Cover Story

Pill Side Effects Hard to Swallow  by Brittany Shoot
Pill Side Effects Hard to Swallow

When the first generation of birth control pills was approved for sale in 1960, “the pill,” as it came to be known, was heralded as a great liberator. At long last women could reliably control their fertility. After just two years on the market, more than a million women were incorporating the pill into their daily routine. Within five years, the pill had become the most popular form of birth control in North America.

At the time, the assumption was that a woman would take a hormonal contraceptive for a few short years before having children. However, from the start, the high doses of hormones in the pill worried women’s health advocate Barbara Seaman, author of the 1970 book The Doctor’s Case Against the Pill. Using the book to draw attention to several key safety concerns about hormonal contraceptives, Seaman partnered with Wisconsin Senator Gaylord Nelson, who called a U.S. Senate hearing to investigate the safety and of theh pill n 1975.

(Winter 2014 )        

The hearings created a stir, and, in the following years, the U.S. government mandated that drug fact sheets accompany prescription medication—including birth control pills.

Today, birth control pills tend to be made with synthetic hormones. However, reports of serious health risks have again brought the issue to the women’s health agenda. In the U.S., thousands of women have taken legal action in the form of class-action lawsuits against pharmaceutical giant Bayer HealthCare Pharmaceuticals, the manufacturer of the birth control pills Yaz, Yasmin and others that contain the synthetic hormone drospirenone (DRSP). Drospirenone has been linked to a variety of serious, even fatal side-effects, including deep vein thrombosis, pulmonary embolism, stroke and heart attack.

“We get calls from people wanting to start class actions every week,” says Matthew Baer, the pharmaceutical and product liability lawyer leading the class action suit at London, Ontario’s Siskinds LLP.

“Ninety-five percent of the time, nothing ever comes of it.” But Baer and his colleagues began hearing about a similar legal approach in the U.S., where the same contraceptive pills are sold and where there are 10 times as many consumers. “Once we had eight or nine people contact us on their own initiative, all with the same problem, without us having done any advertising, we knew there were a lot of people in Canada,” Baer explains. More than 1,700 women in Canada have now contacted the firm. By March 2010, Siskinds filed a class action on behalf of clients, and on April 15, 2013, the Ontario Superior Court certified this case as a class proceeding.

Both Yaz and Yasmin contain DRSP, which was touted as something of a miracle drug when Yasmin first hit the Canadian market in 2004. But it wasn’t until so-called sister pill Yaz, which contained a slightly higher dose of the hormone estradiol, was released in Canada in 2008 (2006 in the U.S.) that a major marketing push thrust both Yaz and Yasmin into the spotlight.

Alluring television spots for Yasmin pointed to a promising list of benefits. In addition to preventing unwanted pregnancy, the drug was said to handily combat moodiness, fatigue, bloating, irritability, increased appetite, muscle aches, headaches and anxiousness. TV viewers saw happy couples dancing in the rain and were encouraged to “Ask about Yasmin and the difference a little chemistry can make.” And women did. Advertisements broadcast on U.S. airwaves are seen in Canada, even though it is illegal for

Canadian pharmaceutical companies to target consumers with brand product advertising. Still, sales doubled within a year. Some women who took Yasmin reported that it helped them shed a few pounds and even gain a bra cup size. By 2008, Yaz was one of the most popular contraceptives in Canada and the best-selling birth control pill in the U.S.

And then, almost as quickly as Yaz and Yasmin spiked in popularity, the complaints began. Yaz and Yasmin had been touted to treat acne, yet the drugs weren’t proven to do that. Bayer was forced to spend $20 million to air new ads clarifying the pill’s proven benefits. In an effort to do additional damage control, the company launched to provide advice about its oral contraceptives.

There were other problematic reports that Yaz and Yasmin were sometimes prescribed to treat premenstrual dysphoric disorder, a severe form of PMS whose existence remains highly contested by many physicians and psychiatrists. Health Canada mandates that doctors cannot prescribe drugs based strictly on untested benefits.

But the biggest problem came when side-effects like blood clots, heart attacks and strokes, including two dozen fatalities, were reported. In Canada, 23 deaths have reportedly been linked to women who took Yaz and Yasmin. The youngest person was 14 years old, and more than half of the fatalities were women under

26. Most of the deaths occurred within the first few months of taking the pill and involved blood clots. The U.S. Food and Drug Administration cautioned in 2011 that drospirenone increases the risk of blood clots by 74 percent compared with pills that have been on the market longer. Health Canada issued a similar warning.

Severe gallbladder inflammation is another reported side-effect, as well as a risk of deep vein thrombosis and pulmonary embolisms—blockages that result from blood clots in the central veins and arteries. As in most class actions, the lawyers believe the plaintiffs who have come forward may represent only a small percentage of those who have been adversely affected.

