focus /

Pharmacovigilance and prescribing decisions

One of the important roles of a drug regulatory agency is to provide timely and accurate information on the safety and efficacy of medicines. While pre-approval clinical trials characterize the common adverse reactions associated with a new medicine and some of the less common serious adverse reactions, the full safety profile of the medicine continues to be refined after approval based on information from marketing experience.

Lingua Inglese

Ameridose, LLC: Recall of Unexpired Products in Circulation

FDA’s preliminary findings have raised concerns about a lack of sterility assurance for products produced at and distributed by this facility.

Lingua Undefined

Comunicato Stampa Ema su medicinali contenenti codeina (31-10-2012)

L' Agenzia Europea dei Medicinali (EMA) ha avviato una revisione sui medicinali
contenenti codeina. La codeina è un analgesico largamente utilizzato (un
farmaco per alleviare il dolore) che è autorizzato per l'uso negli adulti e nei
bambini. La codeina viene convertita in morfina nel corpo da un enzima chiamato
citocromo P450 isoenzima 2D6 (CYP2D6).

Lingua Undefined

Comunicato Stampa Ema su medicinali contenenti codeina (31-10-2012)

Lingua Undefined

Classic Zi Xiu Tang Bee Pollen Capsules And Ultimate Formula Capsules by Zi Xiu Tang Success: Recall - Undeclared Sibutramine

Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

Lingua Undefined

Hospira Symbiq Infusion System Touchscreen: Class 1 Recall - May Not Respond to Selection

Failure of touchscreen to respond to user input could result in a delay or interruption in therapy or over delivery or under delivery of medication.

Lingua Undefined

Ethicon Endo-Surgery Circular Stapler Sets: Class I Recall - User Difficulty With Firing Stapler Devices

Failure to complete the firing stroke of the stapler can result in severe pain, sphincter dysfunction, rectal wall damage, sepsis, bleeding, and occlusion of the rectal canal.

Lingua Undefined

Over-The-Counter Eye Drops and Nasal Sprays: Drug Safety Communication - Serious Adverse Events From Accidental Ingestion by Children

Accidental ingestion of active ingredients tetrahydrozoline, oxymetazoline, or naphazoline may cause serious and life-threatening adverse events.

Lingua Undefined

Accutron, Inc. Ultra PC% Cabinet Mount Flowmeters for Nitrous Oxide-Oxygen Sedation Systems: Class I Recall - Flowmeter May Continue To Release Nitrous Oxide Gas When The Oxygen Is Turned Off

When not mixed with oxygen, inhaling nitrous oxide can lead to temporary and permanent brain damage and death.

Lingua Undefined

New England Compounding Center (NECC): FDA Statement on Fungal Meningitis Outbreak

Healthcare professionals should follow-up with patients administered an NECC injectable product, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution.

Lingua Undefined

Farmacovigilanza

Pharmacovigilance and prescribing decisions

Ameridose, LLC: Recall of Unexpired Products in Circulation

Comunicato Stampa Ema su medicinali contenenti codeina (31-10-2012)

Comunicato Stampa Ema su medicinali contenenti codeina (31-10-2012)

Classic Zi Xiu Tang Bee Pollen Capsules And Ultimate Formula Capsules by Zi Xiu Tang Success: Recall - Undeclared Sibutramine

Hospira Symbiq Infusion System Touchscreen: Class 1 Recall - May Not Respond to Selection

Ethicon Endo-Surgery Circular Stapler Sets: Class I Recall - User Difficulty With Firing Stapler Devices

Over-The-Counter Eye Drops and Nasal Sprays: Drug Safety Communication - Serious Adverse Events From Accidental Ingestion by Children

Accutron, Inc. Ultra PC% Cabinet Mount Flowmeters for Nitrous Oxide-Oxygen Sedation Systems: Class I Recall - Flowmeter May Continue To Release Nitrous Oxide Gas When The Oxygen Is Turned Off

New England Compounding Center (NECC): FDA Statement on Fungal Meningitis Outbreak

Pagine

Form di ricerca

Pagine