Class Action Lawsuit Filed Against Depo-Provera (update!)
Parents Sue After Their 14-Year-Old Daughter Died with Birth Control “Patch”
IARC Monographs Programme Finds Combined Estrogen-Progestogen Contraceptives and Menopausal Therapy are Carcinogenic to Humans
PARENTS SUE AFTER 14-YEAR-OLD DAUGHTER DIED WITH BIRTH CONTROL PATCH. When the parents of 14 year-old Alycia B. of WI found out their daughter was sexually active, they put her on birth control, choosing the hormonal patch instead of the Pill.
When on 7May04, Alycia died suddenly of blood clots in her lower pelvis, Michael and Lorie B. decided to sue the deadly drug’s manufacturer in the hopes of having it taken off the market.
The patch, which releases a dose of contraceptive hormones into a woman’s blood stream through the skin, has been responsible for at least 17 deaths in women age 17 to 30 since its release in 2002, according to the US Food and Drug Administration.
In September 2004, a study by the FDA revealed 21 “life-threatening” conditions related to the patch such as blood clots, strokes, and heart attacks.
The Browns’ lawsuit claims the company intentionally withheld information from its own clinical trials and Food and Drug Administration records suggesting the increased risks. Thus far, Alycia is the youngest of the patch’s victims. Her mother told the La Crosse Tribune that the suit is only partly about collecting damages. “More than anything, I want it taken off the market,” she said. “Maybe I’ll be able to save a life, if people know what happened to her.”
Earlier this month, Ortho-McNeil agreed to improve the warnings on the labels for the patch to include the information that it had possible fatal side effects.
The company admitted that the patch exposes women to about 60 percent more estrogen than those using typical birth-control pills.
Previous LifeSiteNews.com coverage:
Ortho McNeil Corp Admits Birth Control Patch Blood Clot Connection
http://www.lifesite.net/ldn/2005/nov/05111404.html
FDA:
U. S. Food and Drug Administration
5600 Fishers Lane,
Rockville MD 20857-0001
1-888-INFO-FDA
(1-888-463-6332)
[http://www.lifesite.net/ldn/2005/nov/05112102.html 21Nov05 LifeSiteNews.com, H. White; N Valko RN, 27Nov05]
CLASS ACTION LAWSUIT FILED AGAINST DEPO-PROVERA
A class-action lawsuit of $700 million has been filed against the drug manufacturer, Pfizer, maker of Depo-Provera, a birth-control hormone injection.
Women suing Pfizer claim the injections have caused bone loss leading to osteoporosis. One new study also links the drug to increased susceptibility to sexually transmitted diseases (STDs).
Pfizer has come under legal fire for at least two other drugs it manufacturers anti-depressant Zoloft and Celebrex for alleged serious side-effects, including heart-attacks and death. [Lifesite.net, Class Action Suit Says Depo-Provera Birth Control Drug Causes Osteoporosis, 12/21/05, http://www.lifesite.net/ldn/2005/dec/05122101.html; Abstinence Clearinghouse E-Mail Update, 12/28/05]
IARC Monographs Programme Finds Combined Estrogen-Progestogen Contraceptives and Menopausal Therapy are Carcinogenic to Humans
An IARC Monographs Working Group has concluded that combined estrogen-progestogen oral contraceptives and combined estrogen-progestogen menopausal therapy are carcinogenic to humans (Group 1), after a thorough review of the published scientific evidence.
At the same time, the Working Group stressed that there is also convincing evidence that oral contraceptives have a protective effect against some types of cancer…
There are both beneficial and adverse effects for oral contraceptives and menopausal therapy. Each woman who uses these products should discuss the overall risks and benefits with her doctor.
The Working Group, comprising 21 scientists from 8 countries, was convened by the IARC Monographs Programme of the International Agency for Research on Cancer (IARC), the cancer research agency of the World Health Organization. Major public health importance “These new IARC Monographs [volume 91] address exposures that are experienced daily by many millions of women world-wide,” said Dr Peter Boyle, Director of IARC. “It is of enormous public health importance that we identify and understand the full range of effects of these products.” Worldwide, more than 100 million women about 10% of all women of reproductive age currently use combined hormonal contraceptives. In addition, there has been widespread use of hormonal menopausal therapy: approximately 20 million women in developed countries at its peak around the year 2000. ORAL CONTRACEPTIVES INCREASE RISK OF SOME CANCERS AND DECREASE RISK OF OTHERS Use of OC’s increases risk of breast, cervix and liver cancer
but decreases risk of endometrial and ovarian cancer In contrast, the risks of endometrial and ovarian cancer are consistently decreased in women who used combined oral contraceptives. The reduction is generally greater with longer duration of use, and some reduction persists at least 15 years after cessation of use. More work needed to assess risks and benefits Because use of combined estrogen-progestogen contraceptives increases some cancer risks and decreases risk of some other forms of cancer , it is possible that the overall net public health outcome may be beneficial, but a rigorous analysis is required to demonstrate this. This should be done on a country-by-country basis and also consider the effects on non-malignant diseases. COMBINED MENOPAUSAL THERAPY INCREASES RISK OF CANCER Breast cancer and endometrial cancer are increased Overall risks a WHAT IS NEW, AND WHAT DOES THIS MEAN FOR ME? More cancer sites are targets of oral contraceptives Menopausal therapy now “Carcinogenic to humans” Consider risks and benefits of hormonal products and use only under careful medical supervision ABOUT THE IARC MONOGRAPHS
This category is used when there is sufficient evidence of carcinogenicity in humans. Exceptionally, an agent (mixture) may be placed in this category when evidence of carcinogenicity in humans is less than sufficient but there is sufficient evidence of carcinogenicity in experimental animals and strong evidence in exposed humans that the agent (mixture) acts through a relevant mechanism of carcinogenicity.
