Medication Recall- Mainly Flu / Cold
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 Medicine Effervescent
Alka-Seltzer Plus Cold medicine (cherry or orange)
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 Liquid 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 Relief
Triaminic Expectorant Chest & Head
Triaminic Syrup Co ld & Allergy
Triaminic Triaminicol Cold & Coughincreased 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 Medicine Effervescent
Alka-Seltzer Plus Cold medicine (cherry or orange)
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 Liquid 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 Relief
Triaminic Expectorant Chest & Head
Triaminic Syrup Co ld & Allergy
They are voluntarily recalling the following medicines because of a c ertain
ingredient that is causing strokes and seizures in children:
Orange 3D Cold & Allergy Cherry (Pink)
3D Cold & Cough Berry
3D Cough Relief Yellow 3D Expectorant
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:
http://www.fda.gov/cder/drug/infopage/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-–42671 [FR Doc. 01-20300] [TXT] [PDF]
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PDF requires the free Adobe Acrobat Reader
Date updated: December 23, 2005
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-–42671 [FR Doc. 01-20300] [TXT] [PDF]