QuarterWatch® Reports

Signals for Two Newly Approved Drugs and 2010 Annual Summary

In this issue of QuarterWatch™ we examine signals for two recently approved drugs and report the case totals for the full calendar year.

We analyze reports for dabigatran (PRADAXA) involving its effects on blood clotting, examining cases of too much anti-clotting effect (hemorrhages) and too little clot inhibiting effect (reported thromboembolic events).

For the new drug for multiple sclerosis, dalfampridine (AMPYRA), we examine case reports that suggest that some patients report it makes it more difficult to walk while the intended benefit was to improve walking speed.

In addition we update our reporting on the smoking cessation drug varenicline (CHANTIX) and dronedarone (MULTAQ), a drug for heart rhythm disorders.

We also examine patient death reporting for the pulmonary hypertension drug bosentan (TRACLEER).

The annual results also include a ranking of the drugs most frequently associated with reports of serious injury. Prominent were opioid pain medications, blockers of Tumor Necrosis Factor (TNF), acetaminophen, the antibiotic levofloxacin (LEVAQUIN), and the antipsychotic quetiapine (SEROQUEL).

QuarterWatch™ is an independent publication of the Institute for Safe Medication Practices (ISMP). We analyze computer excerpts from the FDA Adverse Event Reporting System (FAERS). These reports (best known as MedWatch reports) are a cornerstone of the nation’s system for monitoring the safety of prescription drugs after FDA marketing approval.