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Understanding What Are the Side Effects of the Drug Daxas?

4 min read

According to clinical studies, some of the most commonly reported side effects with the drug Daxas (roflumilast) include diarrhea, decreased weight, and nausea. This medication is used to reduce flare-ups in adults with severe chronic obstructive pulmonary disease (COPD) and chronic bronchitis.

Quick Summary

An exploration of Daxas side effects, including frequently reported gastrointestinal issues, weight loss, and sleep disturbances, along with more serious psychiatric risks like depression and suicidal thoughts. It covers management strategies for these adverse reactions.

Key Points

  • Gastrointestinal (GI) Issues are Common: Diarrhea, nausea, and abdominal pain are the most frequently reported side effects of Daxas, particularly during the initial weeks of therapy.

  • Weight Loss Often Occurs: Unintentional weight loss is a significant and common adverse reaction, especially in patients with higher baseline body weight or pre-existing low body weight.

  • Monitor Mental Health Closely: Daxas carries a risk of psychiatric side effects, including insomnia, anxiety, depression, and, rarely, suicidal thoughts or behavior.

  • Timing Matters: Many common side effects, such as GI discomfort and headache, tend to be more pronounced at the beginning of treatment and often improve with continued use.

  • Initial Dose Adjustment May Help: Starting with a lower dose for the first four weeks can help some patients better tolerate Daxas and minimize initial side effects.

  • Alert a Doctor Immediately for Serious Symptoms: Suicidal thoughts, severe allergic reactions, or signs of serious infection are medical emergencies that require prompt attention.

  • Not a Rescue Inhaler: Daxas is for long-term maintenance and does not treat sudden, acute breathing problems. A separate rescue inhaler should always be available.

In This Article

Common Side Effects of Daxas

Daxas, the brand name for roflumilast, is a medication prescribed to manage severe chronic obstructive pulmonary disease (COPD). While it helps reduce the frequency of COPD exacerbations, patients often experience adverse reactions, particularly during the first weeks of treatment. The most frequently reported side effects are centered around gastrointestinal (GI) and neurological systems.

Gastrointestinal Discomfort

GI issues are among the most common adverse effects reported by patients taking Daxas. The active substance, roflumilast, can cause the following symptoms:

  • Diarrhea: Often mild or moderate, diarrhea is the most reported side effect and can lead to discontinuation if severe.
  • Nausea and Vomiting: Patients may experience feelings of sickness or actually vomit, especially at the start of therapy.
  • Abdominal Pain: Stomach aches are also a common complaint.
  • Decreased Appetite: Many users report a reduced desire to eat, which contributes to another common side effect: weight loss.

These symptoms typically appear in the initial weeks of treatment and often diminish over time. However, if they persist or become severe, patients should consult their healthcare provider.

Weight Loss and Insomnia

Another very common side effect of Daxas is unintended weight loss. Clinical trials showed that a significant percentage of patients experienced a decrease in body weight, which was particularly noticeable in those who were overweight or obese at the start of treatment. For patients who are already underweight, this can be a serious concern, and regular weight monitoring by a doctor is advised. Reduced appetite and GI upset are thought to be contributors to this effect. If significant and unexplained weight loss occurs, healthcare providers may consider discontinuing the medication.

Insomnia, or trouble sleeping, is another frequent adverse reaction. Some studies have found a higher incidence of sleep disturbances in elderly patients and those with a lower body weight. It is crucial to inform a doctor if sleep problems arise or worsen during treatment.

Serious Psychiatric Side Effects

Though less common than GI or weight issues, the psychiatric side effects associated with Daxas can be serious. The manufacturer and regulatory bodies have issued warnings regarding mental health risks, particularly in patients with a history of depression. It is important for both patients and their caregivers to be aware of these potential reactions.

  • Anxiety and Nervousness: Some individuals may experience increased feelings of anxiety or nervousness.
  • Depression: Daxas has been linked to depression, which can manifest as feelings of sadness or hopelessness.
  • Suicidal Ideation and Behavior: Rare instances of suicidal thoughts and behaviors, including completed suicides, have been reported in clinical trials and post-marketing experience. These can occur in patients with or without a prior history of depression.

