Prescribing Information

[Jenny]

I notice a lot of people asking questions about medication or
posting about issues that may be results of medication. So I
thought I'd mention something important that many people don't
seem to be aware of.

Every drug that is approved in the U.S. must have Prescribing
Information which follows a format that I think is required by
the FDA. In the old days, this Prescribing Information had to
be included with every prescription your pharmacist dispensed,
but this is no longer true.

The Prescribing Information contains important
information about:
1. The effectiveness of the medicine (often you will find it
is far less effective than you were led to believe. For
example, the Prescribing Information for anti-fungal
medicine prescribed for female yeast infections shows that
it only works about half the time.)

2. Drugs that interact dangerously with this drug.

3. Side effects and how common they might be.

4. Warnings--for example, did you know that Amaryl is
associated with a chance of heart attack that is two and a
half times that of other diabetes drugs? Or that there are
some cases of liver failure associated with Avandia?

5. The correct dose for the drug and the signs and treatment
for overdosage.

6. Dangers to pregnant or nursing women.

7. Cancer risk. (Did you know, for example, that Avandia
causes fatty tumors (lipomas) in mice? These are not
cancerous, but I have had one, and they are quite painful
when removed.)

8. Effects on blood sugar--did you know that Septra/Bactrim
can cause hypos, for example?

You can find the Prescribing Information online by googling
the drug name and the words "Prescribing Information."
Sometimes they are web pages, sometimes they are PDF files.

Make it a habit to look at the Prescribing Information before
you fill the prescription for a new drug. You can save
yourself a world of grief.

Just this fall a doctor erroneously prescribed me an overdose
of a common drug--he got it confused with another version. The
pharmacy dispensed it as written, though the PI made it very
clear that the max dose was 500 mg less! Doctors are always
prescribing drugs for me that are counterindicated in a person
who has tinnitus, too. Fortunately, this is something that is
mentioned in the Prescribing Information, too.

I make it a habit to read up on

--Jenny

http://www.geocities.com/lottadata4u/ Type 2 Diabetes info
http://www.geocities.com/jenny_the_bean/ Low Carb info

[Maryl]

"Jenny" <lottadatacarbs@hotmail.com> wrote in message
news:gPqdne2RKrfmDh3enZ2dnUVZ_vudnZ2d@rcn.net...
>I notice a lot of people asking questions about medication or
>posting about issues that may be results of medication. So I
>thought I'd mention something important that many people
>don't seem to be aware of.
>
> Every drug that is approved in the U.S. must have
> Prescribing Information which follows a format that I think
> is required by the FDA. In the old days, this Prescribing
> Information had to be included with every prescription your
> pharmacist dispensed, but this is no longer true.
>
<snip>
> You can find the Prescribing Information online by googling
> the drug name and the words "Prescribing Information."
> Sometimes they are web pages, sometimes they are PDF files.
>
> Make it a habit to look at the Prescribing Information
> before you fill the prescription for a new drug. You can
> save yourself a world of grief.
>
> Just this fall a doctor erroneously prescribed me an
> overdose of a common drug--he got it confused with another
> version. The pharmacy dispensed it as written, though the PI
> made it very clear that the max dose was 500 mg less!
> Doctors are always prescribing drugs for me that are
> counterindicated in a person who has tinnitus, too.
> Fortunately, this is something that is mentioned in the
> Prescribing Information, too.
>
> I make it a habit to read up on
>
> --Jenny
>
> http://www.geocities.com/lottadata4u/ Type 2 Diabetes info
> http://www.geocities.com/jenny_the_bean/ Low Carb info

Thanks! This is excellent information and a very helpful
suggestion.

