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Spotlight On Painkiller Safety

Millions of Americans who take medications in the controversial class of painkillers known as Cox-2 inhibitors, along with the drug companies that make billions off them, will be keeping close tabs on a three-day Food and Drug Administration hearing set to start Wednesday.

The Early Show medical correspondent Dr. Emily Senay says the questions before the FDA are whether these drugs are safe and who should be taking them. The agency will hear evidence about the benefits and risks of the arthritis drugs known as Cox-2 inhibitors, to decide whether regulatory action is needed.

The popular arthritis drug Vioxx was voluntarily recalled last September when research showed it might increase the risk of cardiovascular problems. Two newly-released studies suggest similar problems with other Cox-2 drugs, such as Celebrex and Bextra.

"This meeting is not only about the safety profile of these medications, and the actions should they take about these specific medications, but this is a public forum. So we're likely to hear a lot about how we got here in the first place. How was it that risk factors for cardiovascular events like stroke and heart attacks, which were clearly there in some of the early studies, were not taken more seriously? So there are a lot of questions here, not only on the role of the FDA, but also the role of the corporations. How did we get there? These drugs were vetted and approved by the FDA and yet we're at this place in time when we're questioning whether or not they should be on the market."

One possible outcome, Senay says, is a so-called "black-box warning, which is the strongest warning the FDA can make the manufacturers put on the packaging, which would warn doctors about cardiovascular risk. But they could do alot of other things, too. They could do potentially nothing. They could say the evidence isn't there that this is a big enough problem. That's probably unlikely. And of course, they could take these drugs off the market.

"There are certainly many experts out there who feel this entire class of drugs is too risky. There are others who are saying (these drugs) have some benefit and we need strike the balance between the benefit and the risk."

Senay notes that the fresher studies on Celebrex and Bextra actually aren't from new data. "This is data we knew about before. However, the complete studies are now published. And what's important about these studies is, they're the strongest type of studies that give us the best evidence. They're known as randomized controlled trials. And they really did show an increased risk of cardiovascular events in every single one of those studies.

"In addition, there are other studies that have come out now which look back at how patients did who were on these medications that also seem to be converging with this idea that this increases cardiovascular events.

"So, the evidence is certainly growing and becoming stronger that this is a real thing and something obviously needs to be done to get the word out at least."

In the meantime, Senay suggests, patients with heart disease or at risk of heart disease may want to consider alternatives to these drugs until further studies are completed, or the FDA decides what it's going to do. Consult with your doctor to assess your individual risk versus benefit because, for many people, these drugs provide very effective for pain relief.

Should you choose to give up any of these drugs, don't forget that over-the-counter meds such as aspirin, acetaminophen and ibuprofen are proven to safe and effective for pain relief. But again, you need to ask your doctor about which ones are right for you. It's important to remember that every drug has side effects, and you really need to pay attention to the directions and take these drugs with care.