non-depressed women as they transition into menopause may help to further delineate the relationship between menopausal symptoms and depression.
While some questions remain, these findings underscore the importance of screening for depressive symptoms in perimenopausal women. Depression is a relatively common problem in this population, particularly in those with more severe vasomotor symptoms. The authors point out that recognition and treatment of depression in women during the menopause transition may reduce the burden of menopausal or vasomotor symptoms. April Hirschberg, MD Cohen LS, Soares CN, Vitonis AF et al. Risk for new onset of depression during the menopausal transition: the Harvard study of moods and cycles. Arch Gen Psychiatry 2006; 63: 385-90. Freeman EW, Sammel MD, Lin H et al. Associations of hormones and menopausal status with depressed mood in women with no history of depression. Arch Gen Psychiatry 2006; 63:375-82. Reed SR, Ludman EJ, Newton KM et al. Depressive symptoms and menopausal burden in the midlife. Maturitas 2009; 62: 306-310.