Health and Nutrition with Nature's Sunshine: PHENYLPROPANOLAMINE (PPA)

http://www.fda.gov/cder/drug/infopage/ppa/

Phenylpropanolamine (PPA)

Update - On December 22, 2005 the FDA issued a notice of proposed rulemaking (notice) 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 recognized as safe and effective. Written and electronic comments and new data can be submitted by March, 22, 2006.

Phenylpropanolamine-containing products (OTC); tentative final monographs [PDF] [HTML]

The Food and Drug Administration (FDA) is taking steps to remove phenylpropanolamine (PPA) from all drug products and has requested that all drug companies discontinue marketing products containing PPA. In addition, FDA has issued a public health advisory concerning phenylpropanolamine. This drug is an ingredient that was used in many over-the-counter (OTC) and prescription cough and cold medications as a decongestant and in OTC weight loss products.

In response to the request made by FDA in November 2000, many companies have voluntarily reformulated and are continuing to reformulate their products to exclude PPA while FDA proceeds with the regulatory process necessary to remove PPA from the market.

We have received numerous requests for a list of products containing PPA. Since companies continue to reformulate their products, FDA is not maintaining a comprehensive, updated list of products that still contain PPA. FDA is aware of emails circulating widely that list many products allegedly containing PPA. These emails, however, generally contain dated and inaccurate information and should be ignored.

The FDA recommends that consumers read the labels of OTC drug products to determine if the product contains PPA. The Agency believes this to be the most accurate method for determining the PPA content of OTC products rather than providing an incomplete or out-of-date list of products that may have already been reformulated and no longer contain PPA. (Introduction updated 03/07/2003)

Scientists at Yale University School of Medicine recently issued a report entitled "Phenylpropanolamine & Risk of Hemorrhagic Stroke: Final Report of the Hemorrhagic Stroke Project." This study reports that taking PPA 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 PPA.

FDA's Nonprescription Drugs Advisory Committee recently discussed this Yale study along with additional information on phenylpropanolamine. The Advisory Committee determined that there is an association between PPA and hemorrhagic stroke. It recommended that PPA be considered not safe for over-the-counter use.

For more information on this public health advisory, please see the items below.

FDA Talk Paper on Phenylpropanolamine (PPA). 11/6/2000
Public Health Advisory. Subject: Safety of Phenylpropanolamine (PPA) 11/6/2000
Questions and Answers about Phenylpropanolamine (PPA). 11/6/2000
Science Background Statement on Safety of Phenylpropanolamine (PPA). 11/6/2000
FDA Letter to Manufacturers of Drug Products Containing Phenylpropanolamine (PPA) dated 11/3/2000 Optional Format: PDF Posted 11/6/2000
Nonprescription Drugs Advisory Committee Meeting: Safety Issues of Phenylpropanolamine (PPA) in Over-the-Counter Drug Products, (10/19/00). This link leads to the meeting agenda, roster, questions, presentation slides, and briefing information, including the Yale Hemorrhagic Stroke Project: Final Study Report
Federal Register Announcement: Phenylpropanolamine; Proposal to Withdraw Approval of New Drug Applications and Abbreviated New Drug Applications; Opportunity for a Hearing. Pages 42665--2671 [FR Doc. 01-20300] [TXT] [PDF]

I urge you to review the list of medicines with PPA and avoid these medications. All drugs containing PHENYLPROPANOLAMINE are dangerous. You may want to try calling the 800 number listed on most drug boxes and inquire about a REFUND. Please read this CAREFULLY. Also, please pass this on to everyone you know. 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 the medication. Problems were not found in men, but the FDA recommended that everyone (even children) seek alternative medicine'

The following medications contain Phenylpropanolamine :-
1. Acutrim Diet Gum Appetite Suppressant
2. Acutrim Plus Dietary Supplements
3 Acutrim Maximum Strength Appetite Control
4. Alka-Seltzer Plus Children's Cold Med icine Effervescent
5. Alka-Seltzer Plus Cold medicine (Cherry or Orange)
6. Alka-Seltzer Plus Cold Medicine Original
7. Alka-Seltzer Plus Cold & Cough Medicine Effervescent
8. Alka-Seltzer Plus Cold & Flu Medicine
9. Alka-Seltzer Plus Cold & Sinus Effervescent
10. Alka Seltzer Plus Night-Time Cold Medicine
11. BC Allergy Sinus Cold Powder
12. BC Sinus Cold Powder
13. Comtrex Flu Therapy & Fever Relief
14. Day & Night Contac 12-Hour Cold Capsules
15. Contac 12 Hour Caplets
16. Coricidin D Cold, Flu & Sinus
17. Dexatrim Caffeine Free
18. Dexatrim Extended Duration
19. Dexatrim Gelcaps
20. Dexatrim Vitamin C/Caffeine Free
21. Dimetapp Cold & Allergy Chewable Tablets
22. Dimetapp Cold & Cough Liqui-Gels
23. Dimetapp DM Cold & Cough Elixir
24. Dimetapp Elixir
25. Dimetapp 4-Hour Liquid Gels
26. Dimetapp 4-Hour Tablets
27. Dimetapp 12-Hour Extentabs Tablets
28. Naldecon DX Pediatric Drops
29. Permathene Mega-16
30. Robitussin CF
31. Tavist-D 12-Hour Relief of Sinus & Nasal Congestion
32. Triaminic DM Cough Relief
33. Triaminic Expectorant Chest & Head
34. Triaminic Syrup Cold & Allergy
35. Triaminic Triaminicol Cold & Cough

I just found out and called the 800# on the container for Triaminic and they informed me that they are voluntarily recalling the following medicines because of a certain ingredient that is causing strokes and seizures in children:
1 Orange 3D Cold & Allergy Cherry (Pink)
2. 3 D Cold & Cough Berry
3. 3D Cough Relief Yellow 3D Expectorant
They are asking you to call them at 800-548-3708 with the lot number on the box so they can send you postage for you to send it back to them, and they will also issue you a refund. If you know of anyone else with small children, PLEASE PASS THIS ON.

PLEASE PASS THIS WEBPAGE ALONG TO YOUR FRIENDS AND FAMILIES so everyone is are informed.

To confirm these findings, please take time to check the following:
http://www.fda. gov/cder/ drug/infopage/ ppa/

This article was forwarded to me by my friend George. Thanks for sharing George. I am always horrified that people take all these over the counter chemicals. Here is just one more great reason for preventive health care and learning how to use herbs and the other foods that God made for us to nurture and heal our bodies and minds.

Learn preventive health! Join me this year at the National Natural Health Education classes and Online Webinars so you can learn which foods, herbs and nutrients can safely replace these poisons. Keep an eye on my blog http://herbsplus4health.blogspot.com, check in often, as I add events and classes every week.

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