Contraception – Chemical Methods / Hormonal Contraception / Emergency / Morning After Pill

Implanon

Implanon Implantable Device Approved The U.S. Food and Drug Administration (FDA) has approved an implantable contraceptive and abortifacient device called Implanon. Implanon is made by Organon USA, Inc. Implanon is an off-white, non-biodegradable, etonogestrel-containing single sterile rod implant for subdermal use. The implant is 4 cm long with a diameter of 2 mm. Each Implanon rod consists of an ethylene vinylacetate copolymer core, containing 68 mg of the synthetic progestin etonogestrel, surrounded by an EVA copolymer skin. A doctor inserts the prescription-only device under a woman's skin in her arm. It is designed to work for 3 years. Implanon is a progestin-only device and does not contain estrogen. Implanon works by suppression of ovulation, increased viscosity of cervical mucus and alterations in the endometrium (lining of the uterus in which an embryo would normally implant). The FDA notes that Implanon "may be less effective in women who are overweight or who are taking medications that induce lever enzymes." Thirty other countries have permitted the use of Implanon for as long as 8 years. Women who use Implanon are more prone to spotting at unpredictable times. Implanon has similarities to Norplant, which was pulled off the market in 2000 after a decade of availability in the USA. Norplant was a product consisting of 6 rods placed under a woman's skin, designed to work for 7 years. [Family Foundations, Sept/Oct...

Plan B: A Grave Threat to Women's Health (8/06)

On July 31, 2006, the U.S. Food and Drug Administration (FDA) announced that it was working with the manufacturer of the Plan B. "Morning after Pill," Duramed Research, Inc., to resolve the remaining policy issues preventing Plan B from being sold over-the-counter (OTC)–rather than by prescription (Rx).   The Family Research Council opposes making Plan B available OTC for the following reasons related to women's health and matters of law: •   Birth control pills, which are essentially a lower dose regimen of Plan B, require a prescription. They are not available OTC. They require an appointment with a licensed clinician to determine contraindications, obtain a prescription, and provide for medical oversight throughout the usage period. "Birth control pills are available by prescription only for sound medical reasons: They can cause significant or life-threatening conditions such as blood clots and heart attacks. Birth control pills are contraindicated for women with diabetes, liver problems, heart disease, breast cancer, deep vein thrombosis, and for women who smoke and are over 35. A medical exam is necessary to ensure that none of these contraindications exists. For example, according to the Centers for Disease Control, approximately 1.85 million women of reproductive age (18-44) have diabetes; approximately 500,000 do not know that they have the disease."1 The OTC status would increase access to Plan B to larger populations of women, including women who have not been screened for contraindications. •   Lack of scientific studies examining risks. There is a clear lack of scientific studies on the long-term-effects of Plan B with respect to high dosage and repeated use in both women and adolescents. While the...

Fertility Awareness to Avoid Pregnancy

Natural Fertility Awareness For a look at natural methods that prevent pregnancy without the chemical pollution and possible abortifacient or pre-implantation effects of the pill, patch, the shot, or emergency contraception (EC/Morning After Pill, MAP), go to www.ccli.org, or visit these pages:   Natural Family Planning Research Database The Effectiveness of the Creighton Model Ovulation Method in Avoiding and Achieving Pregnancy“Use Effectiveness of the Creighton Model Ovulation Method of Natural Family Planning”; Fehring, Richard J.; Lawrence, D.; and Philpot, D., Journal of Obstetric, Gynecologic, and Neonatal Nursing Vol. 23, No. 4 . May 1994. pp. 303-309 Click here...

EC / Morning After Pill NOT Required by HHS to be Distributed in States (2004)

The entire Alabama Congressional Delegation contacted AL Department of Public Health Director Dr. Donald Williamson in 2004, urging him to stop dispensing Emergency Contraception (also called Plan B, or the Morning After Pill) in county health departments. Dr. Williamson responded that he was required by the federal government to do so. The AL Delegation then contacted Secretary Tommy Thompson, and Dr. Williamson contacted Dr. Alma Golden, at the U.S. Department of Health and Human Services to verify this. Here is the letter of the AL Delegation back to Dr. Williamson. EC Congressional Delegation Letter to ADPH Director Dr. Donald Williamson [15June2004] Thompson Letter to Congressman Aderholt 23 July 2004 Golden Letter to Dr....

