Re: Injectable contraceptive can weaken bones (CBC.ca)
From: Anna (anonymous@obgyn.net)
Sat Nov 27 14:21:54 2004
Ellen,
Thanks for doing all that digging! I appreciate you taking the time to
share the info with us. Very interesting information. Geez.
By the way, are you Canadian? I am, but I live in California now.
-Anna
At Tue, 23 Nov 2004, Ellen wrote:
>
>I've done a bit more digging... here's what the Canadian Women's Health
>Network (http://www.cwhn.ca/pr/11-19-04.html) has to say about
>Depo-Provera:
>
>For Immediate Release
>
>Winnipeg, November 19, 2004
>
>>From the Canadian Women's Health Network:
>Significant Bone Loss Associated with Depo-Provera Use is Sadly No
>Surprise; We Call For Action To Make Sure This Doesn't Happen Again
>
>This week, the pharmaceutical company Pfizer issued letters in both
>Canada and the United States warning about a serious health risk to
>women who use their long-acting, injectable contraceptive drug,
>Depo-Provera.
>
>Pfizer announced that they will be warning doctors and women and
>adolescents who use Depo-Provera that the drug may cause a significant
>loss of bone mineral density, that the loss increases with duration, and
>that the loss may not be completely reversible.
>
>In other words, these women and girls face an increased risk of
>developing osteoporosis and the fractures associated with the condition.
>Pfizer also announced that studies on the impact of bone loss during
>this key period in young women are ongoing.
>
>These warnings come as no surprise to the women's health groups who, in
>the early 1980's, were already raising concerns about Depo-Provera, its
>risks to women's health and autonomy, and the troubling circumstances
>under which the drug was being tested and used.
>
>The history of Depo-Provera's approval in Canada is yet another example
>of the weaknesses in Canada's drug approval system, a system that is
>supposed to protect the health of Canadians—including women.
>
>The approval and marketing of Depo-Provera in Canada speaks to a lack of
>women-sensitive research, the absence of rigorous, transparent drug
>review and post marketing surveillance processes, and the hazards of
>ignoring community voices. We are angry and feel betrayed by this
>latest example of women being used as guinea pigs without their
>knowledge or consent. Just as with hormone replacement therapy, it has
>been women's health groups to first ring the alarm bells about our own
>health issues.
>
>Health Canada approved Depo-Provera for use as a contraceptive in April
>1997 after several previous applications by the manufacturer had been
>denied due to concerns being raised by independent researchers and
>community groups.
>
>Six years earlier, the Canadian Coalition on Depo-Provera sent a letter
>to Benoit Bouchard, then National Minister of Health and Welfare,
>pointing out the risks of osteoporosis identified in a study conducted
>in New Zealand in 1991 and published in the British Medical Journal
>which noted a decrease in bone density in Depo users, thereby increasing
>their risk factor for osteoporosis, a condition that is a significant
>health risk for Canadian women.
>
>Yet Depo was widely promoted by health professionals to young women and
>Pfizer was even allowed to advertise its product directly to consumers,
>something that is illegal in Canada.
>
>We ask, why have we had to wait for thirteen years for the drug company
>and the government to acknowledge these risks?
>
>How many women and adolescent girls have been unnecessarily exposed to
>an increased risk of osteoporosis as a result of using Depo-Provera? And
>who will take responsibility for any resulting fractures? It is
>important that we learn from this error. Hormone replacement therapy,
>Vioxx, and Depo-Provera are stories about drugs that all indicate the
>need for a serious review of Canada's drug approval and monitoring
>systems. Action is required.
>
>We call on:
>
>1. Health Canada and the Standing Committee on Health to hold hearings
>to review the history of the use, approval and post marketing
>surveillance of Depo-Provera.
>
>2. Pfizer Canada to establish an independently managed compensation
>fund.
>Calcium supplements and vitamin D to build bone strength, extra
>calcium-rich food, exercise programs to increase bone mass, monitoring
>by health care professionals and possible health care all have costs. We
>call on Pfizer Canada to use its profits from the sale of Depo-Provera
>to cover the costs that women and Canada's health care system will have
>to assume.
