Clinical Question: Topamax and Seroquel in a Woman with Bipolar Disorder Planning toBreastfeed
Published: December 1, 2009A clinician asks: “I am a psychiatrist treating a patient with Bipolar Disorder on Seroquel andTopamax. I would like to know what information is available regarding the safety of thesemedications to the infant if used during breastfeeding.”With regard to topiramate (Topamax), there is relatively little information on breastfeeding.Onecase seriesincluded five women with epilepsy treated with topiramate during pregnancy andlactation. Breastfed infants had very low topiramate concentrations, and no adverse effects wereobserved in the infants.The literature includes a handful of case reports assessing the use of quetiapine (Seroquel) in breastfeeding women.The largest seriesincluded six women treated with multiple medications,including quetiapine. Levels of quetiapine were typically low in the breast milk and infantserum. Four of the six infants showed normal development; two of the children had milddevelopmental delays. It is not clear if these delays were a result of exposure; however, it isreassuring to note that in the two children showing mild delays, estimated levels of quetiapineexposure through breast milk were not higher than in the children with no delays. Based on thelimited number of case reported in the literature (a total of 8 mother-infant pairs), there appearsto 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, anddecisions regarding the use of these drugs in breastfeeding women involve a carefulconsideration of the risks and benefits. For women with bipolar disorder, breastfeeding raisesconcerns for another reason. The sleep deprivation associated with exclusively breastfeeding anew infant may be destabilizing for those with bipolar disorder and may precipitate a relapseduring this vulnerable time.Ruta Nonacs, MD PhD
Published: August 10, 2009Many patients ask questions about generic medications, wondering how they differ and if they’reas safe and as effective as the more expensive brand name versions. To better understand thisconcept, 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 anddeveloped this medication, which received Food and Drug Administration (FDA) approval in1987. Eli Lilly was allowed to be the sole manufacturer until the patent for Prozac expired in2001, at which point other drug manufacturers were able to apply to the FDA to be able to sellgeneric versions of this medication. Because the manufacturers of generic medications did nothave the initial start up costs of researching, developing, and marketing the medication, they areable to sell fluoxetine more cheaply. One example of a company which produces genericfluoxetine is Teva Pharmaceuticals Industries, which was granted FDA approval for fluoxetine inJanuary of 2002.Companies producing generic versions of medication, such as Teva, must demonstrate to theFDA that their product has the same active ingredient, in this case fluoxetine hydrochloride,dosage, efficacy, performance, and strength of Prozac. The fluoxetine hydrochloride productthey produce must also be cleared by the body in the same method and time frame as the brandname product; the risks and benefits also need to be the same.While the active ingredient is the same, generic medications may have different inactiveingredients. Generic fluoxetine will look different from brand-name Prozac because the FDAdoes not allow generic medications to look identical to brand-name versions. For example, the20mg pulvule (capsule) by Eli Lilly has an opaque green cap and off-white body, while genericfluoxetine 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 andwithout any noticeable change in effectiveness or side effects. Occasionally, patients notice adifference between a generic version and a brand name version or sometimes between genericmedications by different manufacturers. These may be due to differences in the inactiveingredients, fillers, or binders.All generic medications must meet the same manufacturing standards as brand-namemedications 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 firstline, when a generic version of the medication is available.Betty Wang, MDhttp://www.fda.gov/Drugs/EmergencyPreparedness/BioterrorismandDrugPreparedness/ucm134451.htm
Depression and Menopausal Symptoms Go Together
Published: August 17, 2009It is well established that women are at increased risk for developing depression compared tomen. It has been hypothesized that this vulnerability to depression may be hormonally mediated,and several longitudinal studies have documented an increased risk of depressive symptomsduring perimenopause or the menopausal transition. Based on the results of two prospectivecohort studies, approximately one-third of women will develop their first episode of depressionduring 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 themenopause transition, and depression have indicated thathot flushes and night sweats areassociated with depression in perimenopausal women.A recent large cross-sectional population- based surveyof midlife women has attempted to better understand the impact of depression onmenopausal symptoms.This study included a sample of women (ages 45-70), who were obtained randomly from twolarge health plans, one in Washington State and the other in Massachusetts. The majority of the2530 eligible women had previously taken hormone replacement therapy and had sincediscontinued it. Women who were taking SSRI or SNRI antidepressants were included. Of the2530 eligible women, 1358 women completed the telephone survey examining depressivesymptoms using the Patient Health Questionnaire (PHQ-8) and the Wiklund MenopauseSymptom Checklist. 580 of these women were taking hormone replacement therapy and wereexcluded 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 thewomen reported moderate to severe depressive symptoms. After adjusting for age and bodymass index, those women with moderate to severe depressive symptoms were almost twice aslikely to report recent vasomotor symptoms (hot flashes or night sweats) than the women with noor mild depressive symptoms.Women with severe depression were also more likely to report their vasomotor symptoms assevere, 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 experiencedmoderate 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 symptomsand the intensity of menopausal symptoms.
The authors concluded that depressive symptoms“amplified” or were associated with more severe vasomotor symptoms, but they also noted thatthis study could not rule out the possibility that more severe vasomotor symptoms were in factworsening 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 dosageswere not included in the results). Also because women who were on hormone therapy wereexcluded, it is not known what impact hormonal replacement therapy may have on depressivesymptoms. Longitudinal studies comparing depressed and non-depressed women as theytransition into menopause may help to further delineate the relationship between menopausalsymptoms and depression.