FDA Warns of Antihistamine-Related Deaths in Young Children

Although the Food and Drug Administration FDA approved labeling for the antihistamine, promethazine, already contained a warning about the risk of serious breathing problems when the drug is used by children, a number of deaths in children under two years of age has prompted Emergency Alerts to both healthcare professionals and consumers to advise of a label change that contains “strengthened warnings.”

The Alert released as part of the Patient Information Sheet states that:

“Medications containing promethazine hydrochloride (HCl) should not be used for children less than two years old because of possible breathing problems.  This includes promethazine HCl in any form: syrups, suppositories, tablets, or injectables.  Cases of breathing problems, some causing death, have been reported to the FDA when the drug was used in children less than two years old.”

Parents and caregivers are also cautioned about being “careful and get a doctor’s advice about giving promethazine HCl in any form to children age two and older.  The labeling on all products, brand name and generic, has been changed to reflect these strengthened warnings.”

One manufacturer of suppositories and tablets has already notified healthcare professionals of the changed label.

“The FDA is issuing this safety alert to make sure that healthcare professionals, other caregivers, and patients realize that the warnings apply to promethazine HCl syrups as well.”

In addition to the same patient Alert, the FDA has issued the following “Considerations” and “Data Summary” to healthcare professionals, other caregivers, and patients:

  • All medications containing promethazine HCl—syrups, suppositories, injectables, and tablets— are contraindicated for use in pediatric patients less than two years of age because of the potential for fatal respiratory depression.
  • Caution should also be exercised when administering promethazine HCl medications to pediatric patients two years of age and older.

“Wyeth, a company which markets tablets and suppositories under the brand name Phenergan, has changed the product labeling to show that the drug is contraindicated in children under two.   Wyeth sent a letter to healthcare professionals, alerting them of the labeling change for their tablet and suppository products.   Wyeth is not marketing syrups, but some generic companies still do.   The generic labels also have been changed.”

“Promethazine HCl, an antihistamine, is marketed as tablets, suppositories, injectables, and syrups.   The drug is not for children under two, because it can cause serious side effects, including respiratory depression that could be fatal.   FDA has received reports of serious adverse events, including seven deaths and twenty-two cases of respiratory depression in children under two years of age.”

Promethazine has been an approved drug since March, 1951, and has been the subject of a number of label changes through the years as additional data has become available with respect to adverse reactions and side-effects.

The FDA has provided the following summary of that information for consumers:

“Promethazine is an antihistamine which can be taken by mouth as a tablet or syrup, rectally as a suppository, or by injection.”

The drug is approved for use with respect to the following conditions:

  • “hay fever,” or, a stuffy runny nose from allergy
  • watery, itchy eyes due to inhaled allergies and foods
  • mild allergic skin reactions with itching and swelling
  • allergic reactions to blood or plasma
  • dermographism, a form of hives known as “skin writing”
  • serious allergic reactions along with epinephrine and other treatments
  • sedation before or after surgery, or during childbirth
  • prevention and control of nausea and vomiting after surgery
  • along with meperidine (demerol) or other pain medicines
  • sedation, relief of anxiety, and production of light sleep from which the patient can be easily aroused
  • treatment and prevention of motion sickness

The FDA advises that Promethazine should not be given to:

  • children under two years of age
  • patients who are unconscious
  • patients who are allergic to promethazine, any of the ingredients in promethazine, or to other phenothiazines
  • patients with lung symptoms including asthma
  • children who are vomiting unless the vomiting is prolonged and there is a known cause

There are a number of “major potential risks and side effects of promethazine therapy.” Although the following list has been provided by the FDA, the agency cautions that “this list is not complete.’

  • Severe drowsiness and reduced mental alertness. Promethazine may cause drowsiness which may impair your ability to ride a bike, drive a car, or operate machinery.  This may be worsened if taken with alcohol or other drugs that also cause central nervous system (CNS) slowing such as sedatives, pain medicines, tranquilizers or certain drugs for depression.
  • Serious breathing problems.  Promethazine should not be used in patients with poor lung function such as chronic obstructive lung disease or breathing problems while sleeping (sleep apnea).
  • Increased risk of seizures.  Promethazine should be used with caution in patients with seizures or who are on other medicines which may also increase the risk of seizures.
  • Bone-marrow problems and blood cell production.  Promethazine should not be used in patients with bone-marrow problems or used with other drugs that affect the bone marrow’s production of blood cells.
  • Neuroleptic malignant syndrome.  This potentially deadly syndrome includes symptoms such as fever, muscle rigidity, mental changes, changes in pulse or blood pressure, fast heartbeat, increased sweating or irregular heart rhythm.
  • The most common side effects are drowsiness, changes in blood pressure, skin reactions, blood cell changes and breathing problems.  Increased excitability or abnormal movements may occur after one dose of promethazine.  If they do, consult your doctor about using another medicine.

Patients are cautioned to tell their healthcare professional if they suffer from any of the following conditions before taking promethazine in any form.

  • narrow-angle glaucoma
  • an enlarged prostate
  • a stomach ulcer
  • an intestinal blockage
  • a bladder blockage
  • heart problems
  • liver problems
  • breathing or lung problems
  • sleep apnea (breathing problems when sleeping)
  • seizures
  • drink alcohol
  • are trying to become pregnant, are already pregnant, or are breast-feeding

In addition to the above information, the FDA cautions that promethazine and “certain other medicines can interact with each other.”

As a result, the FDA advises patients to tell their  healthcare professional “about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.  Some medicines may affect how promethazine works or promethazine may affect how your other medicines work.  Know the medicines you take. Keep a list of them with you to show your healthcare professional.”

The FDA advises consumers to “especially” tell their healthcare professional if they are taking:

  • medicines that affect your brain such as anti-anxiety medicine, sleeping pills, pain medicines, sedatives, narcotics, antidepressants or tranquilizers
  • epinephrine
  • a monoamine oxidase inhibitor (MAOI) which is used to treat depression or other mental disorders
  • medicines called anticholinergics

Any serious adverse events should be reported immediately to theFDA’s MedWatch reporting system by completing a form on line at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178), by mail using the postage-paid address form provided online (5600 Fishers Lane, Rockville, MD 20852-9787), or by telephone (1-800-FDA-1088).

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