New Guidelines to Reduce Internal Bleeding Risks
Issued for Taking Antiplatelet with NSAID
Medical groups join to improve patient safety when
taking the most widely used class of medications in U.S.
Oct. 6, 2008 – The good news is that Americans
continue to live longer. The bad news is the longer we live the more
medical challenges we face. New guidelines were released today for
reducing the risk of ulcers and gastrointestinal bleeding among those
senior citizens using nonsteroidal anti-inflammatory drugs (NSAIDs)
along with antiplatelet agents.
The
American College of Cardiology in collaboration with the
American College of Gastroenterology and the
American Heart Association released consensus guidelines.
Gastrointestinal bleeding is a major and
potentially life-threatening complication for patients taking
antiplatelet and NSAID therapy, according to Deepak L. Bhatt, M.D.,
document co-chair and chief of cardiology, VA Boston Healthcare System.
Patients taking low-dose aspirin, plus NSAIDs, have
a two- to four-fold increased risk of gastrointestinal bleeding compared
with those not taking these medications.
“There are strategies to minimize or reverse GI
injury, especially as many of the medications become less costly as
generics become available.”
NSAIDs – the most widely used class of medications in the United
States – can reduce fever, pain, and inflammation (swelling and
redness). Some are available over the counter (OTC), while others
require a prescription. The best-known NSAID is aspirin (which also acts
as an antiplatelet agent). Other common NSAIDs are ibuprofen, ketoprofen
and naproxen.
Antiplatelet drug treatment, which reduces the
blood’s ability to clot, is considered a cornerstone in cardiovascular
prevention – preventing an event (or subsequent event) in people with
atherosclerotic disease. This is usually accomplished by prescribing
daily low-dose aspirin.
Antiplatelet agents (usually aspirin plus
clopidogrel) are also recommended for patients after receiving coronary
artery stents to prevent dangerous clotting that could cause a heart
attack.
As more Americans survive and live with heart
disease in addition to conditions that require them to take NSAIDs
(e.g., arthritis, inflammation and related musculoskeletal pain),
managing GI risk will become an increasingly important part of
cardiovascular care.
“Doctors are uncertain about how best to prevent
bleeding complications in patients receiving antiplatelet therapy and
NSAIDs, which are both commonly used, and can cause erosions in the
stomach lining,” said Dr. Bhatt.
“These recommendations represent the collective
expertise of leading cardiologists and gastroenterologists, as well as
an extensive review of the literature, and provide specialists with
practical measures to manage competing risks and help improve patient
safety.”
“We must be more proactive in assessing individual
patient risk to be able to prevent gastrointestinal problems as
antiplatelet therapy is actually initiated,” said David A. Johnson,
M.D., immediate past president of the American College of
Gastroenterology and professor of medicine and chief of gastroenterology
at Eastern Virginia Medical School.
“Communication among cardiologists,
gastroenterologists and primary care physicians is critical. At the same
time, patients must tell their doctors about any and all medications
they are taking—prescription and over-the-counter medicines—so
appropriate measures can be taken to reduce risk.”
In fact, according to a recent survey, 18 percent
of patients failed to report recent use of non-prescription NSAIDs,
which greatly complicates attempts to manage risk. Since GI problems may
arise with few, if any, symptoms (e.g., blood in stool, fatigue,
abdominal pain), ongoing monitoring is also important.
“The recommendations will help physicians evaluate
the risk profile for each patient and either change medications or
provide appropriate therapies to help reduce GI complications,” said
Elliott Antman, M.D., a member of the writing group and a professor of
medicine at Harvard Medical School.
Reduce Problems
To reduce problems, providers must assess
individual patient risk factors for possible GI complications,
including:
● age,
● previous history of ulcers or bleeding,
● presence of H. pylori (a common bacteria that contributes to the
development of stomach ulcers),
● dyspepsia or GERD (gastroesophageal reflux disease or “acid
reflux”) symptoms, as well as
● the simultaneous use of NSAIDs, anticoagulants and/or
corticosteroids.
The presence of several risk factors further
increases the possibility of bleeding.
These recommendations are part of an ongoing
dialogue between the three collaborating organizations and, according to
the authors, will be updated as more definitive data are accrued.
This
document was developed by the American College of Cardiology Foundation
Task Force on Expert Consensus Documents, which helps guide clinical
practice in areas where rigorous evidence may not be available or the
evidence to date is not widely accepted.
About the American College of Cardiology
The American College of Cardiology is leading the way to optimal
cardiovascular care and disease prevention. The ACC is a 36,000-member
nonprofit medical society and bestows the credential Fellow of the
American College of Cardiology upon physicians who meet its stringent
qualifications. The College is a leader in the formulation of health
policy, standards and guidelines, and is a staunch supporter of
cardiovascular research. The ACC provides professional education and
operates national registries for the measurement and improvement of
quality care. For more information, visit
www.acc.org.
About the American College of Gastroenterology
Founded in 1932, the American College of Gastroenterology (ACG) is an
organization with an international membership of more than 10,000
individuals from 80 countries. The College is committed to serving the
clinically oriented digestive disease specialist through its emphasis on
scholarly practice, teaching and research. The mission of the College is
to serve the evolving needs of physicians in the delivery of high
quality, scientifically sound, humanistic, ethical, and cost-effective
health care to gastroenterology patients. To learn more, visit
www.acg.gi.org.
