Risk of Hemorrhagic Stroke from Phenylpropanolamine in OTC meds

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Phenylpropanolamine Information Page

U.S. Food and Drug Administration • Center for Drug Evaluation and

Research

 

 

Drug Information

 

 

- http://www.fda.gov/cder/drug/infopage/ppa/default.htm -

 

 

Phenylpropanolamine (PPA) Information Page

 

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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 used in many over-the-counter (OTC) and prescription cough and cold

medications as a decongestant and in OTC weight loss products.

 

We have received numerous requests for a list of products containing PPA.

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. Therefore, there is no comprehensive, updated list

available from FDA. FDA is aware of emails circulating widely that list many

products allegedly containing PPA. Those emails are no longer valid and should

be ignored. Please read the labels of OTC products to determine if they contain

PPA. (Paragraph added 2/20/2002)

 

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.

 

a.. FDA Talk Paper on Phenylpropanolamine (PPA). 11/6/2000.

b.. Public Health Advisory. Safety of Phenylpropanolamine

(PPA). 11/6/2000.

c.. Questions and Answers about Phenylpropanolamine (PPA). 11/6/2000.

d.. Science Background Statement on Safety of Phenylpropanolamine (PPA).

11/6/2000.

e.. FDA Letter to Manufacturers of Drug Products Containing

Phenylpropanolamine (PPA) dated 11/3/2000. Optional Format: PDF Posted

11/6/2000.

f.. 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.

g.. 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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FDA/Center for Drug Evaluation and Research

Last Updated: February 20, 2002

Originator: OTCOM/DLIS

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