Mirena iud and antibiotics

Mirena

SIDE EFFECTS

The following serious or otherwise important adverse reactions are discussed in elsewhere in the labeling:

  • Ectopic Pregnancy
  • Intrauterine Pregnancy
  • Group A Streptococcal Sepsis (GAS)
  • Pelvic Inflammatory Disease
  • Alterations of Bleeding Patterns
  • Perforation
  • Expulsion
  • Ovarian Cysts

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data provided reflect the experience with the use of Mirena in the adequate and well-controlled studies as well as in the supportive and uncontrolled studies for contraception and heavy menstrual bleeding (n=5,091). The data cover more than 12,101 women-years of exposure, mainly in the contraception studies (11,761 women-years). The frequencies of reported adverse drug reactions represent crude incidences.

Table 1 : Adverse Reactions ≥ 5% Reported in Clinical Trials with Mirena

System Organ Class Adverse Reactions % (N= 5,091)
Reproductive system and breast disorders alteration of menstrual bleeding pattern, including:
unscheduled uterine bleeding 31.9
decreased uterine bleeding 23.4
increased scheduled uterine bleeding 11.9
female genital tract bleeding 3.5
amenorrhea 18.4
genital discharge 14.9
vulvovaginitis 10.5
breast pain 8.5
benign ovarian cyst and associated complications 7.5
dysmenorrhea 6.4
Gastrointestinal disorders abdominal/pelvic pain 22.6
Nervous system disorders headache/migraine 16.3
Musculoskeletal and connective tissue disorders back pain 7.9
Skin and subcutaneous tissue disorders acne 6.8
Psychiatric disorders depression/depressive mood 6.4

Other adverse reactions occurring in < 5% of subjects include alopecia, (partial and complete) device expulsion, hirsutism, nausea, and PID/endometritis.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Mirena. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Arterial thrombotic and venous thromboembolic events, including cases of pulmonary emboli, deep vein thrombosis and stroke
  • Device breakage
  • Hypersensitivity (including rash, urticaria and angioedema)
  • Increased blood pressure

Read the entire FDA prescribing information for Mirena (Levonorgestrel-Releasing Intrauterine System)

Explore Methods

The recent slew of Mirena IUD lawsuit ads are creepy. But are they true? We’re going to fearlessly wade into the scary things these ads claim, because we think the over 2 million U.S. women now using IUDs deserve the real info—without the hype.

What problems are being reported—and how common are they?

Some of the ads say 47,000 women have had problems with the Mirena. But where does that number come from? The Food and Drug Administration (FDA) scrutinizes drugs and devices for safety before they can be sold in the U.S., then continues collecting information about problems people have with drugs and devices after they’re on the market and being used more broadly.

Anyone can report problems to the FDA. Since Mirena came on the market in 2001, the FDA has received about 47,000 reports of problems with it. Many millions of women have used a Mirena over the 12 years it’s been on the market, so this number is actually a small fraction of the total—and it includes common complaints in addition to the rarer, scarier problems the lawsuit ads often focus on.

Here’s how the problems break down (and more about each below):

  • almost half (45%, or about 21,500 women) of the complaints are about IUD expulsion

  • pain during or after the IUD placement makes up 25% of the complaints (or 11,700 women)

  • complaints about more bleeding make up 21% (or 10,100 women)

  • complaints of less bleeding or no period account for 6% (or 2,800 women)

  • complaints of pregnancy with the IUD make up 5% (or 2,200 women)

  • perforation of the uterus accounts for 3% of the complaints (or 1,300 women)

Let’s look at the scientific evidence about how common each problem is and what it means if it happens to you.

Expulsion

It’s not surprising that almost half of the reported problems with Mirena were expulsion—it’s relatively common, occurring in up to 8% of women who get an IUD. Expulsion is a fancy way of saying that an IUD has been pushed out of its ideal location at the top of the uterus. The uterus is one big muscle, so this sometimes happens. In a complete expulsion, the IUD is pushed all the way out of the uterus into the vagina. In a partial expulsion (a.k.a. dislocation), an IUD is pushed only part way out and a woman may not know that her IUD isn’t where it should be.

If a woman doesn’t recognize a partially expelled IUD, it can mean the IUD isn’t working to prevent pregnancy. Signs of a partial expulsion include cramping, pain, and feeling the plastic of the IUD at the top of the strings. This is why doctors often advise checking on the IUD strings. If recognized quickly, a partial expulsion is not a big problem: the IUD needs to be removed, and a woman can decide if she wants to try another IUD or switch to a different method. After expelling one IUD, there may be a higher chance of expelling the next one.

