Bayer

IUD Side-effect Complaints Rise with Increased Use

Devices such as Bayer’s Mirena are increasing in popularity, and more patients are complaining of adverse affects.

The latest study by the CDC’s National Center for Health Statistics shows that women are using IUD devices like Bayer’s Mirena more than seven times as much as they were a decade ago, according to a WebMD report on October 18, 2012.

However, the news comes as the FDA has received more than 45,000 adverse reports of complications among women using Mirena. The Adverse Events report on November 20, 2012 tracks the FDA’s AERS reports through June 30, 2012.

No votes yet

Nordic Acquires Rights to Trasylol from Bayer

The companies have reached an agreement on rights to market the aprotinin injection.

Nordic Group announced today that it has reached an agreement with Bayer HealthCare in which Nordic will acquire Trasylol (aprotinin injection) worldwide excluding the United States. Under this agreement, Nordic will become the Marketing Authorization Holder for aprotinin in the relevant Territories. This follows the opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) from February 2012, recommending that the marketing authorisation for aprotinin should be reinstated in the European Union.

No votes yet

Lawsuit Alleges Yaz Causes Blood Clots, Other Severe Adverse Effects

A Massachusetts woman has filed a lawsuit claiming the Bayer oral contraceptive caused clots leading to a pulmonary embolism.

According to court documents, on May 15th 2012, a Massachusetts woman, Janel Mahon, filed a lawsuit in Illinois Southern District Court (case no. 3:2012cv10881) alleging she suffered blood clots leading to a pulmonary embolism from Yaz. Yasmin, which was approved by the FDA in 2001, and its sister drug Yaz, which was approved in 2006, are oral contraceptives that combine estrogen and a fourth generation progestin, drospirenone, to prevent pregnancy. Yaz and Yasmin are manufactured by Bayer Healthcare Pharmaceuticals.

No votes yet

Bayer Challenges Generic License for Cancer Drug

The drugmaker has filed an objection to a patent allowing a competitor to sell a generic version of its Nexavar cancer treatment.

Drugmaker Bayer has filed an appeal against an Indian Patents Office's order, which allowed domestic drugmaker Natco Pharma to sell a generic version of the German firm's cancer drug 'Nexavar' in India, with the Intellectual Property Appellate Board. In March this year, the government had invoked a law permitting Hyderabad-based Natco Pharma to manufacture and sell cancer-treatment drug Nexavar at a price over 30 times lower than charged by its patent-holder Bayer Corporation.

No votes yet

Bayer Updates Labels on Combination Oral Contraceptives

The labels of combination oral contraceptives with drospirenone indicate the drugs may bear a higher risk of venous thromboembolism.

Wayne, NJ,- In agreement with the U.S. Food and Drug Administration (FDA), Bayer HealthCare Pharmaceuticals Inc. today announced that it has updated the labels for its drospirenonecontaining combination oral contraceptives (COCs) in the United States.

No votes yet

Bayer Updates Labels on Combination Oral Contraceptives

The labels of combination oral contraceptives with drospirenone indicate the drugs may bear a higher risk of venous thromboembolism.

Wayne, NJ,- In agreement with the U.S. Food and Drug Administration (FDA), Bayer HealthCare Pharmaceuticals Inc. today announced that it has updated the labels for its drospirenonecontaining combination oral contraceptives (COCs) in the United States.

No votes yet

FDA Drug Safety Communication: Safety Review Update on the Possible Increased Risk of Blood Clots with Birth Control Pills Containing drospirenone

The U.S. Food and Drug Administration (FDA) is informing the public that it has not yet reached a conclusion, but remains concerned, about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills. FDA has completed its review of the two 2011 studies that evaluated the risk of blood clots for women who use drospirenone-containing birth control pills, previously mentioned in FDA's Drug Safety Communication issued on May 31, 20112.

No votes yet
Syndicate content