The Top Ten of anything usually designates the ‘best’ but not in this case.
An online report from Adverse Events Inc., an independent company that analyzes the FDA’s database of Adverse Event Reporting System (AERS), has just issued its Top Ten list of Dangerous Drugs for the second quarter Q2 of 2011.
Compared to the first quarter of 2011 (Q1), the second quarter saw an increase in the number of adverse events or complications attributed to drugs – 161,784 compared to 152,871 for Q1 of 2011. Looking back even further, Q1 in 2010 saw 120,517 complications reported.
Adverse event reports appear to be steadily trending upward as the reporting goes back to Q1 in 2008 where there were about 90,000 reports.
Among the Top Ten drugs reported for Q2 2011 there were 21,355 deaths, 7,778 reports of disability, and 51,309 cases of hospitalization.
So which drugs made the Top Ten?
- Tysabri, a treatment for multiple sclerosis and Crohn’s disease had more than 6,000 reports with the Top Adverse Event – Fatigue. A relapse of MS and headache were reported, as well as 174 deaths.
- Nexium, a treatment for gastroesophageal reflux disease, difficulty digesting and peptic ulcers, had 4,833 reports, the Top Adverse Event being drug dose omission and ineffective drug, and 61 deaths.
- Reglan treats vomiting, nausea and there were 4,316 reports with the Top Adverse Event – Tardive dyskinesia, as well as 217 deaths.
- Clozaril reduces symptoms of schizophrenia. The drug had 3,240 reports with Top Adverse Event – 1,395 Deaths
- Pradaxa used to treat atrial fibrillation by thinning the blood had 3,071 reports with the Top Adverse Event- Dyspepsia, dizziness and gastrointestinal hemorrhage, as well as 201 deaths.
- Yaz, a contraceptive, had 3,058 reports with the Top Adverse Event – Pain, there were also 58 deaths reported.
- Remicade, a treatment for Crohn’s disease saw 2,192 reports with the Top Adverse Event – Infusion related reaction, dyspnea and pyrexia, and 174 deaths.
- Chantix, a smoking cessation drug, had 2,003 reports with the Top Adverse Event reported – Depression and 103 deaths.
- Avandia, a treatment for type 2 diabetes, which the FDA announced would be pulled from the market beginning in November 2011, saw 1,507 reports with the Top Adverse Event – Myocardial infarction and 839 deaths.
- Yasmin, an oral contraceptive had 1,345 reports with the Top Adverse Event – Pain and 25 deaths.
It is widely believed that the FDA’s database for reporting is woefully inadequate with about 10 percent of actual real-life complications ever making their way to be officially reported.