The bottom line: Expulsion can be uncomfortable—and it’s definitely inconvenient—but it does not have lasting effects or cause infertility as some of the Mirena lawsuit ads imply.

Pain and bleeding

During insertion: IUD insertion pain is worse for some women than for others. (Even for women who experience a lot of pain during insertion, they often say it was worth the gain of hassle-free birth control.) After the IUD has been inserted, continuing pain may be a sign of a partial expulsion or another problem, so if the pain doesn’t go away within a few days of insertion, it’s definitely a good idea to check in with a health care provider.

During periods: In the long run, many women using a Mirena experience less period pain than they did before getting the IUD. About one-third of users have frequent or longer bleeding in the first three months, and about two-thirds have some spotting or bleeding between periods. After a year, about three-quarters of women have infrequent or no bleeding at all. On the other hand, some of the problems women report to the FDA are about lighter or nonexistent periods. Some Mirena users see this as a benefit, but if you’re not prepared for these possible changes, they can seem like a problem.

The bottom line: Only you know what’s normal for your body in terms of pain and periods. Learn as much as you can about how your pain and bleeding might be affected by any type of IUD before trying one. If after your IUD is inserted you have pain or bleeding beyond what you expected, talk to your health care provider.

Perforation and migration

For about 1 in 2,000 women, the IUD can get stuck in or puncture the uterus—also known as perforation. A U.S. woman aged 20-39 is more than 10 times more likely to have a stroke (12 in 2,000) than to experience perforation. Perforation only happens when the IUD is being put in. Highly skilled providers who have inserted many IUDs are less likely to have perforations. Women who are breastfeeding or have given birth within the last month are more likely to experience perforations because the muscle of the uterus is softer at those times.

What does it mean if there is a perforation? If it’s recognized immediately, the health care provider will stop the insertion. It takes about a week for the uterus to heal, and then a woman can have another IUD inserted if she wants. More than half of perforations may go unrecognized at the time of insertion. That may mean that a woman thought she had great birth control when she may not have. If undiagnosed for months, a perforation can make removing the IUD difficult, and can sometimes require surgery. Even in the worst-case scenario of an undiagnosed perforation that requires surgery, it shouldn’t have an impact on the woman’s future fertility.

Many of the lawsuit ads warn of IUDs migrating outside the uterus. Although it is extremely rare, there have been cases when an IUD has gotten past all of the thick layers of muscle of the uterus and entered the body cavity. How rare is this? So rare that even with tens of millions of women using IUDs worldwide, we can’t estimate how often it happens. We just know that there have been case reports in medical journals.

The bottom line: Perforation is rare and, if it’s recognized quickly, it’s not a major health event. Many providers will have you come back 4-6 weeks after an IUD placement to check on the strings and make sure everything is okay. If you’re worried, you can check your own strings. If you can’t find your strings, see your health care provider.

Pregnancy, now and later

Can you get pregnant with an IUD? Unfortunately, method failure is a risk with any and all contraceptives. So, yes—for a very small number of women, the IUD can fail and an accidental pregnancy can result. For the Mirena, this happens for about 2 in 1,000 women. That’s way less common than 90 pregnancies in 1,000 women using the pill—but it’s not zero.

What about getting pregnant after having an IUD? Studies have repeatedly shown that in the year after removing an IUD, over 80% of women who want to have a baby do get pregnant—exactly the same as for women who have never used an IUD. In other words, using an IUD now has no impact on future motherhood.

The bottom line: IUDs fail way less than other kinds of birth control, and they don’t affect your ability to get pregnant in the future.

Serious problems with IUDs are rare—but we understand that’s small comfort if you or someone you care about experiences them. Each person has to weigh the risks and benefits when making any decision, including about birth control, and we hope that this and our other information about IUDs helps create a more complete picture than the lawsuit ads alone.

Corinne Rocca, PhD, MPH, is an Epidemiologist at the Bixby Center for Global Reproductive Health at the University of California, San Francisco. Her wish is that all young women have the information they need and feel empowered to protect themselves from both unintended pregnancy and sexually transmitted diseases. Research aside, she loves hiking and recently climbed Mount Kilimanjaro.

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The FDA has not issued any major action or communication, such as a recall or safety warning, regarding Mirena.
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Bayer Healthcare Pharmaceuticals is facing hundreds of lawsuits over claims that its birth control product, Mirena, caused serious neurological side effects for women who used it.

