Particulate matter could potentially serve as a focal point for infection should any pre-existing peritonitis exist, and may lead to a fatal outcome.

This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice.

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Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.

This is a summary of a Press Release issued by the Food and Drug Administration (FDA). The link below will take you to the original press release containing complete information, including instructions about what to do if you are affected.

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The U.S. Food and Drug Administration today approved a new use for Avastin (bevacizumab) to treat patients with persistent, recurrent or late-stage (metastatic) cervical cancer.

This is a summary of a Press Release issued by the Food and Drug Administration (FDA). The link below will take you to the original press release containing complete information, including instructions about what to do if you are affected.

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The U.S. Food and Drug Administration is advising consumers to be aware of products sold online claiming to prevent or treat the Ebola virus. Since the outbreak of the Ebola virus in West Africa, the FDA has seen and received consumer complaints about a variety of products claiming to either prevent the Ebola virus or treat the infection.

This is a summary of a Press Release issued by the Food and Drug Administration (FDA). The link below will take you to the original press release containing complete information, including instructions about what to do if you are affected.

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The U.S. Food and Drug Administration today approved Belsomra (suvorexant) tablets for use as needed to treat difficulty in falling and staying asleep (insomnia).

This is a summary of a Press Release issued by the Food and Drug Administration (FDA). The link below will take you to the original press release containing complete information, including instructions about what to do if you are affected.

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Use of the affected product may cause serious adverse health consequences, including sepsis, limb loss, and death.

This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice.

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Today, the U.S. Food and Drug Administration approved the XVIVO Perfusion System (XPS) with STEEN Solution, a device for preserving donated lungs that do not initially meet the standard criteria for lung transplantation but may be transplantable if there is more time to observe and evaluate the organ’s function to determine whether the lung is viable for transplantation.

This is a summary of a Press Release issued by the Food and Drug Administration (FDA). The link below will take you to the original press release containing complete information, including instructions about what to do if you are affected.

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FDA seeks permanent injunction against Michigan cheese manufacturer

August 11, 2014

On August 8, 2014, the U.S. Department of Justice, at the request of the U.S. Food and Drug Administration, filed a complaint for permanent injunction in the U.S. District Court for the Eastern District of Michigan against S. Serra Cheese Company, of Clinton Township, Michigan, and its owners, Stefano Serra and Fina Serra. This is [...]

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FDA approves first non-invasive DNA screening test for colorectal cancer

August 11, 2014

The U.S. Food and Drug Administration today approved Cologuard, the first stool-based colorectal screening test that detects the presence of red blood cells and DNA mutations that may indicate the presence of certain kinds of abnormal growths that may be cancers such as colon cancer or precursors to cancer. This is a summary of a [...]

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Arize: Public Notification – Undeclared Drug Ingredient

August 11, 2014

Undeclared sulfoaildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of [...]

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