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OXYCONTIN LAWYERS
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Purdue Pharma's "Dear Health Care
Professional" letter warning physicians of the associated dangers of
Oxycontin ...
July 18, 2001
Dear Health Care Professional,
Reports of illegal misuse, abuse, and diversion of OxyContinÒ
Tablets from various parts of the country have prompted Purdue Pharma
L.P. to revise sections of the prescribing information, specifically
1) WARNINGS (including a new Box Warning) which call attention to the
potential for misuse, abuse and diversion and 2) INDICATIONS which
reinforces the appropriate patient population for whom this product is
intended.
OxyContinÒ is an opioid agonist and a Schedule II controlled
substance with an abuse liability similar to morphine. This should be
considered when prescribing or dispensing OxyContinÒ in situations
where the prescriber or pharmacist is concerned about an increased
risk of misuse, abuse, or diversion. While concerns about abuse,
addiction, and diversion should not prevent the proper management of
pain, healthcare professionals should be alert to the problems of
misuse, abuse, and diversion.
The labeling changes will be implemented within the next several
weeks. In the meantime, we want you to be aware of this important
safety information. Listed below are highlights of important changes
to WARNINGS and INDICATIONS. You should consult the full prescribing
information accompanying this letter for all of the changes.
The following BOX WARNING has been added:
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WARNING:
OxyContinÒ is an opioid agonist and a Schedule II
controlled substance with an abuse liability similar to
morphine.
Oxycodone can be abused in a
manner similar to other opioid agonists, legal or illicit.
This should be considered when prescribing or dispensing
OxyContinÒ in situations where the physician or pharmacist is
concerned about an increased risk of misuse, abuse, or
diversion.
OxyContin® Tablets are a controlled-release oral
formulation of oxycodone hydrochloride indicated for the
management of moderate to severe pain when a continuous,
around-the-clock analgesic is needed for an extended period of
time.
OxyContin® tablets are NOT intended for use as a
prn analgesic.
OxyContin® 80 mg
and 160 mg Tablets ARE FOR USE IN OPIOID TOLERANT PATIENTS
ONLY. These tablet strengths may cause fatal respiratory
depression when administered to patients not previously
exposed to opioids.
OxyContinÒ (oxycodone hydrochloride controlled-release)
TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN,
CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED OR CRUSHED
OxyContinÒ TABLETS LEADS TO A RAPID RELEASE AND ABSORPTION OF
A POTENTIALLY FATAL DOSE OF OXYCODONE.
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This is also reinforced in WARNINGS.
The INDICATIONS AND USAGE section now reads:
OxyContinÒ tablets are a controlled-release oral formulation of
oxycodone hydrochloride indicated for the management of moderate
to severe pain when a continuous, around-the-clock analgesic is
needed for an extended period of time.
OxyContin® is NOT intended for use as a prn
analgesic.
Physicians should individualize treatment in every case,
initiating therapy at the appropriate point along a progression
from non-opioid analgesics, such as nonsteroidal anti-inflammatory
drugs and acetaminophen, to opioids in a plan of pain management
such as outlined by the World Health Organization, the Agency for
Healthcare Research and Quality [formerly known as the Agency for
Health Care Policy and Research], the Federation of State Medical
Boards Model Guidelines, or the American Pain Society.
OxyContinÒ is not indicated for pain in the immediate
post-operative period (the first 12-24 hours following surgery),
or if the pain is mild, or not expected to persist for an extended
period of time. OxyContinÒ is only indicated for post-operative
use if the patient is already receiving the drug prior to surgery
or if the postoperative pain is expected to be moderate to severe
and persist for an extended period of time. Physicians should
individualize treatment, moving from parenteral to oral analgesics
as appropriate. (See American Pain Society guidelines.)
It is important that you forward any
adverse event information associated with the use of OxyContinÒ
Tablets to Purdue Pharma L.P. at 1-888-726-7535 (prompt #2). You can
also report this information directly to the FDA via the MedWatch
system at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail (using a
postage-paid form), or the internet at
www.fda.gov/medwatch.
If you have any questions on how to prevent and detect abuse or
diversion of this product, you should contact your State Professional
Licensing Board or State Controlled Substances Authority for
information.
The abuse and diversion of prescription drugs has become a
significant public health issue in the United States. Purdue Pharma
L.P. is proud to be the first pharmaceutical manufacturer to
voluntarily revise prescribing information for a Schedule II opioid in
order to address the issue of abuse and diversion.
Sincerely,
Robert F. Reder, MD
Vice President, Medical Affairs and Worldwide Drug Safety
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