Makers pull cold medicines sold for infants

LadyT

LadyT

JPP Modarater
Contributor
http://www.cnn.com/2007/HEALTH/10/11/infant.drugs/index.html

....After reviewing reports of side effects over the last four decades, the FDA found 54 child fatalities from over-the-counter decongestant medicines.

The agency found 69 reports of children's deaths connected with antihistamines, which are used to treat runny noses, The Associated Press said.

The FDA review of the safety of cold medicines follows a request by Baltimore health commissioner Dr. Joshua Sharfstein and other city officials who said 900 children under four in Maryland had overdosed on the products in 2004, AP reported......
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Damocles said:
Those children. Overdosing on infant medications... I mean, can't they read directions?!!11!!

;)
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LOL. Seriously. When I was 5 months, I knew exactly how much benadryl to take.

On a serious/funny note, I was watching the Soup this week (which takes funny clips from shows throughout the week and makes fun of the) and a news reporter opened her segment with something to the effect of "If you use cold medicine to get your kids to sleep, be careful......"
 
LadyT said:
LOL. Seriously. When I was 5 months, I knew exactly how much benadryl to take.

On a serious/funny note, I was watching the Soup this week (which takes funny clips from shows throughout the week and makes fun of the) and a news reporter opened her segment with something to the effect of "If you use cold medicine to get your kids to sleep, be careful......"
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I think some parents do that though. My sister in law would at times tell me, ohh, he's not feeling that good, you can give him some benadryl and he'll go right out. Oh really, how convienent!

I always wondered about that.
 
Darla said:
I think some parents do that though. My sister in law would at times tell me, ohh, he's not feeling that good, you can give him some benadryl and he'll go right out. Oh really, how convienent!

I always wondered about that.
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Really? I don't know any parents that admit doing that. I'm guessing its more widespread than I'd ever imagine.
 
The main ingredient of benadryl is actually what they use in most over-the-counter sleep aids, with a little bit of rebranding. It's not addictive and it just makes you tired. Now, it won't cure true insomnia...

But I don't think that was the problem in this case. There was another ingredient. And these medicines aren't indicated for children under two anyway. I think they're just chaning the label to say more strongly that it should never be used in that age group. And even in children 2-10 it's not a good idea to use it like crazy.
 
900 children under four in Maryland had overdosed on the products in 2004,


What kind of parents would allow their children to OD on cough medication! Its common sense, the instructions are clearly printed on the label!

I think there's a case for 900 manslaugter, or negligent homicide cases here.


:pke:



(just kidding)
 
A lot of overdoses on COUGH MEDICINE are caused by a teenager or something wanting to get high.

"Robo-tripping"

The mere thought of drinking that much robotussin makes me want to puke.
 
And honestly, the only time anyone ever really NEEDS cough medicine is whenever they have cancer. Other than that cough drops or an antihistamine should be more than enough.
 
Cypress said:
900 children under four in Maryland had overdosed on the products in 2004,


What kind of parents would allow their children to OD on cough medication! Its common sense, the instructions are clearly printed on the label!

I think there's a case for 900 manslaugter, or negligent homicide cases here.


:pke:



(just kidding)
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Always starting trouble.
 
uscitizen said:
Parents using benadryl as kiddie tranqs....

None of you had read about this ?
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Lesson 2.

When stereotyping make sure to use qualifiers like "many" rather than just "Parents tranq their kids using medications!"

See how somebody can't suggest that you overgeneralize when you use more adjectives, especially those that qualify a less than 100% amount while still getting your point across...

Keep trying grasshopper, you'll get there.
 
Good point but parents only mean more than one of them...

Lesson 3: always leave an opening to weasel out of.
 
uscitizen said:
Parents using benadryl as kiddie tranqs....

None of you had read about this ?
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Some parents have always tried different ways to "calm" children, to make them sleep. I've been outraged to hear of mothers giving a baby "just a drop" of brandy, etc. A pretty common practice (and not harmful to the child) is to give pablum as soon as a baby is able to handle it. Somehow it helps the baby to sleep longer during the night.
 
Thorn said:
Some parents have always tried different ways to "calm" children, to make them sleep. I've been outraged to hear of mothers giving a baby "just a drop" of brandy, etc. A pretty common practice (and not harmful to the child) is to give pablum as soon as a baby is able to handle it. Somehow it helps the baby to sleep longer during the night.
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Just give them a shot of whiskey... knocks em right out... of course that is after they get over the "holy shit what did you just give me" phase.

;)
 
Thorn said:
Some parents have always tried different ways to "calm" children, to make them sleep. I've been outraged to hear of mothers giving a baby "just a drop" of brandy, etc. A pretty common practice (and not harmful to the child) is to give pablum as soon as a baby is able to handle it. Somehow it helps the baby to sleep longer during the night.
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I'm sorry, when was the safety of diphenhydramine used as a sleep aid called into question?
 
