The FDA has issued an emergency alert warning that giving the antihistamine promethazine to children under 2 years of age may result in serious breathing problems, and that two deaths have allegedly been linked to giving young children the antihistamine.
All types of the drug are being warned against, including syrups, suppositories, tablets and injectable forms.
The alert, warning both doctors and parents, states: "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."
Wyeth, who's antihistabime tablets and suppositories are marketed under the brand name Phenergan, has changed it's labeling in response to this danger.
Antihistamines are typically used to treat food and inhaled allery symptoms such as runny nose, itchy eyes, and for other allergic reactions such as itching and swelling. It has also been used as a sedative before surgery, to control nausea and vomiting after surgery and in the prevention and treatment of motion sickness.
As well as children under 2 years, Promethazine should not be given to anyone who is unconscious, who has asthma, or anyone who is vomiting without known cause.
Other risks and side effects of taking the antihistamine Promethaine include, drowsiness, reduced mental alertness, brathing problems, risk of seizure, bone-marrow problems, fever, muscle rigidity, and changes in blood pressure.