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 However, the information it contains is now very outdated and is therefore of little value in 2005 and beyond.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. 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