| August
9, 2007
FDA: Heartburn Drugs Seem OK for Heart
FDA: Heartburn Drugs Prilosec, Nexium Don't Appear to
Carry a Risk of Heart Problems
The popular heartburn drugs Prilosec and Nexium don't appear
to spur heart problems, say preliminary U.S. and Canadian probes
announced Thursday.
The Food and Drug Administration and its Canadian counterpart
began reviewing the drugs, used by tens of millions of people,
back in May, when manufacturer AstraZeneca provided them an early
analysis of two small studies that suggested the possibility of
a risk.
Those studies compared treating the chronic heartburn known as
gastroesophageal reflux disease, or GERD, with either of the two
drugs or with surgery, and tracked patients for five to 14 years.
The company's initial analysis counted more patients treated with
drugs who had had heart attacks, heart failure or heart-related
sudden death.
The FDA followed up on those studies, and found that they seemed
skewed: Patients who underwent surgery were younger and healthier
than those treated by drugs, suggesting the heart link was a coincidence.
While the studies' designs make safety assessments difficult,
many of the participants who developed heart problems had risk
factors before starting the drugs, Health Canada said Thursday.
The FDA then looked at 14 additional studies of the drugs, and
found no evidence of heart risks. In fact, in a few studies where
patients received either medication or a dummy pill, those who
took the heartburn drugs actually had a lower incidence of heart
problems.
The FDA plans to complete its probe within three months, but
issued a public notice Thursday that it "does not believe
that health care providers or patients should change either their
prescribing practices or their use of these products at this time."
Health Canada reached the same initial conclusion. It also urged
doctors and patients to make no changes until its own probe is
finished by year's end, noting that untreated GERD can lead to
serious complications.
The drugs are among a family of acid-reducers known as proton
pump inhibitors. FDA's Dr. Paul Seligman said Thursday that while
the agency's focus is on Nexium and Prilosec, it is "interested
in the data from all similar products" as it looks for all
available evidence to settle the heart question.
Nexium is the world's No. 2 selling drug, with 2006 sales of
$6.7 billion, according to health care research firm IMS Health.
Source: www.medicinenet.com
Comments:
Despite the evidence suggesting that the popular heartburn
drugs Nexium and Prilosec do increase the heart risk, FDA
has denied to take action and has urged doctors to continue
the current regimen, noting that ‘unrreated GERD could
lead to serious complications.’ It is interesting
to read that though the manufacturer of these drugs, AstraZeneca,
has provided the data from their studies suggesting there
is increased incidence of heart attack, heart failure and
heart related sudden death in patients treated with the
drugs; FDA rejected the results saying that ‘the studies
seemed skewed.’ Nexium, being the world's No. 2 selling
drug with 2006 sales of $6.7 billion, is a critical product
for AstraZeneca, who would not be happy if its use were
reduced. Yet it the FDA still wants the drugs to be continued
as it is. This makes us wonder whose side FDA is really
on?
Read about Dr. Rath's fight against pharma cartel making
“business with disease” on www.drrathresearch.org
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