The recent recall of Yaz Plus, a hormonal contraceptive pill, in South Africa, threw the spotlight on the safety of birth control pills, with several lawsuits and controversies concerning Yaz and its counterparts (including Yaz, Yasmin, Ocella, Zarah, etc.) reported over the years in the United States.
Bayer, the pharmaceutical company that manufactures Yaz Plus, has paid more than $850 million so far to settle claims involving side effects. Moreover, the recent recall raises questions on pharmaceutical accountability, legal redress, and the benefit-risk trade-offs in contraceptive care.
Unpacking the Yaz Plus recall
The recent recall of Yaz Plus in South Africa has implications for women globally. The South African Health Products Regulatory Authority (SAHPRA) revealed that certain packs in batch WEW96J contained “24 light orange hormone-free tablets and four pink film-coated hormone tablets,” reversing the intended arrangement. SAHPRA CEO Dr. Boitumelo Semete-Makokotlela described the recall as “necessary to protect the public from the affected batch’s potential ineffectiveness.”
While Bayer and SAHPRA have tried to rectify this problem, the recall also shows that pharmaceutical manufacturing mistakes can have serious consequences.
Legal battles in the US
Yaz, launched in the US in 2006, was initially marketed as more than just birth control. It claimed added benefits in treating moderate acne and premenstrual dysphoric disorder. However, thousands of lawsuits since then have alleged that Bayer failed to adequately warn consumers of severe side effects, including blood clots, strokes, and pulmonary embolisms.
According to Christie Nicholson at Findlaw, “Reports have suggested that women taking Yaz are two to three times more likely to develop blood clots,” a claim central to many legal cases against Bayer. Plaintiffs in these cases argue that drospirenone, the active ingredient in Yaz, significantly increases these risks.
To date, Bayer has settled thousands of lawsuits in the US, agreeing to pay over $850 million to women who experienced severe health complications, including deep vein thrombosis and pulmonary embolism.
Nicholson also says that experts estimate Bayer could face an additional $2.6 billion in settlements as unresolved cases surface. Despite these payments, Bayer has not admitted liability, often requiring plaintiffs to sign agreements absolving the company of legal responsibility for their injuries.
FDA's role and ongoing concerns
Since the medication's approval, the US Food and Drug Administration (FDA) has issued numerous warnings about Yaz. In 2008, the agency criticized Bayer over the company's television advertisements, saying they minimized the pill's risks while exaggerating its benefits. In 2012, the FDA forced Bayer to change the labeling on Yaz to include a clearer warning that drospirenone increases the risk of blood clots.
Other FDA actions have included contraindications for patients with pre-existing conditions of high blood pressure, a history of blood clots, and heart disease. While these actions show the agency's concern about the pill's safety, they beg the question: Why has the FDA stopped short of issuing a full recall of Yaz here in the US, even as evidence of its risks mounts?
My personal reflection
Having taken Yaz Plus for six years, the news of this recall strikes close to home. While I never experienced severe side effects, I remember times when I felt unexplained fatigue and headaches. I later learned these could be linked to hormonal contraceptives. I now wonder how many women have unknowingly experienced serious health risks, possibly attributing them to life’s stresses rather than their medication?
Informing patients of Yaz’s potential side effects
Healthcare providers can use HIPAA compliant emails to notify patients about hormonal birth control recalls and inform them about the associated risks.
Moreover, HIPAA compliant email platforms, like Paubox, use advanced security measures, making them secure and limiting access to authorized recipients only. So, providers can personalize these emails, urging specific patients taking Yaz Plus to schedule a consultation or give them more information on identifying possible side effects.
Related: Using email to inform patients about Depo-Provera risks
FAQs
What makes HIPAA compliant emails secure?
Yes, HIPAA compliant emails are secure because they use encryption and other security measures to protect patients' protected health information (PHI) from unauthorized access or disclosure.
Additionally, using platforms like Paubox enhances email security throughout the email transmission process and at rest, safeguarding patient data from potential threats or breaches.
What types of information can providers send via HIPAA compliant emails?
Providers can use HIPAA compliant emails to send sensitive health information, like patient education materials, appointment reminders, treatment plans, and other medical communications.
Does HIPAA apply to minors' reproductive health information?
Yes, however, state laws may allow minors to access reproductive services like contraception or abortion without parental consent. In such cases, HIPAA protects the minor's health information, preventing providers from disclosing it to parents without the minor's consent, unless required by law.
