Rx Drug-Related Harm and Deaths Continue to Rise

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION

A Catalyst for Public Debate: Promoting Openness, Full Disclosure, and

Accountability

http://www.ahrp.org 

 

FYI

 

One has to wonder why discovery of defective cars are front page news while

defective FDA-approved prescription drugs are accepted as part of life's

risk.

 

According to the database maintained by the National Highway Safety

Administration there were 34 deaths alleged to be attributable to defective

Toyota cars (13 of those deaths occurred between 2005 and 2010). Toyota has

recalled 8.5 million cars.

 

Yet, defective FDA-approved drugs that kill thousands of people every week!

 

The latest Quaterwatch report by the Institute for Safe Medication

Practices, that analyzing serious adverse events reported to the FDA's

Medwatch found that the number of consumers harmed and killed by

FDA-approved prescription drugs keeps rising.

http://www.ismp.org/QuarterWatch/2008Q2.pdf

 

"In the third quarter of 2009 the steady increase continued in reported

serious, disabling and fatal adverse drug events. Cases meeting the

QuarterWatch criteria totaled

29,065 cases, an increase of 2,256 cases (8.4%) from the same quarter in the

previous year. For the first three quarters of 2009, combined case reports

increased by 8.1% from the first three quarters of 2009."

 

GlaxoSmithKline's diabetes drug, Avandia, and AstraZeneca's, antipsychotic,

Seroquel, are the two worst drugs--if one considers the magnitude of harm

produced by these drugs, coupled with these drugs' controversial (at best)

clinical value.

 

According to Quaterwatch analysts,

 

"Rosiglitazone (AVANDIA). More than 1000 reports of patient deaths were

received for

rosiglitazone in the first three quarters of 2009, more than any other drug

we monitor.

Rosiglitazone is an oral medication for treating Type 2 or adult onset

diabetes. Most

deaths were attributed to cardiovascular causes, a problem for which the FDA

has

required warnings. While these cases do not appear to signal previously

undetected risks

of rosiglitazone, the large number of reports alleging serious and fatal

injuries associated

with rosiglitazone further reinforces concerns about its cardiovascular

safety. The

company, GlaxoSmithKline, told us it believed most reports were generated by

lawsuits.

In February 2010 the FDA announced it was conducting an overall safety

review of

rosiglitazone and would present its findings to a special advisory committee

meeting in July."

 

. Quetiapine (SEROQUEL, SEROQUEL XR). In the third quarter of 2009,

quetiapine,

a drug approved for several severe mental disorders, was the suspect drug in

more

possible cases of diabetes than all other drugs combined. AstraZeneca, which

manufactures this best-selling antipsychotic drug, told us it believed most

of the diabetes

cases were related to lawsuits. The mandatory Medication Guide to warn

patients about

the risk of diabetes does not primarily use the word "diabetes" but rather

describes the

disorder as "high blood sugar (hyperglycemia)," potentially minimizing this

serious risk."

 

The FDA has been shown to be complicit in its failure to act--despite a

mounting epidemic of drug-induced catastrophes.

A mountain of evidence documents the harm these drugs have produced--and

internal documents confirm that manufacturers used corrupt practices to

market these hazardous drugs.

 

Healthcare overhaul must include a shift at the policy level: FDA's drug

safety policy must be geared twoard effectively reducing preventable

drug-induced deaths. 

 

 

 

Contact: Vera Hassner Sharav

veracare@ahrp.org

212-595-8974

 

 

 

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http://www.newsinferno.com/archives/19032

Avandia, Seroquel Have Most Adverse Event Report

Date Published: Friday, March 5th, 2010

Avandia's <http://www.yourlawyer.com/topics/overview/avandia>
cardiovascular problems have long been the subject of concern and
controversy. Now, reports FiercePharma, an adverse event (AE) report for
last year's third quarter indicated that GlaxoSmithKline's Avandia
(generic: rosiglitazone) was number one on the list. The Institute for
Safe Medication Practices issued the report.

The diabetes drug Avandia, was reported 1,218 times; 1,000 were serious
or ended in death, said FiercePharma. Seroquel (generic: quetiapine),
AstraZeneca's antipsychotic medication, followed with 977 reports,
according to FiercePharma. Lioresal (generic: baclofen), made by
Novartis had 796 adverse event reports; fentanyl, a pain medication,
688; and Enbrel (generic: etanercept), manufactured by Amgen and Pfizer
for rheumatoid arthritis and psoriasis, was cited 495 times. The report
includes information from an array of sources and the Institute follows
adverse event reports for some 2,000 medications, said FiercePharma.

We have long been following GlaxoSmithKline's and Avandia's controversy
and legal woes. For instance, Avandia was recently cited in a U.S.
Senate report, which sparked some debate about the drug maker's
activities and the medication's safety. The release of the Senate
Finance Committee report charged that the drug maker downplayed the
drug's heart risks. According to a prior Associated Press report, in a
30-page "white paper," Glaxo claimed the Senate report "mischaracterizes
and distorts" the company's record.

Meanwhile, Avandia's cardiovascular problems have been the subject of
concern since May 2007, when a meta-analysis of 42 clinical trails
published by the Cleveland Clinic showed that patients taking the drug
had a 43-percent higher risk of having a heart attack. In November 2007,
a black box warning---the Food & Drug Administration
<http://www.fda.gov/> (FDA's) strongest safety warning---detailing
Avandia's association with myocardial ischemia was added to the drug's
labeling.

The Senate Finance Committee report was the result of a two-year
investigation, and drew on 250,000 pages of documents, including emails
from GlaxoSmithKline officials, as well as interviews with Glaxo and FDA
officials and anonymous whistleblowers. According to the report, in July
2007 the FDA's own scientists estimated that Avandia was responsible for
more than 80,000 heart attacks. Two of the FDA's own doctors wrote in an
October 2008 memo that Avandia should be removed from the market because
it poses serious heart-related dangers to patients, the report said.

The Senate report also claimed that Glaxo tried to undermine criticism
of the drug: "GSK executives attempted to intimidate independent
physicians, focused on strategies to minimize or misrepresent findings
that Avandia may increase cardiovascular risk, and sought ways to
downplay findings that a competing drug might reduce cardiovascular risk."

Since the release of the Senate report, calls have increased for the FDA
to pull Avandia off the market.

< This entry was posted on Friday, March 5th, 2010 at 9:15 am and is
filed under Avandia
<http://www.newsinferno.com/archives/category/pharmaceuticals/avandia>,
Pharmaceuticals
<http://www.newsinferno.com/archives/category/pharmaceuticals>.

 

 

 

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