Dexatrim, Acutrim, Triaminic and many more Linked to Strokes, FDA Issues Public Health Warning on PPA
Nov 07 '00
Wouldn’t it be great to take a magic pill each day that would help you control your appetite and eat less? What if that pill was available for only pennies at the drug store? Would you buy it? What if you found out that this “magic pill” contained an ingredient that increased your risk of having a stroke by 1600%? Would you still buy it? How desperate are we to look good? Is weight loss important…at any cost?
PPA: What it is, Why it’s Unsafe
Phenylpropanolamine (PPA) is a key ingredient in most diet pills, including Dexatrim and Acutrim. It’s a central nervous system stimulant, and is used as an appetite suppressant. It’s also used in many decongestants (including Dimetapp and Triaminic). PPA has been the subject of a five-year-study by the FDA to evaluate claims that its use was linked to increased risk of hemorrhagic stroke.
The results of this study were released this week, and the FDA has officially recommended that PPA be reclassified as “unsafe”. They also issued a public health warning of the risk of Phenylpropanolamine hydrochloride and it’s correlation with increased risk of stroke (bleeding inside the brain).
Many of us in the medical industry were privy to a study released last month by Yale University of Medicine researchers, who independently studied this drug. Their conclusion was that people who take medicines containing PPA had a significantly increased risk of suffering a stroke within only three days after starting the medication. Some of the stroke victims were relatively young women who had taken only one dose of the medication when they had their stroke. The Yale study showed that individuals who took cold medicines containing PPA were 23 times more likely to have a stroke, and those who took PPA as an appetite suppressant were 16 times more likely to have a stroke (than those who did not take PPA). The Yale study was started in 1994 in response to concerns of the link between PPA and stroke risk to provide the FDA with additional information on which to base their decision.
Hemorrhagic stroke (severe bleeding in the brain) follows only heart disease and cancer as a top killer in the US. The National Institute of Neurological Disorders tells us that over 500,000 Americans have strokes each year, and almost 160,000 Americans died of strokes in 1995 (this was the last year data was available; however, stroke deaths were rising significantly each year).
Are PPA Medications Recalled? What are the retailers doing?
The FDA did not officially recall medications containing Phenylpropanolamine hydrochloride, and instead asked manufacturers to discontinue their marketing of these medications. Some stores such as Walgreen’s have already pulled all medicines containing PPA off of the shelves. Walgreen’s said that 75 of their 550 cough and cold medications contain PPA. The Consumer Healthcare Products Association (CHPA) had previously disputed the Yale study, calling it “inconclusive”; their response to the recent FDA Health Advisory has been to state that each company must make their own decision.
How Desperate Are We?
The question that springs to mind for me, at least, is why products containing PPA are still available. I visited three stores today to see if they were still stocking PPA products; all of them had every cold and diet pill medicine in stock as far as I could tell. Pharmaceutical manufacturers will clearly be hurt by this ruling, as will some retailers no doubt. And yet, how important is this versus the risk to the public?
The warning letter that I received was quick to emphasize that other OTC diet medications may pose risks of their own. Ephedra, for example, is under review by the FDA as well for potentially lethal complications, and Ma Huang has been associated with serious risks (including death) as well.
So just how desperate are we? Will consumers continue to purchase medication for weight loss, voluntarily taking the increased risk of stroke just to help them drop a few pounds? Will parents heed the FDA warnings and cease giving PPA containing medicines to their children, and themselves? And will consumer demand for safe products win out, and force manufacturers to stop making these products and for retailers to pull these products from the shelves? Or will greed and vanity take precedence over safety concerns? It appears that only time will tell….
One more note – you might be wondering if I’ve personally tried Phenylpropanolamine hydrochloride. The answer is a solid and unqualified yes. I’ve tried diet pills (didn’t like them, they made me dizzy and didn’t suppress my appetite for long enough to keep me from grazing) and many of the cough and cold medications in my home contain PPA. I find it interesting that the FDA advised that PPA use should be restricted to adults only in weight loss medication, and I was shocked to see how many of the cold/allergy medicine that I have for my kids contained this ingredient.
For us, at least, the answer is simple. All of the products in our home containing PPA were rounded up, and thrown out unless they were still in a sealed box. If manufacturers do not voluntarily recall these medicines, I will discard those as well; otherwise I will exchange those that are still in sealed boxes to the store for other “safe” cold medications. I fully realize that no medication is completely safe, and that studies continue to come out that show risks in almost every product and supplement. This one, however, is backed by a five-year-study that was specifically conducted to provide the additional data to help the FDA decide whether or not they should issue this health advisory. It has credible scientific backing, and I’m not willing to risk my health – or my children’s health – to challenge their findings.
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Please note: Most of the scientific data above was paraphrased from the resources below. There is nothing directly “copied”; however, I would not dream to pretend that this is all original (as in, from my head). If it makes you feel better, imagine giant quotation marks around the entire review. The important thing to me is to get the word out to others as quickly as possible.
Please use these resources (as I did) for your further research on this subject:
http://www.stroke-site.org/z%20old%20kra-kai%20website/pathway.html
http://vm.cfsan.fda.gov/~dms/fdweight.html
http://vm.cfsan.fda.gov/~lrd/fr97064a.html (1997 proposal)
http://www.fda.gov/opacom/catalog/ots_diet.html (Teen dieting advice) http://www.fda.gov/fdac/features/1998/298_stroke.html
http://www.mindonline.com/fdadiet.htm#Product
http://my.webmd.com/content/asset/uspdi.202462 (partial list of medicines containing PPA, some basic instructions on PPA – issued before the FDA advisory)
http://www.medicaldata.com/
http://www.crnusa.org/Shellgovt090100.html
http://webmd.lycos.com/content/article/1728.59879
http://www.wellweb.com/nutri/fdaart.htm
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Member: Amy
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