The pulmonary arterial hypertension drug bosentan had the most reported serious adverse events in 2010, according to a report from the Institute for Safe Medication Practices.
Bosentan (Tracleer) was involved in 4,665 cases reported to the Food and Drug Administration’s Adverse Event Reporting System, also known as MedWatch. In second place is the synthetic opiate analgesic fentanyl, with 3,035 cases reported, the ISMP said.
Three spots in the top 10 are taken by biological products for rheumatoid arthritis and other autoimmune disorders: infliximab (Remicade), etanercept (Enbrel), and adalimumab (Humira). There are two psychiatric medications in the top 10: the antipsychotic quetiapine (Seroquel) and the smoking cessation aid varenicline (Chantix), the ISMP reported.
For 2010, a total of 141,829 serious, disabling, and fatal adverse drug events were reported to the FDA, which was up 21.1% from the 2009 total of 117,093. That increase of 24,736 cases represents "the largest absolute 1-year increase since our records began in 1998," the ISMP said.
Note: Based on data from the Food and Drug Administration’s Adverse Event Reporting System.
Source: Institute for Safe Medication Practices