Tag Archives: safety

Morning-After Pill Still Strong

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June 20 marks the fifth anniversary of the U.S. Food and Drug Administration’s (FDA) approval of over-the-counter Plan B One-Step, a type of “morning-after pill” (itself a type of emergency contraception), without age restrictions. The first morning-after pill was approved by the FDA in 1998, but political backlash prevented easy access to it for more than a decade.

In 2011, the FDA was poised to approve over-the-counter access for Plan B for people 17 and older. The Department of Health and Human Services intervened, raising concerns that young girls might not be able to use the drug safely — even though studies have shown that Plan B is safer than taking an aspirin. The Obama administration, however, claimed that younger people still needed a prescription to ensure they understood the proper use of Plan B.

Access to Plan B gives teenagers another chance to avoid unwanted pregnancy.

The wrangling continued. In early April 2013, a federal district court judge dismissed that claim, stating that the Obama administration’s restrictions were a “politically-motivated effort to avoid riling religious groups and others opposed to making birth control available to girls.” On April 30, the FDA announced that the morning-after pill would be available without prescription to users 15 years of age and older.

The fight to expand over-the-counter access for the morning-after pill wasn’t over. Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, stated that “over-the-counter access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States.” It wasn’t until June 2013 — five short years ago this week — that the FDA approved Plan B One-Step for over-the-counter sale without age restrictions, after the Department of Justice dropped its appeal. In February 2014, certain generic morning-after pills were similarly approved.

Today, let’s celebrate this expanded access to the morning-after pill by reviewing what we need to know about this important form of contraception. Continue reading →

“Instrument of Torture”: The Dalkon Shield Disaster

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This Dalkon Shield is archived at the Dittrick Medical History Center and Museum at Case Western Reserve University. Photo: Jamie Chung

This Dalkon Shield is archived at Case Western Reserve University. Photo: Jamie Chung

These days, IUDs, or intrauterine devices, have stellar reputations as highly effective contraceptives. Along with implants, IUDs can be more effective than permanent sterilization, and their safety record is fantastic. We also have powerful regulations in place to keep dangerous medical devices off the market, and the FTC can keep manufacturers from making false claims in advertising.

But a previous generation of birth-control users might associate IUDs with dangerous pelvic infections and miscarriages. That’s because a single device, called the Dalkon Shield, almost single-handedly destroyed an entire generation’s trust in IUDs. At the time of its debut, there were dozens of IUDs on the market — but the Dalkon Shield unfairly tainted the reputation of all of them. With no FDA or FTC regulations reining in untested devices or false advertising, women in the late 1960s and early 1970s didn’t enjoy the protections that we take for granted today. And it was actually the Dalkon Shield’s string, which was made with a material and by a method that hasn’t been used in IUDs before or since, that made it dangerous.

Today, IUDs are the most popular form of contraception among physicians wishing to avoid pregnancy.

We’ve known about IUDs for more than a century, and have made them out of ebony, ivory, glass, gold, pewter, wood, wool, and even diamond-studded platinum. These days, IUDs release hormones or spermicidal copper ions, but these older devices were simply objects inserted into the uterus that acted as irritants, possibly enlisting the immune system to kill sperm. They were not as effective as modern-day IUDs.

The Dalkon Shield was invented in 1968, was made primarily of plastic, and had “feet” — four or five on each side — to prevent expulsion. In 1970, after being marketed independently, it was sold to family-owned pharmaceutical giant A.H. Robins Company, of Robitussin fame. It was manufactured in the same factory where ChapStick was produced, and retailed for $4.35.

Dr. Hugh J. Davis, the Dalkon Shield’s primary inventor, claimed that users of his device had a 1.1 percent pregnancy rate — but that number was based on a small, methodologically flawed study conducted over eight months. In fact, the Dalkon Shield had a 5.5 percent failure rate over the course of a year. The fact that the Shield didn’t provide high protection against pregnancy was a huge problem, but its design also dramatically increased risk for pregnancy complications. Of the tens of thousands of users who became pregnant while wearing the Dalkon Shield, 60 percent of them had miscarriages. Continue reading →

Let’s Talk Contraception: Dispelling Myths About Emergency Contraception

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EmergencyContraceptionSince 1998, when the Food and Drug Administration first approved the morning-after pill, there have been controversies about its sale and use. Initially, age restrictions were enforced to regulate its sale, and some hospitals and pharmacies refused to provide it to their patients. After considerable pressure from public and medical groups, emergency contraception (EC) is available for sale to anyone at their local pharmacy, with the exception of ella and the copper IUD, both of which require prescriptions.

