Bayer spent $270 million advertising birth-control pill Yaz as “the solution” for women desperate for relief from premenstrual syndrome (PMS), and acne, whether mild, moderate or severe. Federal authorities later Bayer to clarify that Yaz had only been approved to treat symptoms of premenstrual dysphoric disorder (PMDD) and moderate acne.
Yaz is an oral contraceptive (combination birth control pill) that received U.S. Food and Drug Administration (FDA) approval in 2006 for use by women to prevent pregnancy. Approximately one to two out of 100 women may get pregnant during their first year taking Yaz, making it no more effective than older and usually less expensive pills. But for some women, Yaz doesn’t cause bloating or weight gain, two side effects that can be common with most birth control pills, making it a desirable contraceptive choice.
Yaz is also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. PMDD is a condition characterized by more severe symptoms than those associated with premenstrual syndrome (PMS). While Yaz is approved for the treatment of PMDD symptoms, it has not been evaluated for the treatment of PMS, nor has the effectiveness of Yaz for PMDD been evaluated for use for more than three menstrual cycles.
In 2007, the FDA expanded Yaz uses to include treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have experienced at least one period (menstruation). But in 2008, the FDA stated that Yaz’ presumed success in treating acne was “misleadingly overstate(d),” according to ABC News. And state authorities accused its manufacturer, Bayer, of “deceptive advertising.”
With millions of women already opting to take Yaz, possibly founded on statements in prior advertisements, Bayer denied any wrongdoing but still issued corrective ads in 2009 as a part of an “unusual legal settlement” with the Department of Justice (DOJ), which required the pharmaceutical company to correct “misleading assertions” about the drug.
The new television ads, designed to clear up any misconceptions to consumers and reeducate patients on the actual benefits of taking Yaz, stated, “Yaz is for the treatment of premenstrual dysphoric disorder, or PMDD, and moderate acne, not for the treatment of PMS or mild acne.” The curative ads cost Bayer a total of $20 million, an amount agreed upon by the drug-making corporation and the DOJ.
In 2011, Bayer and Yaz faced controversy yet again, when multiple independent studies pointed to an increased risk of blood clots in patients taking the fourth-generation oral contraceptive compared to other leading birth control pills. In 2012, after the FDA completed its review of the observational studies, the federal agency concluded that drospirenone-containing birth control pills, such as Yaz, may in fact be associated with a higher risk (as high as a three-fold increase in risk) for blood clots than other progestin-containing pills.
Yaz’ two active ingredients, drospirenone and ethinyl estradiol, prevent ovulation (the release of an egg from the ovaries) and cause changes in a woman’s cervical and uterine lining, making it harder for sperm to get to the uterus and meet with an egg, and more difficult for a fertilized egg to attach to the uterine wall. Ovulation is key for pregnancy, and without it, pregnancy cannot occur.
Yaz is different from most birth control pills because it contains a new generation of synthetic progesterone called drospirenone, which is closely related to spironolactone, a diuretic. Drospirenone is one of several different progestins that are used in birth control pills. Drospirenone also has anti-androgenic properties, which means it works against testosterone and other hormones.
Most birth control pills combine a synthetic version of the female hormone progesterone (known as progestin) with a synthetic version of the female hormone estrogen. The progestin in Yaz is considered “fourth generation” because it’s the fourth reformulation of synthetic progesterone since the birth control pill was introduced in the 1960s. In addition to drospirenone, Yaz contains synthetic estrogen in the form of ethinyl estradiol.
Yaz is available in blister packs. It is the only combination oral contraceptive with 24 active pills that include hormones and four inactive pills. This gives the patient an increased dose of hormones during the month. Most birth control pills include seven inactive pills. Each of the 24 active pills is light pink and contains 3 mg drospirenone and 0.02 mg ethinyl estradiol as betadex clathrate. The four inactive tablets are white.
