Child Medicine Recall

[JellyBean]

Hi All,
received the following information today about a certain ingredient called PHENYLPROPANOLAMINE which is apparently found in many over-the-counter child medicines that the FDA are recalling. I'm not sure how up to date this info is, but
I always recommend checking the ingredients in childhood medications and don't administer them unless you feel informed and convinced of its safety.
X


Subject: All drugs containing PHENYLPROPANOLAMINE are being recalled.




Medicine Recall

All drugs containing PHENYLPROPANOLAMINE are being recalled.
STOP TAKING anything containing this ingredient. It has been
linked to increased hemorrhagic stroke (bleeding in brain)
among women ages 18-49 in the three days after starting use
of medication. Problems were not found in men, but the FDA
recommended that everyone (even children) seek alternative
medicine.

The following medications contain Phenylpropanolamine:

Acutrim Diet Gum Appetite Suppressant
Acutrim Plus Dietary Supplements
Acutrim Maximum Strength Appetite Control
Alka-Seltzer Plus Children's Cold Medi cine Effervescent
Alka-Seltzer Plus Cold medicine (cherry or or ange)
Alka-Seltzer Plus Cold Medicine Original
Alka-Seltzer Plus Cold &Cough Medicine Effervescent
Alka-Seltzer Plus Cold &Flu Medicine
Alka-Seltzer Plus Cold &Sinus Effervescent
Alka Seltzer Plus Night-Time Cold Medicine
BC Allergy Sinus Cold Powder
BC Sinus Cold Powder
Comtrex Flu Therapy &Fever Relief
Day & Night Contac 12-Hour Cold Capsules
Contac 12 Hour Caplets
Coricidin D Cold, Flu &Sinus
Dexatrim Caffeine Free
Dexatrim Extended Duration
Dexatrim Gelcaps
Dexatrim Vitamin C/Caffeine Free
Dimetapp Cold &Allergy Chewable Tablets
Dimetapp Cold &Cough Liqui-Gels
Dimetapp DM Cold &Cough Elixir
Dimetapp Elixir
Dimetapp ! 4 Hour L iquid Gels
Dimetapp 4 Hour Tablets
Dimetapp 12 Hour Extentabs Tablets
Naldecon DX Pediatric Drops
Permathene Mega-16
Robitussin CF
Tavist-D 12 Hour Relief of Sinus &Nasal Congestion
Triaminic DM Cough Rel! ief
Triaminic Expectorant Chest &Head
Triaminic Syrup Cold & Allergy
Triaminic Triaminicol Cold &Cough

I just found out and called the 1800# on the container
for Triaminic and they informed me that they are voluntarily recalling the following medicines because of a certain ingredient, (phenylpropanolamine), is causing strokes and seizures in children. :

Orange 3D Cold &Allergy Cherry (Pink)
3D Cold &Cough Berry
3D Cough Relief Yellow 3D Expectorant

If you know of anyone else with small children, PLEASE PASS THIS ON. THIS IS SERIOUS STUFF!

DO PASS ALONG TO ALL ON YOUR MAILING LIST so people are informed. They can then pass it along to their families.

To confirm these findings please take time to check the
following:
(link removed due to forum rules)

PLEASE PASS THIS ON TO YOUR CHILDREN IN CASE THEY GIVE IT TO THEIR CHILDREN OR TO FRIENDS WHO HAVE CHILDREN AND GRANDCHILDREN.

[Olive]

is this australian?? i cant find any info on the ACCC website

[Early Kids]

I have some of those in my cupboard, my kid were prescribed them by the GP!

[Olive]

my dimetapp DM doesnt contain the banned ingrediant

[AnyDream]

Look this up on snopes. It is an old advisory from the early 2000s, and relates to a whole heap of US formulations.

I believe the brand names have either been reformulated since then, or that compound was never used in the Australian formulation in the first place.

[Early Kids]

I googled PHENYLPROPANOLAMINE and came up with an old thing saying it was banned and another thing which said there was an email going around, which is true but outdated.

My things don't contain that ingredient either.