Plan B Activist Admits: Easy Access Has Not Reduced Pregnancies or Abortions (2005)

A prominent advocate for Plan B, the morning-after pill [Emergency Contraception], admitted today that "real world" experience of easy access to the drug has not reduced the numbers of pregnancies or abortions. Pressed by CWA's Wendy Wright at the National Press Club's Newsmaker Forum, Kirsten Moore, president and CEO of Reproductive Health Technologies Project, conceded there is no evidence that easy access to the morning-after pill reduces the number of pregnancies or abortions. And after alleging there have been no increases, she immediately concedes there have been increases in the countries where it is easily available. Moore said, "I think it's an honest question, the experts had estimated that we would see a drop by up to half in the rates of unintended pregnancy and the rates of abortion. And in fact in the real world we're not seeing that, were not necessarily seeing an increase either. Again, where we see the increases, correlation does not equal causation."  To listen to the full panel discussion, visit www.cwfa.org. [CWA, www.cwfa.org, 202-488-7000 ext. 126; AAPLOG, 7Dec05] [Whatever happened to that little boy who, ignoring political correctness, told the truth about the Emperor?  Kristin Moore will either be excoriated, discredited, or completely ignored by the media.  Maybe all three – because she told the truth. ...

Chemical Pollution ‘Messing’ with Female Metabolic Processes: Commentary

[Comment: When will the pharmaceutical industry and their feminist sales force – left-wing women’s groups – stop messing with women’s bodies by pushing sales of steroidal hormones (used in menopausal therapy and oral contraceptives)? Drug companies are apparently searching for a way that women can continue using hormone replacement therapy, but there are health risks associated with the use of these drugs. Unpatentable products, on the other hand, do not have the same money-making potential as do patented products. Some natural products are alternatives to hormone replacement therapy. These non-estrogen products relieve menopausal symptoms and, unlike hormone replacement therapy, they aren’t associated with the risks of heart disease, stroke and breast and uterine cancers.    Karen Malec,  Coalition on Abortion/Breast Cancer]   ABORTION-BREAST CANCER NEWS HEADLINES “‘Safe Window’ Allegedly Found for Hormone Replacement Therapy” Four years ago, the Women’s Health Initiative (WHI), a government-funded study, ended prematurely when researchers said they found that use of combined hormone replacement therapy (HRT) – synthetic estrogens and progestin – raises risk of heart attacks, strokes and breast cancers. The WHI’s 2002 findings were widely publicized and women rushed to their doctors to find some alternative to HRT for the relief of menopausal symptoms. Different cancer risks are associated with the use of combined HRT and oral contraceptives (OCs) versus estrogen-only HRT and OCs. Doctors generally prescribe estrogen-only HRT to women with hysterectomies, but not to women who still have their wombs. Researchers learned in the 1970s that estrogen-only OCs increase the risk of uterine cancer. Progestins (progesterone-like hormones) were added to estrogen-only HRT and OCs because they did not increase uterine cancer risk....

The FDA Again Postpones Decision on Releasing EC/MAP OTC; AAPLOG Statement (26Aug05)

Press Release, Friday, 26 August 05 The Food and Drug Administration (FDA) announced  26Aug05 that it needs public input to decide whether Plan B, the “morning-after pill,” can be sold both without a prescription for those aged 17 and over, yet require a prescription for those 16 and under. STATEMENT OF THE AMERICAN ASSOCIATION OF PRO-LIFE OBSTETRICIANS AND GYNECOLOGISTS on THE FDA’S  DECISION TO DELAY ACTION ON OVER-THE-COUNTER (OTC) APPROVAL REQUEST FOR EMERGENCY CONTRACEPTION  27 August 2005… The requested FDA approval of Over The Counter Emergency Contraception for women 17 years of age and older would be bad medical practice. Further, it would be a disaster for many women–especially for teenagers, who are more prone to risk-taking behavior, and more susceptible to sexually transmitted diseases (STDs/STIs). And certainly 17 year olds would procure it for 13 year olds, so the OTC age limit, in practice, is unworkable. EC simply is not as effective as advertised.  The pubic is told that if taken right after unprotected midcycle intercourse,  EC will prevent 88% of expected pregnancies.  This is, at best, a very poor half-truth. Recent large studies in Scotland (See A Glaiser et al, Advanced Provision of Emergency Contraception Does Not Reduce Abortion Rates, Contraception 2004;69:361-366, at www.contraceptionjournal.org)  and San Francisco (See TR Raine et al, Direct Access to Emergency Contraception Through Pharmacies and Effect on Unintended Pregnancy and STIs, JAMA, 2005; 293:54-62, at www.jama.com) demonstrate this  point. Women in these studies were given the EC to take home and put on the nightstand for immediate availability after unprotected sex.  But they had the same abortion rates and the same unintended pregnancy rates...