Watermark said:
I'm sorry, when was the safety of diphenhydramine used as a sleep aid called into question?
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Will this do?
Stojanovski SD, Rasu RS, Balkrishnan R, Nahata MC.Division of Pharmacy Practice and Administration, The Ohio State University College of Pharmacy, Columbus, OH 43210, USA,
OBJECTIVES: This study examined trends in physician-prescribing of medications for children with sleep difficulties in outpatient settings in the US. Additionally, we explored the incidence of physician prescribing patterns of medications with high abuse potential for children with sleep difficulties. METHODS: A cross-sectional study was conducted on patients aged < or =17 years with sleep difficulties from 1993-2004 using data from the National Ambulatory Medical Care Survey (NAMCS). Office visits were considered related to sleep difficulties if relevant ICD-9 codes were recorded and if sleep difficulties were reported as the reason for the visits. Medications were retrieved using the NAMCS drug codes, and all analyses were weighted to determine national estimates. RESULTS: During 1993 to 2004, approximately 18.6 million visits occurred for sleep related difficulty in children. The highest percentage of visits were by school-aged children (6 to 12 years). Pediatricians saw 35% of patients, psychiatrists saw 24%, and general/family practice physicians saw 13% of the patients. Eighty-one percent of visits among children with sleep difficulties resulted in a prescription for a medication. Many of these medications prescribed lack FDA approved labeling to assure their effectiveness and safety in this population. CONCLUSION: The findings of this study suggest that physicians frequently prescribed medications for sleep difficulties in children in US outpatient settings. Of particular concern is prescribing of many unapproved medications for this population.

Merenstein D, Diener-West M, Halbower AC, Krist A, Rubin HR.Robert Wood Johnson Clinical Scholars Program, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.
OBJECTIVE: To determine if infants aged 6 to 15 months with frequent parent-reported nighttime awakenings require reduced parental aid during a week of diphenhydramine hydrochloride treatment and 2 and 4 weeks after its discontinuation. DESIGN: Double-blind, randomized, controlled clinical trial. SETTING: The study was conducted from May 1, 2004, through May 1, 2005; patients were recruited nationally. PARTICIPANTS: Forty-four participants aged 6 to 15 months. INTERVENTIONS: Placebo or diphenhydramine was administered in infants 30 minutes before anticipated bedtime. MAIN OUTCOME MEASURES: The primary outcome was dichotomous: a parental report of improvement in the number of night awakenings requiring parental assistance during the intervention week, which ended on day 14. Secondary outcomes were improved sleep during the 2 weeks before days 29 and 43, parental overall happiness with sleep, and improved sleep latency. RESULTS: On June 6, 2005, the data safety monitoring board voted unanimously to stop the trial early because of lack of effectiveness of diphenhydramine over placebo. Only 1 of 22 children receiving diphenhydramine showed improvement compared with 3 of 22 receiving placebo. To reach the a priori determined sample size and have a positive outcome (ie, rejecting the null hypothesis), the trial would have needed to enroll 16 more participants in each arm, with 15 of the 16 in the diphenhydramine group and 0 of 16 in the placebo group improving. CONCLUSION: During 1 week of therapy and at follow-up 2 and 4 weeks later, diphenhydramine was no more effective than placebo in reducing nighttime awakening or improving overall parental happiness with sleep for infants.

Nine JS, Rund CR.Office of the Medical Investigator, University of New Mexico School of Medicine, Albuquerque, New Mexico 87131-0001, USA.
As an antihistamine, diphenhydramine (DPH) is well known for its use in allergy treatment. Since its introduction in 1946, it has been marketed under various trade names, the most popular being Benadryl. Three years after its introduction, the first fatality due to DPH toxicity was reported in 1949.To better understand the incidence of fatalities due to DPH monointoxication, we reviewed deaths that were reported from 2 data sources: (1) the English-language literature using PubMed, from 1946 through 2003; and (2) the Annual Report of the American Association of Poison Control Centers Toxic Exposure Surveillance System (ARAAPCCTESS), from 1983 through 2002. The results were then tabulated using age, gender, clinicopathologic findings, and toxicology results.Combined results from both data sets show the following mean (and range) for age and DPH levels: Adult, 35.6 years (18-84) and 19.53 mg/L (0.087-48.5); pediatric, 8.6 years (1.25-17) and 7.4 mg/L (1.3-13.7); infant, 31 weeks (6 weeks-11 months) and 1.53 mg/L (1.1-2.2), respectively.Most deaths were certified as accident or suicide; however, 6 infant homicides were reported. The most common symptoms for all cases were cardiac dysrhythmias, seizure activity, and/or sympathetic pupil responses. The most common autopsy finding was pulmonary congestion.
Marinetti L, Lehman L, Casto B, Harshbarger K, Kubiczek P, Davis J.Montgomery County Coroner's Office, 361 West Third Street, Dayton, Ohio 45402, USA.
The Montgomery County Coroner's Office has encountered a series of 10 infant deaths over an 8-month period in infants under 12 months old with toxicology findings that include a variety of drugs commonly found in over-the-counter (OTC) cold medications. The drugs detected were ephedrine, pseudoephedrine, dextromethorphan, diphenhydramine, chlorpheniramine, brompheniramine, ethanol, carbinoxamine, levorphanol, acetaminophen, and the anti-emetic metoclopramide. Toxicology findings were confirmed in 2 different matrices in 9 of the 10 cases and by 2 different analytical methods. The blood concentrations of the drugs and the case histories, as well as the cause of death for each infant, if available, will be given. The majority of these deaths were either toxicity from the OTC cold medications directly or as a contributory factor in the cause of death. Only two of the cases were the result of possible child abuse. Caregivers may be under the mistaken notion that OTC cold medications formulated for children are also safe for use in infants. These cases demonstrate that not only is administration of some OTC cold medications not safe, but use of OTC cold medications in infants can result in toxicity that can lead to death.
 
Of course you shouldn't give it to infants. You shouldn't give any adult medication to infants. But it's not like it's a ghastly crime. You guys are acting like they are using it for an illegitimate purpose... it's purpose as a sleep-aid is just as legitimate as it's purpose as an anthistamine.
 
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