x-posting dari milis sebelah mengenai PPA.

---------- Forwarded message ----------
From: ghozan_gmail <ghozan10032...@gmail.com>
Date: 2009/4/22
Subject: Re: [MLDI] Trs: Trs: DRUG RECALL. Please read.
To: Mailing List Dokter Indonesia <dok...@itb.ac.id>


Harap hemat bandwith
----------------------
sudah di jawab BPOM ya.

ini sekedar numpang posting di milis ini.

informasinya itu benar tp sudah expired.
artinya produk yg masuk dalam daftar tersebut sudah tdk mengandung PPA lagi
semenjak ada  peringatan dari FDA.

ini saya copas dari url aslinya :

This widely circulated email forward warns recipients that medications
containing phenylpropanolamine (PPA) have been recalled by the US Food and
Drug Administration (FDA). The message contains a long list of products that
supposedly contain phenylpropanolamine and therefore should be avoided.

The core information in this email forward was true several years ago.
However, the information it contains is now very outdated and is therefore
of little value in 2005 and beyond.

In November 2000, the FDA issued a Public Health Advisory concerning the
safety of products containing phenylpropanolamine hydrochloride. The
advisory noted that the "FDA is taking steps to remove phenylpropanolamine
from all drug products and has requested that all drug companies discontinue
marketing products containing phenylpropanolamine."

The FDA issued this health advisory after a study revealed that using
phenylpropanolamine "increases the risk of hemorrhagic stroke (bleeding into
the brain or into tissue surrounding the brain) in women. Men may also be at
risk."

Consequently, in the years since this advisory was issued, pharmaceutical
companies selling products in the US have indeed removed phenylpropanolamine
from their products as requested by the FDA. Therefore, the medications
listed in these emails have, in all likelihood, been reformulated and no
longer contain phenylpropanolamine.

In fact, the FDA's Phenylpropanolamine (PPA) Information Page advises that
people ignore these emails and check the labels of individual medications
instead:


 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.


If consumers still have medications purchased several years ago, they should
certainly check the labels to ascertain if PPA is present.

Other nations have also taken steps to control phenylpropanolamine or
educate the public about its use.


Lantas bagaimana dengan di Indonesia....

hehehe....saya ndak tahu.....coba tanya Bu Husniah.

Kalau  FDA sudah jelas :

Questions and Answers
Safety of Phenylpropanolamine

November 6, 2000

1. What action is the FDA announcing today?

The FDA has asked firms that market pharmaceutical or drug products
containing phenylpropanolamine (fen-el-pro-pa-nol-a-mine) to voluntarily
discontinue marketing them. We are also alerting consumers to the risks
associated with the use of products containing phenylpropanolamine.

2. What is phenylpropanolamine?

Phenylpropanolamine is an ingredient used in prescription and
over-the-counter (OTC) drug products as a nasal decongestant to relieve
stuffy nose or sinus congestion and in OTC weight control drug products to
control appetite.

3. Why is phenylpropanolamine unsafe when this product has been in use for
many years?

On May 11, 2000, FDA received results of a study conducted by scientists at
Yale University School of Medicine that showed an increased risk of
hemorrhagic stroke (bleeding of the brain) in people who were taking
phenylpropanolamine. Phenylpropanolamine has been used for many years and a
very small number of people taking the drug have had strokes. The Yale study
helped show that the number of people having strokes when taking
phenylpropanolamine was greater than the number of people having strokes who
were not taking phenylpropanolamine. Although the risk of hemorrhagic stroke
is very low, FDA has significant concerns because of the seriousness of a
stroke and the inability to predict who is at risk. Because of continued
reports to the FDA of hemorrhagic stroke associated with phenylpropanolamine
and the results of the Yale study, we now feel that the risks of using
phenylpropanolamine outweigh the benefits and recommend that consumers no
longer use products containing phenylpropanolamine.

4. Are there any population groups at higher risk when using products
containing phenylpropanolamine?

The Yale University study showed that the risk of hemorrhagic stroke was
found mostly in women; however, men may also be at risk.

5. What types of products contain phenylpropanolamine?

Phenylpropanolamine is found in some prescription and OTC nasal
decongestants and cough/cold products and OTC products for weight control.

6. If a patient brings me, a pharmacist, a prescription containing
phenylpropanolamine, should I fill it?

FDA has not said that such prescriptions should not be filled. However, you
should make sure that both the prescriber and the consumer are aware that
the drug contains phenylpropanolamine and have discussed the risks and
benefits of taking the product as prescribed.

7. My family has been using products that contain phenylpropanolamine; is
there any danger?

In the Yale study, the increased risk of hemorrhagic stroke was detected,
among women using the drug for weight control and for nasal decongestion, in
the 3 days after starting use of the medication. While the risk of
hemorrhagic stroke is very small, for this reason we suggest you stop taking
the drug immediately and use an alternative drug product.

8. Is there another medicine that I can take in place of my medicine that
contains phenylpropanolamine?

Yes, there are other products on the market that do not contain
phenylpropanolamine. Ask your pharmacist or health care provider what other
products are available for your needs.

9. How will I know if my OTC products contain phenylpropanolamine?

OTC drug products containing this ingredient may be identified by looking
for "phenylpropanolamine" in the list of active ingredients on the label. If
you are still unsure, check with your pharmacist to help you determine if a
product contains phenylpropanolamine.

10. How will I know if my prescription nasal decongestant or cough/cold
products contains phenylpropanolamine?

If you are using a prescription nasal decongestant or cough/cold product you
should talk to your pharmacist or health care provider to determine if
phenylpropanolamine is present.

11. If I have questions about drug products whom can I call?

Call 1-888 INFO FDA (1-888-463-6332)

12. How can I report a side effect with phenylpropanolamine?

FDA encourages anyone aware of a serious adverse reaction, including
consumers, to submit a MedWatch report.

You can report an adverse event in two ways:

 a.. Visit www.fda.gov/medwatch and click on "How to Report"
 b.. Call 1-800-FDA-1088
http://www.fda.gov/cder/drug/infopage/ppa/qa.htm


salamku,
bapakeghozan
http://ghozan.blogsome.com

----- Original Message -----
From: "rismawati lie" <lie_rismaw...@yahoo.com>
To: "Mailing List Dokter Indonesia" <dok...@itb.ac.id>
Sent: Wednesday, April 22, 2009 3:34 PM
Subject: [MLDI] Trs: Trs: DRUG RECALL. Please read.


Harap hemat bandwith
----------------------
Dear Dokter,

Sekarang banyak beredar e-mail seperti dibawah ini dan hari sabtu atau
minggu tgl 18 / 19 April 2009 di surat kabar kompas kalau PT Tempo memasang
berita kalau obat yang mengandung Phenylpropanolamin tidak bahaya buat kita
dengan referensi dari BPOM. Apakah benar ? Mohon konfirmasi dan penjelasan
dikarenakan saya masih punya anak balita. khan serem juga.

Terima kasih,
Risma (Jakarta)

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