According to a study published in the Archives of Internal Medicine, an analysis evaluated so-called Med-Watch reports of drug side effects and deaths to the U.S. Food and Drug Administration. According to reporting of adverse events, they more than doubled over an eight-year period.
The study examined adverse events from the period 1998 to 2005, and used the FDA’s MedWatch reporting system’s data for analysis. Scientists at Wake-Forest School of Medicine and the Institute for Safe Medication Practices in Huntingdon Valley, Pennsylvania conducted the research. Drug companies must file reports with the FDA when they have reason to believe that their drug was related to a fatality or an adverse event.
An adverse drug event as defined by the FDA means an event precipitated by a drug that resulted in death, disability, or that required some sort of medical intervention to prevent grievous bodily harm from occurring.
During the years 1998 to 2005 in which the study took place, 467,809 serious adverse events were reported. The authors pointed out that in the first year of the study there were only 34,966 adverse events, while in the last year of the study there were 89,842 adverse events. Total numbers of fatal adverse drug events also multiplied during the study from 5,519 to 15,107 in the same study period.
The study correlated outpatient prescriptions for the same time period, which grew from 2.7 billion prescriptions to 3.8 billion. One of the more shocking aspects of the study were the large number of deaths attributable to painkillers, such as oxycodone and fentanyl - some 9,000 deaths.
Other drugs included in the top 15 drug deaths were antipsychotics and acetaminophen, the ingredient in Tylenol. Many drugs revealed in the study were related to safety withdrawals, including Vioxx and Fen-Phen. The skyrocketing deaths outlined in the study spotlight the importance of more closely managing patient prescription needs.
| SUSPECT DRUG DEATHS |
|
| Oxycodone |
5,548 |
| Fentanyl |
3,545 |
| Clozapine |
3,277 |
| Morphine |
1,616 |
| Acetaminophen (Tylenol) |
1,393 |
| Methadone |
1,258 |
| Infliximab |
1,228 |
| Interferon beta |
1,178 |
| Risperdal |
1,093 |
| Etanercept |
1,034 |
| Paclitaxel |
1,033 |
| Hydrocodone-acetaminophen |
1,032 |
| Zyprexa |
1,005 |
| Vioxx |
932 |
| Paxil |
850 |
| DRUGS CAUSING DISABILITY OR OTHER SERIOUS OUTCOME |
| Estrogens |
11,514 |
| Insulin |
9,597 |
| Infliximab |
8,754 |
| Interferon beta |
8,320 |
| Paxil |
8,095 |
| Vioxx |
7,766 |
| Warfarin |
6,250 |
| Lipitor |
6,022 |
| Etanercept |
5,586 |
| Celebrex |
4,822 |
| Phentermine |
4,607 |
| Clozapine |
4,388 |
| Interferon alfa |
4,162 |
| Zocor/simvastatin |
3,885 |
| Effexor |
3,688 |