Major Medical Concerns Regarding EC: APFLI Statement (8/05)

Dear Dr. Crawford: On behalf of the members of Alabama Physicians For Life, Inc., I am again writing to ask you to raise the bar for medical safety by refusing to release emergency contraception (EC) over-the-counter (OTC), for the following reasons. Sexual Predation/Promiscuity. Easy access to EC is a sexual predator’s dream come true. Pressure on young girls by older boys/men to use EC will be very strong. Those already sexually active will learn to take EC prior to sexual activity; promiscuity will obviously increase. STDs. Studies in Sweden [http://sti.bmjjournals.com/cgi/content/full/78/5/352] and Washington state [http://www.doh.wa.gov/cfh/STD/morbidity.htm] both showed increased Chlamydia rates with EC use. In Sweden, following OTC availability of EC in the late 1990’s, there was a 30% increase in Chlamydia infections from l999 to 2001.  In Washington state, in the five years following the start of the “pharmacist direct pilot project,” (l997-2002), there was a 23% increase in Chlamydia infection among teens.  How can the FDA honestly suggest that EC-OTC is good national public health policy when, without physician oversight, these increased and undiagnosed STDs could result in infertility and cervical disease? Ectopic Pregnancy. Studies by WHO, described by the British government, show a 6% ectopic pregnancy rate with EC. If EC were OTC, there would be a lack of physician oversight, which would endanger those women experiencing ectopic pregnancy. How can this be considered responsible national public health policy? [http://www.dh.gov.uk/PublicationsAndStatistics/LettersAndCirculars/CMOUpdate/CMOUpdateArticle/fs/en?CONTENT_ID=4003844&chk=2uZJEX; CMO update #35, dated 4-2-03, content # 20]  Hormone Doses. How is it that women receiving low-dose oral contraceptives must have a physical exam and receive a prescription, for medical oversight purposes, while any woman/girl would be able...

Study: Shows Access to Contraceptives Does Not Stop Unplanned Pregnancies (AGI, 2005)

A new report form the Alan Guttmacher Institute provides wide ranging statistics and demographic information on women who had abortions. In addition to reporting that [surgical] abortion numbers continued to drop in 2001 and 2002, the report contains findings that may bolster arguments made by social conservatives on several different issues, including one finding that would indicate contraceptive use may not stop unplanned pregnancies. The Alan Guttmacher Institute is the research arm of Planned Parenthood and openly supports abortion and widespread access to contraceptives. The report placed great emphasis on the fact that 48 percent of pregnancies in the US are unplanned. Of those unplanned pregnancies, 47 percent end in abortion, 40 percent are carried to full term and 13 percent end in miscarriage. Advocates of abortion often argue that to decrease abortions, unintended pregnancies must be reduced through increased access to contraceptives. But the Guttmacher Institute's research indicates that 53 percent of women who have unintended pregnancies used a contraceptive method during the month they got pregnant. The data also indicates that marriage plays a unique role as a protector of the unborn. According to the report, "Married women account for a lower proportion of abortions (17%), in part because they have low rates of unintended pregnancy," but even in cases of unintended pregnancies, married women "are more likely than unmarried women to continue the pregnancy." And cohabitation is not an adequate substitute for marriage. "About 25% of abortions occur among women living with a male partner to whom they are not married, although such women make up only about 10% of all women aged 15-44." The report...

EC Use in Australia (2004)

Australia House of Representative Notice Paper[to Australia Health Minister Tony Abbott, 2June04, with questions about levonorgestrel MAP]*3613 MR MURPHY: To ask the Minister for Health and Ageing —(1) In respect of the sale without prescription of the drug Postinor-2, which contains the active ingredient levonorgestrol, is he aware of the article titled “Adverse reactions and emergency contraception” in The Lancet on 14 April 2001, which states that (a) several writers in the United Kingdom have remarked on the scarcity of safety data regarding the adverse reactions from use of the drug levonorgestrel, (b) 5% of women have a genetic susceptibility to breast and ovarian cancer and another 5% have a genetic susceptibility to thromoembolic disease, and (c) the relevant tests will not generally be done before a pharmacist supplies levonorgestrel to women who may have stopped taking daily hormones because they had adverse reactions. (2) Can he explain how the women who take levonorgestrel without prescription will be protected against the potential side-effects of the drug. (3)  Is he able to say what scientific evidence his department relies on when deciding on the sale without prescription of products containing levonorgestrel; if not, when will he require the withdrawal from sale of Postinor-2 and, if he will not, why not. (4) Can he explain how the precautionary principle applies to the supply without prescription of levonorgestrel to women; if not, why not. *3614 MR MURPHY: To ask the Minister for Health and Ageing —(1) In respect of the sale without prescription of the drug Postinor-2, which contains the active ingredient levonorgestrel, is he aware of the article by Professor Richards...