Yaz is indicated for use by women to prevent pregnancy. The FDA has also approved the birth control pill for the treatment of symptoms related to premenstrual dysphoric disorder (PMDD), in such women who choose to use an oral contraceptive as their method of contraception. Although the FDA advises that in making the diagnosis of PMDD, care should be taken to rule out other cyclical mood disorders before prescribing treatment with Yaz.
Yaz has not been evaluated for the treatment of premenstrual syndrome (PMS), despite previous marketing claims by its manufacturer Bayer. However, Yaz’ uses were extended in 2007 to include the treatment of moderate acne (or moderate acne vulgaris) in women at least 14 years of age who have had at least one period. According to the FDA, Yaz should be used for this purpose only if the patient also desires an oral contraceptive for birth control.
Every month, when a female begins ovulating, she experiences what is known as menstruation (a period), or the regular discharge of blood and shedding of mucosal tissue from the inner lining of the uterus through the vagina. Besides bleeding, a woman on her period may experience abdominal and pelvic pain and cramping, lower back pain, bloating, sore breasts, food cravings, acne, mood swings and irritability, headaches, or fatigue.
Premenstrual syndrome, or PMS, is a group of symptoms that start about one to two weeks before a woman’s period and can include emotional as well as physical symptoms. No one knows the exact cause of PMS, but hormonal changes can trigger the symptoms associated with it. Most women experience at least some symptoms of PMS, with the symptoms typically going away after their period starts.
But for some women, the symptoms can become so severe that they interfere with their lives. These women have a condition called premenstrual dysphoric disorder (PMDD). Johns Hopkins Medicine said that PMDD “may be an abnormal reaction to normal hormonal changes.” The hormone changes can cause a serotonin deficiency. Serotonin is a naturally occurring substance in the brain and intestines that can affect mood and cause physical symptoms.
Acne is a common skin disease that causes pimples, or zits, which are the result of clogged hair follicles (pores) under the skin. Most pimples form on the face, neck, back, chest and shoulders, and can appear as whiteheads, blackheads, or red, inflamed patches of skin. While acne is not a very serious condition, it can cause scars and unsightly blemishes that can be permanent, and acne that is deep in the skin can cause hard, painful cysts.
Acne can affect anyone, although it is most common in teenagers and young adults, but it tends to run in families. There are many mistruths about what causes acne, such as dirty skin and stress. Blackheads and pimples are not caused by dirt, and while stress can worsen acne, it is not the underlying cause of it.
Some also believe that chocolate and greasy foods may prompt pimples to appear. But research shows that chocolate, nuts and greasy foods rarely have an effect on acne in most people. Although diets high in refined sugars or dairy products may be related to acne in some people, according to the National Institutes of Health (NIH).
The medication’s label instructs Yaz users to take one tablet daily by mouth at the same time every day. Tablets must be taken in the order directed on the blister pack.
The drug’s failure rate may increase when users miss pills or take the pills incorrectly. Single missed pills should be taken as soon as remembered, according to the label. Severe vomiting or diarrhea may affect absorption, and additional contraceptive measures should be taken in cases of gastrointestinal disturbances. If vomiting occurs within three to four hours after taking Yaz, this should be considered a missed dose, according to the instructions.
Instructions on how to start taking Yaz vary depending on when you plan to start the pack and whether you are switching from a different form of birth control. Women taking Yaz for the first time should take their first light pink pill on the first day of their period (Day1) or on the first Sunday after the onset of their period. Yaz should not be considered effective as a contraceptive until after you a have taken it for seven consecutive days.
Patients with preexisting kidney, liver or adrenal disease should not take Yaz because this could cause serious heart and health problems. Serum potassium levels should be checked in women starting Yaz because of the possibility of high potassium levels, called hyperkalemia. Because drospirenone is chemically similar to spironolactone, Yaz should not be used in patients with preexisting kidney problems.
