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Sumulat si Dr. Luis Abola, MD, FPCP, Medical Director ng Bayer HealthCare-Consumer Care na gustong ituwid ang mga kamalian sa aking nasulat tungkol sa Saridon. Ito ang kanyang paliwanag:
“Saridon now contains propyphenazone, a derivative of phenacetin:
“The reformulated Saridon contains propyphenazone. It is a derivative of a different family of analgesics. It is not a derivative of phenacetin. It is Paracetamol that is an active metabolite of phenacetin.”
Mali ang binigay sa akin na datos ng isang kolumnista’t abogada ng ibang pahayagan. Paracetamol lang naman pala ang Saridon, eh, papaano ito makakamatay? Halos lahat ng mga gamot sa headache at iba pang nararamdaman natin ay paracetamol!
Ang propyphenazone ay walang kaugnayan sa phenacetin.
Ayon kay De. Abola, totoo na ang Saridon ay dating phenacetin ang nilalaman kung kaya ito ni-recall ng US FDA. Nangyari ito noong 1983 at ang pinakialaman ng US FDA ay ang orihinal na formulation ng Saridon noong 1933 na 250mg ng phenacetin, 150mg ng propyphenazone, 50mg caffeine at 50mg pyrithyldione.
Binago ang formula ng Saridon noon pang 1981, dalawang taon bago nangyari ang recall. Noong lumabas ang utos ng recall, dalawang taon nang napalitan ng Bayer ang ingredient na phenacetin ng paracetamol.
Ang Saridon na binebenta ng Bayer HealthCare-Consumer Care sa Pinas ay ang reformulated Saridon na naglalaman ng Paracetamol, Propyphenazone at Caffeine.
Pinadalhan din ako ni Dr. Abola ng Lareb Report ng Phamacovigilance Center ng Netherlands at wala roong nabanggit na allergic reaction na nakamamatay.
Nabanggit lamang na ang propyphenazone ay maaring magbigay ng anaphylaxis reaction o allergy ngunit walang binanggit na kahit anong makakamatay. Ang nabanggit lamang ay isang mabigat na reaksyon na stridor (paghingang may sipol) kasama ng urticaria na galing sa propyphenazone ngunit hindi ito produkto ng Bayer na Saridon kundi iba pang gamot ang pinanggalingan.
Dagdag pa ng isang report noong 1996, galing kay Van der Klauw: “a 20 year report on drug-associated anaphylaxis shows that while propyphenazone was reported to have probably/possibly caused anaphylaxis, other drugs such as Ibuprofen, Naproxen, Diclofenac are also in the list of possible causes.”
Ayon kay Dr. Abola: “In another independent study by Kiersch and Minic published in the Current Medical Research and Opinion Journal in 2002 on the action and analgesic efficacy of Saridon compared to other pain-killers, it states that no serious adverse events were reported from Saridon use. In fact, adverse events were experienced by only 3.4% of those taking Saridon, lower than the 9.72% of those taking paracetamol. Saridon was even assessed by the patients to be better tolerated compared to paracetamol.
“In our most recent Periodic Update Safety Reporting covering the period of November 2008-November 2009, which was generated by our global pharmacovigilance and submitted to health authorities, there were no case reports on fatal outcomes.
“Paracetamol, Propyphenazone, Caffeine (Saridon Triple Action) is registered and marketed in 50 countries including Austria, China, Hong Kong, Indonesia, Netherlands, Portugal, Spain, among others.
There was no regulatory authority request or company concern that would have required the preparation of a Risk Management Plan.
“Approximately 25.8 million patients worldwide were treated during this period. Nine new medically confirmed case reports were received of which 8 were serious and 1 was non-serious. 25 non-medically confirmed reports were also received including 5 serious reports. Considering the approximate number of worldwide users, this incidence is extremely low. There were no case reports on fatal outcomes received. Since the start of marketing in 1981, only 173 medically confirmed case reports on Saridon have been received.
“Bayer HealthCare-Consumer Care would like to assure the public that its Paracetamol, Propyphenazone, Caffeine (Saridon Triple Action) is clinically proven safe and effective pain relief against headache, muscle pain and toothache. Saridon Triple Action has been duly approved by the Food and Drug Administration of the Philippines.”
Okey na po, Dr. Abola. Naiintindihan na namin ang sitwasyon at na ligtas na gamot ang Saridon ng kumpanyang Bayer.
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