Contraceptives

Birth-control Pill Mishap Leads to Lawsuits, Baby Boom

In the aftermath of a pharmaceutical packaging error, patients are giving birth to surprise babies, and some are litigating.

Shanta Russell had been taking her birth-control pills faithfully for more than a dozen years without a hitch. So when pregnancy tests kept turning up positive in June 2011, she was stunned.

Shock turned to anger three months later when the single Kansas City woman received a recall notice in the mail warning that the pills she had taken may have been placed in the wrong order in their blister packs. The mistake could render the pills ineffective.

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FDA Approves Watson’s Generic Version of Plan B One-Step

Watson Pharmaceuticals has received the go-ahead to launch its generic version of the emergency contraceptive.

Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that its subsidiary Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Next Choice™ ONE DOSE (Levonorgestrel Tablet, 1.5 mg), the generic equivalent to Teva Women's Health's Plan B One-Step. Watson plans to launch the product immediately.

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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.

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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.

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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.

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