The Mirena intrauterine device (IUD) is a t-shaped piece of plastic inserted into the uterus to prevent pregnancy. The device, which uses a hormone called levonorgestrel, was approved for sale in the United States by the FDA in 2000. Bayer estimates that the Mirena is the most-prescribed IUD in the United States, with 2 million women using it worldwide.

A new set of lawsuits consolidated in the U.S. District Court for the Southern District of New York claims that Mirena caused a neurological disorder that falsely resembles a tumor. The disorder is called pseudotumor cerebri, or idiopathic intracranial hypertension. The cause is unknown, but obesity, some medications, and various health problems are among the risk factors. According to the Mayo Clinic, symptoms include headaches, worsening vision, tinnitus, and nausea.

Currently, 856 cases—more than 150 filed in the last two months—are pending in the intracranial hypertension lawsuit against Bayer, according to the United States Judicial Panel on Multidistrict Litigation (MDL). The first cases were filed in December 2016. The federal court agreed to consolidate them in April 2017, meaning that a ruling will affect all the consolidated cases.

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So far, experts note there is little medical literature supporting the claims that Mirena caused the plaintiff’s injuries—a major factor that will likely determine the outcome of the case.

IUDs have only recently become one of the most popular birth control options available in the United States. For more than a decade, the IUD was not considered a desirable option, due in part to the Dalkon Shield, an IUD that came on the market in 1970, harmed hundreds of thousands of women using it, and resulted in a class-action lawsuit against the manufacturer. Activists have also criticized the use of long-acting reversible contraception like IUDs on women of color as a coercive practice.

According to the CDC, the use of long-acting reversible contraceptive methods has increased nearly five times between 2002 and 2013. Guttmacher estimates the IUD is now the fourth most popular form of contraception on the market in the United States. There was also a reported uptick in the popularity of the IUD after the 2016 election. With new IUD models, like Liletta and Skyla becoming available, as well as the long-term affordability of the IUD compared to other methods, the IUD has become a well-known, highly effective birth control method. And the Mirena is one of the most popular models.

“The most popular IUDs that patients come asking for is the Mirena or Paragard,” Dr. Kristyn Brandi, an assistant professor of obstetrics, gynecology, and women’s health at Rutgers-New Jersey Medical School, told Rewire.News. “Patients for Mirena want long term birth control and typically will want something that makes their periods lighter or go away all together. Those are some of the benefits for Mirena.”

Mirena is also the IUD with the most complaints to the FDA. Since the FDA’s initial approval of Mirena in 2000, the federal agency has amassed 95,008 reports about the drug in its Adverse Events Reporting System, or FAERS. The number of complaints have risen as the IUD has gained popularity. Since 2007, complaints have increased tenfold. More than a third of the reports cite expulsion of the Mirena from the uterus (32,084) or dislocation of the device (10,793). Other complaints include genital or vaginal hemorrhaging (12,144) and pain (6,122). There were also reports of pregnancy using Mirena (3,971).

FDA spokesperson Deborah Kotz says that there are limitations to the data in the FAERS database, including duplicate and incomplete reports. Kotz also cautions that the rate of occurrence cannot be established with the reports. The under-reporting of events may be another factor. The exact number of people using the Mirena is unknown, so FDA data is not a complete picture of the actual number of adverse events experienced with it. Moreover, Kotz said, “Existence of a report does not establish causation: For any given report, there is no certainty that a suspected drug caused the reaction.”

In addition to reporting their complaints about Mirena—or any other drug or device—to the FDA through MedWatch, patients can report directly to Bayer through their Women’s Health hotline or online support page. At Bayer, a safety team reviews the adverse events, collects more information on the case, and follows up with the patient on a case-by-case basis.

The FDA also reviews reports of adverse events. The FDA has not issued any major action or communication, such as a recall or safety warning, regarding Mirena. Experts familiar with the FDA reporting process say this is likely because the majority of the complaints about Mirena refer to known side effects outlined in the product label, such as expulsion or perforation.

