American Regent have recalled another of their injectable medications, vasopressin. This is because there is not enough of the active drug in the injection.
Vasopressin is used to treat and prevent post-operative abdominal distention, during abdominal roentgenography and in diabetes insipidus. Abdominal roentgenography is X-ray photography of the abdomen and the vasopressin is used to dispel gas shadows.
Diabetes insipidus occurs when the body can no longer regulate its own water supply. Normally when the body becomes too low on water the hormone vasopressin is released to tell the kidneys to stop producing urine. In diabetes insipidus this hormone doesn’t tell the body to stop producing urine and allows too much water to be passed from the body, causing excessive urination and dehydration.
Symptoms of diabetes insipidus are: needing to pass large amounts of urine, very frequently (as often as every 15 minutes), feeling constantly thirsty, sleeping difficulties and tiredness resulting from interruption of sleep due to excessive urination and feeling unwell.
Children may also cry, have a raised temperature and fail to gain weight. Older children may wet the bed when they have previously been toilet trained.
Some people with mild diabetes insipidus can manage their condition just by drinking lots of water during the day. In more severe cases, a manufactured version of the hormone vasopressin is given via injection. It is also available as a nasal spray.
The affected vasopressin injections are:
Lot number 9677, expiry date October 2011
Lot number 0052, expiry date January 2012
Lot number 0294, expiry date October 2011
Lot number 0442, expiry date December 2011
Lot number 0663, expiry date April 2012
All of the above injections are in 10ml doses.
Further affected lot numbers for 1ml doses are:
Lot number 9532, expiry date August 2011
Lot number 9618, expiry date September 2011
Lot number 9707, expiry date October 2011
Lot number 0104, expiry date February 2012
Lot number 0124, expiry date February 2012
Lot number 0273, expiry date October 2012
Lot number 0346, expiry date November 2011
Lot number 0400, expiry date December 2011
Lot number 0618, expiry date March 2012
Lot number 0758, expiry date May 2012
A 0.5ml dose with lot number 0103 was also affected.
Medical professionals are urged to return these products to American Regent. Physicians with questions about the recall should call the Customer Service Department at 1-877-788-3232: Monday thru Friday from 8:30 AM to 7:00 PM EDT.
Patients who have had an adverse reaction after having these injections can report them to the FDA online at:
www.fda.gov/medwatch/report.htm
Sources:
FDA Press Release, 2nd August 2011 - http://www.fda.gov/Safety/Recalls/ucm266615.htm
Diabetes Insipidus, NHS Choices, page accessed 6th August 2011 - http://www.nhs.uk/Conditions/Diabetes-insipidus/Pages/Introduction.aspx
Reviewed August 8, 2011
by Michele Blacksberg R.N.
Edited by Jody Smith