Normally, when people do not feel well, the first thing they will do is go to the local pharmacy to get something that can alleviate 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.
These OTC drugs began life as prescription drugs. But the FDA has a long history of approving the conversion of prescription drugs to OTC. In general, these prescription changes to OTC have been made for drugs that have been widely used, have a well-understood side effect profile, and are considered by the FDA to be relatively safe for the broader population. In addition, the FDA generally only approves these conversions for the lowest effective dose available to help ensure that broader availability through OTC does not coincide with the increase in adverse events.
Take, for example, OTC pain medications. These can be very effective, but they are not totally benign. Every year during the flu season, the FDA issues warnings about taking too much acetaminophen as this medication is not only in Tylenol but also in over 600 OTC medications. In fact, paracetamol is the main cause of calls to the Poison Control Center at > 100,000 / year. The reason? Ingestion of more than three grams a day of paracetamol may cause liver failure. Clearly, 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 with respect to 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. In addition, with regard to GI effects, Celebrex was safer than comparators. 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 than would be obtained by taking the OTC version of these drugs using the recommended dosing schedule.
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 their risk-benefit profile. Based on PRECISION, it is at least 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 to go the OTC road before – with Lipitor. Unfortunately, this failed. To meet FDA requirements for OTC approval, Pfizer conducted a large clinical trial to determine if patients taking OTC Lipitor would receive their own blood tests at a pharmacy to see if the drug improved their cholesterol profile . However, patients did not follow through taking control of their own health care by obtaining their LDL-c levels tested – a key requirement of the FDA. As a result, Pfizer finalized the OTC Lipitor program.
However, pain medications are different. When people are suffering, they will seek relief. They are very motivated and will know quickly if OTC Celebrex is working for them or not. This is an ideal situation for an over-the-counter medication.
Who would benefit from an OTC version of Celebrex? Certainly Pfizer, who would have a major new revenue generator for their Health Care Consumer Business – assuming they keep it! But insurance companies will be winners as health insurance does not cover OTC drugs. But, 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.