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Purdue Responds to Letter from Pennsylvania
Attorney General Mike Fisher
Purdue Pharma L.P. received a letter
on Wednesday, August 21 from Attorney General Mike Fisher of
Pennsylvania in which he called upon Purdue to stop what he termed
“aggressive marketing practices, such as conversion charts in pens”
to sell its prescription medication, OxyContin (oxycodone HCl
controlled-release) Tablets.
Patients who come to a doctor’s office with pain are often taking
some pain medications. Before the doctor prescribes any new pain
medication it is important to determine the patient’s current dosage
in some standard manner. Dose titration and conversion information
is important for the patient’s safety - to ensure that patients do
not receive too little or too much medicine. Such dose titration and
conversion charts are commonly provided as a service to physicians.
“Purdue is responsible in its marketing and promotional activities.
We do not agree that our distribution of this promotional item was
in any way inappropriate, however, this is not an issue since the
pen in question is no longer being distributed” said Michael
Friedman, Chief Operating Officer of Purdue. “ On August 17, in
compliance with FDA regulations, Purdue discontinued all promotional
materials currently in use to replace them with updated materials
that reflect the recent labeling changes the company has made, in
cooperation with the FDA. This action was undertaken as part of the
standard regulatory procedure to update our promotional items and is
not in response to any request from law enforcement. We regret that
the Attorney General did not seek clarification from us on this
issue before making these critical remarks today.”
The medications on the dosing chart, which combine narcotic
analgesics with acetaminophen or aspirin, are often prescribed for
moderate or moderately severe pain , . OxyContin is indicated for
the management of moderate to severe pain when a continuous,
around-the-clock analgesic is needed for an extended period of time.
“Therefore, since there is an overlap between the indications of
these medications and OxyContin, it is entirely appropriate for a
physician to consider changing treatment for some patients who are
taking those medications on the dosing chart for moderate pain to
OxyContin, if the physician judges that a continuous,
around-the-clock analgesic is needed for an extended period of
time,” says J. David Haddox, D.D.S., M.D., a pain physician who is a
senior medical director at Purdue Pharma.
The dosing chart in the pen contained the following language “For
patients with moderate to severe pain requiring opioid therapy for
more than a few days” and included warnings and precautions known as
“fair balance” information.
“There are several circumstances in which physicians will change a
patient’s medication to better manage their treatment, including
progression of pain or disease”, according to Dr. Haddox. “As
chronic use of acetaminophen has been associated with an increased
risk of liver toxicity, extended analgesic therapy with single
entity opioid analgesics is sometimes appropriate. When making such
a change in therapy, it is important for the physician to have
accurate information as to the appropriate conversion dose from one
drug to another.”
The labeling for OxyContin contains the following warning for
patients and physicians:
OxyContin 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 OxyContin 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.
Oxycontin Tablets are to be swallowed whole and are not to be
broken, chewed, or crushed. Taking broken, chewed, or crushed
oxycontin tablets leads to rapid release and absorption of a
potentially fatal dose of oxycodone.
Full prescribing information for OxyContin Tablets can be found
online at the Purdue web site at http://www.pharma.com/news/docs/oxyPackageInsert.pdf.
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