Drugs Q & A

Why Was Distalgesic Discontinued?

Distalgesic is a pain-relieving medication that contains two active ingredients: paracetamol (also known as acetaminophen) and dextropropoxyphene. It was first introduced in the 1970s and was commonly used to treat moderate to severe pain, such as postoperative pain, dental pain, and chronic pain.

However, in 2005, the European Medicines Agency (EMA) recommended that Distalgesic be withdrawn from the market due to safety concerns. The agency found that dextropropoxyphene, which is a type of opioid, had a high risk of causing serious side effects, such as heart rhythm disturbances and overdose. In addition, the EMA found that the benefits of using Distalgesic did not outweigh the risks.

As a result, Distalgesic has been withdrawn from the market in many countries, including the United Kingdom and many European countries. In the United States, dextropropoxyphene was withdrawn from the market in 2010, and products containing the drug are no longer available.

What are the disadvantages of Distalgesic?

Distalgesic was withdrawn from the market due to safety concerns, primarily related to its active ingredient dextropropoxyphene. The disadvantages of Distalgesic include:

1.      Risk of overdose: Dextropropoxyphene, which is an opioid, has a narrow therapeutic index, meaning that the difference between a therapeutic dose and a toxic dose is small. Overdose can occur accidentally or intentionally and can be life-threatening.

2.      Risk of addiction: Opioids such as dextropropoxyphene have a high risk of addiction and dependence, especially when used for a prolonged period or in high doses.

3.      Risk of heart rhythm disturbances: Dextropropoxyphene can cause changes in the electrical activity of the heart, leading to a potentially life-threatening condition called torsades de pointes.

4.      Interactions with other medications: Dextropropoxyphene can interact with other medications, including antidepressants, sedatives, and antihistamines, leading to an increased risk of side effects or overdose.

5.      Lack of efficacy: The efficacy of Distalgesic in treating pain has been questioned, with some studies showing that the combination of paracetamol and dextropropoxyphene may not be more effective than paracetamol alone.

Due to these disadvantages and safety concerns, Distalgesic has been withdrawn from the market in many countries. Patients should talk to their healthcare provider about alternative pain-relieving options that may be safer and more effective.

It is important for patients to talk to their healthcare provider before taking any pain-relieving medication and to follow the dosage and administration instructions provided by the healthcare provider or pharmacist. Patients should also be aware of the potential risks and side effects associated with the medication and should seek medical attention immediately if they experience any severe or persistent symptoms.

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Dr. Oche Otorkpa PG Cert, MPH, PhD

Dr. Oche is a seasoned Public Health specialist who holds a post graduate certificate in Pharmacology and Therapeutics, an MPH, and a PhD both from Texila American University. He is a member of the International Society of Substance Use Professionals and a Fellow of the Royal Society for Public Health in the UK. He authored two books: "The Unseen Terrorist," published by AuthorHouse UK, and "The Night Before I Killed Addiction."
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