Gel Tested for "Safer Sex" (2/05)

Doctors at the Mount Sinai School of Medicine have tested a gel that when applied topically in the vagina, may help prevent infection by both H.I.V. and herpes simplex virus. AIDS researchers have long sought such a microbicide. The effectiveness of the gel, called PRO 2000 and made by Indevus Pharmaceuticals, was shown in a pilot study of 20 H.I.V.-infected women. Ten were treated intravaginally with PRO 2000, and 10 with a placebo gel. An hour later, secretions were collected and examined for evidence of viral infection. The study found that the gel significantly reduced virus levels while causing no inflammatory response, and a new 14-day study is under way to test whether repeated applications will cause unacceptable side effects. A much larger study of the effectiveness of the gel has been financed and is to include more than 3,000 women at nine different sites, Dr. Keller said. Dr. Betsy Herold [senior author of the study, professor of pediatrics and microbiology, Mount Sinai] referred to the unfortunate experience with nonoxynol-9, once believed to be protective against H.I.V. but now thought to increase the risk of viral transmission by irritating mucosal lining in men and women. [Dr. Marla J. Keller, a professor of medicine and the lead author on the study, presented the data at the 12th Conference on Retroviruses and Opportunistic Infections in Boston on 24Feb05;  8Mar05, New York Times VITAL SIGNS, By NICHOLAS...

Oral Contraceptives: Mechanism of Action (Feb 2005: Birth Control)

Scientists Refute Study Touting The Pill's Benefits Mechanism of Action for Oral Contraceptives Described     SCIENTISTS REFUTE STUDY TOUTING PILL'S BENEFITS — A recent study touting a list of unexpected health benefits for the birth-control pill was wrong and should be discounted, say scientists with the landmark Women's Health Initiative, whose database was used for the study. Researchers at Wayne State University in Detroit were using Women's Health Initiative data to overturn the common wisdom on the pill. Epidemiologist Ross Prentice is the chief statistician for the health initiative. Dr. Rahi Victory and co-authors at Wayne State, Dr. Susan Hendrix & Dr. Michael Diamond, did not get authorization or input from the health initiative, as is customary, before presenting their data at the annual meeting of the American Society for Reproductive Medicine on Oct. 20. Women are urged to disregard the Wayne State findings. A separate survey by the CDC in 12/04 found that 82% of women aged 15-44 had used the pill at some point. Past studies have produced cautions about the birth-control pill (increases the risk of heart attack, stroke, blood clots and certain types of cancer). Those warnings still stand. [AP report in The Seattle Times;http://seattletimes.nwsource.com/html/health/2002116425_pill11m.html 11Dec04.Julia Sommerfeld: 206-464-2708 or [email protected]] MECHANISM OF ACTION — This information is from Dr. Hanna Klaus M.D., FACOG [Natural Family Planning Center of Washington, D.C. and Teen STAR Program]: “While .75 mg of levonorgestrel (LNG) x 2 induces far less nausea and vomiting than Preven, not to speak of trying to swallow 40 oral contraceptive tablets, fewer pregnancies are putatively prevented, as not many women repeat the dose of...

Approval for Over-The-Counter EC/Plan B Withheld (1/05)

Keeping women and adolescent girls safe for a little longer, the Food and Drug Administration announced its intention on Friday, January 21, to put off its decision on whether to allow over-the-counter availability for Plan B, an emergency contraceptive. Barr Laboratories applied for over-the-counter status for Plan B in May of 2004 and were told by the FDA at that time that it was “not approvable.” Barr Laboratories resubmitted its request later this past summer with the new requirement that it be available only for girls 16 and older. The reluctance to approve the emergency contraceptive for teen use may have something to do with similar cases in Europe, where the drug was made available to adolescents without parental consent or physician referral. In places where over-the-counter contraceptives have been made available, premarital sex has increased. A recent JAMA study also gives credence to the FDA’s decision to wait. The report, “Direct access to emergency contraception through pharmacies and effect on unintended pregnancy and STIs: a randomized controlled trial” found that women who relied on emergency contraceptives did not lower their rates of premarital pregnancy, compared to similar women who did not take contraception pills. [Jessemyn Pekari, Abstinence Clearinghouse E-Mail Update,...

