Phenylpropanolamine Waarskuwing

[Kleinbekkie]

Ek het die volgende epos ontvang (vir die tweede keer) en ek heg dit hier aan. Ek het die webtuiste wat hulle aandui gaan besoek en ek plaas hier 'n skakel daarheen. Die eerste keer het ek dit ignoreer, maar dit blyk nou dat dit nie 'n 'hoax' epos is nie.

http://www.fda.gov/cder/drug/infopage/ppa/

[Kleinbekkie]

Hier is nog iets daaroor:

Food and Drug Administration
Public Health Advisory
Subject: Safety of Phenylpropanolamine

November 6, 2000

 The Food and Drug Administration (FDA) is issuing a public health advisory concerning phenylpropanolamine hydrochloride. This drug is widely used as a nasal decongestant (in over-the-counter and prescription drug products) and for weight control (in over-the-counter drug products). FDA is taking steps to remove phenylpropanolamine from all drug products and has requested that all drug companies discontinue marketing products containing phenylpropanolamine.

Phenylpropanolamine has been marketed for many years. A recent study reported that taking 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. Although the risk of hemorrhagic stroke is very low, FDA recommends that consumers not use any products that contain phenylpropanolamine.

FDA’s Nonprescription Drugs Advisory Committee (NDAC) recently discussed this study and other information on phenylpropanolamine. NDAC determined that there is an association between phenylpropanolamine and hemorrhagic stroke and recommended that phenylpropanolamine not be considered safe for over-the-counter use.

Although this 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. FDA does not consider the conditions for which phenylpropanolamine is used (over-the-counter or by prescription) as justifying the risk of this serious event. Other products are available for use.

In the meantime, consumers can identify over-the-counter cough-cold, nasal decongestant, and weight control products containing this ingredient by looking for "phenylpropanolamine" in the list of active ingredients on the label. Consumers can check with their health care provider or pharmacist to see whether their prescription cough-cold or nasal decongestant product contains phenylpropanolamine. We advise consumers to discuss alternative over-the-counter and prescription products with their health care providers or pharmacists.

[Kleinbekkie]

Plaas, is dit moontlik dat jy by Suzanne kan uitvind of dit regtig so is?

[Afrikanermeisie]

Ek weet hulle het Colclear (perspilletjies) ook van die mark onttrek omdat die mense glo Tik daarvan maak. 

[Boerseun]

Pers pilletjies ken ek as Sinucon.....
Ja die apteker het my dit ook meegedeel toe ek laas daarvoor gevra het, dit is nogal jammer want dit werk nogal goed om tik..., ag ek bedoel verkoues te verlig.

[Afrikanermeisie]

Hehe tikkop! Daar is twee soorte, Colcleer is die gladde pers ene en ek dink Sinucon is die een met die spikkels op, maar ek mag verkeerde wees, ek is nie baie kieskeurig as dit kom by tik... ag ek bedoel verkoue nie. 

OOS-KAAP: Tikslawe ‘steel’ ons verkouemedisyne
AMELIA DE MILANDER
23/04/2008 01:07:02 AM - (SA)

PORT ELIZABETH. – “Ek sal seker maar weer my ouma se boererate moet probeer dié winter.”

Dít is al wat me. Coreen Jantjies van Gelvandale as antwoord het nadat sy gehoor het goedkoop ver­koue­medisyne gaan dalk dié winter so skaars soos hoendertande wees.

Apteke sukkel reeds om die staatmakers van talle huishoudings soos Colcleer en Sinucon, wat teen goeie pryse vinnige verligting vir ’n kopverkoue bied, by groothandelaars in die hande te kry.

Al verduideliking wat verteenwoordigers van farmaseutiese maat­skappye het, is dat die efedrien wat dié middels se hoofbestanddeel is gereeld met die invoer daarvan by internasionale lughawens voete kry of selfs by die farmaseutiese vervaardigers vasgelê word.

Efedrien is ook een van die hoofbestanddele in die dwelm tik. Volgens supt. Rodney Visser, bevelvoerder van die polisie se eenheid teen georganiseerde misdaad in die Oos-Kaap, koop sindikate hul efedrien in die sluikhandel.

“Ons sluit ook nie die waarskynlikheid uit dat daar werknemers bin­ne die farmaseutiese maatskappye is wat die efedrien steel om aan dwelmsindikate te verkoop nie,” het Visser gesê.

Dit is ook maklik vir tikvervaardigers om dié middels met efedrien oor die toonbank by apteke te koop.

Die Medisynebeheerraad (MBR) het onlangs voorgestel dat alle medikasie wat efedrien bevat, herklassifiseer word as skedule 2-medisyne om verkope beter te beheer.

Tot dié nuwe regulasie ingestel is, duur ’n landwye tekort aan die goedkoper verkouemiddels voort.

“Dit beteken die verbruiker sal dié winter meer geld moet betaal vir verkouemedisyne,” het ’n Baaise apteker, wat anoniem wil bly, gesê.