Madris Tomes, CEO and founder of Device Event, a company that analyzes FDA adverse event reports, suggests that a potential FDA action would likely be triggered by a critical mass of women showing side effects not known to be associated with Mirena at an unprecedented rate. Such was the case with another Bayer birth control device, Essure. The company is removing Essure from the market on December 31, 2018, claiming low sales, after the FDA issued a restriction on sale and distribution of the device earlier this year. Unlike the women behind the famed Essure Problems Facebook group, which has more than 40,000 members and leveraged congressional support to remove Essure from the market, users of Mirena are not politically organized. Dozens of Facebook groups citing Mirena problems exist, with membership ranging from just a few members to nearly 5,000. The FDA says it continues to monitor the safety of Mirena, as it does with all approved drug products.

Of the Mirena FDA complaints, 697 are reports of intracranial hypertension—the side effect at the center of hundreds of lawsuits filed since December 2016.

In a statement to Rewire.News, a Bayer representative said that an increasing number of cases of intracranial hypertension in levonorgestrel users have been submitted to the company, either directly originating from the litigation process or as a consequence of the associated public attention. Still, it says, the reporting rate for intracranial hypertension in levonorgestrel IUD users is low. Even accounting for under-reporting, “the observed rates do not indicate an increased risk in a population,” the manufacturer said in a statement to Rewire.News.

“The reporting frequency of post-marketing reports on intracranial hypertension in Mirena users has in recent years been influenced by the ongoing litigation,” Bayer’s representative said. “The observed increase in reporting rates per se does not, therefore, represent a safety signal.”

According to Mayo Clinic, the cause of intracranial hypertension is not known, but two risk factors are obesity and the use of some medications. In a 1995 letter to the New England Journal of Medicine, doctors suggested the syndrome may be linked to levonorgestrel, the progestin hormone used in Mirena. In 1995, plaintiffs made the same claims that intracranial hypertension was caused by using Norplant, which also used a progestin hormone. Available research about Mirena does not show that intracranial hypertension can be caused by its levonorgestrel hormone.

A 2015 medical study by Dr. Mahyar Etminan surveyed FDA’s adverse event reports and found “a higher than expected number” of reports in the FAERS database of intracranial hypertension related to the use of Mirena. The study called for further investigation of the relationship between Mirena and intracranial hypertension. But Dr. Etminan’s study came under fire for its faulty analysis of available data, and later, Dr. Etminan admitted his study had methodological flaws and that he was being paid by the lawyers suing Bayer, which he did not disclose at the time his article was published. “As the lead author of this article, I acknowledge that neither of the analyses in the article provide evidence that Mirena use increases the risk for intracranial hypertension,” Dr. Etminan said in a sworn affidavit.

A 2017 study found that women who use a levonorgestrel IUD like Mirena may have increased risk of developing the false tumors, but does not suggest that the IUD itself can cause them.

Dr. Brandi also says more research would be needed to prove that Mirena is causing intracranial hypertension. It is not one of the known side effects included in the manufacturer’s label for the device, a significant detail in the multi-district litigation. Plaintiffs could argue that Bayer did not adequately warn them it was a possible outcome of using Mirena.

Side effects outlined in the label are considered known risks to the manufacturer, the FDA, providers, and patients. The prioritized warnings in the label pertain to complications with getting pregnant on Mirena (such as ectopic pregnancy, septic abortion, and miscarriage), pelvic inflammatory disease, irregular bleeding, perforation and expulsion.

“I always tell my patients these are the typical side effects that we have studied that we think are related to the IUD,” said Dr. Brandi. “But we don’t have all the evidence.”

Dr. Brandi says that providers should listen to any side effects their patients experience when using a new drug, regardless of whether or not they are outlined in the drug label. In choosing their birth control methods, patients should consider the potential side effects along with the benefits of preventing pregnancy.

Many providers stress that any potential risks associated with Mirena are rare.

Dr. Adam Jacobs, medical director of the division of family planning at the Mount Sinai Health System, says that the Mirena IUD has far less risk associated with it than many commonly prescribed medical devices on the market.

Still, as Mirena has gotten more popular, Bayer has faced an increase in litigation over side effects.

As of October 2018, there has been a total of 2,300 lawsuits against Bayer for the Mirena device, according to the manufacturer’s third-quarter annual report. Most were claims that the Mirena perforated the uterus, migrated, or was expelled. In July 2016, a federal judge ruled in favor of Bayer in nearly 1,300 lawsuits claiming perforation or migration injuries from the Mirena. In that ruling, the federal judge decided that the plaintiffs were unable to prove that the Mirena was the cause of the plaintiffs’ injuries. (The judge had earlier excluded the testimony of the plaintiffs’ medical experts, finding them unreliable.) In April 2018, Bayer offered $12.2 million to settle 4,600 perforation cases.

