Other safety alerts
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| The United Kingdom: Methotrexate: advise patients to take precautions in the sun to avoid photosensitivity reactions |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that photosensitivity reactions are known side effects of methotrexate treatment and can be severe. Patients should be advised to take precautions to protect their skin in the sun.
The MHRA has recently received a Coroner’s report following a case of a photosensitivity reaction in a patient on methotrexate. This reaction was found to have contributed to death by secondary infection. As a result of this, the MHRA has reviewed the information available to healthcare professionals and patients regarding these reactions and sought advice from the Pharmacovigilance Expert Advisory Group (PEAG) of the Commission on Human Medicines.
Photosensitivity reactions are established side effects of methotrexate treatment and are currently listed in the product information, including the Patient Information Leaflet. However, the PEAG was concerned that it is not a well-known side effect and many patients may not be aware of the additional risks of sun exposure during methotrexate treatment.
Prescribers and pharmacists are reminded to inform patients of the risk of photosensitivity reactions and to advise them to use a product with a high sun protection factor and clothing that covers the skin when in the sun. The MHRA is working with Marketing Authorisation Holders of methotrexate medicines to provide updates to the product information as appropriate.
Photosensitivity reactions often look and feel like sunburn. They can leave sun-exposed skin with a rash, redness, swelling, blisters, red bumps or oozing lesions. Severe cases can cause secondary skin infection. Photosensitivity reactions fall into two categories: phototoxic reactions and photoallergic reactions. In phototoxic reactions, a drug is activated by exposure to UV light and causes damage to the skin that can look and feel like a sunburn or a rash. These reactions can happen within minutes or after hours of exposure and are usually limited to the skin that has been exposed. Photoallergic reactions occur when UV rays interact with the ingredients in medicines or other products applied directly to the skin. The body’s immune system recognizes changes caused by sun exposure as a foreign threat. The body produces antibodies and attacks, causing a reaction. These reactions are distinct from “recall” reactions where radiation-induced dermatitis and sunburn can reappear on re-exposure to radiation and sunlight while on methotrexate therapy.
Advice for healthcare professionals:
- Photosensitivity reactions (which include phototoxicity, where a drug is activated by exposure to UV light and causes damage to the skin that can look and feel like a sunburn or a rash) are known side effects of methotrexate treatment and can occur with both low-dose and high-dose treatment.
- Reactions manifest as severe sunburn such as rashes with papules or blistering, with some patients reporting swelling; rarely, photosensitivity reactions have contributed to deaths from secondary infections.
- Healthcare professionals, including those prescribing and dispensing methotrexate, should remind patients to take precautions to protect themselves from the sun and UV rays.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/methotrexate-advise-patients-to-take-precautions-in-the-sun-to-avoid-photosensitivity-reactions
In Hong Kong, there are 10 registered pharmaceutical products containing methotrexate. All products are prescription-only medicines. So far, the Department of Health (DH) has received 90 cases of adverse drug reaction related to methotrexate, but these cases were not related to photosensitivity reactions.
The product inserts of the above locally registered pharmaceutical products containing methotrexate include safety information about photosensitivity reactions. The risk of photosensitivity reactions associated with the use of methotrexate is also documented in overseas reputable drug references such as the “Martindale: The Complete Drug Reference”. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Thursday, Aug 31, 2023
Issued at HKT 16:00
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