1. February 2010 (2009 Quarters 1-3).  In the first three quarters of 2009 the steady increase continued in domestic serious adverse drug events reported to the FDA.  We also examined the system breakdown that led thousands to complain they had lost their sense of smell—many permanently-- because of two over-the-counter cold remedies, Zicam Nasal Gel and Swabs. In addition, the report examines new signals for cardiovascular events associated with rosiglitazone (AVANDIA), and possible cases of diabetes linked to quetiapine (SEROQUEL).  Also, product quality problems continued in 2009 and 2010.
2. October 2009 (4th Quarter 2008). Serious, disabling and fatal adverse events reported to the FDA increased by 25% for the full year of 2008, the largest increase since the beginning of our historical data in 1998. The biggest identifiable safety factor in the increase was reports associated with the massive recalls of generic drugs that occurred throughout the year. We also found that approximately half the increase occurred because of more voluntary reporting to the FDA, and from certain manufacturers. While the FDA added important new black black box warning for varenicline (CHANTIX) and psychiatric side effects, a better and clearer warning about accident risk is needed. Given the association of varenicline with aggressive, violent and hostile behavior we recommend that the ban on varenicline be extended from pilots and missile crews to all active duty military personal, police and emergency workers.
3. May 2009 (3rd Quarter 2008). More than 1000 patient deaths have been reported in connection with the recall of the heart drug digoxin, but a year later no testing has been performed to determine how many are directly linked to defective tablets. For the third quarter of 2008 reported serious, disabling adverse drug events were 30.5% higher than the same quarter one year ago, but little changed from previous quarters. More than 100 cases of serious injuries were reported in connection with a muscle relaxant (Lioresal Intrathecal) that is delivered to the spinal fluid through an implanted pump. We recommend that the Medication Guide for varenicline (Chantix) should be strengthened to include warnings about risk of vehicle and other accidents, and of psychiatric side effects involving aggression and violence towards others.
4. January 2009 (2nd Quarter 2008). Questions arise on manufacturing practices, recall effectiveness and premarket testing for psychiatric adverse effects. (2nd Quarter 2008 data)  A surge in reports for montelukast (SINGULAR) is linked to FDA Early Communication that it is studying an association with psychiatric side effects.  A massive recall of the heart drug digoxin (DIGITEK brand) led to reports of more than 600 patient deaths, but a direct link to defective tablets was hard to assess.
5. October 2008 (1st Quarter 2008). Reported patient deaths reach a record high. The recall of heparin and reports about varenicline (CHANTIX) account for large numbers of events. (1st Quarter 2008 data)  For a second quarter Chantix accounted for more adverse events than any other drug. It also accounted for more reports of serious injury than the 10 most frequently prescribed brand name drugs combined.
6. May 2008. A strong safety signal was seen for varenicline (CHANTIX) a drug to help people stop smoking.  (4th Quarter 2007 data)  Chantix accounts for more reported serious adverse events than any other prescription drug during this quarter.  Among new risks highlighted was the potential to cause accidents because Chantix can interfere with thinking, effect vision and other sensory input, and impair motor control of muscles.

For more details on the history of ISMP's QuarterWatch program, and more information for consumers on preventing medication errors and adverse reactions, click here.