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Promethazine Contraindicated in Children Younger than Two
In 2005, Wyeth Pharmaceuticals notified health care professionals that Phenergan brand promethazine hydrochloride was contraindicated in children under the age of two because the drug could cause fatal respiratory depression. Now, the labeling on all products containing promethazine HCl, both brand name and generic, has been changed to reflect these strengthened warnings. Promethazine has a number of uses, including as an antihistamine, a perioperative sedative and antiemetic, and to help control postoperative pain. It is available in several formulations, including syrups, suppositories, tablets or injectables.
Practitioners should also be cautious when using promethazine in older children because respiratory depression can also occur in this age group, even when the dose has been calculated according to the child's weight. This risk may increase when promethazine is used along with other drugs that can cause respiratory depression.
Length: 66
Rating: 0.00 (0 ratings)
Tags: Promethazine HCl Hydrochloride Phenergan FDA Fatal Respiratory Depression Children Patient Safety Drug Reaction
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Severe Tissue Injury with IV Promethazine (Dec. 06)
This story originally aired in December 2006. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern.
The Institute for Safe Medication Practices recently warned that administering promethazine parenterally may cause more severe tissue injuries than previously recognized. Promethazine, which is commonly sold under the trade name Phenergan, has many uses including as an antihistamine, a sedative and an antiemetic.
ISMP points that out promethazine is a known vesicant which is highly caustic to the intima of blood vessels and surrounding tissue. Deep intramuscular injection into a large muscle is the preferred parenteral route of administration, and is least likely to cause damage. But promethazine is also given by slow IV push in many hospitals. The IV route, along with inadvertent intra-arterial or subcutaneous administration is most likely to result in significant complications, ranging from burning and pain to paralysis, tissue necrosis, and gangrene. Sometimes surgical intervention such as fasciotomy, skin graft or even amputation is needed.
ISMP describes several recent cases where severe tissue damage occurred following IV administration of promethazine. For example, in one case a 19-year-old woman who went to the emergency department with flu-like symptoms was given Phenergan IV. During the injection, she cried out in pain, and after the injection she told the nurse that her arm was still in significant pain and that she felt "something was wrong." The nurse reassured her and then left the room. The patient's arm and fingers became purple and blotchy and then over the next several weeks eventually turned black and shriveled. Her thumb, index finger, and top of her middle finger eventually had to be amputated.
ISMP points out that the product labeling makes several recommendations to reduce the risk of these adverse events. They include giving the drug in concentrations no greater than 25 mg/mL, administering the drug at a rate no greater than 25 mg/minute, injecting the drug through the tubing of an infusion set that's running and known to be working satisfactorily, and stopping the injection immediately if the patient reports burning in order to investigate whether there might be intra-arterial placement or perivascular extravasation.
In addition to the manufacturer's recommendations, ISMP lists about a dozen other strategies to prevent or minimize tissue damage when giving IV promethazine. Here are several suggestions.
• Stock promethazine only in the 25 mg/mL concentration (not the 50 mg/ml) since this is the highest concentration of promethazine that can be given IV.
• Consider 6.25 to 12.5 mg of promethazine as the starting IV dose, especially for elderly patients.
• Give the medication only through a large-bore vein and check the patency of the access site before administering.
• Administer IV promethazine through a running IV line at the port furthest from the patient's vein.
• Consider administering IV promethazine over 10-15 minutes.
• Before administering the drug, tell patients to let you know immediately if burning or pain occurs during or after the injection.
Length: 224
Rating: 4.90 (7 ratings)
Tags: Promethazine FDA Tissue Injury IV Phenergan Drug Reaction
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Severe Tissue Injury with IV Promethazine
The Institute for Safe Medication Practices recently warned that administering promethazine parenterally may cause more severe tissue injuries than previously recognized. Promethazine, which is commonly sold under the trade name Phenergan, has many uses including as an antihistamine, a sedative and an antiemetic.
ISMP points that out promethazine is a known vesicant which is highly caustic to the intima of blood vessels and surrounding tissue. Deep intramuscular injection into a large muscle is the preferred parenteral route of administration, and is least likely to cause damage. But promethazine is also given by slow IV push in many hospitals. The IV route, along with inadvertent intra-arterial or subcutaneous administration is most likely to result in significant complications, ranging from burning and pain to paralysis, tissue necrosis, and gangrene. Sometimes surgical intervention such as fasciotomy, skin graft or even amputation is needed.
ISMP describes several recent cases where severe tissue damage occurred following IV administration of promethazine. For example, in one case a 19-year-old woman who went to the emergency department with flu-like symptoms was given Phenergan IV. During the injection, she cried out in pain, and after the injection she told the nurse that her arm was still in significant pain and that she felt "something was wrong." The nurse reassured her and then left the room. The patient's arm and fingers became purple and blotchy and then over the next several weeks eventually turned black and shriveled. Her thumb, index finger, and top of her middle finger eventually had to be amputated.
ISMP points out that the product labeling makes several recommendations to reduce the risk of these adverse events. They include giving the drug in concentrations no greater than 25 mg/mL, administering the drug at a rate no greater than 25 mg/minute, injecting the drug through the tubing of an infusion set that's running and known to be working satisfactorily, and stopping the injection immediately if the patient reports burning in order to investigate whether there might be intra-arterial placement or perivascular extravasation.
In addition to the manufacturer's recommendations, ISMP lists about a dozen other strategies to prevent or minimize tissue damage when giving IV promethazine. Here are several suggestions.
• Stock promethazine only in the 25 mg/mL concentration (not the 50 mg/ml) since this is the highest concentration of promethazine that can be given IV.
• Consider 6.25 to 12.5 mg of promethazine as the starting IV dose, especially for elderly patients.
• Give the medication only through a large-bore vein and check the patency of the access site before administering.
• Administer IV promethazine through a running IV line at the port furthest from the patient's vein.
• Consider administering IV promethazine over 10-15 minutes.
• Before administering the drug, tell patients to let you know immediately if burning or pain occurs during or after the injection.
FDA Patient Safety News: February 2008
For more information, please see our website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=72#5
Length: 224
Rating: 5.00 (6 ratings)
Tags: phenergan severe tissue injury IV promethazine
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Preemption ruling at the Supreme Court with Jan Schlichtmann and Scott Drake
In November the Supreme Court will hear arguments in Wyeth v. Levine. The case, in a brisk parade of similar ones will help define the contours of a signature project of the Roberts court. Scott Drake talks with Jan Schlichtmann about the upcoming ruling. No ruling has great potential to limit access of ordinary citizens to the court house or removes the over sight of the trial bar over an often times reckless drug industry. Tune into this important discussion of what is at stake in this key preemption case.
Length: 377
Rating: 5.00 (2 ratings)
Tags: law legal podcast Supreme Court preemption Wyeth Levine Roberts pharmaceutical labeling phenergan LBN Attorney arg
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