MaryL

[Bj]

"Jenny" <lottadatacarbs@hotmail.com> wrote in message
news:gPqdne2RKrfmDh3enZ2dnUVZ_vudnZ2d@rcn.net...
>
> You can find the Prescribing Information online by googling
> the drug name and the words "Prescribing Information."
> Sometimes they are web pages, sometimes they are PDF files.
>

You can also ask the pharmacist for a copy of the PI -- they
should have one around or be able to get one. Also pick up a
magnifying glass to read it with if you get the drug company
printed version. bj

[Ozgirl]

bj wrote:
> "Jenny" <lottadatacarbs@hotmail.com> wrote in message
> news:gPqdne2RKrfmDh3enZ2dnUVZ_vudnZ2d@rcn.net...
>>
>> You can find the Prescribing Information online by
googling the drug
>> name and the words "Prescribing Information." Sometimes
they are
>> web pages, sometimes they are PDF files.
>>
>
> You can also ask the pharmacist for a copy of the PI --
they should
> have one around or be able to get one. Also pick up a
> magnifying glass to read it with if you get
the drug
> company printed version.

Doesn't it come included in the box there?

[Sarah]

"Jenny" <lottadatacarbs@hotmail.com> wrote in message
news:gPqdne2RKrfmDh3enZ2dnUVZ_vudnZ2d@rcn.net...
>I notice a lot of people asking questions about medication or
>posting about issues that may be results of medication. So I
>thought I'd mention something important that many people
>don't seem to be aware of.
>
> Every drug that is approved in the U.S. must have
> Prescribing Information which follows a format that I think
> is required by the FDA. In the old days, this Prescribing
> Information had to be included with every prescription your
> pharmacist dispensed, but this is no longer true.
>
> The Prescribing Information contains important
> information about:
> 1. The effectiveness of the medicine (often you will find it
> is far less effective than you were led to believe. For
> example, the Prescribing Information for anti-fungal
> medicine prescribed for female yeast infections shows
> that it only works about half the time.)
>
> 2. Drugs that interact dangerously with this drug.
>
> 3. Side effects and how common they might be.
>
> 4. Warnings--for example, did you know that Amaryl is
> associated with a chance of heart attack that is two and
> a half times that of other diabetes drugs? Or that there
> are some cases of liver failure associated with Avandia?
>
> 5. The correct dose for the drug and the signs and treatment
> for overdosage.
>
> 6. Dangers to pregnant or nursing women.
>
> 7. Cancer risk. (Did you know, for example, that Avandia
> causes fatty tumors (lipomas) in mice? These are not
> cancerous, but I have had one, and they are quite painful
> when removed.)
>
> 8. Effects on blood sugar--did you know that Septra/Bactrim
> can cause hypos, for example?
>
> You can find the Prescribing Information online by googling
> the drug name and the words "Prescribing Information."
> Sometimes they are web pages, sometimes they are PDF files.
>
> Make it a habit to look at the Prescribing Information
> before you fill the prescription for a new drug. You can
> save yourself a world of grief.
>
> Just this fall a doctor erroneously prescribed me an
> overdose of a common drug--he got it confused with another
> version. The pharmacy dispensed it as written, though the PI
> made it very clear that the max dose was 500 mg less!
> Doctors are always prescribing drugs for me that are
> counterindicated in a person who has tinnitus, too.
> Fortunately, this is something that is mentioned in the
> Prescribing Information, too.
>
> I make it a habit to read up on
>
> --Jenny
>

Using Google to find prescribing information will sometimes
lead to out of date information. Prescribing information is
updated as new data becomes available, like newly discovered
side effects.

The best place to look for up to date prescribing information
is the FDA web site. http://www.fda.gov/search.html

The best way to search for prescribing information in the FDA
search box: "prescribing information" +"drug name".

There will frequently be links to a lot of safety related
items as well as prescribing information.

Sarah

[Jenny]

Ozgirl wrote:
>
> Doesn't it come included in the box there?
>
No! This is one of the maneuvers the big drug companies pulled
some years ago here in the U.S. around the time they started
their saturation TV ad campaigns for new drugs. They got the
laws changed so that they didn't have to include the actual PI
insert with a prescription.

Instead you usually get an extremely dumbed down information
sheet printed by the pharmacy computer which is written for
someone who reads--and thinks--at the third grade level. The
side effects are glossed over, the drug interactions section
lists only things that will kill you, and you are told to
contact your doctor if you have any concerns.

