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Q: How many adverse drug reactions are reported to the FDA?
A: According to the Institute for Safe Medication Practices, which monitors adverse drug events (ADEs), the FDA received 179,855 reports of serious or fatal adverse drug reactions in 2011.
However, there is a general consensus in the drug world that only about 1 percent of serious events ever get reported to the FDA, so this number is probably very conservative.
The top 10 drugs with the largest number of reports sent directly to the FDA by health care practitioners and consumers in 2011, in order of frequency, were:
+ Pradaxa (generic name dabigatran).
+ Coumadin (warfarin).
+ Levaquin (levofloxacin).
+ Zestril (lisinopril).
+ Zocor (simvastatin).
+ Cymbalta (duloxetine).
+ Cipro (ciprofloxacin).
+ Bactrim (trimethoprim/sulfamethoxazole or TMP-SMZ).
It is interesting to note Pradaxa surpassed all other monitored drugs in several categories, including overall number of reports (3,781), deaths (542), hemorrhage (2,367), acute renal failure (291) and stroke (644). It was also suspect in 15 cases of liver failure.
Coumadin (warfarin) has been prominent in the rankings for many years. It accounted for 1,106 reported ADEs overall, including 731 reports of hemorrhage and 72 deaths.
There are three options for submitting a voluntary adverse event report:
1. Complete Form 3500 online at https://www.accessdata.fda.gov/scripts/medwatch.
2. Call 800-FDA-1088 to report by telephone.
3. Download a copy of Form 3500 at www.fda.gov/medwatch /SAFETY/3500.pdf and either fax it to 800-FDA-0178 or mail it back using the postage-paid addressed form.
It is very important for consumers to report side effects from their medication to the FDA.
Richard P. Hoffmann, Pharm.D., has been a pharmacist for more than 40 years. Send questions to him at 2960 E. Coventry Court, Hernando, FL 34442.