[Indadhanu]

This is just a chain email

Here is the actual FDA recall notice... from 2000... http://www.fda.gov/Drugs/DrugSafety/.../ucm052236.htm

Safety of Phenylpropanolamine

Food and Drug Administration
Public Health Advisory
Subject: Safety of Phenylpropanolamine

November 6, 2000

The Food and Drug Administration (FDA) is issuing a public health advisory concerning phenylpropanolamine hydrochloride. This drug is widely used as a nasal decongestant (in over-the-counter and prescription drug products) and for weight control (in over-the-counter drug products). FDA is taking steps to remove phenylpropanolamine from all drug products and has requested that all drug companies discontinue marketing products containing phenylpropanolamine.

Phenylpropanolamine has been marketed for many years. A recent study reported that taking phenylpropanolamine increases the risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is very low, FDA recommends that consumers not use any products that contain phenylpropanolamine.

FDA’s Nonprescription Drugs Advisory Committee (NDAC) recently discussed this study and other information on phenylpropanolamine. NDAC determined that there is an association between phenylpropanolamine and hemorrhagic stroke and recommended that phenylpropanolamine not be considered safe for over-the-counter use.

Although this risk of hemorrhagic stroke is very low, FDA has significant concerns because of the seriousness of a stroke and the inability to predict who is at risk. FDA does not consider the conditions for which phenylpropanolamine is used (over-the-counter or by prescription) as justifying the risk of this serious event. Other products are available for use.

In the meantime, consumers can identify over-the-counter cough-cold, nasal decongestant, and weight control products containing this ingredient by looking for "phenylpropanolamine" in the list of active ingredients on the label. Consumers can check with their health care provider or pharmacist to see whether their prescription cough-cold or nasal decongestant product contains phenylpropanolamine. We advise consumers to discuss alternative over-the-counter and prescription products with their health care providers or pharmacists.

From the Australian Government Department of Health and Aging Therapeutic Goods Association site: Phenylpropanolamine

Phenylpropanolamine

7 March 2006

On 6 November 2000 the US Food and Drug Administration (FDA) issued a "Public Health Advisory" statement notifying that it was "taking steps to remove phenylpropanolamine from all drug products and has requested that all drug companies discontinue marketing products containing phenylpropanolamine" <http://www.fda.gov/bbs/topics/ANSWERS/ANS01051.html>.

The statement followed advice from the FDA's Non-prescription Drugs Advisory Committee that there is an association between phenylpropanolamine and haemorrhagic stroke and that phenylpropanolamine not be considered safe for over-the-counter use. The FDA advised that the risk of haemorrhagic stroke was "very low" but there were significant concerns because of the seriousness of a stroke and the inability to predict who was at risk. Further information is available on the FDA's Phenylpropanolamine Information Page <http://www.fda.gov/cder/drug/infopage/ppa/default.htm>.

On 22 December 2005 the FDA issued a notice of proposed rulemaking for over-the-counter (OTC) nasal decongestant and weight control products containing phenylpropanoloamine preparations. This proposed rule reclassifies phenylpropanolamine as nonmonograph (Category II) not generally recognised as safe and effective.

In Australia, substantial action to limit the availability of many of the products of concern to the US FDA was taken in 1983. This followed a number of Australian reports of episodes of severe high blood pressure attributed to high doses of PPA in appetite suppressant products. Since that time PPA has only been available in cough and cold products from pharmacies in relatively low doses (25mg or less per dose). Specific label warnings were required.

Since 1984 there has been only one Australian adverse drug reaction report to the TGA and that report did not relate to high blood pressure or stroke. This provides some assurance that the current concerns in the US were largely dealt with in Australia in 1983.

In June and July of 2001 the last remaining products containing PPA were voluntarily withdrawn from the Australian market by their sponsors. There are now no products containing PPA authorised for supply in Australia.

The TGA has become aware of information originating from the US regarding the PPA situation that has been circulating widely in the Australian community via email messages. It is not immediately apparent to recipients that this information relates to the US market, not Australia, particularly since some of the brand names mentioned, such as Dimetapp and Robitussin, are familiar to Australian consumers. As a result people have been misled into believing that certain products mentioned in these email messages contain PPA and are subject to drug recalls in Australia. This is not the case; there are no drug recalls in force in Australia relating to PPA and no products containing PPA on the Australian market.

If consumers have concerns about any medicines, they are encouraged to discuss these concerns with their doctor or pharmacist.

[JellyBean]

Thanks guys for the clarification. As I said, I have no idea how up to date the info is - sometimes info like that takes forever to circulate via email etc.
Don't take pharma drugs here so a little indifferent to it all but thought someone else may care to know! Looks like the issue is done and dusted which is good....