If any new or worsening psychiatric symptoms are observed, including changes in mood or behavior, patients or their caregivers should immediately contact a healthcare provider. For patients with a history of depression or suicidal thoughts, the risks and benefits of taking Daxas must be carefully weighed before starting treatment.

Managing Side Effects and When to Seek Medical Help

Managing the side effects of Daxas often involves collaboration between the patient and their healthcare provider. For common side effects like GI upset, symptoms often subside as the body adjusts to the medication. Starting with a lower initial dose (250mcg for the first four weeks) before increasing to the maintenance dose (500mcg) can also help to mitigate initial side effects and improve tolerability.

For more persistent issues, or for weight loss and mental health changes, active monitoring is key. Patients should have their weight checked regularly, and any unexplained loss should be investigated. Immediate medical attention is required for serious allergic reactions, characterized by swelling of the face, lips, or tongue, and difficulty breathing. Likewise, any signs of severe infection or new psychiatric symptoms warrant immediate contact with a doctor.

Comparison of Common vs. Serious Daxas Side Effects

Feature Common Side Effects Serious Side Effects
Frequency More frequent, especially in the first few weeks. Less frequent, but require immediate attention.
Symptom Type Gastrointestinal upset (diarrhea, nausea), headache, insomnia, decreased appetite, weight loss. Psychiatric issues (anxiety, depression, suicidal thoughts), severe allergic reactions (angioedema), severe infections.
Onset Often starts early in treatment and may resolve over time. Can occur at any time, sometimes after the initial weeks.
Management Often managed with continued treatment or dose adjustments; contact doctor if persistent. Requires immediate medical evaluation and potential discontinuation of the drug.
Monitoring Regular weight monitoring is essential. Close monitoring for mood or behavioral changes by patient and caregiver.

Conclusion

In conclusion, understanding what are the side effects of the drug Daxas is crucial for patients with severe COPD. While many individuals experience common and manageable issues like gastrointestinal upset and weight loss, especially at the beginning of treatment, the potential for serious psychiatric side effects must be acknowledged. Open communication with a healthcare provider is paramount for monitoring symptoms, managing potential side effects, and ensuring the continued safety and effectiveness of the treatment plan. Patients should be aware that Daxas is a preventive medication, not a rescue inhaler, and any concerning symptoms should be promptly addressed with a medical professional. Further information on Daxas can be found in the manufacturer's product monograph. [https://www.astrazeneca.ca/content/dam/az-ca/downloads/productinformation/daxas-product-monograph-en.pdf]

Frequently Asked Questions

Diarrhea is a very common side effect, especially when you first start taking Daxas. It often resolves with continued treatment. If it is severe, persistent, or bothersome, consult your doctor or pharmacist for advice.

Yes, weight loss is a common side effect of Daxas. Regular weight monitoring is recommended. If you experience significant or unexplained weight loss, your doctor may re-evaluate your treatment.

Daxas is associated with an increased risk of psychiatric issues, including insomnia, anxiety, depression, and, in rare instances, suicidal ideation. Patients or caregivers should immediately report any new or worsening mood changes to a doctor.

You should not stop taking Daxas abruptly without consulting your doctor. Your doctor may suggest adjusting your dose or exploring other strategies to manage side effects. Discontinuing without medical advice may worsen your COPD symptoms.

Early side effects, often occurring within the first few weeks, commonly include gastrointestinal issues like diarrhea and nausea, as well as headache, insomnia, and decreased appetite. For many, these subside over time.

Daxas should not be taken by patients with moderate to severe liver impairment. Use is also not recommended for those with a history of depression associated with suicidal thoughts, or those with certain severe immune diseases.

No, Daxas is not a rescue medication. It is a long-term maintenance treatment to reduce the frequency of COPD exacerbations. You should always have a separate rescue inhaler for sudden shortness of breath.

Signs of a severe allergic reaction, though rare, include swelling of the face, lips, or tongue, and difficulty breathing. If these occur, stop taking Daxas and seek immediate emergency medical attention.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.