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Vilhelmsson, 2011 What can we learn from consumer reports on psychiatric adverse drug reactions with antidepressant medication?


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http://www.ncbi.nlm.nih.gov/pubmed/22026961 Antidepressant withdrawal syndrome was often reported by consumers but not always mentioned in official drug literature, "and when it is mentioned it is generally regarded as rare."


"The consumer reports gave another perspective of experiences with antidepressants," containing more potentially serious psychiatric ADRs that are not always listed the physicians' desk reference, especially "a sensation of unreality, irritability, aggressiveness, suicidal thoughts, and depression."


BMC Clin Pharmacol. 2011 Oct 25;11:16.

What can we learn from consumer reports on psychiatric adverse drug reactions with antidepressant medication? Experiences from reports to a consumer association.


Vilhelmsson A, Svensson T, Meeuwisse A, Carlsten A.



Nordic School of Public Health, Gothenburg, Sweden. andreas.vilhelmsson@nhv.se


Abstract at http://www.ncbi.nlm.nih.gov/pubmed/22026961 Free full text at http://www.biomedcentral.com/1472-6904/11/16




According to the World Health Organization (WHO) the cost of adverse drug reactions (ADRs) in the general population is high and under-reporting by health professionals is a well-recognized problem. Another way to increase ADR reporting is to let the consumers themselves report directly to the authorities. In Sweden it is mandatory for prescribers to report serious ADRs to the Medical Products Agency (MPA), but there are no such regulations for consumers. The non-profit and independent organization Consumer Association for Medicines and Health, KILEN has launched the possibility for consumers to report their perceptions and experiences from their use of medicines in order to strengthen consumer rights within the health care sector. This study aimed to analyze these consumer reports.




All reports submitted from January 2002 to April 2009 to an open web site in Sweden where anyone could report their experience with the use of pharmaceuticals were analyzed with focus on common psychiatric side effects related to antidepressant usage. More than one ADR for a specific drug could be reported.




In total 665 reports were made during the period. 442 reports concerned antidepressant medications and the individual antidepressant reports represented 2392 ADRs and 878 (37%) of these were psychiatric ADRs. 75% of the individual reports concerned serotonin-reuptake inhibitor (SSRI) and the rest serotonin-norepinephrine reuptake inhibitor (SNRI). Women reported more antidepressant psychiatric ADRs (71%) compared to men (24%). More potentially serious psychiatric ADRs were frequently reported to KILEN and withdrawal symptoms during discontinuation were also reported as a common issue.




The present study indicates that consumer reports may contribute with important information regarding more serious psychiatric ADRs following antidepressant treatment. Consumer reporting may be considered a complement to traditional ADR reporting.



From the paper:


"....In Sweden drug-related problems may account for as much as 12% of hospital admissions [21] and the medical burden of fatal ADRs [Adverse Drug Reactions] is estimated to occur in 3% of all deaths [22]. Antidepressants drugs are commonly implicated in FADRs [23].



The most reported antidepressants to KILEN were: Sertraline (26%), Citalopram (24%), Venlafaxine (18%), Paroxetine (13%), Mirtazapine (8%) Fluoxetine (6%), and Escitalopram (5%). Sertraline and Citalopram were the most common antidepressants according to both reports (116 and 107), total ADRs (626 and 570) and psychiatric ADRs (226 and 226) (Table ​(Table2).2). Women were responsible for 323 of the submitted reports compared to men with 98 reports. 21 individuals did not report their gender and eight individuals did not submit their age. Of the psychiatric ADRs were women responsible for 622 (70.8%) and men 208 (23.7%), whilst 5.5% did not report their gender (Table ​(Table3).3).



The most frequently reported psychiatric ADRs to KILEN were anxiety, a sensation of unreality, insomnia, uneasiness/nervousness, irritability, aggressiveness, suicidal behavior, and depression (Table ​(Table2).2). The most common ADR was anxiety (4.2-7.9%). Insomnia was reported for all antidepressants to KILEN (2.3-6.1%). The ADR uneasiness/nervousness was reported for five antidepressants (2.3-2.8%). Experiencing a sensation of unreality was a common ADR in four analyzed antidepressants (2.8-6.2%). Depression was a reported psychiatric ADR in three antidepressants (2.1-3.5%). Irritability, aggressiveness was a reported psychiatric ADR for six antidepressants (2.1-3.5%). Suicidal behavior was a reported psychiatric ADR for all antidepressants in the KILEN material (1.9-3.2).


