Watch Out: When taking new drugs

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According to a recent study in the New England Journal of Medicine , when the US FDA approves a new drug, it requires the manufacturer of that product to do post-marketing surveillance about safety in the general population mostly because pre-marketing studies often restrict entry to many groups of people who will ultimately get those drugs – such as people with many common serious pre-existing conditions – so there are always surprises – some small, some large – when a drug starts getting used in a much broader segment of the population than was the case in the original studies.
As well, common sense will tell you that it always takes a few years to learn about many of the potential negatives of a new product – say hello to anti-reflux medications, anti-depressants, NSAIDS, anti-osteoporosis drugs, and on and on and on.
These new drugs always benefit some people, but they also often harm some, so it’s vital to keep monitoring all medications for ultimate safety, but especially new ones.
According to this study, however, many new pharmaceutical products are not evaluated for safety after they come out.
The pharma companies – and the FDA – have strenuously denied these claims, and they’ve put forward a number of counter-arguments including the fact that it just takes a long time to enroll enough patients to do the kind of post-marketing studies the FDA asks for.
In the end, most drugs that are released have more benefits than drawbacks.
But not all do – several drugs have been withdrawn from the market in recent years, always with accompanying loud headlines about safety issues – so as a medication user, what you need to know is that your doctor simply can’t assure you that the new and improved drug she or he has advised you take you is as safe and as effective as the data has promised and that you’ll simply have to wait a few more years to find out if you’ve actually been on something that you would have been better off avoiding, which is why I think that unless there’s a compelling argument to try some new product, it generally makes more sense to try an older better-understood product first.

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