Boston Collaborative Drug Surveillance Program

BCDSP publication on the risk of venous thromboembolism during exposure to the contraceptive patch EVRA compared to oral contraceptives containing norgestimate and ethinyl estradiol

A BCDSP study using a nested case-control design with a case-control as well as a cohort analysis found no increased risk of venous thromboembolism in users of the new contraceptive patch EVRA compared to conventional oral contraceptive pills containing norgestimate and ethinyl estradiol. The original study has been published in: Contraception 2006 Mar;73(3):223-8. (click for free access to fulll text at the journal's website)

 

Interact - The BCDSP Newsletter

Contents of the current issue (April 2005):
- How to Critically Appraise Case-Control Studies
- Cholestatic Liver Disease with Flucloxacillin and Flucloxacillin Prescribing Habits in the UK
- Antidepressants and the Risk of Suicidal Behaviours
- Statins and Newly Diagnosed Diabetes

Download Interact 4-05 (Adobe pdf-file, 0.3 MB)

 

BCDSP publication in JAMA on antidepressants and suicide

A BCDSP study with data from the GPRD on the risk of suicide and antidepressants has recently been published in JAMA (JAMA 2004;292(3):338-43). The study covered a topic of high current interest and received major attention from regulatory authorities, medical professionals and the public.
The risk of suicidal behavior after starting antidepressant treatment was found to be similar among users of amitriptyline, fluoxetine, and paroxetine compared with the risk among users of dothiepin. The risk of suicidal behavior was increased in the first month after starting antidepressants, especially during the first 1 to 9 days. A possible small increase in risk (bordering statistical significance) among those starting the newest antidepressant, paroxetine, was of a magnitude that could readily be due to uncontrolled confounding by severity of depression. Based on limited information, we also conclude that there is no substantial difference in effect of the 4 drugs on people aged 10 to 19 years.

 

BCDSP studies show no association between MMR vaccination and autism

Speculations on an association between MMR vaccination and autism has recently caused considerable uncertainty about the safety of MMR vaccination and even parents refusing to have their chlldren vaccinated. The BCDSP has conducted several well-designed studies on the epidemiology and possible causes of autism (Pharmacotherapy 2003;23()12):1524-30).
The BCDSP studies concluded that there is no current evidence for an association between MMR vaccination and autism. In contrast a major cause of the recent large increase in the number of boys diagnosed with autism probably is due to changing diagnostic practices.

 

Recombinant hepatitis B vaccine and the risk of multiple sclerosis

A potential link between the recombinant hepatitis B vaccine and an increased risk of multiple sclerosis (MS) has been evaluated in several studies, but some of them have substantial methodologic limitations. The BCDSP conducted a nested case-control study that was recently published in Neurology (Neurology. 2004 Sep 14;63(5):838-42).
The analyses included 163 cases of MS and 1,604 controls. The OR of MS for vaccination within 3 years before the index date compared to no vaccination was 3.1 (95% CI 1.5, 6.3). No increased risk of MS was associated with tetanus and influenza vaccinations. We concluded that these findings are consistent with the hypothesis that immunization with the recombinant hepatitis B vaccine is associated with an increased risk of MS, and challenge the idea that the relation between hepatitis B vaccination and risk of MS is well understood.