Over the past 50 years, there have been some true breakthroughs in medicine. And some of these even came from the pharmaceutical industry. Take a blood pressure drug like Losartan, for instance. And the diabetes drug Metformin.
But today, the world is a very different place. The market is flooded with drugs that don’t work. Or drugs that do more harm than good. And physicians and patients are rightly skeptical about the credibility of drug-company research.
Sometimes, these drugs look great in clinical trials. They gain FDA approval. They hit the market amid great publicity. Hurrah–it’s the next great wonder drug.
And then the trouble starts.
Men and women start reporting adverse effects to their doctors. When this happens, the doctors report the problems–or are supposed to report them–to the FDA. You can also report problems yourself to the FDA.
Then, once the FDA receives enough complaints, it adds the drug to their “watch list.”
But when a drug makes the FDA’s watch list, it does not mean that the agency has concluded that it poses the health risks reported. It only means the agency will study the drug to determine whether or not there is truly a causal link. Of course, it may take 10 years for the FDA to decide. Between all the government holidays and punting the problem to some quasi-scientific “committee” for further study.
A recent FDA drug “watch” proved so useless, it motivated doctors at Harvard to do their own studies to figure out what was really happening. I’ll tell you more about this in an upcoming Daily Dispatch.
If the FDA does establish a causal link, it then considers a regulatory response.
Sometimes, the FDA recommends gathering more data to better characterize the risk. That means they’ll do more research. Then convene another committee.
Or sometimes, the FDA just recommends revising the drug’s label. And in many cases, Big PHARMA gets away with just a slap on the wrist. The FDA asks the drug company to do a risk-evaluation and mitigation strategy.
In addition, just because a drug goes on the “watch list,” it doesn’t mean the FDA suggests clinicians should stop prescribing these drugs. Or that patients should stop taking them. Heaven forbid you should stop taking a drug that causes retinal detachment without just cause!
So now, you know what the “watch list” really means. It means the FDA bureaucrats pull down their watches, so they can administer a slap on the wrist. And last fall, the FDA added eight new drugs to its “watch list.”
One drug on this list, Zyrtec, is used to treat seasonal allergies. And it’s available without a prescription. The FDA put it on the watch list because of reports of oculogyric crisis. An oculogyric crisis is uncontrolled eye movements. It’s often seen in epilepsy patients. Now, patients who took Zyrtec also report experiencing this symptom. But don’t go into convulsions about it just yet, according to FDA. It’s still on the market.
The FDA also put proton pump inhibitors on the watch list for reports of pneumonia. Physicians prescribe drugs from this whole class to treat heart burn and other digestive issues. So, what’s a little pneumonia when it comes to dealing with indigestion?
As I said yesterday, I never recommend trying a new drug unless it’s been on the market for at least seven years. And even then, use caution.
For more information about new drugs added to the FDA’s watch list, you can visit the FDA’s web site. And if you take a drug and experience an adverse effect, make sure you report it to your physician and to the FDA.
Source:
1. http://www.fda.gov/Drugs/default.htm