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Misc. News : Recalls & Alerts Last Updated: Apr 20, 2011 - 9:38:09 AM


Recalls and Safety Alerts - Show #82, December 2008
By FDA
Dec 1, 2008 - 10:27:38 AM

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Statin Use and the Risk of ALS

A recent FDA analysis provides new evidence that using statins does not increase the risk of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease also known "Lou Gehrig's Disease." Cholesterol-lowering statins such as Lipitor (atorvastatin calcium) and Zocor (simvastatin) have been shown to reduce the risk of heart disease in a wide variety of patients.

FDA undertook its review after receiving a higher than expected number of reports of ALS in its adverse event reporting system. FDA's report, which was published recently in the journal Pharmacoepidemiology and Drug Safety, was a pooled analysis of 41 clinical trials ranging from 6 months to 5 years duration. In this analysis, the incidence of ALS was 4.2 cases per 100,000 patient-years in trial patients treated with statins, and 5.0 cases per 100,000 patient-years in patients receiving placebo. These results showed that patients treated with a statin did not have an increased incidence of ALS compared with placebo patients. FDA will continue to evaluate additional data as it becomes available.

Additional Information:

FDA MedWatch Safety Alert. Statin drugs and amyotrophic lateral sclerosis (ALS). September 30, 2008.
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Statin


Leukemia Risk with Intra-Articular Use of Phosphocol P 32

Covidien and Mallinckrodt, the manufacturers of Phosphocol P 32, have informed healthcare professionals that this drug may increase the risk of leukemia in certain situations. Phosphocol P 32 is used to treat peritoneal or pleural effusions in patients with metastatic cancer. It is instilled into the peritoneal or pleural cavities, where it locally irradiates tissues.

The manufacturers report that two children, ages 9 and 14, developed acute lymphocytic leukemia about 10 months after they received Phosphocol P 32 by intra-articular injection. Phosphocol P 32 is not indicated for intra-articular injection in treating hemarthroses, and its safety and effectiveness in children have not been established.

Phosphocol P 32 can also cause radiation injury to the small bowel, cecum and bladder when it is instilled into the peritoneal cavity.

Additional Information:

FDA MedWatch Safety Alert. Phosphocol P 32 (Chromic Phosphate P 32 Suspension). September 18, 2008.
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Phosphocol


Problems with Medtronic Intrathecal Catheters

Medtronic has alerted healthcare professionals about the potential for misconnections between certain sutureless intrathecal catheters and the implanted infusion pumps to which they're attached. The four affected products are:

• INDURA 1P Intrathecal Catheter, model 8709SC

• Intrathecal Catheter, model 8731SC

• Sutureless Pump Connector Revision Kit, model 8578

• Intrathecal Catheter Pump Segment Revision Kit, model 8596SC

The affected catheters are used in conjunction with implanted Medtronic infusion pumps to deliver medications directly to the intrathecal space in the spine. They are used primarily to treat chronic, intractable pain and severe spasticity. The affected pumps are the SyncroMed II, SyncroMed EL and IsoMed. This action does not include Medtronic MiniMed infusion pumps.

The company says it has received reports of misalignment or incomplete connection between the sutureless pump connector and the catheter port. This can cause the catheter to disconnect from the infusion pump, or it can cause an occlusion between the catheter and the pump. In either case, the patient can experience severe underdosing. In those receiving baclofen, this can result in a withdrawal syndrome that can be fatal.

Medtronic is stressing the importance of using proper techniques when connecting the pump and catheter. This includes verifying that there is backflow of CSF through the catheter, ensuring that the sutureless connector and the pump are aligned, snapping the sutureless connector to the pump firmly, and tugging on and rotating the connection to be sure the attachment is secure.

The firm also recommends that patients and caregivers be educated to recognize the symptoms of drug underdose and withdrawal and to seek immediate medical assistance. Clinicians should keep in mind that patients who have had intrathecal therapy interrupted may be drug naïve when the therapy is resumed and so may need an adjustment in dosage.

