MEDICATION ALERT BULLETIN 09.2024
1. HEALTH CANADA: RISK OF RHABDOMYOLYSIS WITH LINEZOLID USE
Product information for linezolid-containing medications (including injection solution, powder for suspension, and tablets) in Canada is being and will be updated regarding the risk of rhabdomyolysis associated with the drug in the Precautions, Adverse Effects, and Patient Information sections.
Information for Healthcare Professionals:
Cases of rhabdomyolysis associated with elevated creatine kinase (CK) have been reported with linezolid use. In some cases, rhabdomyolysis may lead to acute kidney injury (AKI).
Consider regular monitoring of creatine kinase (CK) levels in patients who:
- Are at high risk for myopathy or rhabdomyolysis
- Are currently using or have recently used medications associated with myopathy or rhabdomyolysis
- Exhibit any signs or symptoms of rhabdomyolysis, including muscle pain, muscle weakness, dark urine
- If symptoms of rhabdomyolysis occur, linezolid should be discontinued and appropriate intervention measures should be initiated.
Source: Health Product InfoWatch: June 2024 – Canada.ca
Electronic information page of the National DI & ADR Center, accessed on 08/08/2024
2. MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA): ADDITION OF NEW LABEL AND REMINDER OF THE RISK OF SERIOUS ADVERSE EVENTS WHEN DISCONTINUING TOPICAL CORTICOSTEROIDS
Topical corticosteroids are highly effective in treating inflammatory skin conditions such as atopic dermatitis and psoriasis. Topical corticosteroids have varying degrees of potency:
- Low potency (e.g., hydrocortisone acetate 1% cream)
- Medium potency (e.g., Mometasone furoate 0.1% cream or lotion)
- High potency (e.g., Betamethasone dipropionate 0.05% cream)
- Very high potency (e.g., clobetasol 0.05% cream or ointment)
The use of the lowest effective potency corticosteroid should be prioritized.
In the coming year, topical corticosteroids will have new labels added according to their potency to help select medications more accurately and simplify medication guidelines for patients who need to use multiple corticosteroids of varying potencies. The new labels will be: Mild steroid; Moderate steroid; Strong steroid; and Very strong steroid.
Serious adverse effects of topical corticosteroids
Considered effective and safe, topical corticosteroids rarely cause serious adverse effects such as skin atrophy, adrenal insufficiency, or more rarely, Cushing’s syndrome due to systemic absorption of the medication. These adverse effects are associated with the dosage, potency, and duration of use of topical corticosteroids.
The effect of skin thinning is characterized by translucent skin, where small blood vessels under the skin may be visible. This thin skin area is more susceptible to injury and striae. Symptoms of skin thinning are very difficult to detect in patients with brown or black skin, so close monitoring of these individuals is necessary.
The risk of adrenal insufficiencyKidney increases when abusing topical corticosteroids. Symptoms of adrenal insufficiency include low blood pressure, shock, and fainting. This is a serious, life-threatening adverse effect, and patients need to be promptly treated. Sudden discontinuation of topical steroids can be dangerous if the patient has symptoms of adrenal insufficiency, and the patient needs to use oral corticosteroid replacement therapy.
Cushing’s syndrome presents with symptoms such as a red, round, enlarged face, numerous pimples, excessive hair growth on the face and body, high blood pressure, weight gain, stretch marks, slow-healing wounds, and frequent infections.
Patients using corticosteroids, especially those who need to use them for a long time or require very potent corticosteroids, should be instructed on how to recognize these symptoms and contact a healthcare facility immediately when adverse effects occur.
In cases of psoriasis, the use of multiple types of topical corticosteroids can lead to the risk of developing more severe conditions such as generalized pustular psoriasis.
Additionally, there are some reports of the adverse effects of “skin damage upon discontinuation of topical steroids” (Topical Steroid Withdrawal – TSW) that are less frequently mentioned.Although there are still some symptoms that are not clearly understood, current evidence suggests that these symptoms include 4 stages:
- After stopping the medication for a few days, acute manifestations such as red, burning skin, discharge may spread to areas not treated with the medication.
- Dry, itchy skin accompanied by peeling (the phenomenon of skin flaking).
- The skin heals but becomes more sensitive, and intermittent flare-ups may occur.
- The skin returns to its state before stopping topical corticosteroids. The recovery time may be prolonged.
If symptoms suspected to be TSW occur, consideration should be given to continuing the use of topical corticosteroids and seeking alternative treatment therapies.
MHRA’s assessment of skin damage upon discontinuation of topical corticosteroids
The MHRA has conducted an assessment of adverse reaction reports up to August 2023 and noted 267 reports of TSW reactions or symptoms related to TSW. The majority of these reports contained information indicating that patients experienced serious adverse effects when using medium to very potent corticosteroids for extended periods to treat atopic dermatitis.
Reported symptoms primarily included burning itching, cyclical skin peeling, skin shedding, and oozing on the skin. The reports also emphasized that these adverse effects were severe and that patients required medical support due to psychological distress. The MHRA has also received a smaller number of reports indicating that similar reactions may occur even during the use of topical corticosteroids. However, overall, the reported reactions related to discontinuation of the medication were of greater severity.
According to the MHRA, there are over 11 million prescriptions for topical corticosteroids each year. Current dataThe frequency of TSW reactions is estimated to be rare. However, the frequency of these reactions has not been determined due to uncertainties in drug adverse reaction reports and many patients being re-prescribed. The number of reports of adverse reactions must be considered in the context of millions of people being treated with effective topical corticosteroids without encountering any issues.
Recommendations for Healthcare Professionals
- Adverse reactions occur after prolonged use of medium to high-potency topical corticosteroids (approximately 6 months or more), especially when used to treat atopic dermatitis – commonly referred to as “skin damage upon discontinuation of topical corticosteroids” (Topical Steroid Withdrawal – TSW).
- TSW symptoms may include redness, tingling, burning skin, and may extend beyond the treatment area.
- The risk of experiencing these serious reactions increases with prolonged use of high-potency topical corticosteroids.
- Topical corticosteroid-containing medications will have potency labels added to assist in counseling patients.
- When prescribing or dispensing topical corticosteroid medications, it is important to instruct the patient on the dosage, frequency of use, application site, and when to discontinue the medication.
- If the previous discontinuation of corticosteroids may be related to TSW, consider alternative treatment options.
- Support patients experiencing TSW and discuss the treatment plan with them.
Source: Topical steroids: introduction of new labelling and a reminder of the possibility of severe side effects, including Topical Steroid Withdrawal Reactions – GOV.UK (www.gov.uk)
Website of the National DI & ADR Center, accessed on 08/08/2024
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