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Jack Sisson's Life Ethics Blog

We must find new ways through many ethical issues, especially regarding bioethics, medical ethics, and criminal justice. Jack Sisson's 'Life Ethics' blog focuses on numerous areas of concern, including the philosophical and ethical dilemmas surrounding stem-cell research, abortion, medical research, and health care.

 

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Every day we hear about dangerous drugs and medical devices. The U.S. Food and Drug Administration (FDA) routinely reports on investigations, warnings, injuries and recalls. Unfortunately much of the press surrounding these drugs and devices fails to highlight the fact that a growing number of these products are injuring one specific group, women.
Drugs like bisphosphonates, birth control medications as well as devices like transvaginal mesh and metal-on-metal hip implants are created for and/or marketed toward women. All of these products have had ongoing reports of dangerous risks and injuries to the very users they are supposed to be benefitting.
Why is this happening? Each drug and medical device has its own specific set of possible side effects and associated injuries, but there is a common thread underlying all of the products that safety advocates believe may be the reason for the concerning injuries suffered by women users. These products are not being adequately tested for the people they are supposed to be helping.
Although they are made for women, many of these medical products are not designed for women or tested on women before flooding the market. As a result, poorly designed products, many with known complications, are readily available for unsuspecting women.
Another issue is that although serious injuries have been reported by users, the FDA has been slow to act and require a change by manufacturers. In the meantime, product manufacturers have been able to reap financial benefits at the expense of women's health and safety.
Products Dangerous to Women
Of the growing number of unsafe drugs and medical devices hurting women, certain products have an increasing number of reported risks and injuries.
Birth Control - Yaz, Yasmin
Yaz and Yasmin are two popular birth control medications that contain drospirenone, a manmade hormone that imitates the effects of progesterone. The pills inhibit ovulation and thus prevent pregnancy. When the product was initially made available to the public, it was very popular due to marketing highlighting its ability to clear up acne and lessen other hormonal side effects. Bayer is responsible for the Yaz line of birth control and had slick marketing campaigns while downplaying any evidence that it had a higher percentage of side effects than many other birth control pills. In fact, Bayer has been repeatedly admonished by the FDA for misleading advertisements and, more recently, watered down warnings.
However, label warnings failed to caution women and prescribing doctors of the dangerous risks and potential side effects associated with using the drug. Drospirenone-containing birth control medications, such as Yaz, Yasmin, Ocella, Beyaz, Gianvi, Zarah, Loryna and Seyda have an increased risk of side effects such as:
- Deep Vein Thrombosis
- Stroke and heart attack
- Blood clots
- Pulmonary embolism
- Gallbladder and kidney disease
These complications can have long-term health effects and in some cases, even death may be the result.
Due to the number of complications that have been connected to using drospirenone-containing drugs, the FDA required manufacturers to include the increased risk of blood clots on warning labels and to run corrective advertisements for overstating the drugs' effectiveness in treating hormonal side effects and downplaying dangerous risks of side effects.
Numerous studies have also been conducted on the safety of birth control pills, like Yaz and Yasmin. In fact, the results of two studies published in the British Journal of Medicine revealed that women taking these types of birth control medications were 2-3 times more likely to develop blood clots than women taking other types of birth control drugs. Drug labels in Europe require this type of warning information and knowledge of the associated dangers is widespread among European doctors. However, in the U.S., birth control medications containing drospirenone continue to be sold and strongly marketed to women on television. Although studies on the dangers continue, safety advocates fear the FDA's response has been sluggish.


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