Once again, the publisher of ConsumerMedSafety.org, the Institute for Safe Medication Practices (ISMP), has analyzed medication errors and serious side effects reported to the US Food and Drug Administration (FDA), this time for the third quarter of 2008. Previous publications are available elsewhere on this website (search "QuarterWatch").
As before, we have identified important safety problems with specific medicines and notified FDA and appropriate manufacturers of our findings. We also let your doctors, nurses, and pharmacists know about them by getting the word out through various media outlets.
During the period July - September 2008, we evaluated computer excerpts of 24,872 serious, disabling, and fatal adverse drug events submitted during the third quarter of 2008. The reports involved 854 different drugs which led to 2,778 deaths, 1,162 cases of disability, and 20,932 other
kinds of serious injuries. Of the 854 different drugs associated with death and disability, 53 drugs accounted for 100 or
more reported cases.
In particular, two areas stand out among our findings. Concerns
continue regarding serious problems our nation seems to be facing to ensure generic drugs are manufactured with adequate
quality control. In the first quarter of 2008, there were urgent recalls of most of the
nation’s supply of one form of generic heparin and millions of fentanyl patches from several generic drug manufacturers. In the second quarter, about 50% of the nation’s supply of generic digoxin was recalled because over-strength tablets may have been manufactured and distributed.
An additional generic digoxin recall was announced in March 2009. In the third and fourth quarters of 2008, urgent recalls were announced for generic versions of morphine sulfate, propafenone, and isosorbide. All involved over- or under-strength tablets that could have significant health consequences. In addition, two NJ plants of the Actavis Group were closed and all
products manufactured there were recalled due to manufacturing concerns. In December 2008, KV Pharmaceuticals’ plants were closed to resolve quality control problems.
The concern regarding the manufacture of generic drugs has received little public and
official notice in part because FDA does not require disclosure of the size and impact of
a product recall. To cite one example, neither Caraco Pharmaceutical Laboratories
nor FDA would reveal how many
digoxin tablets were involved in its March 31, 2009, recall notice. Based on these findings, it seems apparent that FDA’s
current system for inspecting plants, dealing with violations, and managing product recall notices requires systematic
independent review.
Warnings with varenicline. We continue to be concerned about the safety profile of varenicline which accounts for more psychiatric side effects reported to the FDA than any other prescription drug. In addition, no action has been taken to
provide a prominent warning about the drug’s potential to cause motor vehicle accidents through its effects on mood, memory, vision and motor control. Further,
little follow-up has occurred in response to reports of aggression, physical assaults, and
homicidal thoughts. While we might
assume that these serious side effects have been disclosed to patients who consent to take varenicline, such violence affects
patients’ families and the public at large, from whom consent to the possibility of violence has clearly not been obtained.
You can find the complete report, which includes findings with additional drugs and an infusion pump device, on our health professionals website. Click here |
