The Food and Drug Administration (FDA) announced on November 19, 2010 its intention to withdraw medications containing the drug propoxyphene from the United States market due to new data that reveals the drug may be toxic to the heart. It has asked that all manufactures of propoxyphene voluntarily withdraw their products, a request that Xanodyne Pharmaceutical, Inc., maker of Darvon and Darvocet, has already agreed to comply with. The FDA has stated that it expects that companies manufacturing generic forms of propoxyphene will also concede to its request.
If you are taking propoxyphene, contact your healthcare professional to discuss switching medications. Even though numerous alternatives are available, including codeine, oxycodone, aspirin, acetaminophen, and ibuprofen, it is not advised that you take yourself off of your currently prescribed medication without first consulting with a doctor. Because propoxyphene is a narcotic, suddenly discontinuing its use could cause withdrawal symptoms such as nausea, vomiting, diarrhea, anxiety, and shivering.
Although you shouldn’t wait too long to speak with your healthcare professional about alternatives to propoxyphene, it is imperative that you immediately contact him or her if you experience any of the following side effects, which could be indicative of a heart problem:
- An abnormal heart rate or rhythm
- Dizziness and lightheadedness
- Fainting or feeling like you might pass out
- Heart palpitations
- Shallow breathing/feeling short or breath
Even when propoxyphene is taken at recommended doses, it can cause significant changes to the heart’s electrical activity. In rare cases, sudden death can occur. And relatively small shifts in your health, such as dehydration and a change in medications, can place you at increased risk of an adverse reaction. Elderly patients and those with impaired kidney function are particularly susceptible due to a decreased ability to eliminate propoxyphene from the body. The FDA points out, however, that changes to heart are not cumulative, and ending use of the drug eliminates the risk.
Propoxyphene can be deadly even if taken as prescribed, but one of the most dangerous aspects of the drug is the thin margin between a therapeutic dose and an overdose. A high proportion of overdoses are accidental and even taking as little as four times the recommended dose can cause your breathing and heart rate to slow. Six times the standard dose can cause seizures and toxic psychosis. Taking alcohol and other depressants can significantly increase the risk of an overdose. And because propoxyphene is a narcotic, it has the potential to create tolerance. A patient may increase his or her dose in order to achieve the same effect and suffer an overdose, the symptoms of which include:
- A bluish skin tone
- Coma
- Convulsions
- Decreased or difficulty breathing
- Extreme sleepiness
- Low blood pressure
- Very small pupils
- Decreased heart function
- Irregular heartbeat
Finally, some individuals may experience an allergic reaction to propoxyphene and develop symptoms such as:
- A rash
- Hives
- A swollen face and mouth
- Cold, clammy skin
- Confusion
- Unconsciousness
- Difficulty breathing
- Chest tightness
Any of the symptoms described above, whether the result of heart rhythm abnormities (arrhythmia), an overdose, or an allergic reaction, are cause to seek medical assistance immediately.
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