| Title |
Mixed Approach Retrospective Analyses of Suicide and Suicidal Ideation for Brand Compared with Generic Central Nervous System Drugs
|
|---|---|
| Published in |
Drug Safety, December 2017
|
| DOI | 10.1007/s40264-017-0624-0 |
| Pubmed ID | |
| Authors |
Ning Cheng, Md. Motiur Rahman, Yasser Alatawi, Jingjing Qian, Peggy L. Peissig, Richard L. Berg, C. David Page, Richard A. Hansen |
| Abstract |
Several different types of drugs acting on the central nervous system (CNS) have previously been associated with an increased risk of suicide and suicidal ideation (broadly referred to as suicide). However, a differential association between brand and generic CNS drugs and suicide has not been reported. This study compares suicide adverse event rates for brand versus generic CNS drugs using multiple sources of data. Selected examples of CNS drugs (sertraline, gabapentin, zolpidem, and methylphenidate) were evaluated via the US FDA Adverse Event Reporting System (FAERS) for a hypothesis-generating study, and then via administrative claims and electronic health record (EHR) data for a more rigorous retrospective cohort study. Disproportionality analyses with reporting odds ratios and 95% confidence intervals (CIs) were used in the FAERS analyses to quantify the association between each drug and reported suicide. For the cohort studies, Cox proportional hazards models were used, controlling for demographic and clinical characteristics as well as the background risk of suicide in the insured population. The FAERS analyses found significantly lower suicide reporting rates for brands compared with generics for all four studied products (Breslow-Day P < 0.05). In the claims- and EHR-based cohort study, the adjusted hazard ratio (HR) was statistically significant only for sertraline (HR 0.58; 95% CI 0.38-0.88). Suicide reporting rates were disproportionately larger for generic than for brand CNS drugs in FAERS and adjusted retrospective cohort analyses remained significant only for sertraline. However, even for sertraline, temporal confounding related to the close proximity of black box warnings and generic availability is possible. Additional analyses in larger data sources with additional drugs are needed. |
X Demographics
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Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Spain | 1 | 33% |
| Unknown | 2 | 67% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 3 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 33 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 33 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Postgraduate | 4 | 12% |
| Researcher | 3 | 9% |
| Student > Ph. D. Student | 3 | 9% |
| Other | 2 | 6% |
| Student > Bachelor | 2 | 6% |
| Other | 3 | 9% |
| Unknown | 16 | 48% |
| Readers by discipline | Count | As % |
|---|---|---|
| Pharmacology, Toxicology and Pharmaceutical Science | 4 | 12% |
| Medicine and Dentistry | 3 | 9% |
| Computer Science | 3 | 9% |
| Nursing and Health Professions | 3 | 9% |
| Business, Management and Accounting | 2 | 6% |
| Other | 2 | 6% |
| Unknown | 16 | 48% |
Attention Score in Context
This research output has an Altmetric Attention Score of 2. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 19 May 2018.
All research outputs
#14,963,216
of 23,015,156 outputs
Outputs from Drug Safety
#1,386
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#251,606
of 438,158 outputs
Outputs of similar age from Drug Safety
#17
of 21 outputs
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