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The first thing you need to know about email fliers warning against medications containing the potentially stroke-causing ingredient phenylpropanolamine hydrochloride is that they are five years old, as is the FDA health advisory that inspired them. The second thing you need to know is that while the warnings were basically accurate when issued, most if not all of the over-the-counter drugs that once contained phenylpropanolamine have since been reformulated with different ingredients. Even so, if you are concerned that you may have been or may yet be harmed by this substance, the FDA has provided a toll-free number you can call for further information. Read more...

Comments

June 27, 2006 at 12:48 pm
(1) D says:

I don’t know about the emails being five years old…. or the websites talking about this. I just looked at the US Food and Drug Administration page and the page was updated on Dec, 2005. So make sure you are not misinforming people because this is a very serious topic.

December 8, 2006 at 2:53 pm
(2) Scott says:

D,
The article you’re referring to says that the FDA made the request in November 2000 to the pharmaceutical companies and that many companies have since reformulated their medications.

January 20, 2007 at 2:33 pm
(3) Susan says:

A new study has been released. The findings are reported in the January 9th, 2007 issue of Neurology.

Overall, 1.7 percent of the women were exposed to PPA within 14 days of the stroke, compared with 0.7 percent of controls, in the 14 days prior to the index date. All of these exposures were due to cold remedies containing PPA. None of the subjects were using appetite suppressants.

The risk of stroke associated with PPA exposure was more than double the normal risk. In addition, more recent and larger and longer PPA exposures were also found to be related to increased stroke risk.

Among the women, the stroke was increased by 4-fold, but the risk among the men did not reach statistical significance.

January 25, 2007 at 12:27 pm
(4) Dave says:

How long does this take to mess up a person. Becouse I’ve been taking cold and flu remeadies for a long time. at lease two to three maybe four times a year.I think they have filtered out the bad stuff that was in these medications to help people,not to hurt them.

February 18, 2007 at 10:15 pm
(5) BeN says:

Why is it, that this ingredient “suddenly” becomes dangerous nearly 50 YEARS after it was first introduced to the consumer public??

Nonsense.

Planned re-scheduling or removal of drugs and certain food additives by the FDA takes place YEARS IN ADVANCE of their actual removal. Very doubtful this information is available to the public, as to specific actions and dates.

Now…if there are actual cases of cerebral hemmorrhage & stroke effects from this ingredient…WHY did they just “suddenly” begin appearing in 2000??

Was there a …..sudden last minute formula change to facilitate this??

The plot thickened.

March 3, 2007 at 12:14 pm
(6) Kevin says:

One thing you need to consider is how long people keep medications in their medicine cabinet. So the warning should still be forwarded because I never heard of it when it first came out and my parents had an old bottle in theirs!

March 21, 2007 at 7:31 am
(7) chris says:

it is always better to be safe then sorry. just check your bottles in your cabinet and look at what you buy. but if it was that dangerous wouldnt it be on the news, on bill boards, newspapers, etc. not just passed around by personal emails. and wouldnt companys take care of this in 2000, now being 2007 if companys are still using this drug shounldnt they be brought on charges. any way i did check my meds and they did not have it in it

April 18, 2007 at 6:18 pm
(8) Gillian says:

Odd how this became a problem just as the major drug companies were releasing the initial weight loss drugs(Meridia) with the big price tags. I used Acutrim through out the 80′s and 90′s with no side effects except appetite control – at a low dollar cost! Now that that option is gone, I can get script for a marginal appetite suppressent for some serious bucks. Of course weight problems and obesity means ‘mo $ for the docs and the pharm cos – no wonder they nix an OTC solution. Interesting that you can still buy the product to use on your DOG!!!

June 17, 2007 at 11:10 am
(9) Phil Harris says:

The study quoted by D is very flawed and anyone with doubts should read the article at the following link. Folks there is just no proof that Phenylpropanolamine has ever caused problems. At the time of the FDA Request over a Billion doses a year were being used and yet only few cases were ever linked to this drug and they all were directly related to the abuse of diet pills. http://neurology.jwatch.org/cgi/content/full/2007/403/1

July 25, 2007 at 11:35 pm
(10) lei says:

most coughs and colds medications in our country contain phenylpropanolamine, what should we purchase then?

