Yaz and its history of recalls and safety concerns
Yaz, a popular birth control pill, has a documented history of product recalls and safety warnings. These actions, initiated by both the manufacturer Bayer and regulatory agencies, stem from two primary issues: manufacturing errors and concerns over the primary active ingredient, drospirenone. While not subject to a permanent, widespread recall in the US due to the blood clot risk, the drug has been the focus of thousands of lawsuits and significant regulatory pressure for more than a decade.
The 2024 Yaz Plus recall in South Africa
In November 2024, Bayer initiated a Class II recall in South Africa for a specific batch of its contraceptive pill, Yaz Plus. The recall was prompted by a packaging error in a limited number of blister packs within batch WEW96J. The correct packaging consists of 24 pink hormone-containing tablets followed by four light orange hormone-free pills. However, the faulty packs contained the incorrect number and order of pills—24 inactive tablets and only four active ones.
This mix-up had critical implications for contraceptive efficacy. Women relying on these packs could have inadvertently taken a full month's worth of inactive pills, believing they were protected from pregnancy. Manufacturer Bayer and the South African Health Products Regulatory Authority (SAHPRA) acted quickly to inform healthcare professionals and the public, advising those with affected batches to stop use and seek a replacement.
The unpublicized 2009 U.S. recall
Long before the 2024 incident, Yaz faced a significant, but largely unnoticed, recall in the United States in 2009. The U.S. Food and Drug Administration (FDA) reported that thousands of boxes of Yaz and its generic counterpart, Ocella, were recalled because they were manufactured out of specification. This meant that the levels of drospirenone, the active ingredient, did not meet quality control standards. This recall was notable for its lack of public announcement, with the FDA's notice buried deep within its enforcement reports rather than in a high-profile consumer alert.
The drospirenone connection and blood clot risk
The most persistent and serious controversy surrounding Yaz and its related products, Yasmin and Ocella, centers on its use of the synthetic progestin drospirenone. Since its approval, multiple studies and regulatory reviews have shown that drospirenone-containing birth control may carry a higher risk of blood clots compared to older, levonorgestrel-based pills.
- Higher risk: Several studies suggest drospirenone users face a 1.5 to 3 times greater risk of developing venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), than users of other oral contraceptives.
- Serious complications: These clots can lead to life-threatening events, such as heart attack, stroke, or PE, which can be fatal.
- Extensive lawsuits: The increased risk has led to thousands of lawsuits against Bayer. By 2019, Bayer had reportedly settled over 19,000 cases related to blood clots, heart attacks, and strokes, with settlements exceeding $2 billion.
- FDA warnings and labeling changes: In 2012, the FDA required stricter labeling on drospirenone products to clearly communicate the higher blood clot risk, a major step following years of reports and advocacy.
Comparison of Yaz recall drivers
| Reason for Concern | Primary Issue | Regulatory Action | Outcome | Impact on User |
|---|---|---|---|---|
| 2024 Yaz Plus Packaging Error | Manufacturing quality control failure. Inactive and active pills were mixed up in a specific batch. | Class II recall by Bayer in consultation with SAHPRA. Public warnings issued. | Affected batch removed from shelves. Corrective measures implemented by Bayer. | Ineffective contraception, potential for unwanted pregnancy. |
| 2009 U.S. Generic Yaz Potency | Manufacturing inconsistency. Batches were out of specification for drospirenone levels. | FDA-overseen recall, but not widely publicized to consumers. | Affected batches removed. Public awareness was low. | Ineffective contraception, reduced protection from pregnancy. |
| Drospirenone Blood Clot Risk | Pharmacological effect of the active ingredient, drospirenone. | FDA-mandated labeling changes, multiple safety warnings. | Product remains on the market with updated warnings. Lawsuits and settlements pursued by affected individuals. | Heightened risk of serious, potentially fatal blood clots compared to other contraceptive options. |
Why hasn't Yaz been fully recalled in the U.S. due to blood clots?
Despite the thousands of lawsuits and the clear evidence of a higher blood clot risk, the FDA has not mandated a full recall of Yaz over safety concerns. The agency's position, based on a 2012 review, was that while the risk of blood clots is higher with drospirenone, the overall risk is still small for most women. Instead of removal, the FDA opted to strengthen label warnings to ensure both doctors and patients are fully aware of the potential risks, enabling them to make informed decisions. Critics, however, pointed out potential conflicts of interest among FDA advisory committee members and argued for a more comprehensive recall, but the drug remains on the market.
Conclusion
The recalls involving Yaz have been driven by a combination of specific, limited manufacturing defects and broader, more serious pharmacological risks. While a recent packaging error in South Africa highlights quality control issues, the deeper and more long-standing controversy stems from the increased blood clot risk associated with the drug's active ingredient, drospirenone. These concerns have led to extensive litigation against Bayer and resulted in billions of dollars in settlements, despite the drug remaining available on the market with clearer warnings. The history of Yaz serves as a reminder of the importance of pharmaceutical quality control and the ongoing debate surrounding risk versus benefit in drug regulation.
For more information on the history of Yaz litigation and settlements, you can visit Drugwatch.com.
