Tell Us More PFIZER
outrider_at_despammed.com
Date: 11/22/04
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Date: 22 Nov 2004 08:44:53 -0800
"There remains a huge problem in the way {Health Canada} approves and
monitors drugs for safety. ... Women have been reporting problems
related to the Depo-Provera since the 1970s and the Canadian Women's
Health Network has lobbied against its use just as long," said Ford.
But, Ford said: "if companies push long enough" a bad drug gets
approved. Then, she said, it remains on the market until, as in the
case of Vioxx, hormone replacement therapy and Paxil, the problems are
irrefutable.
"Those side effects, included daily migraines, severe hair loss,
vomiting, diarrhea, night sweats and nightmares.
Cross's infant daughter - she had been breastfed nine months while
Cross was on Depo-Provera - also developed lumps in her breasts.
TELL US MORE, PFIZER
Last week's disclosure that prolonged use of the birth control drug
Depo-Provera can cause serious side effects is spurring sufferers to
demand more information from the manufacturer
CHERYL CORNACCHIA
The Gazette
November 22, 2004
CREDIT: ALLEN MCINNIS, THE GAZETTE
Tina Cross, one of many women who used Depo-Provera and suffered severe
side effects while taking it - and more side effects when she stopped
taking it. Her infant daughter, whom she breast-fed, developed lumps in
her breasts.
Members of a Montreal-based online group of Canadian and U.S. women who
have suffered severe Depo-Provera side effects say they will not rest
until Pfizer, the drug's manufacturer, addresses some of their concerns
with the injectable birth-control drug.
Tina Cross, a 28-year-old Dorval mother of two, said Pfizer's
announcement late last week that prolonged use of the Depo-Provera
leads to significant bone loss and an increased risk of osteoporosis is
only the beginning - not the end.
"We want more disclosure," said Cross, a founder of the online group,
which links more than 450 Canadian and U.S. women who have used the
drug - often to disastrous consequences.
Her comments followed Pfizer's warnings about Depo-Provera to doctors
in both Canada and the U.S. on Thursday last week.
What will happen in Canada is not yet known.
Officials for Pfizer Canada said yesterday the company has given Health
Canada the results of the bone-density study and a reviewer has been
assigned.
But, whether and, if so, how soon the drug's Canadian monograph (inside
warning label) will change is up to Health Canada, Sophie McCann, a
company spokesperson said yesterday.
In the U.S., the new information will lead to a "black box warning,"
the official Food and Drug Administration label for drugs that should
only be taken as a last resort.
While many women have no problem taking the drug, Health Canada's
adverse drug reactions monitoring agency received in 2003 more than 200
reports of problems experienced by women taking Depo-Provera.
Cross said she suffered severe symptoms after going on the drug in 2001
and more symptoms once she went off it.
Those side effects, included daily migraines, severe hair loss,
vomiting, diarrhea, night sweats and nightmares.
Cross's infant daughter - she had been breastfed nine months while
Cross was on Depo-Provera - also developed lumps in her breasts.
Others posting their stories on the Web site have, according to Cross,
reported suffering breathing difficulties, chest pain, muscle weakness,
prolonged vaginal bleeding, slurred speech, pulmonary embolism,
convulsions - and multiple fractures.
"I just had to stop taking it," Tanya Gravel, a 29-year-old St. Laurent
woman said she took the drug two years before she stopped in March. "My
chest pains have gone away now."
"I just hope I don't get osteoporosis," she added.
Megan Sewell-Knight is a 33-year-old Ile Bizard mother who breastfed
her daughter, now 4, six months before going off of it because of side
effects.
"I'm terrified for when my daughter hits puberty," Sewell-Knight said.
"What are we going to find out (about the drug) five years down the
road?"
Depo-Provera was approved for use in Canada in 1997 and, since then, it
has become a top-selling birth control drug, especially among Canadian
women, age 17 to 23, who want the convenience of not having to remember
to take a pill each day.
According to IMS Health, which tracks Canadian prescriptions,
Depo-Provera use has more than doubled between 1999 and 2003, from
about 304,000 to more than 624,000 prescriptions a year.
Anne Rochon Ford, a Toronto-based health advocate, said she was pleased
to hear Pfizer's disclosure but that it was far from adequate.
However, she said, there remains a huge problem in the way the federal
government approves and then monitors drugs for safety.
Women have been reporting problems related to the Depo-Provera since
the 1970s and the Canadian Women's Health Network has lobbied against
its use just as long, said Ford.
But, Ford said: "if companies push long enough" a bad drug gets
approved. Then, she said, it remains on the market until, as in the
case of Vioxx, hormone replacement therapy and Paxil, the problems are
irrefutable.
The site for sufferers of side effects is
www.groups.msn.com/DepoProveraUsers.
ccornacchia@thegazette.canwest.com
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