The Institute for Safe Medication Practices (ISMP) analyzed and compiled every report submitted to FDA during the first 3 months of the year. The research found 20,745 reports of serious adverse events (SAE) from prescription drugs in the US, a 34% rise compared to last year’s quarterly average. Even more curious, deaths increased from 1,868 to 4,824 over the previous quarter.

Pfizer’s smoking-cessation drug – varenicline (Champix or Chantix) - received more reports of adverse reactions in the first quarter of 2008 than any other branded drug, according to a new report by.

Thomas Moore, senior scientist at ISMP expressed that  “We don’t know whether we are gaining or losing ground in drug safety,” ISMP combed through FDA’s adverse report updates and selected only those that have primary health significance for the US population, weeding out foreign reports, non-serious events, events that appeared in studies, and reports submitted by lawyers.

Topping the list of offenders was varenicline, with 1,001 reports of SAE reported to the FDA—more than the total number reported for all other branded drugs combined. 

The top 5 drugs associated with SAEs:

1. varenicline (1,001)
2. heparin (779)
3. fentanyl (631)
4. interferon beta (582)

The increase was the largest ever reported to FDA in looking at various quarters. The 2 leading culprits — varenicline & heparin — were not unexpected as both have been heavily publicized in the media.  Heparin had a tough year. Sophisticated contamination with a copycat ingredient upstream of the Chinese manufacturer led to a global recall of many versions of the generic.

Fentanyl is 3rd on the list. This potent opioid painkiller many times more powerful than morphine and widely sold on the black market. Interferon beta is a multiple sclerosis drug marketed under three different brand names; its potent anti-inflammatory effects cause a high rate of side effects, most commonly a chronic flu-like syndrome.

Both veranicline & heparin have been high-profile, not to say sensational, stories in the media since last year. Pfizer’s carefully planned rollout of the breakthrough nicotine-receptor partial antagonist was partially derailed by growing reports of suicidality, bizarre dreams, aggressive and other impulsive behavior, and other side effects. The drug giant was at pains to defend its blockbuster-to-be, arguing that the adverse events may have been symptoms of nicotine withdrawal. But a backlash against the drug has resulted in flagging sales.

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