Desmopressin Removed From UK Market for Bedwetting But Still Approved in the US

Desmopressin nasal spray (DDAVP, MINIRIN, STIMATE) and multiple generic versions), which is used to treat bedwetting in children, is no longer approved for that use in the United Kingdom (UK), according to an April 18, 2007 announcement from the UK equivalent of the Food and Drug Administration.

The UK authorities’ decision was based on reports of serious side effects, including water intoxication, low body sodium levels (hyponatremia) and convulsions.

Unfortunately, the drug remains approved for bedwetting in the United States. However, the current US professional product labeling (also known as a package insert) for desmopressin nasal spray does warn of the possibility of low sodium levels and related water intoxication.

Low sodium levels can be dangerous. The concentrations of sodium are equal in the blood and in the fluid between the cells (extracellular sodium levels) and much lower inside of cells. But if extracellular sodium levels fall, water will seep into the cells in order to increase the extracellular sodium levels, making the cells swell. Most cells in the body can accommodate this swelling, but brain cells cannot because they are confined by the skull. Therefore, most symptoms of low body sodium levels will result from brain swelling.

Common symptoms of low sodium levels include:

• Loss of appetite
• Nausea
• Vomiting
• Headache
• Restlessness
• Fatigue
• Irritability
• Abnormal mental status
• Coma
• Hallucinations
• Decreased consciousness
• Confusion
• Convulsions
• Muscle weakness
• Muscle spasms or cramps

What You Can Do
  
Do not use desmopressin for bedwetting.

Low sodium levels can be a life-threatening emergency.  Seek medical help immediately if the symptoms listed above develop in someone using desmopressin nasal spray.