About the American Heart Association Founded in 1924, the American Heart Association today is the
nation’s oldest and largest voluntary health organization dedicated to
building healthier lives, free of heart disease and stroke. These
diseases, America’s No. 1 and No. 3 killers, and all other
cardiovascular diseases claim nearly 870,000 lives a year. In fiscal
year 2006–07 the association invested more than $554 million in
research, professional and public education, advocacy and community
service programs to help all Americans live longer, healthier lives. To
learn more, call 1-800-AHA-USA1 or visit
americanheart.org.
Medication Guide
for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
By Federal Food and Drug Administration
What is the most important information I should
know about medicines called Non-Steroidal Anti-Inflammatory Drugs
(NSAIDs)?
NSAID medicines may increase the chance of a heart
attack or stroke that can lead to death.
This chance increases:
● with longer use of NSAID medicines
● in people who have heart disease
NSAID medicines should never be used right before
or after a heart surgery called a “coronary artery bypass graft (CABG)."
NSAID medicines can cause ulcers and bleeding in the stomach and
intestines at any time during treatment. Ulcers and bleeding:
● can happen without warning symptoms
● may cause death
The chance of a person getting an ulcer or bleeding
increases with:
● taking medicines called “corticosteroids” and
“anticoagulants”
● longer use
● smoking
● drinking alcohol
● older age
● having poor health
NSAID medicines should only be used:
● exactly as prescribed
● at the lowest dose possible for your treatment
● for the shortest time needed
What are Non-Steroidal Anti-Inflammatory Drugs
(NSAIDs)?
NSAID medicines are use to treat pain and redness,
swelling, and heat (inflammation) from medical conditions such as:
● different types of arthritis
● menstrual cramps and other types of short-term
pain
Who should not take a Non-Steroidal
Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:
● if you had an asthma attack, hives, or other
allergic reaction with aspirin or any other NSAID medicine
● for pain right before or after heart bypass
surgery
Tell your healthcare provider:
● about all of your medical conditions.
● about all of the medicines you take. NSAIDs
and some other medicines can interact with each other and cause serious
side effects. Keep a list of your medicines to show to your healthcare
provider and pharmacist.
● if you are pregnant. NSAID medicines should
not be used by pregnant women late in their pregnancy.
● if you are breastfeeding. Talk to your doctor.
What are the possible side effects of Non-Steroidal
Anti-Inflammatory Drugs (NSAIDs)?
Serious side effects include:
● heart attack
● stroke
● high blood pressure
● heart failure from body swelling (fluid
retention)
● kidney problems including kidney
failure
● bleeding and ulcers in the stomach and
intestine
● low red blood cells (anemia)
● life-threatening skin reactions
● life-threatening allergic reactions
● liver problems including liver failure
● asthma attacks in people who have
asthma
Other side effects include:
● stomach pain
● constipation
● diarrhea
● gas
● heartburn
● nausea
● vomiting
● dizziness
Get emergency help right away if you have any of
the following symptoms:
● shortness of breath or trouble breathing
● chest pain
● weakness in one part or side of your body
● slurred speech
● swelling of the face or throat
Stop your NSAID medicine and call your healthcare
provider right away if you have any of the following symptoms:
● nausea
● more tired or weaker than usual
● itching
● your skin or eyes look yellow
● stomach pain
● flu-like symptoms
● vomit blood
● there is blood in your bowel movement or it is
black and sticky like tar
● unusual weight gain
● skin rash or blisters with fever
● swelling of the arms and legs, hands and feet
These are not all the side effects with NSAID
medicines. Talk to your healthcare provider or pharmacist for more
information about NSAID medicines.
Other information about Non-Steroidal
Anti-Inflammatory Drugs (NSAIDs)
● Aspirin is an NSAID medicine but it does not
increase the chance of a heart attack. Aspirin can cause bleeding in the
brain, stomach, and intestines. Aspirin can also cause ulcers in the
stomach and intestines.
● Some of these NSAID medicines are sold in
lower doses without a prescription (over –the –counter). Talk to your
healthcare provider before using over –the –counter NSAIDs for more than
10 days.
NSAID medicines that need a prescription
Generic Name
Tradename
Celecoxib
Celebrex
Diclofenac
Flector, Cataflam, Voltaren, Arthrotec
(combined with misoprostol)
Diflunisal
Dolobid
Etodolac
Lodine, Lodine XL
Fenoprofen
Nalfon, Nalfon 200
Flurbirofen
Ansaid
Ibuprofen
Motrin, Tab-Profen, Vicoprofen (combined with hydrocodone), Combunox (combined with oxycodone)
Indomethacin
Indocin, Indocin SR, Indo-Lemmon,
Indomethagan
Ketoprofen
Oruvail
Ketorolac
Toradol
Mefenamic Acid
Ponstel
Meloxicam
Mobic
Nabumetone
Relafen
Naproxen
Naprosyn, Anaprox, Anaprox DS, EC-Naproxyn,
Naprelan, Naprapac (copackaged with lansoprazole)
Oxaprozin
Daypro
Piroxicam
Feldene
Sulindac
Clinoril
Tolmetin
Tolectin, Tolectin DS, Tolectin 600
This Medication Guide has been approved by the U.S.
Food and Drug Administration. For more information and updates –
click here.
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