--Jenny

http://www.geocities.com/lottadata4u/ Type 2 Diabetes info
http://www.geocities.com/jenny_the_bean/ Low Carb info

[Alan S]

On Sun, 20 Nov 2005 23:02:30 GMT, "Ozgirl"
<are_we_there_yet@maccas.com> wrote:

>
>Doesn't it come included in the box there?

The generic Diaform (metformin) that I just started on was the
first Australian medication I've ever received without that
information in the box.

Cheers, Alan, T2, Australia.
--
Everything in Moderation - Except Laughter.

[Bj]

"Jenny" <lottadatacarbs@hotmail.com> wrote in message
news:cMidnYX1KKCegxzeRVn-tA@rcn.net...
>
> Instead you usually get an extremely dumbed down information
> sheet printed by the pharmacy computer which is written for
> someone who reads--and thinks--at the third grade level. The
> side effects are glossed over, the drug interactions section
> lists only things that will kill you, and you are told to
> contact your doctor if you have any concerns.
>

And most people don't even read those. They're certainly not
going to read the Small Print Detail Version! which is at
least available if you ask for
it. I've even gotten one for a med I was thinking about taking
-- didn't even have a Rx for it.

Fosamax (weekly version) comes in 4-pill packets -- each with
complete PI & reader-friendly version & stickers to put on
your calendar. I also get the pharmacy's printout with each
refill. bj

bj

[Vbh]

Jenny wrote:
> I notice a lot of people asking questions about medication
> or posting about issues that may be results of medication.
> So I thought I'd mention something important that many
> people don't seem to be aware of.
>
> Every drug that is approved in the U.S. must have
> Prescribing Information which follows a format that I think
> is required by the FDA. In the old days, this Prescribing
> Information had to be included with every prescription your
> pharmacist dispensed, but this is no longer true.
>
> The Prescribing Information contains important
> information about:
> 1. The effectiveness of the medicine (often you will find it
> is far less effective than you were led to believe. For
> example, the Prescribing Information for anti-fungal
> medicine prescribed for female yeast infections shows
> that it only works about half the time.)
>
> 2. Drugs that interact dangerously with this drug.
>
> 3. Side effects and how common they might be.
>
> 4. Warnings--for example, did you know that Amaryl is
> associated with a chance of heart attack that is two and
> a half times that of other diabetes drugs? Or that there
> are some cases of liver failure associated with Avandia?
>
> 5. The correct dose for the drug and the signs and treatment
> for overdosage.
>
> 6. Dangers to pregnant or nursing women.
>
> 7. Cancer risk. (Did you know, for example, that Avandia
> causes fatty tumors (lipomas) in mice? These are not
> cancerous, but I have had one, and they are quite painful
> when removed.)
>
> 8. Effects on blood sugar--did you know that Septra/Bactrim
> can cause hypos, for example?
>
> You can find the Prescribing Information online by googling
> the drug name and the words "Prescribing Information."
> Sometimes they are web pages, sometimes they are PDF files.
>
> Make it a habit to look at the Prescribing Information
> before you fill the prescription for a new drug. You can
> save yourself a world of grief.
>
> Just this fall a doctor erroneously prescribed me an
> overdose of a common drug--he got it confused with another
> version. The pharmacy dispensed it as written, though the PI
> made it very clear that the max dose was 500 mg less!
> Doctors are always prescribing drugs for me that are
> counterindicated in a person who has tinnitus, too.
> Fortunately, this is something that is mentioned in the
> Prescribing Information, too.
>
> I make it a habit to read up on
>
> --Jenny
>
> http://www.geocities.com/lottadata4u/ Type 2 Diabetes info
> http://www.geocities.com/jenny_the_bean/ Low Carb info

Not exactly the same information as given in the leaflet in
all cases in the EU, but at least we get most of it,
thankfully. For those in the UK, the BNF is always worth a
read at http://www.bnf.org . Its the prescription "bible" for
all docs and nurses. Registration is required but it is free.

rxlist.com and drugs.com are also handy sources of information
although based in the US which should always be borne in mind.
Of particular interest when looking at this was the individual
side effect rates for statins and the difference between the
various statins.

VBH