Emergency contraception is widely available, easy to use, and safe!

And yet, after almost 20 years of remarkably safe use, there are still myths regarding its safety, actions and use. Let’s look at some of those myths right now!

First, there are misunderstandings regarding EC’s availability:

Myth: EC is hard to get and you need a prescription.

Since 2013, most ECs are available to buy in pharmacies over the counter to anyone, regardless of age or gender. There are two exceptions: If you need ella, another morning-after pill, you do need a prescription, and the copper IUD requires placement by a health care provider.

Myth: There is only one type of EC available.

There are several different pills available, such as Plan B One-Step or generic equivalents. These all contain levonorgestrol, a progesterone hormone that is also in many other contraceptives. Ella contains ulipristal acetate and works effectively and evenly up to five days after unprotected sex. Ella is dispensed with a prescription. The copper IUD also needs a prescription but is the most effective EC when placed within five days of unprotected sex. It is recommended for obese women or women who have had several episodes of unprotected sex, and its contraceptive effect lasts 10 years. Continue reading →

STD Awareness: The Next Generation of Gardasil Is Coming!

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noisemakersIt’s January, which means it’s time to festoon our surroundings with streamers, throw around the confetti, break out the noisemakers, and shout Happy Cervical Health Awareness Month!

And, in 2015, we have something huge to celebrate: Last month, the Food and Drug Administration (FDA) approved Gardasil 9, the next-generation HPV vaccine, which provides broader protection than the current version. Next month, the new and improved vaccine will start to be shipped to health care providers, and the Advisory Committee on Immunization Practices is expected to give the Centers for Disease Control and Prevention the green light to recommend the vaccine, after which insurance plans and the Vaccines for Children program should start covering it.

The newest version of Gardasil protects against the seven strains of human papillomavirus that together cause 90 percent of cervical cancers.

Why is this news so exciting for people who care about cervical health? Because, while the current version of Gardasil, which debuted in 2006, protects recipients from the two HPV strains that cause 70 percent of cervical cancers, Gardasil 9 will protect against seven strains of HPV that collectively cause 90 percent of cervical cancers. On top of that, both versions of Gardasil protect against the two HPV strains that are together responsible for 90 percent of genital warts.

Gardasil 9 has been shown to be highly effective in clinical studies, and it is safe to use, which means Gardasil just became an even more potent weapon against cancers caused by HPV. Not only that, but vaccination against HPV will also reduce the frequency of precancerous lesions, which are cellular abnormalities that can be treated before progressing into full-fledged cancer. Less pre-cancer means less time, money, and anxiety spent dealing with followup procedures after an abnormal Pap test, for example. Continue reading →

National Infant Immunization Week: A Timely Reminder to Protect Your Child

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babyVaccinations, or immunizations, are important for the health of your baby. National Infant Immunization Week, in its 20th year, continues to educate and inform parents of this important information. In the first two years of your infant’s life, vaccines can protect against 14 diseases.

How wonderful that science enables us to protect our little ones from serious diseases like polio, tetanus, and diphtheria!

Under five years of age, a child’s immune system is not developed enough to defend against some infections that can cause disability and even death. Vaccination schedules for infants are designed to protect them at times when they are most vulnerable to potentially serious diseases — diseases that are easily transmitted and quickly overwhelm an immature defense system. Vaccines contain “germs,” such as inactivated or weakened bacteria or viruses, that can stimulate an immune response. The amount and type of “germs” in vaccines are designed to help infants’ immune systems develop protection from the serious consequences of getting that disease.

Watching your baby undergo painful injections that may give them some uncomfortable reactions like fever and aches can make any parent worry, but these short-term effects are much less serious than getting the disease. For example, mothers — who may not even know they have hepatitis B because they do not show symptoms — can transmit the disease to their baby during childbirth. Years later, that child may develop serious liver disease. By routinely receiving a hepatitis B vaccine at birth, babies are protected from this life-threatening disease. Continue reading →

STD Awareness: Does Gardasil Have Side Effects?

