Health Product InfoWatch: January 2024

Key messages for healthcare professionals:^{Footnote 1}

Drug-induced phospholipidosis

• Cardiomyopathy:
  • In multiple cases of cardiomyopathy in patients treated with Plaquenil, endomyocardial biopsy showed an association with phospholipidosis in the absence of inflammation, infiltration, or necrosis.
  • Monitor cardiac function as clinically indicated during therapy.
  • Discontinue Plaquenil if cardiotoxicity is suspected or demonstrated by tissue biopsy.
• Skeletal Muscle Myopathy or Neuropathy:
  • Muscle and nerve biopsies have shown associated phospholipidosis.
  • Monitor muscle strength and deep tendon reflexes during therapy.
  • Discontinue Plaquenil if muscle or nerve toxicity is suspected or demonstrated by tissue biopsy.
• Drug-induced phospholipidosis may also occur in other organ systems.

Hepatotoxicity

• Serious cases of drug-induced liver injury including hepatocellular injury, cholestasis, acute hepatitis and fulminant hepatic failure (including fatal cases) have been reported during use of Plaquenil. Healthcare professionals should assess the benefits/risk of continuing the treatment in patients with significant liver function abnormalities.

Hepatitis B virus reactivation

• The reactivation of hepatitis B virus has been reported in patients treated with hydroxychloroquine administered individually or more often in combination with other immunosuppressants.

Aggravation of Myasthenia Gravis

• Aggravation of symptoms of myasthenia gravis (i.e., weakness of the skeletal muscles, shortness of breath, dysphagia, diplopia etc.) has been reported in myasthenic patients receiving hydroxychloroquine therapy.

Key messages for healthcare professionals:^{Footnote 2}

Hypocalcemia

• In the post-market setting, severe symptomatic hypocalcemia (resulting in hospitalization, life-threatening events and fatal cases) has been reported, particularly in patients with severe renal impairment, receiving dialysis or treatment with other calcium-lowering drugs.
• While most cases occurred in the first weeks of initiating therapy, it can also occur later. Examples of the clinical manifestations of severe symptomatic hypocalcemia have included QT interval prolongation, tetany, convulsions and altered mental status.
• Patients should be advised to report to their physicians any symptoms of hypocalcemia, such as paresthesias or muscle spasms, twitching and muscle cramps.

Pediatrics

• Based on the data submitted and reviewed by Health Canada, the safety and efficacy of Prolia in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use.
• In clinical trials, hypercalcemia has been reported in pediatric patients with osteogenesis imperfecta treated with denosumab. Some cases required hospitalization and were complicated by acute renal injury.

Key messages for healthcare professionals:^{Footnote 3,Footnote 4}

• There have been post-marketing reports of serious psychiatric symptoms in patients treated with finasteride that sometimes continued after treatment discontinuation. Mood alterations including depressed mood, depression, self-harm injury, suicidal ideation, as well as worsening of pre-existing depression have been reported in patients treated with finasteride.
• It is recommended that all patients be screened for suicidal ideation, self-harm, and depression and/or associated risk factors before treatment initiation.
• Clinical monitoring of all patients for signs and symptoms of psychiatric disorders should continue throughout treatment and afterward.
• Propecia: If these symptoms occur, treatment should be discontinued and patients advised to seek medical advice as soon as possible.
• Proscar: If these symptoms occur, patients should be advised to seek medical advice as soon as possible.