Additional Information:

FDA MedWatch Safety Alert. Medtronic INDURA 1P Intrathecal Catheter Sutureless Pump Connector Revision Kit Intrathecal Catheter Pump Segment Revision Kit. October 2, 2008.
http://www.fda.gov/medwatch/safety/2008/safety08.htm#INDURA

FDA Classifies Medtronic’s Notification Related to Improper Connection of Sutureless Intrathecal Catheters as a Class I Recall. September 26, 2008.
http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1222437479990〈=en_US


Hepatic Failure and Hepatorenal Syndrome with Tarceva

OSI Pharmaceuticals and Genentech are alerting healthcare professionals about hepatic failure and hepatorenal syndrome with the use of Tarceva (erlotinib), particularly in patient with baseline hepatic impairment. Tarceva is approved to treat certain patients with lung or pancreatic cancer.

Patients with hepatic impairment who are treated with Tarceva should be closely monitored during therapy. Treatment should be interrupted or discontinued if patients have severe changes in liver function. Tarceva should be used with extra caution in patients with total bilirubin greater than three times the upper limit of normal.

Additional Information:

FDA MedWatch Safety Alert. Tarceva (erlotinib). September 23, 2008.
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tarceva


Filter Ammonul to Remove Particulates

Ucyclyd Pharma is notifying healthcare professionals that particulate matter has been detected in Ammonul Injection. Ammonul is used as an adjunct in treating hyperammonemia in certain patients with urea cycle disorders.

The company says that the particulates may affect the safe use of Ammonul. Because of this, a specific filter [the Millex Durapore GV 33 mm Sterile Syringe Filter (0.22 µm] must used when Ammonul is admixed into the 10% Dextrose IV bag. Since particulates may not be visible, the filter must be used in all cases, even when particulates cannot be seen. As a precautionary measure, the company will package these filters with all future shipments of Ammonul until further notice.

Additional Information:

FDA MedWatch Safety Alert. Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10%. September 23, 2008.
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Ammonul

Ammonul web site
http://www.ammonul.com/


Drug Name Confusion: Ephedrine and Epinephrine

The Institute for Safe Medication Practices (ISMP) is warning again about the possibility of mix-ups between ephedrine and epinephrine. Not only do the names of these drugs look and sound similar, but since they're both used as vasopressors and vasoconstrictors, they're often stored next to each other. Also, both drugs may be packaged in 1 mL ampuls or vials.

ISMP cites a recent case in which a 57-year-old patient was admitted for excision of a neuroma on her foot. She became hypotensive and nauseated soon after an IV was started preoperatively. An anesthesiologist gave a verbal order for ephedrine, but the nurse taking the order heard epinephrine, and that is what the patient was mistakenly given.

ISMP makes several recommendations for reducing the chance of these mix-ups. Here are some of them:

• Avoid storing epinephrine and ephedrine side-by-side.

• Use tall man letters on computer inventory listings, shelf labels and other places where the drug names appear.

• Use screen alerts on automated dispensing cabinets.

• Where possible, use prefilled epinephrine syringes.

• Keep large vials of epinephrine out of clinical areas to reduce chances of preparing large amounts of the drug.

• To ensure an independent double-check, have the pharmacy prepare infusions and bolus doses for these drugs, except in emergencies.

And finally, when conveying orders verbally, use the "read back" technique. "Read back" means the person receiving the order transcribes it directly onto the patient's record or prescription as it is being given. Then the order is read back to the prescriber, rather than repeating it back from memory. Also, spelling drug names helps assure that the message has been heard and transcribed correctly. ISMP notes that the "read back" technique may not be fully understood, even though it is required by The Joint Commission.

Additional Information:

ISMP Medication Safety Alert! Worth Repeating…Epinephrine-Ephedrine mix-ups. Volume 13, Issue 16. August 14, 2008.
http://www.ismp.org/newsletters/acutecare/articles/20080814-1.asp


Removing Insulin from Cartons

The Institute for Safe Medication Practices warns that storing insulin vials inside their cardboard cartons after the packages have been opened can be a medical emergency waiting to happen. If the vial is accidentally returned to the wrong carton after being used, that sets the stage for a serious insulin mix-up. That is because the next person looking for a particular insulin product could read the label on the carton, assume that it accurately reflects what's inside, and end up administering the wrong product.