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Teen_GroupIn 2006, a vaccine called Gardasil made its debut. Its ability to protect against two of the most widespread strains of human papillomavirus (HPV) means that it doesn’t just protect against an infectious disease — it protects against cancer, too. A persistent HPV infection can trigger cell changes that could lead to cancers of the mouth, throat, cervix, vulva, anus, or penis. Gardasil also protects against two additional strains of HPV that cause most genital warts.

The most common Gardasil side effects are fainting, dizziness, nausea, headache, fever, and hives, as well as possible pain, redness, or swelling at the injection site.

Cervical cancer is not as common in the developed world as it once was, thanks to an effective screening test. The Pap test catches “precancerous” cell changes, allowing the precancer to be treated before it develops into full-fledged cancer. So, while HPV vaccines have the potential to save hundreds of thousands of lives if they can be distributed in countries without widespread access to Pap testing, they have utility in the United States, too. Gardasil has spurred declines in high-risk HPV infections and genital wart incidence among American girls — which means less “precancer” and all the invasive, possibly expensive or painful, treatments that they entail, and a lot fewer genital warts. What’s not to like about that?

Despite this, a lot of people are curious about Gardasil’s side effects. If you enter a few key search terms into Google, you can easily find all kinds of websites warning you of Gardasil’s alleged dangers. So, you might be wondering: Is Gardasil safe?

What are Gardasil’s side effects?

Despite Gardasil’s relatively recent debut, many studies have already been conducted to evaluate its safety — and research continues so that we can consistently reassess its risks and benefits. So far, the consensus is that Gardasil is safe, with very few side effects. According to the Centers for Disease Control and Prevention, the most common Gardasil side effects are fainting, dizziness, nausea, headache, fever, and hives, as well as possible pain, redness, or swelling at the injection site. These reactions are not considered to be serious, some people don’t experience any of them, and they are only temporary. Continue reading →

Gardasil and Mortality

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womenVaccination is one of public health’s greatest achievements, but today’s sociopolitical climate promotes unfounded fears. In turn, this fear-mongering has led to outbreaks of otherwise rare infectious diseases, such as measles and whooping cough. Human papillomavirus (HPV) vaccines protect against two HPV strains that cause 70 percent of cervical cancers, which itself is the second-most common type of cancer in women worldwide. Immunization has the potential to eliminate these viral strains, which would save lives and reduce health care costs — but, unfortunately, vaccine horror stories are a dime a dozen on the Internet, and HPV vaccines like Gardasil are popular targets for vaccine opponents.

Of 57 million Gardasil doses given in the United States, 40 confirmed deaths have occurred in recipients. However, these deaths were not caused by vaccination.

There are many claims flying around that Gardasil causes serious side effects, including death. However, claims that Gardasil can lead to death aren’t supported by good evidence. Generally speaking, people who make these accusations obtain their information from a publicly accessible database called the Vaccine Adverse Event Reporting System (VAERS), which collects claims of adverse events from anyone — including health care providers, patients, or family members.

What is an adverse event?

Most people don’t realize that the phrase “adverse event” cannot be used interchangeably with the term “side effect.” An adverse event is something that occurs after a vaccination — such as a headache, seizure, depression, or death. It could happen one second after being injected with a vaccine or more than a year afterward. It could be a coincidence, or it might be caused by vaccination. For example, if two weeks after receiving a flu shot I get a headache, I could legitimately claim it is an “adverse event,” even if my headache had nothing to do with the shot. An adverse event is only called a side effect if it is found to have been caused by vaccination.

What is VAERS?

Despite its occasional misrepresentation in print media, social media, and the blogosphere, VAERS is not a source of information about verified side effects — it is a database of adverse events that have been self-reported by the public. Anyone can submit a report to VAERS — heck, I could claim that the flu shot gave me telekinetic powers in addition to that headache, and it would be recorded in the database. That doesn’t mean that you should worry about coming down with a nasty case of telekinesis after getting a flu shot at the corner drug store. Continue reading →