The drug is also contraindicated in women who have undiagnosed abnormal uterine bleeding. Do not take Yaz if you have or had breast cancer or other estrogen- or progestin-sensitive cancer, or if you are pregnant. The use of contraceptive steroids may also influence the results of certain laboratory tests, such as coagulation factors, lipids, glucose tolerance and binding proteins.
Ingesting certain medications, whether prescription or over-the-counter (OTC), as well as other vitamins, supplements or other substances in combination with Yaz, can alter the effects of the pills or cause unknown side effects.
The most common side effects of Yaz are spotting or bleeding between menstrual periods, nausea, breast tenderness and headache. These side effects are usually mild and tend to disappear with time.
*Fatigue, irritability, decreased sex drive (libido), weight gain and unstable, rapid shifts in outward emotions were each reported by less than 5 percent of women in the clinical trials.
Yaz’ drug label also warns of serious complications, including heart attack, stroke, deep vein thrombosis (blood clots in the legs), pulmonary embolism (blockages in the lungs), gallbladder disease, high blood pressure, elevated potassium levels, and liver tumors or disease.
In December 2008, an FDA panel voted in favor of strengthening warnings on Yaz birth control pill labels. The FDA’s most serious label, the black-box warning, appears on all Yaz packaging. It cautions women over 35 years old who smoke not to use Yaz. Smoking increases the risk of serious cardiovascular events, which can be life-threatening. This risk increases with age and number of cigarettes smoked.
In 2009, the FDA sent a warning letter to Bayer, the maker of Yaz, regarding the quality of ingredients found during a routine inspection of the manufacturing plant in Germany. The problems at the plant included dirty equipment and failure to adequately test the final products. At least eight batches of the low-quality birth control pills were sent to the U.S.
Then, following a safety review, the FDA in 2012 updated Yaz labels to include information about studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills, including Yaz. The revised drug labels state that some studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing other progestins; other studies found no additional risk of blood clots with these products.
Yaz hit the market in 2006. By 2008, it was the best-selling birth control pill in the U.S., and its sales totaled $781 million in 2009.
Women worldwide were enticed by the splashy advertising that portrayed Yaz as a new generation of birth control that could not only prevent pregnancy but also help women lose weight, cure acne at any level of severity and help with premenstrual moodiness. Some of the commercials used balloons; others depicted euphoric women singing, “We’re Not Gonna Take It,” as they kicked and punched words such as “irritability,” “moodiness” and “bloating.”
The drug was touted as not just a contraceptive but also a cure-all for premenstrual dysphoric disorder, bloating and acne at any level of severity. In addition to preventing pregnancy, Yaz was also marketed by Bayer as a treatment for PMS, an off-label, or unapproved use.
By 2009, the FDA reined in the advertising and forced Bayer to spend $20 million on new ads to correct the off-label Yaz marketing and exaggerated claims.
According to the FDA, prescription drug promotion cannot be false or misleading. It must have a fair balance, be consistent with approved product labeling or the packaging insert, and must only include claims substantiated by adequate and well-controlled clinical studies.
According to the FDA, the Yaz commercials wrongly suggested that the drug was approved to treat PMS and acne at any level of severity when in actuality, the drug is only approved to treat PMDD and moderate acne. The FDA also complained that Bayer overstated the effectiveness of the contraceptive to treat both conditions.
The agency told Bayer that it had minimized the drug’s risks. The commercials’ audio and visual effects distracted viewers from the most important part of the commercial. Quick-changing scenes combined with background music took attention away from the part that disclosed the drug’s risks, according to the FDA.
Bayer denied wrongdoing but agreed to pull the commercials. The company also ran a series of corrective TV ads at the request of the FDA and changed its commercials. Still, problems with how Bayer disclosed information about Yaz continued. Three years after the FDA’s warning about the commercials, an FDA document acknowledged that studies raised questions about the safety of Yaz and its related contraceptives. Scientists have recommended more testing and better labeling to warn about possible risks. Some critics have even recommended recalling the drug altogether.