So ISMP recommends that the cartons be discarded, either in the pharmacy before the insulin is dispensed, or when it is received at the nursing station. This holds true whether the insulin is labeled for a particular patient, or whether it is going into floor stock. The bottom line? Do not dispense or store insulin vials in their cartons on patient care units.

Additional Information:

ISMP Medication Safety Alert! Remove Vials from Cartons. Volume 13, Issue 9. May 8, 2008.
http://www.ismp.org/newsletters/acutecare/articles/20080508-1.asp


Recognizing Warfarin Brand Names

A recent report by the Institute for Safe Medication Practices (ISMP) notes that some health professionals and patients may not realize that Jantoven is a brand name for the drug warfarin. That could result in inadvertently prescribing and dispensing two warfarin-containing medications for the same patient.

ISMP cites the case of a patient who had been taking warfarin at home and continued the drug while in the hospital. On discharge, the physician instructed that the patient continue warfarin at home, and he wrote a new warfarin prescription. The community pharmacy dispensed Jantoven without discussing the nature of the drug with the patient or asking whether the patient was already taking warfarin. The patient, not realizing that the newly prescribed drug was warfarin by another name, took both medications, and that resulted in a severely elevated INR.

ISMP suggests several ways to avoid these kinds of errors, including:

• If a brand name warfarin is prescribed, show both the brand name and the generic name on the prescription label.

• When dispensing the prescription, discuss the nature of the drug with the patient to be sure that he or she is not already taking another warfarin-containing drug.

• When patients are discharged from the hospital, counsel them about the prescriptions they are receiving and what each of them is for.

Additional Information:

ISMP Medication Safety Alert! Warfarin by Generic Name. Volume 13, Issue 19. September 25, 2008.
http://www.ismp.org/newsletters/acutecare/articles/20080925-1.asp


More Heparin Dosing Errors with Neonates

The Institute for Safe Medication Practices (ISMP) reports that serious dosing errors continue to occur when heparin is administered to neonates. ISMP cites an incident in Texas where as many as 17 infants in a neonatal intensive care unit received heparin overdoses. According to ISMP's analysis, the infants may have received up to 100 times more heparin than intended.

ISMP notes that when preparing solutions in the pharmacy, calculation errors are especially prone to occur when heparin is stocked in unfamiliar concentrations e.g., for example, if the pharmacy were to switch from vials containing 1,000 units per mL to vials containing 10,000 units per mL. The possibility of a dosing error increases if the pharmacy fails to verify the concentration of a solution before dispensing.

Another problem, according to ISMP, is that there is no standard dosing protocol when it comes to using heparin for maintaining the patency of venous and arterial lines in neonates. This means a hospital might have to stock heparin solutions in several concentrations ranging from 0.5 units per mL to 10 units per mL, and this can make errors more likely.

In this report and an earlier one, ISMP offered several suggestions to help avoid these potentially tragic errors. For example, the pharmacy could prepare and dispense heparin flush solutions, rather than having nurses do this in patient care areas. Or a hospital could consider using pre-filled heparin flush syringes, which are now available in several concentrations.

ISMP notes that some hospitals use a refractometer to measure the specific gravity of the solutions as they are prepared, and that spectroscopy equipment can also be used to check accuracy. This can differentiate between abnormally high concentrations and the lower concentrations needed for babies. According to ISMP, other hospitals are choosing to outsource the preparation of neonatal heparin flush products, using commercial manufacturers who meet FDA Good Manufacturing Practices and assay their solutions before distribution.

Additional Information:

ISMP Medication Safety Alert! Heparin Errors Continue Despite Prior, High-Profile, Fatal Events. July 17, 2008.
http://www.ismp.org/newsletters/acutecare/articles/20080717.asp






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