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FreeSpirit
Joined: 09 Aug 2001
Posts: 600
Location: Site Admin
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 Posted: Tue Nov 23, 2004 5:12 pm Post subject: FDA Talk Paper New Warnings about Depo Provera |
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Please visit the link below
http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01325.html
FDA Talk Paper
T04-50
November 17, 2004
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA
Black Box Warning Added Concerning Long-Term Use of Depo-Provera Contraceptive Injection
| Quote: | | The Food and Drug Administration (FDA) announced today that a "black box" warning, highlighting prolonged use may result in the loss of bone density, will be added to the labeling of Depo-Provera Contraceptive Injection, an established injectable drug approved for use in women to prevent pregnancy. |
| Quote: | | Black box warnings are designed to highlight special problems, particularly those that are serious, and to give health care professionals a clear understanding of a potential medical complication associated with a drug. Black box warnings provide physicians with important insights as to how to prescribe a drug that may be associated with serious side effects in a way that maximizes its benefits and minimizes its risks |
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In its own way, pain paves the way for a graceful departure ( Ecclesiastes 12:1-14). |
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Vida
Joined: 23 Aug 2002
Posts: 3
Location: Ottawa, Ontario, Canada
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| Posted: Tue Jan 04, 2005 7:01 am Post subject: Health Canada Warnings |
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Health Canada has also followed suit by issuing a warning for BDL. Too little too late for many of us. Hopefully this will be the tip of the iceburg and the other also very serious side affects  will be recognised. |
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aimless
Joined: 15 Jan 2005
Posts: 1
Location: MN
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| Posted: Sat Jan 15, 2005 4:49 pm Post subject: |
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| I just found about the warning this week. I have been taking depo for 3-1/2 years and am wondering why my Drs office didn't send me this information. Since the notice is put in the packaging, and the shot administered at the clinic, do any of us ever see the warning????? |
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FreeSpirit
Joined: 09 Aug 2001
Posts: 600
Location: Site Admin
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| Posted: Sun Jan 16, 2005 12:40 pm Post subject: |
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Hi aimless,
Practitioners have been advised by the drug manufacturer to discuss this when administering depo provera as a method of birth control.
Unfortunately they are not required to issue the information to people
for past injections. Essentially by listing the warnings the drug company has attempted to protect themselves and leave the liability to the practitioners.
Additionally a medical practitioner is (and always was) required to provide you with a
patient information sheet that is included with the drug, even if you are receiving the injection in the office.
For those of you who have not read the complete information from the link provided above the following is pertinent information as well.
| Quote: | | Thus the warning states that a woman should only use Depo-Provera Contraceptive Injection as a long-term birth control method (for example, longer than two years) if other birth control methods are inadequate for her. |
Again I suggest anyone using / considering using depo provera as a method of birth control read the entire site at the link below including the pdf files at the bottom of the webpage.
http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01325.html
Dear Healthcare Professional Letter (Pfizer Inc.) (PDF)
Dear Healthcare Organization Leader Letter (Pfizer Inc.) (PDF)
Label (Pfizer Inc.) (PDF)
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In its own way, pain paves the way for a graceful departure ( Ecclesiastes 12:1-14). |
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