About 32,856 boxes of Yaz (at three packs per box) that had been distributed nationwide were recalled in 2009. The issue cited was with the specifications for the dosage of drospirenone in the pill. Bayer had taken an analytical value that was “out of specification” and averaged it together with another analytical value to get the number needed to be “within specification.”
The FDA published the recall on November 25, 2009, in the “Enforcement Report” section of its website as opposed to the “Recalls, Market Withdrawls, & Safety Alerts” section. The agency had inspected Bayer on this same issue in March 2009 and warned the company about its averaging practice in August 2009.
Aside from this limited recall, Yaz has remained on the market.
Within months of Yaz hitting the market, stories about Yaz-induced medical problems started cropping up. Even though industry-funded studies found no links between Yaz and the assortment of medical problems early on, independent researchers started delving in.
Soon, the FDA’s own study found a 74 percent increased risk of blood clots among those taking drospirenone containing pills, prompting some to call for a Yaz recall. Bayer shot back, contending that there were no risks with this drug above the already documented risks with birth control pills overall and therefore no reason to recall the drug.
Instead of making a final decision about whether or not to recall Yaz, the FDA asked an advisory committee to look into the pill. The FDA often uses independent advisory committees, made up of medical specialists in particular fields, to come up with recommendations. The committee did not recommend that Yaz be recalled.
Members of the nonprofit Project on Government Oversight (POGO) have called the advisory committee’s actions into question. The group pointed out that four committee members, including the committee chair, had financial ties to Bayer. None of the committee members had disclosed any conflicts of interest when making decisions about Yaz.
“Because of the industry ties of these members, the joint committee’s conclusion—which amounted to an endorsement of the safety of these oral contraceptives—should be disregarded,” POGO executive director Danielle Brian wrote to FDA Commissioner Margaret Hamburg.
Consumer watchdogs continue to express concerns about the drug’s safety when compared to other birth control pills and are calling for a stringent review of federal regulators, the drug and the drug maker. Thousands of women who say they were harmed by Yaz have turned to the legal system for help with Yaz-related damages. More than 11,000 patients have filed Yaz lawsuits against Bayer. Bayer has paid at least $750 million to settle thousands of those lawsuits.
Since the occurrences of adverse events in patients taking various medications often go unreported to the FDA, many experts say it is impossible to know precisely how many women have died as a direct result of taking Yaz.
While hormonal contraceptives have been shown to provide some women with measurable benefits, one expert in the field says we don’t know enough about the benefits afforded to women if they choose not to take them, and thereby we are lacking the ability to conclude a true benefit versus risk comparison.
Cynthia Pearson of the National Women’s Health Network weighed in as a part of a blog post for menstruation research, voicing her concerns that not enough is being done by the federal agency to protect the female population from the dangers of contraception containing hormones.
“When I heard that the FDA was asking for a comparison between pregnancy risks and risks of Yaz and Yasmin, and that the women’s health groups were calling for, in their letter to the FDA, a comparison between these oral contraceptives and other brands not containing drospirenone, I immediately wanted to know why the comparison was not between using these pills and not using them – as in using other forms of non-hormonal contraception with similar effectiveness.”
Pearson believes this would provide women and their doctors prescribing these medicines with the “biggest gap,” putting the statistics in “starker relief.” Pearson says there is “too much dependent on the FDA not acknowledging the efficacy of non-hormonal contraceptives.” She also pointed out that the FDA fails to admit that “research funded by the pharmaceutical company producing the drug is not reliable.”
In Pearson’s mind, the FDA’s behavior “should raise some serious suspicions of their motivating force.”
Pearson also pointed out that the federal agency advising women to consult with their doctors is not wise, as many doctors lack specific knowledge of the drugs they are prescribing, due to time constraints, inclination, and the potential for direct or indirect benefits being derived from the backing the drugmakers themselves.
In conclusion, Pearson wondered “if it’s taken this long to get a tentative admission of the blood clot risk [associated with Yaz], what do we not know about the other side effects of these pills?”
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