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Bayer 190 articles

Xarelto bleeding risk lawsuits climb to more than 3,400

xarelto

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

mirena IUD

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

Blood thinner Brilinta performs poorly in stroke study

xarelto

AstraZeneca’s blood thinner Brilinta posted dismal results in a large clinical study pitting the heart drug against aspirin in preventing recurrent heart attacks in the 90 days following a stroke. The benefit was so slight that researchers didn’t think it statistically significant, crushing the drug company’s hopes of racking up annual sales of $3.5 billion by 2023. AstraZeneca is also testing the drug in patients with peripheral artery disease, and hopes to have that data later this year. Brilinta is known as an anti-platelet, which prevents blood clots by preventing platelets in the blood from sticking together. It is used ... Read More

Antidote could boost sales of Xarelto, Eliquis

xarelto

Drugs in a new class of anticoagulants could enjoy a hefty boost in sales if the Food and Drug Administration (FDA) approves an antidote that reverses the blood thinning qualities of the drugs, analysts say. The new class of blood thinners is known as Factor Xa inhibitors, and include Boehringer Ingelheim’s Pradaxa, Johnson & Johnson’s Janssen Pharmaceuticals and Bayer’s Xarelto, and Pfizer’s Eliquis. The drugs are designed to be a more convenient alternative to the long-used warfarin, which interacts poorly with several drugs and foods, requiring patients to be monitored regularly while taking the drug. Factor Xa inhibitors offered similar efficacy ... Read More

Did Xarelto makers withhold critical data from medical journal editors?

xarelto

Questions are being raised whether Johnson & Johnson subsidiary Janssen Pharmaceuticals and Bayer, makers of the blood thinner Xarelto, may have left out critical laboratory data when a peer reviewer at the New England Journal of Medicine requested it in order to confirm the accuracy of the data. The red flag was raised after a reporter with The New York Times found a footnote in a federal legal briefing that suggested that the two drug companies may have mislead editors in order to protect their profits. Xarelto raked in nearly $2 billion in U.S. sales last year. It is the ... Read More