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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 3 of 3. This is the beginning of the thread.
Posted by Joe Bloe on March 19, 2007, at 20:09:33
I looked at this profile for Omacor and found some interesting things mentioned.http://www.drugs.com/omacor.html
I found the side effect profile and some of the warnings surprising.
Here's one:
"FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether Omacor passes into breast milk or if this could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medication to anyone under 18 years old."
Why do they say that it can harm a fetus? I was under the belief that it was beneficial for the fetus and that a pregnant woman should supplement her diet with omega 3s.
Also surprising is this:
"To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled visits to your doctor."
Is the liver test required for cholesterol or because Omacor can harm the liver?
I thought this profile was odd, especially for what I feel is a relatively benign side effect profile from health food store fish oil. Is Omacor in any way fundamentally different from store bought supplement fish oil?
Posted by Larry Hoover on March 20, 2007, at 8:40:54
In reply to Why the Side effect profile for Omacor Omega 3s?, posted by Joe Bloe on March 19, 2007, at 20:09:33
>
> I looked at this profile for Omacor and found some interesting things mentioned.
>
> http://www.drugs.com/omacor.html
>
> I found the side effect profile and some of the warnings surprising.First, the background. Omacor makes health claims. Under many countries' health regulations, that brings an OTC med under scrutiny as if it was a pharmaceutical. Sort of. But nobody has ever done Phase 1 or 2 clinical trials., so they have no data to publish.
> Here's one:
>
> "FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether Omacor passes into breast milk or if this could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medication to anyone under 18 years old."
>
> Why do they say that it can harm a fetus? I was under the belief that it was beneficial for the fetus and that a pregnant woman should supplement her diet with omega 3s.Your beliefs are correct. However, the warning is legal "boilerplate" text. It's what's called a disclaimer.
The drug monograph has a different format, and I find it to be more enlightening. See: http://www.omacor.com/filestore/OmacorSPC.pdf
Sections 4.4 and 4.6 cover the subjects. I'm unable to cut and paste the text out of that document, for some reason. In effect, they say, "We have no data, so buyer beware."
> Also surprising is this:
>
> "To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled visits to your doctor."
>
> Is the liver test required for cholesterol or because Omacor can harm the liver?The warning in the monograph applies to those with impaired liver function going into treatment, not that liver function is altered in normal folk. See special precaution under 4.4.
See section 5.3. No safety issues found during clinical trials.
> I thought this profile was odd, especially for what I feel is a relatively benign side effect profile from health food store fish oil.
I think you're seeing the effects of two things. One, letting lawyers at it. The information in the patients' information sheet actually is altered from that in the physicians' form, but under the rubric of "protecting thy *ss". Two, the effects from pharmaceutical lobbying on regulatory processes. Forcing OTC supps to even address the topics such as pediatric use, pregnancy and lactaction, knowing full well that Phase 1 and 2 trials, let alone focussed Phase 3 trials are not going to ever happen, does not "level the playing field". It tilts it, and greases it, too.
> Is Omacor in any way fundamentally different from store bought supplement fish oil?
Yes, actually, it is. It is not a triglyceride, as all natural fats are, i.e. glycerin, with three alcohol groups, bonded to three distinct fatty acids. Instead, it is ethanol, individually esterified to relatively pure EPA and DHA. This makes it distinct from other natural products, permitting it to be patented. I don't know.....does that make it prescription-only under FDA regs? Whatever. You can just take enriched fish oils, or the regular stuff. You don't need Omacor®. And you needn't worry about it.
Lar
Posted by Joe Bloe on March 21, 2007, at 18:17:15
In reply to Re: Why the Side effect profile for Omacor Omega 3s? » Joe Bloe, posted by Larry Hoover on March 20, 2007, at 8:40:54
This is the end of the thread.
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