Although Yaz has not yet been the focus of a recall, consumer watchdogs are still concerned about the drugs safety, when compared to other birth control pills, and are calling for a stringent review of federal regulators, the drug and the drug maker.
Not only have the drug and its severe side effects come into question, Bayer’s connection with a U.S. Food and Drug Administration (FDA) advisory committee has also been a cause for concern.
Watchdog groups say they’ve found that advisory committee members are on Bayer’s payroll, making the committee’s decision to not recall Yaz suspect.
Studies Prompt Some to Call for a Yaz Recall
Studies Prompt Calls For Yaz Recall
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.
Synthetic Progesterone in Question
Introduced in 2006, Yaz quickly became a best-selling birth control pill on the market. 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 and help with premenstrual moodiness.
Like most other combination birth control pills, Yaz contains a synthetic estrogen and synthetic progesterone. While the synthetic estrogen in Yaz is similar to that used in other oral contraceptives, it’s the synthetic progesterone, drospirenone, which has been called into question.
Drospirenone, which is similar in chemical makeup to a popular diuretic, has been linked to an increase in blood clots, pulmonary embolisms, heart attacks, strokes, gallbladder disease and elevated potassium levels.
FDA Advisory Committee Refuses to Recall Yaz
Yaz Recall discussed by FDA Advisory Committee
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 panel voted 15 to 11 to keep the drug on the market and 21 to 5 to change the drug label.
However, the panel did not approve a Yaz warning label explaining users were more likely to develop blood clots. Within days, members of the nonprofit Project On Government Oversight (POGO) called the 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 at the meeting.
“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.
Former Yaz Users Still Waiting For FDA To Make Changes
Even with the conflicts of interest between Bayer and the FDA unearthed, thousands of Yaz victims are still awaiting changes. There still has not been a Yaz recall, and the drug still remains on the market with only a four-sentence label change noting an increased risk of blood clots for all birth control pill users, not just Yaz. The FDA has yet to take any concrete actions on the conflicts of interest.
Instead, injured patients have turned to the legal system for help with Yaz-related damages. As many as 11,300 patients have filed Yaz lawsuits against Bayer. Bayer has paid $750 million to settle thousands of those lawsuits, as of October 2012.