CELEBREX AND BEXTRA ADVISORIES
--- Painkiller Blues

The US Food and Drug Administration (FDA) issued today a Public Health Advisory which aims to limit the use of Pfizer's Celebrex and Bextra.

I advise you to read today's post in full. I know most of you just read between the lines when you see my post is long.

But hey, it's Christmas, and I promise you this information can save your life or a loved one day.

WASHINGTON (Reuters) - US health officials on Thursday called on doctors to limit prescribing Pfizer Inc. painkillers Celebrex and Bextra in light of recent evidence that they may increase the risk of heart attack and stroke.

The Food and Drug Administration described its health advisory as an interim step. Any additional action would require further evaluation of sometimes conflicting data and public discussion at an advisory meeting set for February.

The FDA said doctors should weigh the benefits and risks for individual patients. The agency also ordered a review of all prevention studies involving Celebrex and Bextra.

[Reuters Health]

There we go.

As doctors, we are advised by the US FDA to weigh the "benefits and risks for individual patients."

Last Monday, concerned US health officials issued a warning of a risk of heart attack and stroke in over-the-counter naproxen, sold in the US as a generic medicine and as several brand names, including Bayer AG's Aleve, and as Roche AG's Naprosyn.

Painkillers are now in the limelight, and they come with grave warnings.

If you remember, last September, Merck voluntarily withdrew its controversial painkiller Vioxx off the market, also because of studies linking its use to increased risks of having heart attacks and stroke.

For the naive and the oblivious, here's some painkiller review:

TYPES OF PAINKILLERS

1. Aspirin and the NSAIDS - includes aspirin, paracetamol, and NSAIDS or nonsteroidal anti-inflammatory drugs, like mefenamic acid and ibufropen.
   
   - these are taken usually to relieve mild to moderate types of pain like headaches, muscle and joint pain. I am quite sure you have taken these at one point in your life.
   
   - they work by preventing the formation of prostaglandins (PGs), which are responsible for the sensation of swelling and pain.
   
   - in blocking the formation of PGs, they block 2 cyclooxygenase (COX) enzymes: COX-1 and COX-2, and this is where its Achilles' heel and primary side effect lies --- COX-1 inhibition causes gastric irritation and renal toxicity while COX-2 inhibition relieves inflammation, pain, and swelling.
   
   - NSAIDS targets both COX-1 and COX-2 inhibition, thereby producing BOTH good and bad effects
   
   - therefore, this led researchers to develop a new class of painkillers --- see # 2



2. The -COXIBS or COX-2 Inhibitors - introduced sometime in 1999 to 2000, this new class of painkillers include Merck's Vioxx, Pfizer's Celebrex and Bextra, and the other -coxibs you often hear.
   
   - these were considered way back then as "wonder drugs" and marketed as better many times over than aspirin and the NSAIDs, simply because they block only COX-2, providing pain relief without stomach trouble.
   
   - back then, everyone was optimistic that these COX-2 inhibitors will be safer than other NSAIDs for longterm use.
   
   - but look where we are now....warnings are issued left and right telling us to be careful and to be aware of the risks in taking these medicines.



3. The OPIODS - includes the big-time and regulated painkillers like morphine and codeine.
   
   - these are the strongest painkillers available in the market today, and here in the Philippines, your doctor must both have an S2 and a Dangerous Drugs Board (DDB) clearance before he can prescribe such medicines.
   
   - these painkillers work by blocking the sensation of pain in your brain and spinal cord.
   
   - these are usually prescribed to patients who are in severe and excruciating pain like those with bone cancer and trauma patients with multiple injuries.

The lesson and the reality here is that there is really no medicine or drug that exists that has no side effect. Sure, a drug must have been manufactured for a specific function, and in this case, the example is that of painkillers.

Painkillers remove the pain, but soon you'll realize a 'new kind of pain' was inflicted --- gastric irritation, renal toxicity, and recently, the increased incidences of heart and stroke attacks among long-time users.

Ironic? Sad? Well, that's reality: there is really no such thing as a wonder drug.

As doctors, we are tasked to decide and weigh the options of prescribing such-and-such class of drugs to Patient A, B, C, etc. Each patient, no matter what the illness, has his/her own set of uniqueness. This must always be taken into consideration.

While we are at it, let me poke some attention to how our own BFAD (counterpart of the US FDA) is handling the current situation.

I'm sure there are quite a number of Filipino patients out there taking Pfizer's Celebrex and Bextra. But how many of them know these developments?

I am also sad and frustrated at the lethargy exhibited by our own drug regulating agency in issuing public health advisories to inform people about these developments.

Click on their site and compare it with this site and see the marked difference.