An oral acne treatment, Diane 35, manufactured by the German drugmaker Bayer AG, and declared responsible for four deaths in France, has been cleared for use by the French Health Authority. Sales had been suspended there for eight months due to an inordinately high Diane 35 blood clot risk, but the European Commission declared it safe for use as an acne treatment.
However, Diane 35 has been regularly prescribed by physicians as an oral contraceptive despite not having been approved for that use. This "off-label" use has resulted in tragic consequences around the world.
A lawsuit was filed in Canada in December 2013 by the parents of an 18-year-old girl who had been using Diane 35 as an acne treatment. Feeling ill, she visited her prescribing physician who found nothing abnormal in her blood work. Despite those findings, she died days later from four cardiac arrests, a pulmonary embolism, and brain hemorrhaging. The suit was filed against Shoppers Drug Mart, a major Canadian prescription service, for failing to warn their daughter about Diane 35's dangerous side effects. The girl became the thirteenth Canadian woman and the eighth under 21 whose deaths have been unofficially linked to Diane 35.
Diane 35 is not available for sale in the United States, but Bayer manufactures two oral contraceptives for the US market that are also under fire. Yasmin, approved by the FDA in 2001, has been prescribed to more than 3 million women worldwide, but the product has come under heavy scrutiny lately for its dangerous side effects, prompting numerous ongoing lawsuits. In Canada, 23 deaths have been attributed to Yaz and Yasmin. To read the entire article click here.