Kirsten Thompson, program and communications director at the Bixby Center for Global Reproductive Health, said that the increase in lawsuits against the birth control manufacturer isn’t a recent phenomena.

“Over the years there has been a steady stream of lawsuits . That’s not new,” said Thompson.

But now lawyers can now find plaintiffs by using targeted advertising online. Once they believe they have a successful causation claim, they may be likely to take on more related cases.

“My impression from speaking to physicians about these types of cases,” Thompson said, “is that it’s cookie cutter. If someone has a claim they think will be successful, a bunch of other people will take it up.”

Betsy Barnes, an attorney for Morris Bart LLC representing clients in the intracranial hypertension multi-district litigation, says that lawyers are filing more cases and that this suit has a better chance of proving that Mirena caused plaintiff’s injuries than the 2016 perforation case did. In October, however, U.S. District Judge Paul Engelmayer ruled that as with the perforation case, none of the plaintiffs’ expert witnesses will be allowed to testify.

As the complaints continue to be filed, health providers and the FDA also underscore the risk-benefit assessment of using Mirena.

“Unfortunately, there is no such thing as a drug or device or any medical product that is risk free,” said the FDA’s Kotz.

Topics and Tags:

Health Systems, IUDs, Law and Policy, Mirena, Sexual Health

Mirena is the brand name of the levonorgestrel-releasing intrauterine system, which is used to prevent pregnancy.

It may also be used to treat heavy menstrual bleeding in women who want to prevent pregnancy.

Levonorgestrel, the active ingredient in contraceptives known as “morning-after pills,” is a form of the hormone progestin and is in a class of medicines known as hormonal contraceptives.

It works by thinning the lining of the uterus, thickening the mucus of the cervix, and preventing sperm from moving and surviving in the uterus.

The levonorgestrel-releasing intrauterine system may also prevent ovulation in some women.

Mirena, which is made of soft plastic, is inserted into the uterus by a healthcare provider and can be left in place for up to five years.

It can be removed by your doctor any time you decide you want to become pregnant and must be replaced with a new device after five years.

The manufacturer of Mirena says the system should only be used by women who have given birth to at least one child.

However, some experts believe women who have not given birth can use Mirena.

Mirena Warnings

Mirena is an effective method of birth control, but it does not protect against sexually-transmitted diseases.

You should not have Mirena inserted if you are pregnant or plan to become pregnant.

Your doctor will give you a pregnancy test before inserting the intrauterine system.

It’s unlikely that you will become pregnant while having Mirena in place, but if you do, you’re at an increased risk for having an ectopic pregnancy (a pregnancy that develops outside the uterus).

You’re also at a higher risk for severe infection, miscarriage, pre-term labor, or death if your pregnancy continues with your Mirena in place.

There’s a risk that the Mirena device could attach to or move through the wall of your uterus. There’s a greater chance this will happen if you are breastfeeding, so be sure to tell your doctor if you are nursing.

However, if you are breastfeeding more than six weeks after giving birth, your doctor will probably tell you it’s OK to have the Mirena inserted.

Mirena may increase your chances of developing pelvic inflammatory disease (PID). This condition can cause infertility, ectopic pregnancy, chronic pain, or even death.

PID happens to less than 1 percent of users, but the risk of developing it is greater if you or your partner have more than one sexual partner. You should tell your doctor if either of you have multiple sexual partners.

Call your doctor right away if you experience severe pain during the first few hours after your Mirena device is inserted. Pain could be a symptom of a serious infection.

Mirena may also increase your risk of developing an ovarian cyst.

This type of cyst can cause pain but usually goes away in a couple of months. In rare instances, surgery is required to remove the cyst.

You will likely experience changes in your menstrual cycle with Mirena in place.

Your periods may be irregular, longer, or heavier during the first 3 to 6 months after the device is inserted.

You also may experience spotting between your periods. Over time, your cycles will probably become lighter and shorter.

If your period stops, it will return once the device is removed.

You should call your doctor if you were having regular periods but have not menstruated in six weeks or if your bleeding becomes heavy after being light for some time.

