Patient Safety at Regulatory Affairs Syndicator

Archive for the 'Patient Safety' Category

Recalls and Safety Alerts: Warning on Combining Triptans and SSRIs/SNRIs

Closed Published by Food and Drug Adminstration (FDA): Patient Safety September 30th, 2006 in Patient Safety, Regulatory Affairs

FDA has alerted healthcare professionals about a possible life-threatening condition that can occur when triptans (e.g., Imitrex) are taken concomitantly with SSRIs (e.g., Paxil and Prozac) or SNRIs (e.g., Cymbalta)

All of these drug increase ser…

Recalls and Safety Alerts: Recall of Ultravist Contrast Agent

Closed Published by Food and Drug Adminstration (FDA): Patient Safety September 30th, 2006 in Patient Safety, Regulatory Affairs

In July, Berlex, Inc. recalled all lots of Ultravist (iopromide) Injection 370mgl/mL, an intravenous contrast agent. These products could contain particulate matter along with crystals. If administered to patients, they could cause vascular thromb…

Recalls and Safety Alerts: Caution on Cleaning and Sterilizing Ultrasound Biopsy Equipment

Closed Published by Food and Drug Adminstration (FDA): Patient Safety September 30th, 2006 in Patient Safety, Regulatory Affairs

FDA has issued a Public Health Notification about the importance of adequately cleaning and sterilizing reusable ultrasound biopsy transducer assemblies between patients. These assemblies are used to obtain biopsy samples guided by an ultrasound ima…

Recalls and Safety Alerts: Mix-up Prompts Azathioprine Recall

Closed Published by Food and Drug Adminstration (FDA): Patient Safety September 30th, 2006 in Patient Safety, Regulatory Affairs

In July, Roxane Laboratories recalled one lot of 50 mg Azathioprine tablets because the bottles in this lot may actually contain Methotrexate. Azathioprine is used to help prevent rejection in kidney transplant patients, and can also be used to mana…

Recalls and Safety Alerts: Warning on Intracranial Hemorrhage with Aptivus

Closed Published by Food and Drug Adminstration (FDA): Patient Safety September 30th, 2006 in Patient Safety, Regulatory Affairs

Boehringer Ingelheim is alerting healthcare professionals about a new black box warning for the company’s antiretroviral drug Aptivus (tipranavir). The warning describes reports of both fatal and non-fatal intracranial hemorrhage (ICH) in patients r…

Preventing Medical Errors: Nostril Errors with Nasal Sprays

Closed Published by Food and Drug Adminstration (FDA): Patient Safety September 30th, 2006 in Patient Safety, Regulatory Affairs

The Institute for Safe Medication Practices recently alerted practitioners that although many nasal sprays are intended to be administered in both nostrils, there are some medications meant to be sprayed into just one nostril. These include calciton…

New from FDA: Easier-to-Use Format for Prescription Drug Labeling

Closed Published by Food and Drug Adminstration (FDA): Patient Safety September 30th, 2006 in Patient Safety, Regulatory Affairs

Over the years, the package inserts that provide information to health care practitioners on prescription drugs have been getting longer and more complex because there is more and more information that has to be conveyed. Now, this prescribing inform…

Preventing Medical Errors: Avoiding Fatal Overdoses with Fentanyl Patches (October 2005)

Closed Published by Food and Drug Adminstration (FDA): Patient Safety August 31st, 2006 in Patient Safety, Regulatory Affairs

This story originally aired in October 2005. In this Special Edition of PSN, we are repeating some of the most important safety issues that continue to pose a public health problem.

FDA has issued a public health advisory about deaths and serious…

Preventing Medical Errors: Avoiding Glucose Monitoring Errors in Patients Receiving Other Sugars (February 2006)

Closed Published by Food and Drug Adminstration (FDA): Patient Safety August 31st, 2006 in Patient Safety, Regulatory Affairs

This story originally aired in February 2006. In this Special Edition of PSN, we are repeating some of the most important safety issues that continue to pose a public health problem.

FDA issued a reminder about the potential for falsely elevated …

Preventing Medical Errors: Possible Connection between Menactra Meningococcal Vaccine and Guillain-Barre Syndrome (December 2005)

Closed Published by Food and Drug Adminstration (FDA): Patient Safety August 31st, 2006 in Patient Safety, Regulatory Affairs

This story originally aired in December 2005. In this Special Edition of PSN, we are repeating some of the most important safety issues that continue to pose a public health problem.

FDA and CDC are alerting health care providers and consumers ab…

Preventing Medical Errors: Luer Lock Misconnections can be Deadly (December 2005)

Closed Published by Food and Drug Adminstration (FDA): Patient Safety August 31st, 2006 in Patient Safety, Regulatory Affairs

This story originally aired in December 2005. In this Special Edition of PSN, we are repeating some of the most important safety issues that continue to pose a public health problem.

Luer fittings, connectors, and locks are small, inexpensive, an…

Preventing Medical Errors: Caution on Accidentally Giving Nimodipine Intravenously (November 2005)

Closed Published by Food and Drug Adminstration (FDA): Patient Safety August 31st, 2006 in Patient Safety, Regulatory Affairs

This story originally aired in November 2005. In this Special Edition of PSN, we are repeating some of the most important safety issues that continue to pose a public health problem.

In a recent Medication Safety Alert, ISMP warns about inadverte…

Preventing Medical Errors: Caution on Power Injection of MRI and CT Contrast Media (October 2005)

Closed Published by Food and Drug Adminstration (FDA): Patient Safety August 31st, 2006 in Patient Safety, Regulatory Affairs

This story originally aired in October 2005. In this Special Edition of PSN, we are repeating some of the most important safety issues that continue to pose a public health problem.

FDA is reminding radiology personnel about the potential for ser…

New Medical Products: FDA Approves HPV and Shingles Vaccines

Closed Published by Food and Drug Adminstration (FDA): Patient Safety July 31st, 2006 in Patient Safety, Regulatory Affairs

FDA recently approved two new vaccines manufactured by Merck and Co. The first one, called Gardasil, prevents cervical cancer, precancerous genital lesions and genital warts caused by human papillomavirus (HPV).

Gardasil is effective against four…

New Medical Products: New Drug Approved for Parkinson?s Disease

Closed Published by Food and Drug Adminstration (FDA): Patient Safety July 31st, 2006 in Patient Safety, Regulatory Affairs

FDA recently approved a new drug to treat Parkinson’s disease, called Azilect (rasagiline). Azilect is an MAO type-B inhibitor that blocks the breakdown of dopamine in the brain. Azilect was approved as a single therapy for treating early Parkinson…