FDA restricts sale and distribution of Essure to protect women and require that patients receive risk information

The U.S. Food and Drug Administration today issued an order to restrict the sale and distribution of the Essure device to ensure that all women considering use of the permanent contraception device are provided with adequate risk information so that they can make informed decisions. The FDA is taking this step after becoming aware […]

FDA permits marketing of mobile medical application for substance use disorder

Today, the U.S. Food and Drug Administration permitted marketing of the first mobile medical application to help treat substance use disorders (SUD). The Reset application is intended to be used with outpatient therapy to treat alcohol, cocaine, marijuana and stimulant SUDs. The application is not intended to be used to treat opioid dependence.

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FDA requests removal of Opana ER for risks related to abuse

Today, the U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. This is the first time the […]

FDA approves first treatment for frequent urination at night due to overproduction of urine

The U.S. Food and Drug Administration on Friday approved Noctiva (desmopressin acetate) nasal spray for adults who awaken at least two times per night to urinate due to a condition known as nocturnal polyuria (overproduction of urine during the night). Noctiva is the first FDA-approved treatment for this condition.

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FDA advises nationwide testing for Zika virus in all donated blood and blood components

The Zika Mosquito

As a further safety measure against the emerging Zika virus outbreak, today the U.S. Food and Drug Administration issued a revised guidance recommending universal testing of donated Whole Blood and blood components for Zika virus in the U.S. and its territories.

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Salmonella Outbreak of Pistachio

 

 

May 20, 2016

On this page:

Update What was the Problem and What was Done About It? What are the Symptoms of Salmonella Infection? How Soon After Exposure do Symptoms Appear? What are the Complications of Salmonella Infections? Who is at Risk? What Specific Products were Recalled? What do Restaurants and Retailers Need […]