After I posted
RUM 2: SARAH, Drug Dependence and announced to several players and leaders in the Philippine health sector, focus shifted about drugs advertising and the molecular combination of paracetamol + ibuprofen of
Alaxan FR. So I emailed the other day
Dr. Suzette Lazo, a friend and Director of the Food and Drugs Administration (FDA,
http://www.fda.gov.ph/) via our CHAT googlegroups, as well as Dr. Nazarita Tacandong, another friend and FDA Deputy Director. I wrote,
Hi Docs Suzette, Nancy,
When Doc Delen de la Paz asked during the DOH Consultative meeting on RUM, "Is it advisable to combine paracetamol + ibuprofen (Alaxan FR) in the first place", I did not ask for her answer but I can see that her implied answer is No.
Doc Isidro Sia also gave the warning of not taking that drug on empty stomach as there is high possibility of adverse health results, suggesting that the combination of those 2 molecules can be tricky.
Another physician friend commented today,
"In response to your question in your blog, it is irrational to combine paracetamol and ibuprofen in my professional opinion. This is an example of fixed dosed combination. But United Lab may have some scientific data to show efficacy, but I have never seen this. I wonder if BFAD then allowed this based on science or based on other reasons."
That's 0-3 score disfavor for Alaxan FR molecular combination. I am no physician nor pharmacist so I have to ask you this question, why FDA allowed such combination given the high use of that drug by the public?
Doc Suzette gave a reply, below. She gave me permission to post her reply in this blog. Meanwhile, here are some of the ads for Alaxan FR, a very popular pain reliever here mainly because of its endorser, Manny Pacquiao.
Noy, this drug has been approved by the FDA since the 80s. The requirement is that for fixed-dosed combinations to be approved they must be compliant on a number of things: show synergy (of efficacy), stability of components in combination, etc. So as this was approved, Alaxan must have complied. Of course, fixed dose combinations get rather contentious sometimes because of differing opinions, which may not hold much water unless supported by evidence. An important issue is if there's a safety problem here? Are (we) seeing cases of drug-related morbidity related to use of the drug? There's no data so far from the people who are criticizing it so where do we go from here?
For your info there are far worse preparations that have been approved and these things sell too. FDA is in the direction of working towards cleaning up the bundle of approved drugs but this wont happen overnight.
Suzette