Before having Mirena inserted, you should tell your doctor if you have ever had:

  • Breast cancer
  • Uterine fibroids or any condition that affects the shape of the inside of your uterus
  • Uterine cancer or cervical cancer
  • An abnormal Pap smear
  • Abnormal vaginal bleeding
  • Liver disease or tumors
  • An untreated vaginal or cervical infection
  • PID
  • A stroke
  • A heart attack or heart disease
  • Slow heart beat
  • High blood pressure
  • Diabetes
  • Severe headaches or migraines
  • Any condition that causes you to faint
  • A blood clotting problem
  • Seizures
  • An ectopic pregnancy
  • Fallopian tube surgery
  • Any condition that affects your immune system, such as leukemia or HIV/AIDS

You should also tell your physician if you have had a serious infection after a pregnancy or an abortion in the past three months.

Pregnancy and Mirena

If you become pregnant while the Mirena device is in place, call your doctor right way and discuss the risks of removing the system.

Hormonal birth control can do some pretty funky—but also amazing!—things to your body. It can change your skin (buh bye, hormonal acne), regulate your periods, and in news-to-my-ears, it can also change your hair. When a friend recently told me that she was convinced her IUD was making her hair curly, I admittedly had my doubts. I’d never heard of such a thing! But after talking to an OB/GYN and a trichologist on the subject, she may actually be onto something.

“The birth control pill can definitely affect the quality and quantity of hair growth,” says Sherry Ross, MD, an OB/GYN and author of She-Ology. “Some women notice their hair thins out when taking the pill, while others notice hair loss. There are also women who notice a fuller, thicker, and shiny head of hair while taking the pill.” She notes that it all comes down to how your body and the hormones work together, and that a family history of hair loss may mean that certain hormonal birth control methods could trigger that same reaction in your body.

IUDs, she explains, can be some of the most common culprits when it comes to hair changes: The Mirena has been known known to cause hair loss in a very (I repeat: very!) small percentage of women: It has alopecia listed as a side effect that effects less than 5 percent of women. According to her, the non-hormonal copper IUD has been associated with hair loss and changing of the texture for a handful of women.

“Many hormones can affect the hair follicles, changing the way they grow and cycle,” confirms Dominic Burg, PhD, a trichologist and hair biologist with Evolis. “Some women have follicles that are especially sensitive to the impact of hormones altered by birth control and this can result in hair cycle shortening, increased shedding, hair thinning and changes in hair quality.” For what it’s worth, this can happen once you stop taking the pill as well. “In this case, it’s the change or absence of the hormones in the pill that triggers a change in the hair cycle,” says Dr. Burg.

To understand why this may happens, it’s important to have a sense of how hormones (as in, the ones that regularly live inside the body, whether you’re on birth control or not) can effect your hair in general. “Hormones effect the body in profound ways. Many of them can also impact the way hair grows, metabolizes, and cycles,” says Dr. Burg, pointing out that its your sex hormones that caused hair to sprout in all those fun and confusing places when you went through puberty (#tbt). “Hormones can affect the way that follicles grow so much that the texture of hair actually changes as a result.”

And going on birth control isn’t the only time your hormones may change what’s happening on the top of your head. “Texture of hair is influenced by the shape of the follicle and the angle that it grows in the scalp—during major hormonal events such as puberty, this can be altered, which results in a change in texture,” says Dr. Burg. Ever heard a woman commenting that pregnancy made her hair curly? Yup, that’s a thing, too.

Pay attention to what’s happening with your hair (like, are clumps of it coming out in the shower? Or has it suddenly gone from straight to curly?), as it relates to other things in your life. Dr. Burg explains that hair changes may happen a few months after the hormone changes do, so you may not realize that the two are connected. “In all cases, you should be looking after your hair cycle and provide your hair with adequate nutrition by eating a good, balanced diet with plenty of vegetables and lean meat or other zinc, iron, B Vitamin, and protein sources,” he says. And if these hairy side-effects are really starting to bug you, talk to your doctor about changing your birth control.

If birth control is changing your hair, embrace your curls with one of these tricks for keeping curls amazing. And if hair loss is happening, here are a few things you can do to deal.

5 IUD myths dispelled

Long-acting reversible contraceptives (LARCs), which include intrauterine devices (IUDs), implants, and injectables, are being offered to more and more women because of their demonstrated safety, efficacy, and convenience. In other countries, as many as 50% of all women use an IUD, but the United States has been slow to adopt this option.1 In 2002, approximately 2% of US women used an IUD.2 That percentage rose to 5.2% between 2006 and 2008, according to a recent survey.3 In that survey, women consistently expressed a high degree of satisfaction with this method of contraception.3

So why aren’t more US women using an IUD?

