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8-MOP (Methoxsalen) - Side Effects and Adverse Reactions

 
 



VII. ADVERSE REACTIONS

  1. METHOXSALEN:

    The most commonly reported side effect of methoxsalen alone is nausea, which occurs with approximately 10% of all patients.  This effect may be minimized or avoided by instructing the patient to take methoxsalen with milk or food, or to divide the dose into two portions, taken approximately one-half hour apart.  Other effects include nervousness, insomnia, and psychological depression.

  2. COMBINED METHOXSALEN/UVA THERAPY:

      PRURITUS: This adverse reaction occurs with approximately 10% of all patients.  In most cases, pruritus can be alleviated with frequent application of bland emollients or other topical agents; severe pruritus may require systemic treatment.  If pruritus is unresponsive to these measures, shield pruritic areas from further UVA exposure until the condition resolves.  If intractable pruritus is generalized, UVA treatment should be discontinued until the pruritus disappears.

    1. ERYTHEMA: Mild, transient erythema at 24-48 hours after PUVA therapy is an expected reaction and indicates that a therapeutic interaction between methoxsalen and UVA occurred.  Any area showing moderate erythema (greater than Grade 2 – See Table 1 for grades of erythema) should be shielded during subsequent UVA exposures until the erythema has resolved.  Erythema greater than Grade 2 which appears within 24 hours after UVA treatment may signal a potentially severe burn.  Erythema may become progressively worse over the next 24 hours, since the peak erythemal reaction characteristically occurs 48 hours or later after methoxsalen ingestion.  The patient should be protected from further UVA exposures and sunlight, and should be monitored closely.

    2. IMPORTANT DIFFERENCES BETWEEN PUVA ERYTHEMA AND SUNBURN: PUVA-induced inflammation differs from sunburn or UVB phototherapy in several ways.  The in situ depth of photochemistry is deeper within the tissue because UVA is transmitted further into the skin.  The DNA lesions induced by PUVA are very different from UV-induced thymine dimers and may lead to a DNA crosslink.  This DNA lesion may be more problematic to the cell because crosslinks are more lethal and psoralen-DNA photoproducts may be “new” or unfamiliar substrates for DNA repair enzymes.  DNA synthesis is also suppressed longer after PUVA.  The time course of delayed erythema is different with PUVA and may not involve the usual mediators seen in sunburn.  PUVA-induced redness may be just beginning at 24 hours, when UVB erythema has already passed its peak.  The erythema dose-response curve is also steeper for PUVA.  Compared to equally erythemogenic doses of UVB, the histologic alterations induced by PUVA show more dermal vessel damage and longer duration of epidermal and dermal abnormalities.

    3. OTHER ADVERSE REACTIONS:  Those reported include edema, dizziness, headache, malaise, depression, hypopigmentation, vesiculation and bullae formation, non-specific rash, herpes simplex, miliaria, urticaria, folliculitis, gastrointestinal disturbances, cutaneous tenderness, leg cramps, hypotension, and extension of psoriasis.

Drug label data at the top of this Page last updated: 2009-02-02

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