The consumer advocacy organization Public Citizen put Yaz and Yasmin on its “Do Not Use” list. The organization says the pills are no more effective than other oral contraceptives. Public Citizen also placed other pills containing drospirenone, including Gianvi and Zarah, on its advisory list. Oral contraceptive pills of a similar chemical makeup are sold under the names Beyaz, Safyral, Syeda, Loryna and Angeliq.

Online forums with names like Yaz and Yasmin contain thousands of posts about side-effects and open threads offering non-hormonal contraceptive suggestions; Facebook pages and group blogs offer the same. As of July 2013, in the United States, Bayer has paid out more than $1.4 billion in damages to more than 6,700 plaintiffs, although the company has admitted no wrongdoing.

Dr. Barbara Mintzes is an assistant professor in the department of anesthesiology, pharmacology and therapeutics at the University of British Columbia and a Michael Smith Foundation for Health Research scholar.

She researches how pharmaceuticals enter the marketplace and monitors testing of drug-safety protocols. When comparing how women fare on a newer, less-researched pill like Yasmin, Mintzes emphasizes risk reduction.

“For someone age 38 or 40 who is going to take a pill—even if she’s taken one before and she’s just switching— she definitely should not switch to Yaz or Yasmin, or one of the higher-risk products because the baseline risk is a lot higher and the relative risk increases pretty similar at different age levels.”

No matter what their age, women who have sex with men must weigh the potential side-effects of contraceptives against their desire for safe, effective birth control. For decades, it’s been the case that some women experience severe migraine headaches while taking the pill.

Others experience elevated blood pressure as a result of pills that contain the hormones estrogen and progestin.

In November 2013, it was reported that women who have taken the pill for three or more years have twice the risk for developing glaucoma. According to some studies, long-term use of the pill has been associated with a slightly elevated risk of breast cancer. However, the risk level goes back to normal 10 years after discontinuing oral contraceptive use.

Among women’s health advocates, there’s an obvious concern about debating the pill. For better or worse, millions of women rely on it as their primary and most effective form of birth control. Women with endometriosis also take contraceptive pills on a continuous-use cycle in an effort to reduce pain and heavy bleeding. If you’re actively trying to prevent pregnancy, finding a pill that doesn’t elicit unpleasant side-effects can be the most foolproof way to manage your fertility.

One problem with criticizing hormonal contraceptives is that it can seem like a political move out of a right-wing playbook. Feminist writer Holly Grigg-Spall’s new book, Sweetening the Pill, chronicles her problems with various pills, including Yasmin, and troubling side-effects, including debilitating mood swings, panic attacks and severe paranoia. Grigg-Spall says that after her book came out, she found herself accused of aiding the spread of religious and anti-choice propaganda. Regardless of women’s political orientation, Grigg-Spall says, “we should consider whether Yaz and Yasmin should be on the market more widely.”

Dr. Diana Zuckerman, president of the National Research Center for Women and Families in Washington, D.C., questions why new birth control pills are approved when many older pills have proven track records. “We believe the FDA should look at why there are 80 different pills available,” she says. “More importantly, they should be compared to each other.”

Mintzes says keeping higher-risk pills on the market may make sense from a business perspective, but it doesn’t make sense from a public health standpoint.

Zuckerman agrees. “Yaz and Yasmin cost more,” she says. “It’s really hard to understand why a doctor would prescribe it, why a patient would take it, and why [regulators] would allow these drugs to remain on the market.”

Some health officials have said drospirenone should be pulled from the market. In the U.S., at the request of plaintiffs’ lawyers, former FDA commissioner David Kessler wrote a 196-page report to back up his assertion that Bayer misled the FDA in regard to the risks associated with Yasmin. In 2012, representatives from a four-organization women’s health coalition wrote an urgent plea to the Food and Drug Administration.

Leaders from the Our Bodies Ourselves health collective, the National Research Center for Women and Families, the National Women’s Health Network and the Jacobs Institute for Women’s Health lobbied for the FDA to reconsider the risk-benefit profiles of drospirenone contraceptives. So far, very little has changed. One additional safety note was added to the 40-odd-page warning label. Neither the FDA nor Health Canada has plans to pull the pills from the market.

Ultimately, it appears the fate of drospirenone will be settled in the courts, a process that could take years. Canadian lawyer Matthew Baer estimates that even if Bayer were to settle out of court, it would likely take two years or more for payouts to reach plaintiffs.

In the meantime, Mintzes encourages doctors to prescribe lower-risk oral contraceptives. “Women should be taking the safest available pill because they all prevent pregnancy similarly.”

Until the legal cases are resolved, however, it remains up to individual women to weigh the evidence.

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