Depo Provera Linked to Bone Density Loss (2004)

DEPO-PROVERA LABELED: LINKED TO BONE DENSITY LOSS The U.S. Food and Drug Administration (FDA) has issued a "black box warning" — the strongest possible FDA warning issued — to the labeling of the Depo-Provera drug, noting that extended use of this injectabel contraceptive can cause "significant bone density loss." [Right to Life, www.cincinnatirighttolife.org. Cincinnati Right to Life, April 2008]   November 17, 2004 Consumer Inquiries: 888-INFO-FDA Black Box Warning Added Concerning Long-Term Use of Depo-Provera Contraceptive Injection 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. Although Depo-Provera Contraceptive Injection has been used for decades for birth control throughout the world and remains a safe and effective contraceptive, FDA and Pfizer, the drug's manufacturer, are taking this action to ensure that physicians and patients have access to this important information. The black box warning for Depo-Provera highlights that prolonged use of the drug may result in significant loss of bone density, and that the loss is greater the longer the drug is administered. This bone density loss may not be completely reversible after discontinuation of the drug.   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.   Black box warnings are designed to highlight special problems, particularly those that are serious, and to give health care...

Little Pills: Targeting Youth with "Anti-Life" Drugs

Summary: In some ways, the introduction of abortion in pill form is not that newsworthy… pills appear more medical and simple–and the more medical and simple a practice appears, the more acceptable it appears. The abortion lobby is fully aware of this and has lobbied intensely for medical approval and involvement in its cause. That is why the morning after pill [MAP, referred to as Emergency Contraception, EC, and marketed in the USA as Preven and as Plan B] and RU 486 (mifepristone, marketed as Mifeprex, the medical abortion) are so important; and that is why the complicity of the medical profession in the abortion movement is so tragic. In March 2001, the Virginia General Assembly defeated a bill calling for over-the-counter (OTC) distribution of the "morning after pill," [MAP/EC] a drug regimen taken after sexual relations, to stop or prevent pregnancy. The morning after pill can contain as much as eight times the daily hormone dose of the traditional birth control pill.[1] Both are currently available by prescription, but abortion advocates are working to remove this requirement for the morning after pill, and are enlisting the medical profession in the cause.   Just one month earlier, for example, America's most vocal pro-abortion litigation organization, the Center for Reproductive Law and Policy (CRLP), filed a Petition with the Food and Drug Administration requesting this change.   The Petition represented such major medical groups as the American Medical Association (AMA) and the American Public Health Association.[2] At about the same time, the morning after pill made news both domestically and abroad because of its distribution to minors in school-based clinics–often without...

EC Does Not Reduce Pregnancy Rates: Commentary & JAMA Study (1/05)

“…this study should be interpreted as telling us that emergency contraception [EC/MAP] is not of any benefit when given in advance for patients to have on hand, or when easily available from a pharmacist, compared to having to obtain a prescription to use it.  That is ALL this study can tell us.  And that, I’m sure, is not what the authors wanted to tell us.”… “In fact, they tried to tell us a lot more in their conclusion…” Direct Access to Emergency Contraception Through Pharmacies and Effect on Unintended Pregnancy and STIs: A Randomized Controlled Trial  JAMA. 2005; 293:54-62 [Comment: this is a new article in 1/05  JAMA by the strong proponents of OTC EC which shows that, in fact, EC does NOT reduce unwanted pregnancies (reducing unwanted pregnancies is, in fact, the only reason to consider making it OTC).  Comments by AAPLOG member Dr Nate Hoeldtke.] COMMENTARY Dr Nate Hoeldtke: “Below I’ve included the abstract and the accompanying editorial. There are several things to note: — Randomized study with three groups of 15-24 yr olds:1) pharmacy access to obtain EC (access from a pharmacist–closer toan over-the-counter model)2) given advance supplies of EC (this is what ACOG has recommended all ob/gyns do)3) clinic access only (need to come in for prescription) “They looked to see if there was any difference in pregnancy rates orsexually transmitted diseases in the three groups. With advancesupplies the women were twice as likely to use EC as the other twogroups. Interestingly, those who had access to get it from apharmacist were not more likely to use it than those had to get aprescription. But here’s the real kicker: They...

