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Bayer 183 articles

Woman sues Xarelto makers after suffering ‘terrifying blood loss’

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Jessica Brown, 37, was taking the blood thinner Xarelto to help prevent strokes caused by her irregular heart rhythm abnormality known as atrial fibrillation, when she said she began suffering terrifying blood loss during her menstrual cycle. She became so weak that she couldn’t walk. She was rushed to the emergency department where she was promptly treated with a two-pint blood transfusion. “I could have bled to death,” Brown says. “Thank God it was just my period and it wasn’t a head injury or something.” Xarelto is a newer blood thinner that hit the market in 2011 as a more ... Read More

Duke researchers face allegations of withholding safety data from Xarelto study

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Researchers at Duke University are being accused of withholding clinical data that was later used by drug regulators to deem the blood thinner Xarelto safe for use in the United States. The accusations stem from a lawsuit filed by patients against the makers of Xarelto claiming they were injured by the drug, known chemically as rivaroxaban. The blood thinner was originally tested against the long-used warfarin for the prevention of strokes in patients with atrial fibrillation at the Duke Clinical Research Institute (DCRI) in 2011 during a clinical trial known as ROCKET AF. The trial, which was published in the ... Read More

Makers of blood thinner Savaysa to test reversal agent

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Portola Pharmaceuticals has entered into an agreement with Japanese drug maker Daiichi Sankyo to develop andexanet alfa as an antidote for its blood thinner Savaysa The drug is currently under review with the U.S. Food and Drug Administration (FDA) as a reversal agent for a similar anticoagulant Xarelto, and is being studied as an antidote for Savaysa in the U.S. Savaysa, known chemically as edoxaban, is the fourth blood thinner in a new class of anticoagulants known as Factor Xa inhibitors. The medication, which also includes the brand name drugs Pradaxa and Xarelto, is designed to be a more convenient alternative to the ... Read More

Xarelto bleeding risk lawsuits climb to more than 3,400

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Product liability lawsuits against the makers of the blood thinner Xarelto were among the fastest growing litigations in the United States for the period of February 16 to March 15, according to a Reuters analysis of statistics from the U.S. Judicial Panel on Multidistrict Litigation. Xarelto, known chemically as rivaroxaban, was approved by the Food and Drug Administration (FDA) in 2011. It is manufactured by Bayer and Johnson & Johnson’s Janssen Pharmaceuticals. Xarelto is indicated for the prevention of strokes in patients with atrial fibrillation, for the prevention and treatment of deep vein thrombosis and pulmonary embolism, and for the ... Read More

FDA requires Bayer to study health risks with Essure birth control device

Essure

The Food and Drug Administration (FDA) is requiring Bayer to conduct a new clinical trial to gather more information about adverse events with its permanent birth control device Essure to determine what health risk the device poses “in a real-world environment.” Essure was approved by the FDA in 2002 and remains the only non-surgical permanent birth control method on the market. The device consists of two nickel alloy coils that are inserted into each of the fallopian tubes where they work with the body create a natural barrier that prevents the sperm from fertilizing the egg. Since the device was ... Read More

Mirena IUD problems more likely in postpartum women

mirena IUD

Mirena IUDs implanted into postpartum women are more prone to migrate and perforate the uterus, according to a study published in Monthly Prescribing Reference (MPR). The study focused on the case of a 28-year-old woman, Ms. R, who four weeks after having a baby requested the long-acting contraceptive intrauterine device Mirena “because she has heard ‘good things’ about it,” according to MPR. The woman had recently decided to abandon the idea of breast feeding and started taking the antidepressant Zoloft to ease symptoms of postpartum depression. The World Health Organization recommends IUD insertion no sooner than four weeks postpartum. However, ... Read More

Bayer faces thousands of lawsuits over its contraceptives

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Pharmaceutical company Bayer has made millions providing women with birth control options. But those profits have come at a price to consumers. Bayer faces thousands of lawsuits from women who claim they have been injured by its contraceptives. Yaz and Yasmin – These popular birth control pills contain the hormones ethinyl estradiol and drospirenone. Yaz was first approved as a contraceptive in 2006 and, later, as a treatment for premenstrual dysphoric disorder (PMDD) and acne. Not long after the drug hit the market, Yaz was linked to reports of blood clots, often leading to serious injuries including pulmonary embolism (blood clot ... Read More

Women sue Bayer over alleged Essure birth control injuries

Essure

Three women have filed a lawsuit against Bayer claiming the company continued to market its permanent birth control device Essure despite racking up more than 16,000 customer complaints. Essure was approved by the Food and Drug Administration (FDA) in 2002 and remains the only non-surgical permanent birth control method on the market. It consists of two nickel alloy coils that are implanted in each of the fallopian tubes where, in time, they build up scar tissue that prevents pregnancy by creating a barrier between the sperm and the egg. Christina Barreros, Maria Johnson and Jaqueline Davis claim that they were ... Read More

Bayer faces mountain of Essure lawsuits

Essure

Bayer faces more than 30 lawsuits from women who claim the company’s permanent birth control device Essure caused them severe health problems, and the number is expected to climb as awareness about Essure complications increases. The lawsuits claim that Bayer failed to warn that the contraceptive implant could cause injuries including abdominal cramping, migraines, and abnormal menstrual bleeding. The device has also been linked to allergic reactions, autoimmune problems and infections. In some cases, the device has migrated from its intended position in the fallopian tubes and punctured organs. Essure was approved in 2002 and remains the only FDA-approved non-surgical ... Read More

PA judge allows Essure lawsuit to proceed

Essure

A federal judge in Philadelphia is allowing a lawsuit filed by five women suing Bayer over injuries caused by the company’s permanent birth control device Essure to proceed. U.S. District Judge John Padova rejected some of the women’s claims but ruled that two were reasonable to stand trial – negligent misrepresentation and negligent failure to warn of the risks. The women claim that the controversial contraceptive device migrated from its intended position in the fallopian tubes and punctured organs. Bayer had asked that the case be dismissed claiming the device was protected under a pre-market approval provision. Essure was approved ... Read More