We are all immersed in pharmceutical TV ads that rattle off a long list of side effects that sound worse than the illness. So, just where does the pharmaceutical industry OR the FDA draw the line on acceptable risk? I mean, some of these drugs are known to lead to cancer or death. Is there ever a time when the FDA says “Whoa!”?
Reading about drugs removed from the market might give a more clear picture as to what is not acceptable. Here is a list…
The point about risk is that this or that might lead to adverse results in some people under some conditions and circumstances. You oughtn’t to get a prescription without your doctor explaining all that to you, and what sort of monitoring would be needed to see if any of this might be starting to happen to you. You should decide together whether that outranks whatever it is you might take the drug to combat. It’s all a matter of balancing out relative disadvantages.
The FDA considers side effects and other risks when deciding when to approve a drug for use. If you’re seeing an ad for a drug, that’s already happened. This is, at some level, a judgment call, but they tend to err on the side of caution.
Keep in mind that although you’re hearing a (legally mandated) list of observed side effects on those ads, that doesn’t mean that those problems are likely, or even common, just that they have been observed to happen at some low frequency during clinical trials. It might be one in a hundred or one in a thousand.
When approving a drug, the FDA has to balance the frequency and severity of the drug’s negative effects against the benefits of treating whatever problem it treats at whatever frequency of benefit is observed. For instance, a drug that makes your arm fall off won’t be approved if it cures mild headaches or acne, but it very well might if it were to cure cancer. It’s often been said that aspirin, if it were introduced today, would never in a million years get approved by the FDA due to its tendency to cause stomach problems.
Birth control pills are usually considered safe and even beneficial for the health of the woman taking them but almost killed my wife. It’s because of a Factor V deficiency that runs in her family. Your doctor should know your history and can make a better determination than reading the warning on a box that doesn’t apply equally to every person.