Acomplia Linked to Depression and Anxiety Risk
Acomplia (rimonabant, manufactured by Sanofi-Aventis) is an anti-obesity drug that was supposed to be a big hit in the U.S. However, earlier this year, U.S. FDA decided not to approve the drug here in the states because the drug was found to increase suicidal thoughts and depression. Acomplia is, however, approved and available in Europe. This week, medical journal The Lancet published a review of clinical trials involving Acomplia to look at the safety and efficacy of this drug.
According to the review analysis (a meta analysis) of 4 past clinical trials involving a total of over 4100 patients, Acomplia did reduce more weight after 1 year of treatment than placebo. However, patients taking Acomplia were more than twice as likely as patients taking placebo to stop treatment because of depression. More anxiety was also seen in the Acomplia treatment group than in placebo. Even though patients with a history or risk of depressive mood were excluded from clinical trials, the observation that depression and anxiety still arose when Acomplia was taken suggests that the drug increases the risk of depression of anxiety. The study researchers suggest that doctors should monitor patients taking Acomplia for these serious psychiatric side effects. Also reported by Reuters.
The Lancet 2007; 370:1706-1713
DOI:10.1016/S0140-6736(07)61721-8Efficacy and safety of the weight-loss drug rimonabant: a meta-analysis of randomised trials
Robin Christensen MSc a, Pernelle Kruse Kristensen BSc a b, Else Marie Bartels DSc c, Prof Henning Bliddal MD a and Prof Arne Astrup MD email address b Corresponding Author
Since the prevalence of obesity continues to increase, there is a demand for effective and safe anti-obesity agents that can produce and maintain weight loss and improve comorbidity. We did a meta-analysis of all published randomised controlled trials to assess the efficacy and safety of the newly approved anti-obesity agent rimonabant.
Methods
We searched The Cochrane database and Controlled Trials Register, Medline via Pubmed, Embase via WebSpirs, Web of Science, Scopus, and reference lists up to July, 2007. We collected data from four double-blind, randomised controlled trials (including 4105 participants) that compared 20 mg per day rimonabant with placebo.Findings
Patients given rimonabant had a 4·7 kg (95% CI 4·1–5·3 kg; p<0·0001) greater weight reduction after 1 year than did those given placebo. Rimonabant caused significantly more adverse events than did placebo (OR=1·4; p=0·0007; number needed to harm=25 individuals [95% CI 17–58]), and 1·4 times more serious adverse events (OR=1·4; p=0·03; number needed to harm=59 [27–830]). Patients given rimonabant were 2·5 times more likely to discontinue the treatment because of depressive mood disorders than were those given placebo (OR=2·5; p=0·01; number needed to harm=49 [19–316]). Furthermore, anxiety caused more patients to discontinue treatment in rimonabant groups than in placebo groups (OR=3·0; p=0·03; number needed to harm=166 [47–3716]).Interpretation
Our findings suggest that 20 mg per day rimonabant increases the risk of psychiatric adverse events—ie, depressed mood disorders and anxiety—despite depressed mood being an exclusion criterion in these trials. Taken together with the recent US Food and Drug Administration finding of increased risk of suicide during treatment with rimonabant, we recommend increased alertness by physicians to these potentially severe psychiatric adverse reactions.Affiliations
a. The Parker Institute, Musculoskeletal Statistics Unit, Frederiksberg Hospital, Frederiksberg, Denmark
b. The Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen, Copenhagen, Denmark
c. Copenhagen University Library, Copenhagen, Denmark
Antenatal Depression Important to Address
We are becoming more aware of postpartum depression - depression that occurs in women after childbirth. However, we know very little about depression that occurs prior to childbirth, at various stages of a woman’s pregnancy. Reuters reported on a study that looks at antenatal depression, and the importance of addressing this type of depression. I’ve included the original study abstract in this post as well, for those of you interested in the scientific citation.
According to the study authors, anxiety and depression can occur during pregnancy and can become associated with postpartum depression, which makes antenatal depression an important condition to treat and to track as a risk factor for postpartum depression. Women who drank and were young when pregnant have higher risks of anxiety and depression during pregnancy. Of course, it will be important for doctors to distinguish between “normal” anxiety and bouts of depression that pregnant women experience as a result of the physico-emotional effects of pregnancy itself from pathological anxiety and depression that warrants medical attention.
Obstetrics & Gynecology 2007;110:1102-1112
© 2007 by The American College of Obstetricians and GynecologistsPrevalence, Course, and Risk Factors for Antenatal Anxiety and Depression
Antoinette M. Lee, PhD1, Siu Keung Lam, MD3, Stephanie Marie Sze Mun Lau, BsocSc1, Catherine Shiu Yin Chong, MBBS4, Hang Wai Chui, MPH1 and Daniel Yee Tak Fong, PhD2From the Departments of 1Psychiatry and 2Nursing Studies, LKS Faculty of Medicine, the University of Hong Kong, Hong Kong; 3Department of Obstetrics and Gynaecology, Kwong Wah Hospital, Hong Kong; and 4Pamela Youde Nethersole Eastern Hospital, Hong Kong.
ABSTRACT
OBJECTIVE: To estimate the prevalence and course of antenatal anxiety and depression across different stages of pregnancy, risk factors at each stage, and the relationship between antenatal anxiety and depression and postpartum depression.
METHODS: A consecutive sample of 357 pregnant women in an antenatal clinic in a regional hospital was assessed longitudinally at four stages of pregnancy: first trimester, second trimester, third trimester, and 6 weeks postpartum. The antenatal questionnaire assessed anxiety and depression (using the Hospital Anxiety and Depression Scale) and demographic and psychosocial risk factors. The postpartum questionnaire assessed postpartum depression with the Edinburgh Postnatal Depression Scale.
RESULTS: More than one half (54%) and more than one third (37.1%) of the women had antenatal anxiety and depressive symptoms, respectively, in at least one antenatal assessment. Anxiety was more prevalent than depression at all stages. A mixed-effects model showed that both conditions had a nonlinear changing course (P< .05 for both), with both being more prevalent and severe in the first and third trimesters. Risk factors were slightly different at different stages. Both antenatal anxiety (adjusted odds ratio [OR] 2.66, P=.004 in the first trimester; adjusted OR 3.65, P<.001 in the second trimester; adjusted OR 3.84, P<.001 in the third trimester) and depression (adjusted OR 4.16, P<.001 in the first trimester; adjusted OR 3.35, P=.001 in the second trimester; adjusted OR 2.67, P=.009 in the third trimester) increased the risk of postpartum depression.
CONCLUSION Antenatal anxiety and depression are prevalent and serious problems with changing courses. Continuous assessment over the course of pregnancy is warranted. Identifying and treating these problems is important in preventing postpartum depression.
Religion and Bipolar Disorder
This past week’s Post Secret had a postcard that said, “My pastor always talks about how if people would find God they wouldn’t need pills. I’m bipolar but took his advice. My pastor is an idiot!!”
An email follow-up to the postcard said, “Sometimes, God answers by giving us the tools to take care of ourselves.” This also generated a flurry of comments about the postcard on the forum.
Amen.
(P.S. For the sake of objectivity, the pastor may be talking about using recreational drugs as an escape from God or from the self, and not necessarily medical conditions requiring medical intervention like bipolar disorder. However, this postcard shows how important it is to include disclaimers and exceptions when you are preaching to a group of people.)