How to view Side Effects and FDA Regulation.

Prostate cancer drugs can really suck with side effects for some but they can be nothing for others. Until you try them you don't know what you'll see. Below is a labeling that I copied over to show how some medications used by prostate cancer survivors can be terrible...

Have a look:

Get emergency medical help if you have any of these signs of an allergic reaction while taking this medication:

Hives
Difficulty breathing
Swelling of your face, lips, tongue, or throat.

Stop taking this drug and seek medical attention or call your doctor at once if you have any of these serious side effects:

Chest pain
Weakness
Shortness of breath
Slurred speech
Problems with vision or balance
Black, bloody, or tarry stools
Coughing up blood or vomit that looks like coffee grounds
Swelling or rapid weight gain
Urinating less than usual or not at all
Nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools
Jaundice (yellowing of the skin or eyes)
Fever
Sore throat
Headache with a severe blistering, peeling, and red skin rash
Bruising
Severe tingling
Numbness
Pain
Muscle weakness
Severe headache
Neck stiffness
Chills
Increased sensitivity to light
Seizure (convulsions).

Less serious side effects of this medication may include:

Upset stomach
Mild heartburn
Diarrhea
Constipation
Bloating or gas
Dizziness, headache, nervousness;
Skin itching or rash
Blurred vision
Ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

This model is scary. The FDA regulates that any observed issues be packaged with a drug. And so it is that I am currently working on clinical trials at SWOG that have listed far less that these one's above. So any guesses on which drug I listed the SE's to above?

And LHRH Agonist like Lupron? An AR like bicalutamide or Xtandi? Zytiga? Nope!!!!

The drug SE's above are from Ibuprofen. Advil. Motrin. And yes it is used by prostate cancer patients and 90% of Americans alike. I am certain that some members here have felt some of these SE's but more than likely most have not felt any of them. In fact if they did, they probably still appreciated taking the drug anyway more than had they read this labeling and refused to take it.

I've been on hormonal therapies and I know that many will cause SE's and I've experienced the SE's. But like Ibuprofen, I'd still consider taking it again knowing that it's possible that I will suffer an SE from it. The FDA regulates the labeling to list far more SE's than I actually felt. And for some men on HT they never feel ANY of the listed SE's for those drugs, but they are rare cases.

In my thread here about a positive attitude, it's been my own observation that SE's can be minimizes by other good practices such as exercise, healthy eating and a positive attitude.

My advice to our support group members is to read the labeling and make sure the drug is safe for them, but don't over emphasize what you read. Each case is different. I will use this post tonight at our UsTOO meeting to show folks that SE's while likely for certain drugs, the labeling can be a deterrent to taking a drug and realizing the positive benefits.

Peace...

Tony

Tony said...
And for some men on HT they never feel ANY of the listed SE's for those drugs, but they are rare cases.

Since several of the listed side effects for HT drugs occur with an 80-90 percent frequency (impotence, testicular atrophy and emotional instability come to mind) they are rare indeed. But since I am on ADT3 and will be for another year and a half I understand your point. There are side effects that I am working to mitigate or avoid. So far I am doing OK with that.

Casey said...
conspiracy theory?

When we see a monkey pile it makes a difference who is on the bottom.

Josh welcome,
That is my mantra. Get with your doctor, understand that each man is different, and try to mitigate SE's. Sometimes it's beyond what I mentioned, diet, exercise, and healthy lifestyle changes sometimes are not enough...

LOL I take it you are either a Josh Turner, or a Josh Turner fan?

Tony

There is a reference book for medical professionals called the "Physicians Desk Reference (PDR)" - and my mother, a medical professional, once told me that if the general public would read the precautions in this publication it would likely scare everyone off of taking anything. . . .

I can also tell you that on the eve of my lasik surgery a number of years ago the 17-page "disclaimer" they make you read and sign includes the full gamut, "up to and including death."

We just need to be smart about all of this, do our research, and don't forget to add a dash of common sense - which is now officially listed on the endangered species list.