PRECISION Study Results Open the Door for Over the Counter Celebrex

Usually, when people do not feel well, they go to the local pharmacy to get something to fix their problem. If they have heartburn or an acidic stomach, they have the option of taking OTC drugs like Zantac or Prilosec. If they are sore and achy from physical activity, they have options like Advil (ibuprofen), Aleve (naproxen) or Tylenol (acetaminophen). For those with allergies, there are antihistamines like Claritin and Zyrtec.

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Many drugs began as prescription drugs and later became over-the-counter (OTC) drugs. The FDA has a long history of approving the conversion of prescription drugs to OTC. In general, the changes to OTC status have been made for the drugs that are used, have a well-understood side effect profile, and are considered by the FDA to be relatively safe for the broader population. Also, the FDA only approves such changes for the lowest effective dose to ensure that broader availability through OTC does not coincide with the increase in adverse events.

Take, for example, such OTC as painkillers. They are very effective, but they are not safe. Every year during the flu season, the FDA issues warnings about taking too much acetaminophen. It can be found in Tylenol and more than 600 OTC medications. In fact, paracetamol is the main cause of calls to the Poison Control Center at > 100,000 calls per year. What is the reason? Ingestion of more than three grams of paracetamol per day may cause liver failure. Acetaminophen is safe when used correctly, but it is a drug, and all drugs have risks.

The recently published PRECISION study was designed to compare the potential risk profile of Celebrex vs Ibuprofen and Naproxen concerning cardiovascular adverse effects (CV). These drugs, like other NSAIDs, are known to raise the risk of heart attacks and strokes when taken for long periods of time at prescribed doses. In PRECISION, Celebrex was shown to be as safe as the other two drugs. In fact, there were fewer CV deaths in patients with Celebrex (2.3%) than in Ibuprofen (2.7%) or Naproxen (2.5%), although these differences were not statistically significant. Also, about CV effects, Celebrex was safer than competitors. Finally, rates of renal adverse events and hospitalizations were higher with Ibuprofen than with Celebrex. Again, it should be noted that all these drugs were tested at prescribed doses, which are higher compared to the OTC drugs and the recommended doses.

Celebrex has been on the market for 17 years and has been extensively studied, probably more than any other drug of this type. The FDA, patients and doctors all have a firm knowledge of its risk-benefit profile. Based on PRECISION, it is equivalent to Ibuprofen and Naproxen in its risk-benefit profile and does not possess the potential hepatic toxicity of Acetaminophen. There seems to be no reason why Celebrex should not appear on the pharmacy shelves next to Advil, Aleve, etc. Should Pfizer seek FDA approval for an OTC version of Celebrex?

It turns out that Pfizer has tried the OTC road before – with Lipitor. Unfortunately, it failed. To meet FDA requirements for OTC approval, Pfizer conducted a large clinical trial to determine if patients taking OTC Lipitor would receive their blood tests at a pharmacy to see if the drug improved their cholesterol profile. However, patients did not follow up with tests of LDL-c levels – a key requirement of the FDA. As a result, Pfizer closed the OTC Lipitor program.

However, pain medications are different. When people are suffering, they will seek relief. They are very motivated and will figure out if OTC Celebrex is working for them or not. It is an ideal situation for an over-the-counter medication.

Who would benefit from an OTC version of Celebrex? Certainly, Pfizer will. It will get a new revenue source for their Health Care Consumer Business – assuming they keep it! But insurance companies will be winners as well because health insurance does not cover OTC drugs. Most importantly, it would also benefit patients, as they would have an additional option in their pharmacies for another pain medication with properties different from those available now. Without a doubt, having more choices when it comes to health is a good thing.