Iowaccess.org

To: All Healthcare Professionals
Re: Further Education on Propoxyphene Products
Date: February 14, 2011
Background for Notice
On November 19, 2010, the U.S. Food & Drug Administration recommended the withdrawal of propoxyphene products
from the US market. The drug was pul ed from the market in response to study data that demonstrated propoxyphene,
even at recommended doses, caused heart rhythm abnormalities including prolonged PR interval, widened QRS
complex, and prolonged QT interval1. If any patients have not been switched from propoxyphene, healthcare providers
should work with patients to find an alternative option to help control their pain. A list of alternative medications is
included in this notice along with information for your patients taking propoxyphene products.

Propoxyphene Drug Information
Propoxyphene is a schedule IV opioid approved to treat mild to moderate pain. It has been available as a single
ingredient or combined with acetaminophen and marketed as generic and branded products (e.g. Darvon®, Darvocet® )
The analgesic effect, onset, and duration of action of propoxyphene hydrochloride 65mg or propoxyphene napsylate
100mg is comparable to that of 650mg of acetaminophen2. Propoxyphene and its metabolite have an extended
elimination half-life of 30-36 hours3 that is even longer in the elderly. This contributes to an accumulation of medication
and increased risk of adverse events. Abrupt discontinuation fol owing prolonged use of any opioid, including
propoxyphene, may lead to withdrawal symptoms.
Monitoring Patients after Therapy Change
• Educate patients on how a new pain medication works, any changes in the onset of effect, and what to expect. • Schedule a follow-up visit to assess pain control and address patient questions. This is an important step to achieve therapeutic success and improve adherence to therapy. • Specific monitoring is suggested for NSAID use in older persons. The American Geriatric Society recommends
baseline identification and eradication of H. Pylori, baseline CBC with creatinine, with repeat creatinine three months after long-term therapy is initiated, and annual CBC with creatinine for duration of therapy [5]. ------------------------------------------------------------------------------------------------------------------
Information for Patients
Propoxyphene is a medication used to help control mild to moderate pain. It is available as a single drug or in
combination with acetaminophen (Tylenol®). Propoxyphene is marketed as generic and under brand names such as
Darvon®, Darvocet®. A recent study led the Food & Drug Administration (FDA) to recommend the withdrawal of
propoxyphene because taking the medicine, even at the recommended doses, could cause serious heart rhythm
problems. There are many other medications you can use to help control your pain. If you are taking propoxyphene, you
should work with your physician, pharmacist, or other healthcare provider to find the right medication for you.
If you have unused propoxyphene, safely dispose of the medication in household trash by:
1) Crush or dissolve the drug in water 2) Mix with something that will hide the medicine or make it unappealing, such as
kitty litter or used coffee grounds 3) Place the mixture in a sealed plastic bag 4) Throw the container in your household
trash. The DEA Drug Take Back Day is on Saturday, April 30th and is another option to get rid of unused propoxyphene.
For more information go to:

Alternatives to Propoxyphene-Containing Medications [1,3,4,5]
To: All Healthcare Professionals
Re: Further Education on Propoxyphene Products
Date: February 14, 2011
Medication
Max. Dose
Patient Considerations
Non-Opioid Analgesics (first choice for mild-moderate pain)
-First-line for management of pain in the elderly -Use with caution if patient consumes more than -Max dose if liver impaired is 2000mg/day -Use NSAIDs cautiously in patients with diabetes, hypertension, renal insufficiency, and history of -NSAIDs demonstrate a dose and time dependent adverse event profile including GI bleeding -Recommend separating concomitant cardioprotective low-dose aspirin administration due to heightened bleeding risk -The American Geriatric Society (AGS)[5] recommends against the first-line use of NSAIDs in geriatric patients -See the 2009 update of the AGS guidelines for more on the use of NSAIDs in older persons[5] Opioid Analgesics (use for moderate-severe pain not control ed by above)
Hydrocodone/
-Use with caution if patient consumes more than acetaminophen 3 alcoholic beverages per day. -Max dose if liver impaired is 2000mg/day of acetaminophen -Monitor for drowsiness, nausea and constipation -Monitor for opioid side effects of drowsiness, -Risk of seizures if used in high doses or in predisposed patients
References:
1Propoxyphene containing products. Postmarket Drug Safety Information for Patients and Providers. www.fda.gov 2Market withdrawal: Propoxyphene-containing products. Kaiser Permanente Interoffice Memorandum. Nov 2010. 3Lexicomp Online. “Propoxyphene, naproxen.” Retrieved January 14, 2011, fro 4Katz JD and Shah, T. Persistent pain the older adult: what should we do now in light of the 2009 American geriatrics society clinical practice guildeine? Pol Arch Med Wewn. 2009 Dec: 119 (12) 795-800. 5American Geriatrics Society Panel on Pharmacological Management of Persistent Pain in Older Persons. Pharmacological management of persistent pain in older persons. J Am Geriatr Soc. 2009; 57: 1331-1346.

Source: http://www.iowaccess.org/nursing/images/pdf/PropoxGuidanceStatement.pdf