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+--- Thread: FDA strengthens heart safety warnings on popular pain relievers (/showthread.php?tid=369)
FDA strengthens heart safety warnings on popular pain relievers - IceWizard - 07-10-2015
Published July 10, 2015
Associated Press
Federal health regulators are bolstering
warning labels on popular pain relievers to
reflect new information about their risks of
heart attack and stroke. The changes announced Thursday apply to prescription non-steroidal anti-inflammatory drugs, or NSAIDs, including arthritis treatments like Celebrex.
The agency said it plans to make similar changes to over-the- counter drugs in the same class, such as Advil and Motrin.
Language on the pills currently warns that
they can increase the risk of heart-related
problems if used long term.
However, the Food and Drug Administration's new warning states that heart attacks and strokes can occur in the first few weeks of taking the drugs. The agency also warns that the risks increase with higher doses of the drugs.
The updates are based on an FDA review of recent studies and recommendations by outside advisers. "In general, patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke," the agency notes in the announcement posted to its website.
The labeling change is the latest step in the
FDA's ongoing safety review of the drugs
which stretches back to 2004. That's when
Merck
(cont)
The labeling change is the latest step in the
FDA's ongoing safety review of the drugs
which stretches back to 2004. That's when
Merck and Co Inc. pulled its blockbuster pain reliever Vioxx off the market because of links to heart attack and stroke.
Vioxx had been heavily advertised as a new kind of NSAID that was supposed to be easier on the stomach. But its withdrawal shook the medical establishment and ushered in a new era of drug safety at the FDA.
In 2005, the agency added boxed warnings
to all prescription NSAIDS, including Pfizer's Celebrex and high-dose versions of ibuprofen and naproxen.
Celebrex is the only drug from the same class as Vioxx that remains on the market.
The prescription NSAIDs are generally used for long-term chronic pain conditions like arthritis.
The agency also added similar warnings to
lower-dose, over-the-counter NSAIDs like
Aleve and Advil.
Those drugs currently warn patients to take the lowest dose possible for as short a period as possible.
They are not intended to be used for pain longer than 10 days, according to their labels.
Advil is marketed by Pfizer Inc., while Aleve is sold by Bayer.
Many generic drugmakers market cheaper versions of the drugs.
Source Fox News
RE: FDA strengthens heart safety warnings on popular pain relievers - Charon - 07-10-2015
celebrex was already banned by FDA. many years ago. it was recommended for those whom had the potential for stroke.
that is about the time i had my stroke. very young. no warnings. i did not learn celebrex could be the causitive factor until many years later.
how or when this med got back into useage is beyond me.
its as bad as thalidomide (which causes babies to be born with flippers. not limbs) being back on the market. for the third time after its bannings.
it is used for nausea in third world countries now. And, of course women r using it. How the children will survive, I don't know.