[MPWG] NEWS: Rx Drugs Under Fire

[Olivia Kwong]

Record number of serious problems, deaths linked to medications, ISMP
report indicates.

The CBS Evening News (10/22, story 6, 1:50, Couric, 
http://www.youtube.com/watch?v=DJF0w73sK-I) reported that "a new
report raises serious questions about the safety of prescription drugs in
this country. More than ever, medications that are supposed to help people
are instead making them sick, and in some cases, even killing them."
         "The number of deaths and serious injuries associated with
prescription drug use rose to record levels in the first quarter of this
year, with 4,825 deaths and nearly 21,000 injuries," the Los Angeles Times
(10/23, Maugh) adds. According to a report from the nonprofit Institute
for Safe Medication Practices (ISMP), "those numbers represent a nearly
three-fold increase in deaths from the previous quarter and a 38 percent
increase in injuries from last year's quarterly average." The ISMP report
is based on data "from voluntary reports of adverse effects to the Food
and Drug Administration (FDA), which made the data public after stripping
information that identified victims. Because the reporting is voluntary,
researchers have speculated that fewer than 10 percent of adverse events
actually makes it into the system." The report found that "the increase in
deaths during the first quarter was not dominated by any one drug.
Instead, 10 drugs each caused more than 100 deaths, compared with an
average of one to three drugs in previous quarters." A considerable number
"of the reports were linked to powerful painkillers or narcotics such as
oxycodone, fentanyl, morphine, methadone, and hydrocodone, all of which
have a high potential for abuse."
         The AP (10/22, Alonso-Zaldivar) noted that "two drugs accounted
for a disproportionately large share of the latest reports." The first was
"heparin, the tainted blood thinner from China that caused an
international safety scandal. The other was Chantix (varenicline), a new
kind of anti-smoking drug from Pfizer." The AP pointed out that "earlier
this year, the FDA warned that Chantix may be linked to psychiatric
problems, including suicidal behavior and vivid dreams. The government
banned it for pilots."
         FDA may upgrade Chantix warnings. The Wall Street Journal (<
http://online.wsj.com/article/SB122469442058758861.html.html>; 10/23, D3,
Mundy) reports that the FDA "said it may upgrade warnings on the Pfizer
Inc. antismoking drug Chantix after a nonprofit safety group cited a new
spate of road-traffic accidents and seizures involving people on the
drug." The ISMP "said 1,001 serious incidents involving Chantix users were
reported in the first quarter of this year, based on its analysis of
government safety data. That is more than the total number of serious
incidents for the top 10 most-prescribed brand-name drugs combined." The
ISMP's "latest figures follow up on a report it issued in May that linked
173 accidents, including some involving automobiles, to Chantix use. In
response, the Department of Transportation, the Federal Aviation
Administration and the Department of Defense barred pilots, air-traffic
controllers, and others from using the drug."
         In the Wall Street Journal's (<
http://blogs.wsj.com/health/2008/10/22/chantix-linked-to-injuries-in-new-report/
>; 10/22) Health Blog, Jacob Goldstein added that "the report points to 15
adverse events reported to the FDA linked to road traffic accidents, and
52 cases that may have involved various kinds of blackouts. But, because
of the nature of the reports, it's not clear that the drug was the cause
of these issues." Goldstein wrote that, "in a statement, Pfizer pointed
out that the type of adverse-event reports the study uses 'are often
unverifiable and lack sufficient medical information to draw any
conclusions.'" MedPage Today (<
http://www.medpagetoday.com/PrimaryCare/Smoking/11428>; 10/22, Peck) also
covered the story.