January 2005: Birth Control

Scottish Study Shows Emergency Contraception (EC/MAP) Does Not Reduce Surgical Abortion Rates Contraceptive Pill Increases Risk of Stroke Among Migraine Sufferers Consumer Reports Magazine Rates Condoms     ADVANCED PROVISION OF EMERGENCY CONTRACEPTION DOES NOT REDUCE ABORTION RATES – “A number of small studies have demonstrated increased use of emergency contraception (EC) when women have a supply available at home. It has been suggested that widespread use of EC could reduce abortion rates. We undertook a community intervention study designed to determine whether offering advanced supplies of EC to large numbers of women influenced abortion rates. All women aged between 16 and 29 years living in Lothian, Scotland, were offered, through health services, five courses of EC without cost to keep at home. Of a population of around 85,000 women in this age group, the study showed that an estimated 17,800 women took a supply of EC home and over 4500 of them gave at least one course to a friend. It was found that nearly half (45%) of women who had a supply used at least one course during the 28 months that the study lasted. In total, an estimated 8081 courses of EC were used. EC was used within 24 h[hours] after intercourse on 75% of occasions. “Abortion rates in Lothian were compared with those from three other health board areas of Scotland. No effect on abortion rates was demonstrated with advanced provision of EC. The results of this study suggest that widespread distribution of advanced supplies of EC through health services may not be an effective way to reduce the incidence of unintended pregnancy in the...

Depo Provera May Triple STD Risk (9/04)

Depo Provera Increases Chance of Chlamydia, Gonorrhea Women who use the injected contraceptive Depo-Provera have a higher rate of sexually transmitted diseases, U.S. researchers [National Institutes of Health, UNC, and Johns Hopkins Univ in Baltimore] reported. This holds true even when behavior and other factors are taken into account. It is possible that Depo-Provera itself causes a susceptibility to STDs [Charles Morrison of Family Health Int’l in Research Triangle Park, N.C., who led the study]"We did adjust for differences in condom use, differences in multiple partners, differences in the number of sexual coital acts," Morrison said. Inner-city and younger women also had a higher risk of STDs, but using Depo-Provera added to the risk, the study found. Morrison said the researchers were especially concerned because Depo-Provera or its generic equivalent are being increasingly used in Africa, where STDs such as the AIDS virus are very common. He said women who use Depo-Provera to prevent pregnancy should take extra care if they are in relationships in which either they or their partner have sex with other people. Like birth control pills, Depo-Provera provides no protection from an infection such as syphilis, gonorrhea or the AIDS virus. "For sexually active women not in a mutually monogamous relationship, limiting the number of partners may also help to reduce the risk," Morrison added. The researchers studied about 800 women age 15 to 45 using two clinics in the Baltimore area — one urban, serving mostly black women, and one suburban with a client base of white, college-age women. Most were single.   The women chose whether they wanted to use Depo-Provera, contraceptive pills,...

November 2004: Birth Control

FDA Issues ‘Black Box” Warning for Depo-Provera New Research Shows Dangers of Condoms in HIV Prevention UK Sex Ed/ Condom Program Backfires       FDA ISSUES ‘BLACK BOX’ WARNING FOR DEPO-PROVERA, Long-Term Use Linked to “Significant” Bone Density Loss —  this is the strongest warning a drug can carry — to the labeling of Pfizer’s injectable contraceptive Depo-Provera (D-P). It works by releasing a high level of progestin to stop the ovaries from releasing eggs & is administered by a shot from a health care worker about every three months; it has a failure rate of about 1% (Wall Street Journal, 11/18). Although FDA says the drug remains “safe and effective,” the agency and Pfizer decided to add the warning label to “ensure that physicians and patients have access to this important information,” according to an FDA release (FDA release, 11/17). The black box warning states that bone density loss increases the longer the drug is used and that such bone density loss is not always completely reversible after use of the drug is discontinued. In addition, the labeling will warn that patients should not use the drug for more than two years unless all other birth control methods have been deemed inadequate (FDA release, 11/17). FDA issued the warning after reviewing data from two separate studies that showed Depo-Provera’s effect on bone density during prolonged use. One study began in 1994 and enrolled 540 women ages 25 to 38. The other study — which started in 1997 and will continue through 2006 — enrolled about 400 girls ages 12 to 18 who were taking the drug and...