October 26, 2007 at 3:04 pm
(11) c says:

The FDA has updated its demands. Please update your site. http://www.fda.gov/cder/drug/infopage/ppa/
,
The best cold medicine out there contains pseduoephedrine. You can currently only get it behind the pharmacy counter, but it’s still pretty cheap. The reason you can only get it behind the pharmacy counter is that people use it to make crystal meth and this is one way to limit access to it.
,
OTC diet pills encourage non-doctor-supervised use and abuse (and hence lead to such catastrophes). People often use them without also using a truly sensible diet and exercise plan, or when they have an underlying condition that could be predisposing them to be overweight or when they have a nondiagnosed (or even diagnosed) medical condition that could make it dangerous for them to use these supplements. While taking them off the market all together might not have been necessary, taking them off the drugstore shelves was probably a very good idea. Too many people dying to be thin in this country.

December 13, 2007 at 2:18 pm
(12) Hafsteinn, Iceland says:

I think the problem with this drug lies mainly on fanatic people in America, no pun intended. This drug is still sold perfectly legally in europe. Thereīs always a risk of stroke when taking stimulants that increase your blood pressure and it is because some people have weak spots on the veins in their brain, so the increased blood pressure from the meds only puts these weaknesses under more strain than usual and thus sometimes cause stroke. Basicly what I’m trying to say is that if you stroke because of PPA you might just as well have a stroke beacause of excessive stress or other stimulants so blaming the drug is kinda ignorant. I really donīt understand why the US FDA is bowing to public opinion instead of informing the public of the real underlying cause. The bottomline is that blaming PPA for strokes is kinda like blaming energydrinks, coffe and alcohol for heart-attacks in people that have a weak heart.

December 19, 2007 at 8:15 am
(13) tom says:

To my recollection, OTC drugs like Alka-Seltzer Plus used to work exceptionally well. Now nothing really works. Pseduoephedrine is about as good as you can get but you have to rely on Sudafed to get it and it seems to jack you up much more than phenylpropanolamine did.

Perhaps OTC like Alka-Seltzer Plus had a good fomula I don’t know.

Its really rediculous and causes serious doubts regarding the FDA’s judgement and use of authority.

May 12, 2008 at 5:51 pm
(14) LindaNJ says:

I’m now 64. I took timed-release Dexatrim containing 75 mg. PPA for at least 10 yrs. until the FDA took it off the market. It certainly helped me keep my weight down, and I took only 1 a day (not several like the people who had strokes did!!!!!) My B.P. has always been low and I am in good health, and walk a lot. I wrote to the FDA telling them all of this before they took it off the market, but to no avail. I’ve now gained about 25 lbs. because of cravings. I think I was certainly in better health taking the Dexatrim all of those years than I am 25 lbs. over weight!!! I also think that I am “pre-diabetic.” I honestly hardly eat anything, but I know people don’t believe that there is such a thing as “low metabolism,” but there certainly is–I am living proof. By the way, I did GREAT on the Zone food, but they stopped selling the pre-packaged meals, so I gained 25 lbs.!

November 19, 2008 at 8:50 pm
(15) kelli martin says:

I to took a ppa product for many years and never had issues. I even had the opportunity to get some in 2005 when I was traveling outside of the states. I find psuedoephedrine to be less effect than ppa, but the phenylephrine is a colossal waste of money.

March 1, 2009 at 1:14 am
(16) SnowflakeHenri says:

c says, is totally right. And kelli martin is too, about phenylephrine. I gave Actifed a chance, but the new formulation does nothing for me when I have allergies and head colds.
Psuedoephedrine with benadryl is the only thing that has any value.

March 1, 2009 at 1:14 am
(17) SnowflakeHenri says:

c says, is totally right. And kelli martin is too, about phenylephrine. I gave Actifed a chance, but the new formulation does nothing for me when I have allergies and head colds.
Psuedoephedrine with benadryl is the only thing that has any value.

July 24, 2009 at 6:10 pm
(18) Rick says:

I am a male who used these diet pills without any issues. My question is why did the FDA remove a product off the market that “may” have only affected 50% of the population??? …and of those 50% less than 2% had these stroke issues.

why not put a warning on the box like they do with most other medications???

Sinces its removal from the US I have gained 75 pounds and I workout daily at the gym (cardio & weights) and eat 1-2 meals a day (no breakfast and usually skip lunch).

June 8, 2010 at 1:18 am
(19) Maryanne says:

I had very bad allergies since college in Manila and I took this medication like multivitamins but I never had a stroke. I did not even know that this was an appetite suppressant. I am still alive and kicking. I did however, started bad headaches since college but I still have them now monthly and thus hormones were the culprit and eliminates the medication as the causative factor. Phenylephrine does not work as good.

June 12, 2012 at 11:10 pm
(20) keith clemons says:

All I can say about the subject is my dog is now BLIND ie: CANT SEE A FLIPPING THING after taking the drug for 1 (one) week aka 7 days.
She passed her vet examine the prev week. Med was given for a slight bladder seep.
Now……….you be the judge.

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