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Archive for the ‘Dangerous Drugs & Medical Devices’ Category

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FDA Mandates Boxed Warning, Patient Checklist for Essure

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The U.S. Food and Drug Administration (FDA) recommended on Nov. 15 a boxed warning and a patient checklist that highlights possible adverse events associated with the use of Essure, Bayer’s permanent contraception device.

The adverse events listed in the new FDA recommendation include:

Perforation of the uterus or fallopian tubes Device migration Hypersensitivity reactions Persistent pain

Adverse Events Related to Essure

Over the past several years, the FDA has been investigating a growing number of adverse events associated with Essure.…
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The History of Risperdal in the Pharmaceutical Marketplace

Also known by the generic name risperidone, Risperdal is a powerful, anti-psychotic medication prescribed to treat schizophrenia, autism and bipolar disorders in adults. Its manufacturer, Johnson & Johnson (J&J), has recently been making headlines, especially in the Huffington Post, where its story has been the subject of a 57,000-word series by Steven Brill.…
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