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U.S. News and Commentary



Wednesday
May012013

Plan B One-Step primer: No testing in teen population; average age was 27 years

Girls as young as 15 can now purchase Plan B One-Step over the counter without needing parental permission.

Photo of product from manufacturer's Web page.Almost all the debate around a federal judge’s regulatory decision has centered around the politics. What’s missing from that debate is a discussion on health risks and proper use. This is especially important because teens tend to get advice on such matters from friends or family members. No doctor will be part of the process should a teen decide to take it.

There are risks and no one is discussing them.

The drug isn’t habit-forming in the physical sense. But females who use Plan B One-Step as regular birth control will actually see the drug’s failure rate increase.

Common adverse reactions—those in more than 4 percent of patients—include heavier menstrual bleeding, nausea and lower abdominal pain.

There’s also a variable no one has discussed—ectopic pregnancy. Such pregnancies occur when an embryo implants somewhere other than the uterus; they occur in roughly 2 percent of all pregnancies. The manufacturer noted, “Up to 10% of pregnancies reported in clinical studies of routine use of progestin-only contraceptives are ectopic.”

Now comes the complicated part.

Plan B One-Step is a progestin-only contraceptive.

Smoking cigarettes and pelvic inflammatory disease caused by sexually transmitted diseases like Chlamydia increase the risk for ectopic pregnancy.

Sexually active teens are at high risk for gonorrhea and chlamydia. The Centers for Disease Control said [boldface added]:

"Adolescent girls (15-19 years of age) and young women (20-24 years of age) are especially hard hit by these two diseases. The largest number of reported cases of both chlamydia and gonorrhea in 2009 was among girls of these two age groups."

While abdominal pain may occur as a normal adverse reaction with Plan B One-Step, abdominal pain also can occur with an ectopic pregnancy. The manufacturer's leaflet said:

“Healthcare providers, however, should consider the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain after taking Plan B One-Step. A follow-up physical or pelvic examination is recommended if there is any doubt concerning the general health or pregnancy status of any woman after taking Plan B One-Step.”

Will teens be tempted to use Plan B One-Step repeatedly? If so, it would be a good idea to make note of adverse reactions and other effects of using progestin only contraceptives in general. For instance, bone loss is a risk for teens who use a progestin only shot for birth control.

Because lower abdominal pain occurred in more than 4 percent of Plan B One-Step users, there’s a concern that such pain may be misinterpreted if medical care is sought and parents are unaware the teen has taken the contraceptive. If an ectopic pregnancy is missed in diagnosis and not treated properly, the consequences could be life-threatening.

The National Institutes of Health advises:

Any teen who presents with amenorrhea, pain, or vaginal bleeding should be evaluated for a possible ectopic pregnancy. Adolescents are more likely to present with pain than adults.

Vomiting may occur after using Plan B One-Step; if it occurs within 2 hours of taking it, the patient can consider repeating the dose, according to prescribing instructions.

Plan B One-Step has not been tested for use in teens, and although the young woman whose photo is posted on the manufacturer’s Web page is black, most testing occurred in Chinese women [boldface added]:

The mean age of women given Plan B One-Step was 27 years. The racial demographic of those enrolled was 54% Chinese, 12% Other Asian or Black, and 34% were Caucasian in each treatment group. 1.6% of women in the Plan B One-Step group and 1.4% in Plan B group were lost to follow-up. The most common adverse events (>10%) in the clinical trial for women receiving Plan B One-Step included heavier menstrual bleeding (30.9%), nausea (13.7%), lower abdominal pain (13.3%), fatigue (13.3%), and headache (10.3%).”

The manufacturer said, “No formal studies have evaluated the effect of race. However, clinical trials demonstrated a higher pregnancy rate in Chinese women with both Plan B and the Yuzpe regimen (another form of emergency contraception).” The Plan B One-Step trial, however, found a “non-statistically significant increased rate of pregnancy among Chinese women…”

One concern no one is discussing relates to adverse effects and teens who may not use the drug properly. If an emergency health situation arises and the parents are unaware the teen has taken the drug, will those conditions increase the potential for a negative outcome?

Numerous questions have not been presented and answered for much of the public.

Furthermore, will the fact that Plan B One-Step be made available to such a young population actually encourage promiscuity and increase the risk for STDs?

If an adverse outcome does occur and the teen has not yet visited a gynecologist, does that place the teen in a potentially negative situation?

Does it make sense to provide a potent drug over the counter to 15 year old girls who aren’t even old enough to qualify for a driver’s license?

Does it make sense for a federal judge to impose regulations as a runaround to Congress and the president of the U.S.?

The administration of President Barack Obama opposed lifting all age limits on the drug.

What the long term impact of the use of the drug by such a young population will be is anyone’s guess. In one sense, a judge has intervened to dilute parental rights. The age of 15 is also younger than the legal age of consent for sex now in many U.S. states.

(Analysis by Kay B. Day/May 1, 2013)

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Reader Comments (2)

I've read that there are a number of tests that have been done on teens - including in 2005 and 2006. Your story either intentionally omitted this, or didn't try to fairly report that side of the story.

June 11, 2013 | Unregistered CommenterD

Not.

Apparently you missed this info taken directly from the manufacturer's website:

“The mean age of women given Plan B One-Step was 27 years. The racial demographic of those enrolled was 54% Chinese, 12% Other Asian or Black, and 34% were Caucasian in each treatment group. 1.6% of women in the Plan B One-Step group and 1.4% in Plan B group were lost to follow-up. The most common adverse events (>10%) in the clinical trial for women receiving Plan B One-Step included heavier menstrual bleeding (30.9%), nausea (13.7%), lower abdominal pain (13.3%), fatigue (13.3%), and headache (10.3%).”

~~Ed.

June 11, 2013 | Registered CommenterKay B. Day, Editor
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