FDA's 17th March 2003 News Release on Recalled Drugs containing Phenylpropanolamine

In November 2000, US Food and Drug Administration (FDA) requested that all drugs containing Phenylpropanolamine be recalled. Since then, drug companies had recalled their products and had also reformulated them to EXCLUDE Phenylpropanolamine (PPA.)

But emails have continued to be circulated on the internet asking consumers not to buy known over-the-counter drugs such as Alka-seltzer, that were said to contain Phenylpropanolamine (PPA).

In view of all these emails, FDA issued a news release on 17th March 2003, asking consumers to ignore these emails saying they " contain dated and inaccurate information and should be ignored."

The following is the Center for Drug Evaluation and Research (CDER) of FDA's news release on its website on 17th March 2003:

" 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to be the most accurate method for determining the PPA content of OTC products rather than providing an incomplete or out-of-date list of products that may have already been reformulated and no longer contain PPA.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 03/07/03)

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."

FDA's advice as of 17th March 2003:

Consumers should read the labels of over-the-counter drug products to determine if the product contains PPA ( phenylpropanolamine)

READ THE LABELS on the following products to ensure that they DO NOT CONTAIN Phenylpropanolamine:

The following list of drugs were identified in the emails circulated on the internet that said to contain PPA prior to FDA's recall.

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 Cold & Allergy
Triaminic Triaminicol Cold & Cough

The following medicines were also voluntarily recalled by the drug companies because of a certain 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 note FDA's news release above that companies have reformulated their products WITHOUT the PPA .

Read the labels first before buying the above products if you are not sure.

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