-
Recent Posts
Categories
- Anesthesiology
- Avandia
- Cardiology
- Clinics
- Consumer Products
- Emergency Rooms
- Endocrinology
- Eye Care
- Family Practice
- FDA 2011
- FDA 2012
- FDA Label Change
- FDA Notice
- FDA Recall
- FDA Safety Communication
- FDA Warning
- Gastroenterology
- Healthcare Professionals
- Hematology
- Hospitals
- Infectious Disease
- Internal Medicine
- Laboratory
- multiple sclerosis (MS)
- Neurology
- OBGYN
- Oncology
- Ophthalmology
- Pain Management
- Patients
- Pediatrics
- Pharmacy
- Psychiatry
- Radiology
- Rheumatology
- Risk Manager
- Uncategorized
Category Archives: FDA 2012
Generic Ultrasound Transmission Gel Safety Communication
Other‐Sonic Generic Ultrasound Transmission Gel: Safety Communication – Risk of Bacterial Contamination AUDIENCE: Risk Manager, OB/GYN, Radiology, Infectious Disease ISSUE: FDA notified health care professionals and facilities to STOP using Other‐Sonic Generic Ultrasound Transmission Gel manufactured June though December 2011, … Continue reading
Posted in FDA 2012, FDA Warning, Infectious Disease, OBGYN, Radiology, Risk Manager
Tagged drug risks, FDA notice, Generic Ultrasound Transmission Gel, Infectious Disease, OBGYN, Other‐Sonic, Radiology, Risk Manager, Safety Communication
Comments Off
Morphine Sulfate Injection USP Carpuject by Hospira Recall
Morphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject by Hospira, Inc: Recall – May Contain More Than Intended Fill Volume AUDIENCE: Risk Manager, Pain Management ISSUE: Customer report of two Carpujects syringes containing more … Continue reading
FDA March 2012 Safety Labeling Changes
The MedWatch March 2012 Safety Labeling Changes posting includes 39 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. The “Summary Page” provides a listing of drug names and safety … Continue reading
Posted in FDA 2012, FDA Label Change, FDA Safety Communication
Tagged Atacand HCT candesartan cilextetil/hydrochlorothiazide, Benicar olmesartan medoxomil, Benlysta belimumab, Celexa citalopram hydrobromide, drug risks, Drug Safety Communication, Enablex darifenacin, fda, FDA March 2012 Safety Labeling Changes, FDA notice, Incivek telaprevir, Janumet sitagliptin and metformin fixed-dose combination, Januvia sitagliptin, Kombiglyze XR saxagliptin/metformin hydrochloride extended-release, Lidocaine in 5% Dextrose Injection Magnevist brand of gadopentetate dimeglumine, March 2012, Revlimid lenalidomide, Reyataz atazanavir sulfate, safety label changes, Safety Labeling Changes, Sporanox itraconazole, Treximet sumatriptan and naproxen sodium, Twynsta telmisartan/amlodipine, Votrient pazopanib, Zestoretic lisinopril/hydrochlorothiazide, Zestril lisinopril, Zmax azithromycin extended release, Zometa zoledronic acid
Comments Off
Birth Control Pills Health Risks
Birth Control Pills Containing Drospirenone: Label Change-Products may be associated with a higher risk for blood clots AUDIENCE: OBGYN, Family Practice, Patient ISSUE: FDA has completed its review of recent observational (epidemiologic) studies regarding the risk of blood clots … Continue reading
Posted in Family Practice, FDA 2012, FDA Label Change, OBGYN, Patients
Tagged Birth Control Pills, Birth Control Pills Health Risks, Drospirenone, drug risks, Family Practice, FDA notice, Health Risks, higher risk for blood clots, OBGYN, safety label changes
Comments Off
Thoratec Corporation HeartMate II Left Ventricular Assist System LVAS Class 1 Recall
Thoratec Corporation, HeartMate II Left Ventricular Assist System (LVAS): Class 1 Recall- Outflow Graft May Kink or Deform Audience: Cardiology , Risk Manager, Transplant Issue: FDA is notifying health care professionals of a Class 1 Recall due to detachment of the … Continue reading
Posted in Cardiology, FDA 2012, FDA Recall, Risk Manager
Tagged Cardiology, Class 1 Recall, Class I Recall, drug risks, FDA recall, HeartMate II LVAS, Left Ventricular Assist System LVAS, Recall, Risk Manager, Thoratec Corporation HeartMate II, Thoratec Corporation HeartMate II Left Ventricular Assist System LVAS Class 1 Recall, Transplant, Ventricular Assist System
Comments Off
Altuzan bevacizumab Counterfeit Product
Altuzan (bevacizumab): Counterfeit Product – Contains no Active Ingredient ISSUE: FDA lab tests have confirmed that a counterfeit version of Roche’s Altuzan 400mg/16ml (bevacizumab),an injectable cancer medication, found in the U.S. contains no active ingredient. Even if the identified … Continue reading
Posted in Family Practice, FDA 2012, FDA Recall, FDA Warning, Healthcare Professionals, Oncology, Patients
Tagged Altuzan, Altuzan bevacizumab Counterfeit Product, bevacizumab, Cancer Drugs, Counterfeit Product, drug risks, Family Practice, FDA recall, FDA warning, Oncology, or Ban Dune Marketing Inc, Recall, Richards Pharma, Richards Services, Roche’s Altuzan 400mg/16ml, Unapproved Drug, Warwick Healthcare Solutions
Comments Off
Celexa citalopram hydrobromide FDA Drug Safety Communication
Celexa (citalopram hydrobromide) – Drug Safety Communication: Revised Recommendations, Potential Risk of Abnormal Heart Rhythms AUDIENCE: Psychiatry, Cardiology ISSUE: FDA is clarifying dosing and warning recommendations for the antidepressant Celexa (citalopram hydrobromide; also available in generic form). In August 2011, FDA … Continue reading
Posted in Cardiology, FDA 2012, FDA Safety Communication, Psychiatry
Tagged Cardiology, Celexa, Celexa citalopram hydrobromide FDA Drug Safety Communication, citalopram hydrobromide, drug risks, Drug Safety Communication, FDA Drug Safety Communication, FDA notice, FDA warning, Potential Risk of Abnormal Heart Rhythms, Psychiatry, Revised Recommendations, safety label changes
Comments Off