Health

Birth Control Pills Recalled Over Packaging Error

The federal Food and Drug Administration has announced that a batch of birth control pills has been recalled because of a packaging error that may leave women at risk of unintended pregnancy.

On Feb. 24, Glenmark Generics Inc. USA – the domestic distributor for Glenmark Generics Ltd. India – issued the recall of seven lots of norgestimate and ethinyl estradiol tablets.

According to a release by Glenmark, select blisters on the packaging were rotated 180 degrees within the card, reversing the weekly ...

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Unsafe Artificial Hip Marketed after FDA Rejection

The New York Times has reported that Johnson & Johnson marketed an artificial hip overseas after the federal Food and Drug Administration rejected its sale in the United States based on a review of company safety studies.

In addition, the company continued to sell a related model of artificial hip in the U.S. after the FDA rejection, which went on the market because the company used a regulatory loophole that enabled it to avoid a similar safety review

According to the Feb. ...

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BMJ Report: Replacement Hips Expose Patients to Potentially Toxic Metals

A report today in the British Medical Journal (BMJ) alleges that metal-on-metal hip replacement surgery has potentially exposed hundreds of thousands of patients around the world to toxic substances.

The report, dated Feb. 28, 2012, states that patients have been misled about their participation in “what has effectively been a large uncontrolled experiment.”

The hip replacement joints in question employ a cobalt-chromium alloy rather than ceramic or polyethylene. The BMJ report states that the procedure has been used close to a million ...

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PA Supreme Court Refuses to Throw out Yaz Lawsuits

King’s Bench Petition Denied

Today the Pennsylvania Supreme Court denied Bayer’s King’s Bench Petition in the Yaz/Yasmin litigation. In plain English, this means that these lawsuits, many of which were pending since 2009, and which were put on hold late last year, can now go forward.

Some Background

Several thousand women from across the country have sued Bayer in state Court in Philadelphia. The basis of the lawsuit is that Bayer Corporation, and its subsidiaries, ...

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Start-up companies provide better access to FDA drug/device side-effect database

Two new start-up companies now allow users to search the Food and Drug Administration’s drug and device databases to see side-effects and malfunctions experienced by others. For years, the FDA has accepted reports from patients, doctors, and manufacturers, and stored detailed information as part of its effort to monitor the thousands of drugs and medical devices in use across the country. While the data are available on its web site, a user is required to download dozens of large files ...

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More Details About the FDA Advisory Committee Vote on Yaz: Majority Have Concerns

Background

On December 8, 2011, an FDA advisory committee held hearings on the safety of Yaz and Yasmin. After nearly a full day of testimony, the committee voted 21-5 that the information about the risks of Yaz provided to doctors and patients were inadequate. The panel voted narrowly, however, that the benefits outweigh the risks overall, and therefore voted not to remove Yaz from the market. The second vote was 15-11.

In the weeks ...

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