>
>3. Provincial and federal governments to seek reimbursement from Pfizer
>for the health costs of caring for women who have been put at risk for
>this drug.
>
>4. Provincial and federal governments to immediately put in place
>community based educational programs for women who have been using
>Depo-Provera.
>
>5. Pfizer to establish an independent health research program to
>support a community based research program for women's health.
>
>Our past history clearly demonstrates that women's health groups can be
>far more reliable and informed source than either the drug companies or
>Health Canada. We ask how we can prevent this from happening again?
>
>Attachment: Coalition on Depo-Provera's letter to Health Canada, 1991
>
>Contact:
>Madeline Boscoe,
>Executive Director, Canadian Women's Health Network and co-founder
>Canadian Coalition on Depo-Provera.
>Cell 204-295-2946
>
>--
>Ellen.
>
>At Tue, 23 Nov 2004, Ellen wrote:
>>
>>Curious... I read an article on this in the Globe and Mail
>>(http://www.theglobeandmail.com), also dated the 19th. What it
>>mentions, that the CBC doesn't seem to, is that Pfizer issued a warning
>>that the bone density loss MAY BE IRREVERSIBLE. Kae is right; the bone
>>density issue has been known about for a long time. What hasn't been
>>clear is whether or not the density could be recoverable; new studies
>>conducted for the FDA indicate in some cases it may not be. The Globe
>>article also said, "The new research, done as a condition of approval
>>for sale in the United States, showed that womn taking Depo Provera for
>>five years had a 5 -6 per-cent decreas in bone density measured in the
>>hip and spine."
>>
>>I haven't checked to see if they have website, but the Canadian Women's
>>Health Network have long believed that D-P was approved in Canada
>>without adequate research into long-term effects. The group is calling
>>for a public inquiry into how it was approved by Health Canada without
>>adequate safeguards.
>>
>>At Mon, 22 Nov 2004, Kae wrote:
>>>
>>>I posted something simalar to this about 6 or 7 months ago. I have been
>>>on Depo Provera for 5 1/2 years and I am now having bone loss in my back
>>>and hips. I was diagnosed with Osteopenia in July and my doctor has put
>>>me on Actonel to reverse this. Also if you read the side effects of
>>>this drug it does state that it is a possability.
>>>
>>>--
>>>KAE
>>>
>>>At Sun, 21 Nov 2004, Anna wrote:
>>>>
>>>>Hi all,
>>>>
>>>>I thought this news article might interest some of you. I found it
>>>>today at cbc.ca, the Canadian Broadcasting Corporation's news website.
>>>>I'll be curious to hear what you think.
>>>>
>>>>-Anna
>>>>
>>>>I'm just going to go ahead and post the whole article here:
>>>>
>>>>Injectable contraceptive can weaken bones, company warns
>>>>
>>>>Last Updated Fri, 19 Nov 2004 18:35:46 EST (CBC)
>>>>
>>>>TORONTO - The manufacturer of an injectable contraceptive is warning
>>>>teenagers and young women that the drug could permanently weaken bones.
>>>>
>>>>Loss of bone density is a side-effect of long-term use of the
>>>>contraceptive, called Depo-Provera, the U.S. Food and Drug
>>>>Administration said this week. The FDA added the drug is still safe and
>>>>effective.
>>>>
>>>>Depo-Provera is a hormone treatment that is injected every three months
>>>>for contraception.
>>>>
>>>>Pfizer Canada cautions women not to use the drug while they're teens or
>>>>young adults because those years are a critical time for bone mass
>>>>development.
>>>>The company is working with Health Canada to issue a warning on the
>>>>drug's packaging.
>>>>
>>>>In a statement, the FDA said patients should only use the drug if other
>>>>types of birth control are not an option or are "inadequate."
>>>>
>>>>Depo-Provera packages in the U.S. currently warn women who have breast
>>>>cancer, liver problems, a past stroke or blood clots in the legs against
>>>>using the drug.
>>>>
>>>>The FDA said it called for a new packaging warning after analysing data
>>>>on the drug's long-term effects on bone density.
>>>
>>--
>>Ellen
>>
>--
>L.
>
![[ endo@obgyn.net ]](../../images/endo_at_obgyn.gif)