How does the FDA know about new side effects for a drug that has already been approved?

The FDA has surveillance programs in place to monitor the safety of drugs after approval.  These programs primarily rely on physicians reporting to the FDA the side effects they see.  While not all physicians routinely make such reports, enough do that unexpected side effects usually come to light.  For some drugs that are approved with some questions about safety, special requirements can be put into place.  These might include so called phase IV studies to gather more safety data or special prescribing programs for high-risk drugs.

For more questions and answers about clinical trials, visit the Talk about Health website.
To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

Hormonal Therapy for Prostate Cancer - Education Video

In an occasional departure from our focus on clinical trials, we thought we would share our latest patient education videos for prostate cancer patients.  Here Dr. Beer discusses hormonal therapy for prostate cancer - very much the way it would be discussed in a clinic visit. 


To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

Chemotherapy for Prostate Cancer - Education Video

In an occasional departure from our focus on clinical trials, we thought we would share our latest patient education videos for prostate cancer patients.  Here Dr. Beer discusses chemotherapy for prostate cancer - very much the way it would be discussed in a clinic visit. 


To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

Cancer Drug Side effects: Are you getting the whole story?

In a word (or two), maybe yes and maybe no.  Lists of side effects are easy to find.  Every drug has them.  These lists may be so long that they become almost meaningless.  As you leaf through these listing, several questions arise: 

1)    Is the list complete? Are there any side effects missing that I need to know about?

2)    Are all these side effects really caused by the drug?

3)    How do I know which of these side effects may happen to me?

How are side effect reported

We will tackle the first two questions, the third deserves its own blog post.  Researchers who study new cancer drugs are the first to report side effects.  Side effects can also be reported to the FDA after a drug is approved and regularly prescribed. Researchers report every adverse event that happens to their patients who are participating in a clinical trial.  Adverse events are reported together with their grade and “relationship to treatment.”  The grade is a measure of severity and for every imaginable adverse event, there is a table that describes what is mild (grade 1), moderate (grade 2), severe (grade 3), and life threatening (grade 4).  Clinic notes in research centers are filled with these mysterious grades whenever anything untoward happens. 

The relationship to treatment is determined by the research physician’s best judgment about whether the adverse event was caused by the drug or not.  There are shades of grey here:  related, probably, possibly, unlikely, and not related.  The decision is basically a judgment call, an educated guess.  Sometimes it’s obvious: you are feeling great and get the flu along with your entire family.  Pretty unlikely the drug had anything to do with it.  Often it is not so obvious.  People with cancer may also have other medical conditions and take many different drugs.  The illness itself takes a toll. When something untoward happens, there are many possible causes. 

With all this reporting, how could side effects go unnoticed?

Rare side effects can, of course, go unnoticed if they didn’t happen during the study.  Sometimes, the source you are relying on (i.e. research paper) listed only a subset of the