“Ai, alles word net duurder – nou medisyne ook,” het mev. Wadia Salie van Koster gesê. “Ek sal maar dié winter moet gemmer trek om saam met my tee te drink. Dit help darem om die sinusse oop te kry en dis nie te duur nie.”

Dr. Jonathan Louw, besturende direkteur van die farmaseutiese maatskappy Adcock Ingram, het tekorte aan goedkoper verkouemedisyne soos Colcleer bevestig. Hy wou vanweë “mededingingskwessies” nie die redes verskaf waarom die aktiewe bestanddele vir dié produkte nie beskikbaar was nie.

. Disprin, nóg ’n jare lange staatma­ker in talle huishoudings se medisynekassie, was ook vir maan­de nie by apteke, staatsklinieke of selfs supermarkte beskikbaar nie.

Dié goedkoop aspirientablette, wat help om bloed te verdun, word gereeld as chroniese medikasie vir onder meer hartlyers voorgeskryf. Groot tekorte het landwyd ontstaan nadat die Enaleni-fabriek in Durban in opdrag van die MBR verlede jaar moes sluit omdat dit nie aan standaarde voldoen het nie.

Slegs ’n duurder ekwivalent was toe beskikbaar.

Volgens mnr. Jiri Kulik van die farmaseutiese maatskappy wat Dis­prin in Suid-Afrika verskaf, sal die voorraad weer eersdaags ten volle beskikbaar wees.

http://www.dieburger.com/Stories/News/Regions/17.0.367950369.aspx

[Plaas Botha]

Plaas, is dit moontlik dat jy by Suzanne kan uitvind of dit regtig so is?

Hier is 'n e-pos wat Suzanne vanaf die Aptekersraad ontvnag het

PSSA Newsletter #34 - 19 June 2008 

Phenylpropanolamine rumours

There is yet another spate of emails purporting to deal with
phenylpropanolamine. Previous newsletters have dealt with this, but once again pharmacists are reminded that they can reassure their clients that the claims in them are groundless.

There are only four products containing phenylpropanolamine that are registered for sale in South Africa, and all four comply with the requirements for sale as schedule 2 products. A fifth product listed in the email contains no phenylpropanolamine at all.
Members are referred to PSSA Newsletter #33/2006, in which the Self-medication Manufacturers Association of South Africa explained the background. This newsletter can be downloaded from the PSSA website.

The PSSA received the following communication from the Medicines Control Council.
 
Medicines containing Phenylpropanolamine
On evaluation of the "Health warning" email that is currently being circulated in the media, it is noted that the mail refers to a number of medicines available in the United States. From the list of products reflected in the mail, the medicines available in South Africa are the following products:

Sinutab ND (Phenylpropranolamine, 18mg/tablet): Indicated for Adults
Rinex diffucaps (Phenylpropranolamine, 30mg/tablet: Indicated for Adults and Children, older than 12 years)
Rinex Paediatric Syrup (Phenylpropranolamine 2,5mg per 5ml)
Rinex Syrup (Phenylpropranolamine 5mg per 5ml)
Dimetapp Elixir (No Phenylpropanolamine present in syrup)

Kindly note that the other products listed on the mail are not available on the South African market.

Further, please note that the Medicines Control Council in December 2000, reviewed the status of drugs containing the substance Phenylpropanolamine (PPA). Council's concerns were based on the findings of a study done in the United States of America in which an increased risk of certain types of stroke was found in women using products containing PPA as appetite suppressants or aids to slimming.

The Council noted that the South African situation is as follows:
*There are currently no slimming preparations or appetite suppressants which contain PPA, registered in South Africa.
*PPA is present in some cough, cold and flu preparations and these preparations are classified as Schedule 2 products or higher, which means that these products may only be sold under a pharmacist's or doctor's supervision.

The MCC at the meeting of 13 December 2000 resolved that:
1. All PPA-containing products available in South Africa be not allowed to contain more than 25 mg of phenylpropanolamine per dose and not more than a 100mg/day total daily dose.

2. That all applicants of products containing more than 100 mg/day total daily dose be required to submit a Dear Doctor and Dear Pharmacist letter informing these health care professionals about the potential risks of hypertensive complications including cerebral haemorrhage associated with PPA and guidelines on how these can be detected and avoided for review and approval by the Council.
The letter should also inform these health care professionals of the steps to be taken to reformulate the product and the package insert amendments being implemented.

3. All applicants of products containing more than 25 mg per dose be required to reformulate these products to contain a lower dose or withdraw these formulations, within 6 months of date of notification of this resolution.

4. That the package insert of all phenylpropanolamine-containing products be amended to include certain warnings and contra-indications for patients.

Further, please also note the inscription in S2 of the Schedules:
Schedule 2:
Phenylpropanolamine, preparations and mixtures where the recommended daily dose for adults does not exceed 100 milligrams and for children 6 to 12 years, does not exceed 50 milligrams, when intended for the symptomatic relief of nasal and sinus congestion.
 

[Kleinbekkie]

Baie dankie vir die moeite, Plaas. Se asb. vir Suzanne ook dankie.

My bekommernis was juis oor die Rinex.