Patient Safety at Regulatory Affairs Syndicator

Archive for the 'Patient Safety' Category

Recalls and Safety Alerts: Caution on use of ACE inhibitors in First Trimester

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

A recent study in the New England Journal of Medicine suggests that ACE inhibitors, which are widely used to treat hypertension, may be associated with an increased risk of major congenital malformations when used by women during the first trimester …

Recalls and Safety Alerts: Caution on Gadolinium-Containing Contrast Agents in Patients with Renal Failure

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

FDA has learned of a rare, possibly fatal disease among patients with renal failure who underwent Magnetic Resonance Angiography (MRA) using Omniscan, a contrast agent containing gadolinium. The disease is called Nephrogenic Systemic Fibrosis/ Nephr…

Recalls and Safety Alerts: Severe Bone and Muscle Pain with Bisphosphonates

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

A recent FDA article describes severe pain associated with two bisphosphonate drugs: Fosamax (alendronate sodium) and Actonel (risedronate sodium).

The article, which was published in the Archives of Internal Medicine, describes over a hundred r…

Preventing Medical Errors: USP Statement on Preventing Errors with Neuromuscular Blocking Agents

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

In a previous show, we told you about a report from the Institute for Safe Medication Practices (ISMP) which warned about inadvertently giving neuromuscular blocking agents such as pancuronium to patients who aren’t receiving ventilator support. Thi…

Preventing Medical Errors: Preventing Errors with Tablet Splitting

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

Splitting tablets is a common practice where tablets of a higher strength than the patient needs are broken in half, or even quarters, to provide the correct dose. This is often done to reduce costs, since the higher strength tablet sometimes costs …

Recalls and Safety Alerts: Promethazine Contraindicated in Children Younger than Two

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

In 2005, Wyeth Pharmaceuticals notified health care professionals that Phenergan brand promethazine hydrochloride was contraindicated in children under the age of two because the drug could cause fatal respiratory depression. Now, the labeling on al…

Recalls and Safety Alerts: Safety Recommendations for Baxter Colleague Infusion Pumps

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

Over the past year, Baxter Healthcare Corporation has issued four urgent safety notices and recalls for the company?s Colleague infusion pump, specifying steps to be taken to address problems with the pumps. FDA is now recommending that users of Col…

Recalls and Safety Alerts: Oxygen Regulator Fires from Incorrect Use of Seals

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

FDA and NIOSH are alerting healthcare professionals that incorrect use of certain seals in oxygen regulators can result in fires and are recommending an important precaution to avoid such fires.

FDA has received 12 reports in which regulators used…

Recalls and Safety Alerts: Possible Contamination of Fluoride Rinses

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

The dental supply company Pascal is recalling the company’s anticavity fluoride rinses because they could be contaminated with bacteria that may cause pneumonia, including Burkholderia cepacia and Pseudomonas aeruginosa.

The recall affects all lo…

Recalls and Safety Alerts: Renal Failure Associated with Bowel Cleansing Agents

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

FDA is notifying healthcare professionals about an association between oral sodium phosphates (OSPs) for bowel cleansing and a type of acute renal failure called acute phosphate nephropathy. These occurrences, which are rare but serious, have been a…

Recalls and Safety Alerts: Generic Acetaminophen Recalled for Labeling Error

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

The distributor IVAX Pharmaceuticals is recalling certain lots of 500 mg acetaminophen tablets and capsules because there’s an error on the product label.

The label incorrectly says, “Do not exceed 12 tablets or capsules in a 24 hour period,” wh…

Recalls and Safety Alerts: Paxil and Increased Risk of Suicidality in Young Adults

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

GlaxoSmithKline is notifying healthcare professionals about new warnings on the risk of suicidality with Paxil (paroxetine) and Paxil CR. These labeling changes relate to adult patients, especially young adults, ages 18 to 24.

The company recent…