This category includes agents, mixtures and exposure circumstances for which, at one extreme, the degree of evidence of carcinogenicity in humans is almost sufficient, as well as those for which, at the other extreme, there are no human data but for which there is evidence of carcinogenicity in experimental animals. Agents, mixtures and exposure circumstances are assigned to either group 2A (probably carcinogenic to humans) or group 2B (possibly carcinogenic to humans) on the basis of epidemiological and experimental evidence of carcinogenicity and other relevant data.
This category is used when there is limited evidence of carcinogenicity in humans and sufficient evidence of carcinogenicity in experimental animals. In some cases, an agent (mixture) may be classified in this category when there is inadequate evidence of carcinogenicity in humans and sufficient evidence of carcinogenicity in experimental animals and strong evidence that the carcinogenesis is mediated by a mechanism that also operates in humans. Exceptionally, an agent, mixture or exposure circumstance may be classified in this category solely on the basis of limited evidence of carcinogenicity in humans.
This category is used for agents, mixtures and exposure circumstances for which there is limited evidence of carcinogenicity in humans and less than sufficient evidence of carcinogenicity in experimental animals. It may also be used when there is inadequate evidence of carcinogenicity in humans but there is sufficient evidence of carcinogenicity in experimental animals. In some instances, an agent, mixture or exposure circumstance for which there is inadequate evidence of carcinogenicity in humans but limited evidence of carcinogenicity in experimental animals together with supporting evidence from other relevant data may be placed in this group.
This category is used most commonly for agents, mixtures and exposure circumstances for which the evidence of carcinogenicity is inadequate in humans and inadequate or limited in experimental animals
This category is used for agents or mixtures for which there is evidence suggesting lack of carcinogenicity in humans and in experimental animals. In some instances, agents or mixtures for which there is inadequate evidence of carcinogenicity in humans but evidence suggesting lack of carcinogenicity in experimental animals, consistently and strongly supported by a broad range of other relevant data, may be classified in this group.
The vol. 91 of the Monograph series, on COMBINED ORAL CONTRACEPTIVES AND MENOPAUSAL THERAPY will be available some time early next year. See http://monographs.iarc.fr/ for more details then.
FOR FURTHER INFORMATION Contact Dr Nicolas Gaudin, Chief of IARC Communications, at . The Working Group’s summary on this topic will soon appear on the IARC Monographs webs ite (http://monographs.iarc.fr/). More details available in the August issue of The Lancet Oncology (http://oncology.thelancet.com/).
Oral Contraceptives and the Risk of Cancer: International Doctors’ Group Echoes Warnings of the World Health Organization (WHO) An intl medical federation has echoed a warning by the World Health Organization about the increased risk of cancer linked to oral contraceptives. More than 50 national associations, representing 30,000 doctors worldwide, make up FIAMC (the group’s French acronym). Previously, combined oral contraceptives had been determined to be carcinogenic to humans, but only primary liver cancer was specifically implicated. The Working Group, after a thorough review of the published scientific evidence, concluded that combined oral contraceptives alter the risk of several common cancers in women. Estrogen-progestogen oral contraceptives were classified in the Group 1 of carcinogenic agents. This category is used when there is sufficient evidence of carcinogenicity in humans. These conclusions are of enormous public health importance, since it is estimated that worldwide, more than 100 million women — about 10% of all women of reproductive age — currently use combined hormonal contraceptives. In addition, there has been widespread use of hormonal menopausal therapy: approximately 20 million women in developed countries. For all these women, the message is that the use of oral contraceptives increases the risk of breast, cervix and liver cancer. On the contrary, the risks of endometrial and ovarian cancer are decreased in women who used combined oral contraceptives. Regarding combined estrogen-progestogen menopausal therapy, WHO warns that it increases the risk of breast cancer and endometrial cancer (at least when progestogens are taken fewer than 10 days per month) and that there is not sufficient evidence to conclude that hormonal therapy has a protective effect at any cancer site. The WHO experts call to a rigorous analysis to demonstrate what can be, at the end, the overall net public health outcome of the use of oral contraceptives. In addition, each woman who uses these products is now invited by WHO to discuss the overall risks and benefits with her doctor, taking into consideration her personal circumstances and family history of cancer and other diseases. FIAMC invites all health care providers to attentively consider the results of the WHO study… and encourages … doctors to spread the methods for natural family planning also in Western affluent societies. [Gian Luigi Gigli, MD President ZE05090723; ROME, 7Sept05; http://www.zenit.org/; The World Federation of Catholic Medical Associations ] |