Vilhelmsson 2011 Table 4.png



The KILEN material showed reports of potentially serious psychiatric ADRs. Some psychiatric ADRs were more reported with certain antidepressants but anxiety, insomnia and suicidal behavior were reported for all drugs. But do these consumer reports differ according to information found in the Summary of Product Characteristics (SPC)? ....However, the consumer reports gave another perspective of experiences with antidepressants. The consumer reports to KILEN contained more potentially serious psychiatric ADRs that are not always listed in FASS, especially experiencing a sensation of unreality, irritability, aggressiveness, suicidal thoughts, and depression. Anxiety was the most reported psychiatric ADR to KILEN for all antidepressants but for some substances anxiety is not listed at all in one version of FASS, but listed as common in the other.


This result goes well in accordance with previous research that consumer/patient reporting does add value to professional reports of ADRs by identifying possible new reactions [13,14,29,30]. For instance was a sensation of unreality an important psychiatric ADR among the consumer reports to KILEN, but is not listed at all as an ADR in FASS. Withdrawal symptoms in connection with discontinuation of antidepressants medication was reported to KILEN but is not always mentioned in FASS, and when it is mentioned it is generally regarded as rare [27,28]. This is worth considering since a study by Tint and colleagues (2008) showed that withdrawal symptoms of antidepressants in depressed patients could be associated with worsening depression symptoms and increasing suicidal ideation [31].


Consumer reporting may be one way of picking up harms that are missed in clinical trials, where for instance the KILEN material introduces a common self reported harm in experiencing a sensation of unreality. The new legislation in the EU-countries to stimulate a systematic consumer reporting can therefore be an important step to take, and hopefully will also the newly established consumer reporting system to the Swedish Medical Product Agency lead to a safer prescription culture. ....Research has also shown that educating general practitioners (GPs) to focus on ADRs improved the ADR reporting [32]. This is particularly serious since only five percent of doctors are estimated to participate in any pharmacovigilance system [33]. Educating physicians more in pharmacology or an active involvement of pharmacists when prescribing medication may therefore be one way to minimize ADRs and thereby increase safety. Maybe increased consumer reporting can lead to an increase in ADR reporting from health professionals. ....However, as Danish research suggests, can consumer ADR report might act as whistleblowers of new and previously undetected ADRs, but if the quality of the reports is questionable they may bring too much noise rather than valuable information to the pharmacovigilance systems [34].


Gender is also an important issue to highlight since the sales of antidepressants are almost twice as high among women compared to men in all age groups [35]. Women reported ADRs to KILEN in a much higher degree, between three to four times more often than men, and sometimes more within certain age groups. Especially women 30-39 years of age was a large frequently reporting group, but also younger women (15-29 years of age) was a common group. This may be an effect of that maybe women to a higher degree turn to non-profit organizations for help. It can also be an effect of women tending to have a higher risk of ADRs than men, which increases with age and increased numbers of drugs prescribed [36]. Citalopram was in particular a commonly reported antidepressant medication by women answering for almost 83% of the psychiatric ADRs for this drug. Both suicidal behavior and depression, which are more frequently associated with women, were commonly reported psychiatric ADRs for Citalopram in the KILEN material. There is an almost two-fold higher occurrence of lifetime prevalence of major depressive disorder and anxiety disorders in females than in males [37], and older women with a previous history of treatment by a psychiatrist may have an increased risk of becoming long-term users of antidepressants [38]. Since depression was a highly reported psychiatric ADR during discontinuation in the KILEN material it may be of importance to include consumer reports when prescribing the drug of choice for instance depression.


However, this study does have several limitations. There is for instance the question of potential problems with polypharmacy, with an unknown interaction between psychotropic drugs, for instance different antidepressants and anxiolytics. As indicated by a Swedish study the prevalence of polypharmacy, as well as the mean number of dispensed drugs per individual, increased for instance year-by-year in Sweden 2005-2008 [39]. Hence we cannot know for sure if the reported consumer reports do contain specific psychiatric ADRs for one antidepressant drug alone or if it is a combined effect due to other drugs. Some of the antidepressants have quite few reports (Mirtazapine, Fluoxetine and Escitalopram) and therefore it is not possible to draw any conclusions for each medication. It is a strength with the KILEN material that consumers are asked to fill in the report form concerning other medications as well, but it is still difficult to know if the reported ADR is a result of a specific medication or the combination of a number of medications. This is however not unique for KILEN but also valid for the report form from the MPA. Nevertheless, consumer reporting may make an important contribution in gaining information about unknown drug interactions. The KILEN data was based on spontaneous consumer reports and thereby a selected material, which may enhance a negative view of antidepressant medication. Despite these limitations the study is still of value since the material gives us unique information of consumer reporting in Sweden.

Edited by Altostrata

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