A general fear of the IUD persists. Women may not even know why they fear the device; they may have simply heard that it is “bad for you.” The negative press the IUD has received in this country probably is related to poor outcomes associated with use of the Dalkon Shield IUD in the 1970s. As a reminder, the Dalkon Shield was blamed for many cases of pelvic inflammatory disease (PID) and other negative sequelae as a result of poor patient selection. In addition, some authorities believe the design of the device was severely flawed, with a string that permitted bacteria to get from the vagina to the uterus and tubes.

Today, clinicians and many patients are better educated about the prevention of chlamydia, the primary causative organism of PID and other sexually transmitted infections (STIs); patients also are better informed about safe sex practices. We now know that women should be screened for behaviors that could increase their risk for PID and render them poor candidates for the IUD.

Clinicians also have expressed concerns about reimbursement issues related to the IUD, as well as confusion and difficulty with insertion procedures and the potential for litigation. In this article, I address some of these issues in an attempt to increase the use of this highly effective contraceptive.

What’s available today
Today there are three IUDs available to US women (FIGURE):

The Copper IUD (ParaGard)—This device can be used for at least 10 years, although, in many countries, it is considered “permanent reversible contraception.” It has the advantage of being nonhormonal, making it an important option for women who cannot or will not use a hormonal contraceptive. Pregnancy is prevented through a “foreign body” effect and the spermicidal action of copper ions. The combination of these two influences prevents fertilization.4

The levonorgestrel-releasing intrauterine system (LNG-IUS) (Mirena)—This IUD is recommended for 5 years of use but may remain effective for as long as 7 years. It contains 52 mg of levonorgestrel, which it releases at a rate of approximately 20 μg/day. In addition to the foreign body effect, this IUD prevents pregnancy through progestogenic mechanisms: It thickens cervical mucus, thins the endometrium, and reduces sperm capacitation.5

The “mini” LNG-IUS (Skyla)—This newly marketed IUD is recommended for 3 years of use. It contains 13.5 mg of levonorgestrel, which it releases at a rate of 14 μg/day. It has the same mechanism of action as Mirena but may be easier to insert owing to its slightly smaller size and preloaded inserter.

Myth #1: The IUD is not suitable for teens and nulliparous women

This myth arose out of concerns about the smaller uterine cavity and cervical diameter of teens and nulliparous women. Today we know that an IUD can be inserted safely in this population. Moreover, because adolescents are at high risk for unintended pregnancy, they stand to benefit uniquely from LARC options, including the IUD. As the American College of Obstetricians and Gynecologists (ACOG) recommends in a recent Committee Opinion on adolescents and LARCs, the IUD should be a “first-line” option for all women of reproductive age.6

Myth #2: An IUD should not be inserted immediately after childbirth

For many years, it was assumed that an IUD should be inserted in the postpartum period only after uterine involution was completed. However, in 2010, the Centers for Disease Control and Prevention (CDC) published medical eligibility criteria for contraceptive use, which included the following recommendations for breastfeeding or non–breast-feeding women:

• Mirena was given a Level 2 recommendation (advantages outweigh risks) for insertion within 10 minutes after delivery of the placenta

• The copper IUD was given a Level 1 recommendation (no restrictions) for insertion within the same time interval

• From 10 minutes to 4 weeks postpartum, both devices have a Level 2 recommendation for insertion

• Beyond 4 weeks, both devices have a Level 1 recommendation for insertion.7

Immediate post-delivery insertion of an IUD has several benefits, including:

1. What is doxycycline?

Doxycycline is an antibiotic medicine belonging to the class called “tetracyclines.” It is used to treat bacterial infections in many different parts of the body. It does not treat viral infections, such as the common cold.

2. Is doxycycline approved to treat anthrax?

Doxycycline is approved to treat anthrax in all its forms .

3. Can medicines in the same class as doxycycline be used to prevent or treat anthrax?

Other drugs in the tetracycline class carry a broad indication for illnesses caused by the anthrax organism (Bacillus anthracis). Because the most up-to-date information about appropriate dosing following exposure to anthrax is available for Cipro (ciprofloxacin), doxycycline, and penicillin G procaine, use of these three drugs has been recommended.

Antibiotic therapy should only be started in the case of suspected or confirmed exposure to anthrax. Antibiotics reduce the risk of severe disease following exposure, but do not prevent exposure.

4. What are some possible side effects of doxycycline?

This list is NOT a complete list of side effects reported with doxycycline. Your health care provider can discuss with you a more complete list of side effects.

