Posted on 04/26/2006 8:45:49 PM PDT by neverdem
ASSOCIATED PRESS
WASHINGTON -- Federal health officials warned parents and doctors Tuesday not to give drugs that contain promethazine hydrochloride to children younger than 2, citing seven cases of death linked to use of the antihistamine.
The Food and Drug Administration said in a safety alert that beyond the deaths, it also has received 22 reports of severe breathing problems associated with use of the allergy drug, all in children younger than 2.
The drug, also known as promethazine HCl, is sold by Wyeth under the brand name Phenergan as well as in various generic versions. The warning covers all forms of the drug, including syrups, suppositories, tablets and injectable liquids.
Parents also should use care in giving the drug to children older than 2, the FDA said.
The labels on all versions of the drug have been updated to reflect the strengthened warnings, the FDA said.
The drug, approved in 1951, is used to treat hay fever, stuffy or runny nose due to allergies and other minor allergies.
On the Net:
Well, with ephedrine off the market, we get "safe" drugs like this one. Thanks, big dumb government.
Phenergan is good stuff actully.
They used it to treat nausea as well.
Phenergan is what always gets my kids through the worst stomach viruses.
The drug was approved in 1951 and they're just figuring this out now?! Unbelievable. Oh, wait a minute, It should be, they're just admitting it now.
Yeah, I was on that a few times when I went to the hospital with uncontrollable vomiting, food poisoning and the like. I had a really bad stomach as a kid. That stuff works. Put me to sleep for a day every time, though.
Huh? Been using it for decades without trouble. Very late in coming with this news. Gotta wonder what this is about?
It is about our litiginous society. I have used it for years as a physician. It works wonderfully for Nausea and Vomiting. There will be alot more children admitted to hospitals because of this.
That was my question, too. It took 55 years for one death (I know, it's one too many) and 22 "episodes"? That doesn't sound dangerous to me, but I'm not the mother of the deceased child. Nor am I her attorney.
In one of my college classes, we had a FDA representative visit our class to lecture us on FDA policies. When she got to the part about how the FDA looks after the safety of the American public in deciding whether to remove a drug from the market. I promptly raised my hand. When she called on me, I asked her quantitatively how many women would have to die before RU-486 was pulled from the market.
I think about the worst thing that could happen to someone is to lose a child and I really feel for those parents but the best intentions can't prevent it.
So what did the FDA rep say in response to your question? And what did the rest of your class say? Did you pass?
I am still taking the class. That incident happened last Tuesday. The entire class gave a nervous chuckle when I asked the question. Her response basically was that FDA tries to do the right thing by weighing the cost-benefit of the particular drug. She must have sensed that I was about to pounce again with that since there is no medical benefit to killing unborn children, so she remarked that their funding came from Congress and hinted that there were political pressures as well. I let her off the hook after that.
I should have my grade by the end of next week. The professor teaching the class went to Cal-Berkeley, if that gives you an indication of what my grade may look like.
Heh. Keep me posted. I'd love to know how that one turned out. I can pray if you'd like.
The prayers of a righteous man (or woman) avail much.
This drug is an excellent anti nausea product and has saved lives stopping and blocking severe nausea from many causes. It was brought out as an antipsychotic and it didn't work there. The chemists at Wyeth saw a big market potential for its anti nausea and sedation properties. Anyone driving should not drive for at least 48 hours after taking a therapeutic dose of promethazine hydrochloride.
It really should not be used as a histamine blocker as it is not a histamine blocker. There are safe and effective anti histamines drugs/histamine blockers as patients can get over safer and more effective allergy medications over the counter histamine blockers and rx histamine blockers .
Here is the profile of what this drug, how it works and its side effect profile. www.wholehealthmd.com/refshelf/drugs_view/1,1524,527,00.html
How It Works:
Promethazine interferes with, but does not block, the release and action of histamine, a naturally occurring substance in the body that causes swelling, itching, sneezing, watery eyes, hives, and other symptoms of allergic reaction. Promethazine also has an anticholinergic effect, meaning it blocks the transmission of certain nerve impulses, which in turn relaxes the smooth muscle tissue controlling activity in the bladder, stomach, intestine, lungs, and other organ systems. This effect thereby helps to ease the symptoms of motion sickness, nausea, gastrointestinal upset, and anxiety.
I was prescribed this medicine two days ago because I got gassed by Mosquito Spray truck, and could not eat because of serious nausea and stomach pains,montezuma's revenge etc. While I am waiting for the Toxicology screen results I took this stuff and it did wonders, I even have been able to stop taking Imodium. It also allowed me to sleep through the night, and the Rx cost me $1.46 with my Drug Benefits. This is overkill as usual and Much ado about nothing. If a child is throwing up and has serious diarrhea like my nephew(16 months with heart condition) recently had this medicine may save his or her life.
Phenergan really helped as it has thousands if not millions with severe nausea.
As I noted, it can be a life saving drug in cases like yours.
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