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The Food and Drug Administration (FDA) has ordered a black box warning to be added to the professional product labeling, or package insert, of the antinausea drug promethazine (PHENERGAN). The warning concerns respiratory depression and death with its use in children less than two years of age. Antinausea drugs are also referred to as antiemetics.
Promethazine is a very old drug first approved for use in the U.S. in 1951. It belongs to the family of drugs known as phenothiazines that...
The Food and Drug Administration (FDA) has ordered a black box warning to be added to the professional product labeling, or package insert, of the antinausea drug promethazine (PHENERGAN). The warning concerns respiratory depression and death with its use in children less than two years of age. Antinausea drugs are also referred to as antiemetics.
Promethazine is a very old drug first approved for use in the U.S. in 1951. It belongs to the family of drugs known as phenothiazines that includes the antipsychotic drugs chlorpromazine (THORAZINE), trifluoperazine (STELAZINE) and a number of others.
Our examination of the FDA’s adverse drug reaction database suggested that seven young children may have died while taking promethazine. However, the FDA estimates that only one in ten serious adverse drug reactions are reported, placing the estimate of the actual number of deaths with this drug closer to 70.
A black box warning is the strongest type of warning that the FDA can require on a drug’s professional product labeling. It is usually reserved for those drugs which are known to cause death or serious injury. Unfortunately, black box warnings are not very effective in changing a physician’s prescribing habits and thus protecting patients from preventable harm. There is no requirement that a physician tell a patient about the existence of a black box warning or that pharmacists give patients the FDA-approved labeling for a drug with a black box warning at the time of dispensing.
The absurdity of requiring a black box warning is that, in general, only pharmacists and physicians see the warning and neither is at risk of harm from the drug. Only the patient or the patient’s child faces the possibility of harm.
The FDA could have required that a Medication Guide be distributed with each new and refilled prescription for promethazine because this drug can cause significant harm. A Medication Guide is FDA-approved written information for patients that is written in non-technical language. We feel that it is irresponsible that the FDA did not take this step to inform consumers.
The text of the promethazine black box warning reads:
WARNINGS PHENERGAN SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH USE OF PHENERGAN IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PHENERGAN HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PHENERGAN TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PHENERGAN BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED. |
Additional information is also required for prescribers in promethazine’s professional product labeling. Physicians are instructed that antiemetics are not recommended for the treatment of uncomplicated vomiting in children, and that their use should be limited to prolonged vomiting when the cause of the vomiting is known.
Physicians are also reminded that promethazine can cause a drug induced movement disorder called extrapyramidal symptoms. These drug induced movements may be confused with the central nervous system signs of an undiagnosed disease such as a brain disorder (encephalopathy) or liver disease.
What You Can Do
You should not administer promethazine tablets or rectal suppositories to children two years of age or less.