Some possible uncommon but serious side effects of doxycycline include:

  • a life-threatening allergic reaction (symptoms are trouble breathing; closing of the throat; swelling of the lips, tongue, or face; hives)
  • blood problems (symptoms are unusual bleeding or bruising)
  • liver damage (symptoms are yellowing of the skin or eyes, dark urine, nausea ,vomiting, loss of appetite, abdominal pain)
  • irritation of the esophagus

Other more common, but less serious, side effects include:

  • nausea, vomiting, diarrhea
  • increased sensitivity of the skin to sunlight
  • vaginal yeast infection

5. What else should I know about doxycycline?

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. If a person is exposed to anthrax, the risk of side effects caused by doxycycline treatment may be acceptable because of the seriousness of the disease. However, if a person has not been exposed to anthrax, these risks may outweigh the benefits.

Some other things to consider:

  • Doxycycline and other members of the tetracycline class of antibiotics are not generally approved for treating patients under 8 years old. These antibiotics can cause swelling of the brain and a condition called bulging fontanels (soft spot on head) in infants.
  • Tetracycline antibiotics are associated with permanent tooth discoloration in children. If used for long periods, they may also slow down the growth of teeth and bones in babies born prematurely. However due to the seriousness of anthrax, dosing instructions for treating inhaled anthrax (post-exposure) is provided in approved prescribing information for doxycycline.
  • Before taking any tetracycline antibiotic, review with your health care provider ALL medicines you are taking, including those you take without a prescription. Tetracycline antibiotics can affect how other medicines work and other medicines can affect how the antibiotic works.
  • Some medicines that can interact with doxycycline are antacids and supplements that contain calcium, iron, magnesium, or sodium bicarbonate. If you take products containing these minerals within 2 hours of the time you take doxycycline, these medicines could decrease the doxycycline’s effectiveness.
  • Birth control pills also may not work as well if you are taking doxycycline. Use other forms of birth control while you are taking this medicine.
  • Throw away any unused doxycycline when it is out of date or when it is no longer needed. Do not take any doxycycline after the expiration date printed on the bottle.

6. Is it safe to buy antibiotics online?

There are online pharmacies from which you can confidently fill your prescriptions. Unfortunately, there are also questionable sites that make buying medicines online risky. Buying a medicine from an illegal Website puts you at risk. You may get a contaminated or fake product, the wrong product, an incorrect dose, or no product at all. Go to: Buying Medicines and Medical Products Online for additional tips on buying medicines online.

7. Is it safe to purchase medicines outside of the United States?

FDA can not assure the quality or identity of products not approved for sale in the United States. Not all countries have the same approval procedures and manufacturing controls as the United States.

Possible risks include fake, unapproved, outdated, or sub-standard products. A document, entitled “Buying Medicine from Outside the United States”, explains FDA’s concerns on this subject.

Does Mirena Intrauterine Device Interact with other Medications?

Severe Interactions

These medications are not usually taken together. Consult your healthcare professional (e.g., doctor or pharmacist) for more in formation.

  • CONTRACEPTIVES/SODIUM TETRADECYL SULFATE

Serious Interactions

These medications may interact and cause very harmful effects. Consult your healthcare professional (e.g., doctor or pharmacist) for more in formation.

  • CONTRACEPTIVES/TROLEANDOMYCIN
  • HORMONAL CONTRACEPTIVES/MYCOPHENOLATE
  • CONTRACEPTIVES/CHLORAMPHENICOL
  • PROGESTIN-CONTAINING CONTRACEPTIVES/ULIPRISTAL
  • HORMONAL CONTRACEPTIVE AGENTS/BOCEPREVIR
  • HORMONAL CONTRACEPTIVE AGENTS/TELAPREVIR
  • HORMONAL CONTRACEPTIVES/MIFEPRISTONE
  • HORMONAL CONTRACEPTIVES/COBICISTAT
  • HORMONAL CONTRACEPTIVES/LESINURAD
  • HORMONAL CONTRACEPTIVES/ENASIDENIB
  • HORMONAL CONTRACEPTIVES/BEXAROTENE
  • HORMONAL CONTRACEPTIVES/SUGAMMADEX

Moderate Interactions

These medications may cause some risk when taken together. Consult your healthcare professional (e.g., doctor or pharmacist) for more in formation.

  • CONTRACEPTIVES/XANTHINE DERIVATIVES
  • HORMONAL CONTRACEPTIVES/BRIGATINIB
  • SELECTED CYP2D6 INHIBITORS/METOPROLOL

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