Show #41, July 2005
Show #41, July 2005
|DNA-based Cystic Fibrosis Test Approved|
FDA has approved the first DNA-based test to help detect cystic fibrosis. The test, called the Tag-It Cystic Fibrosis Kit, is made by the Canadian company Tm Bioscience Corporation.
A DNA sample from the patient's blood is analyzed for a group of variations in the gene causing cystic fibrosis, the CFTR gene. The results can help in the clinical diagnosis of possible CF. It can also help couples identify if they are at risk of having a child with CF and help in newborn screening to identify infants affected with this disease.
However, the Tag-It test should not be used as a stand-alone tool to diagnose CF, since it detects just a limited number of the more than 1300 genetic variations in the CFTR gene. In interpreting the test results, physicians should take into account the patient's clinical condition, ethnic background, and family history. Also, patients may need genetic counseling to help them understand the test results.
|Alert on Certain LifeScan Blood Glucose Meters|
LifeScan, Inc, is notifying users of some of the company's blood glucose testing systems about possible problems that might cause misinterpretation of glucose test results. The affected meters are the OneTouch® Ultra®, the OneTouch® FastTake® and the InDuo® Systems.
These three meter systems were originally designed to allow patients to select one of two units of measure to display their test results. This allowed patients to see their test results in the units customarily used in their own country. Some other companies' meters also let the patient select the proper measurement units.
The feature on these LifeScan meters allows the patient to switch between mg/dL, the standard used in the U.S. and mmol/L, which is used in many other countries. When setting the meter's date and time, it's possible for patient to accidentally switch over to the other measurement units without realizing it, and then, just looking at just the numbers, misinterpret the results and incorrectly assume that the blood glucose level is too high or too low. Over the past year or so, FDA has received several dozen reports of these kinds of errors.
In addition, the measurement units can also be accidentally switched if the meter is dropped while it's being used. This can cause a brief power loss, which can change the measurement units, or change the code number used to program the meter to match a particular vial of test strips, or change the 14 to 30 day glucose average calculated by the meter.
LifeScan has issued a worldwide notification of users and healthcare professionals, and the company is including special instructions in each package of test strips.
Health professionals should remind patients to make sure that their meter's unit of measure is set to "mg/dL," each time they test. They should also confirm that the code number on the meter's display matches the code number on the test strip vial each time they test. Patients can call LifeScan Customer Service at
1-800-515-0915 to confirm that their meter is set to the proper measurement units.
|Recall of Some Neurontin Capsules|
Pfizer recently recalled certain bottles of its epilepsy drug Neurontin (gabapentin). Because of a mechanical failure during manufacture, some of these bottles may contain empty or partially filled capsules. So patients taking these capsules could be underdosed and experience seizures.
At this time, only one lot of 100 mg Neurontin capsules is known to be affected by this problem. It's lot #15224V and it was distributed in October and November, 2004. Pfizer has contacted distributors and pharmacists about the recall. The company has also asked pharmacists to immediately contact their customers who use Neurontin.
Patients taking Neurontin should not discontinue the drug before consulting with their doctors. If they filled a prescription for the product in 100 mg strength between October 1, 2004 and March 15, 2005 and they're concerned that any unused capsules may be part of the recalled lot, they should contact their pharmacist. Consumers can contact Pfizer Medical Information at 1-800-438-1985 if they have questions about the recall.
|Recall of Two Defibrillator Products|
Now for news about two recent recalls of different defibrillator products.
The first recall applies to certain AED20 Automatic External Defibrillators made by MRL Inc., a Welch Allyn company. These defibrillators are being recalled because impact to the device could cause an electrical short, which could prevent the device from analyzing the patient's ECG and thus prevent the defibrillator from delivering a shock.
When this malfunction occurs during use, the AED 20 defibrillator may display an error message that says “Defib Comm”. FDA has received a number of complaints related to this problem, including one instance which may have prevented a patient from being resuscitated.
In May, the company started to notify affected customers. It's providing customers with a loaner device at no cost while their unit is being serviced, and will pay costs associated with shipping, handling and corrective service. Customers can call the company 1-800-462-0777 if they think they may have one of these devices.
Now for the second recall. Laerdal Medical Corporation is recalling all lots of an adapter cable that's used with certain HeartStart and Philips Medical System CodeMaster defibrillators. Wires within the affected cables could break, and if that happens, it could prevent the device from delivering a shock. We've received a number of reports about this type of malfunction, including several that resulted in failures to resuscitate.
The recalled devices are the CM 100 HeartStart® Adapter Cables. These adapter cables allow the Laerdal HeartStart multifunction defibrillator pads to be used with several different defibrillator models, including the HeartStart 4000 defibrillators and the Philips Medical Systems CodeMaster 100 and XL series defibrillators.
The part number for these cables is 920650. If you have any of these adapter cables, you should stop using them and order alternative cables from Philips Medical Systems.
- FDA MedWatch Safety Alert 2005- Laerdal CM 100-Heartstart Adapter Cable.
- FDA MedWatch Safety Alert 2005- MRL Inc. AED20 Automatic External Defibrillators.
|Reminder about Hepatotoxicity of Betaseron|
Berlex, Inc. has issued a reminder to practitioners about the possible hepatotoxicity of Betaseron (interferon beta-1b), which is used to treat relapsing forms of multiple sclerosis.
The company's letter notes that there have been rare reports of serious hepatic injury leading to hepatic failure and transplant in patients on beta-interferon products. It reminds practitioners that the prescribing information for this drug recommends liver function tests at one, three and six months after starting Betaseron therapy, and periodically thereafter if the patient has no symptoms of liver toxicity.
|Recall of Moi-Stir Oral Swabsticks|
Kingswood Laboratories is recalling its Moi-Stir Oral Swabsticks because the product may be contaminated with molds, including Aspergillus and Penicillium. Using the contaminated swab sticks could result in respiratory infections, especially in patients with compromised immune systems.
These swabsticks, which are used to moisten the mouths of patients, were distributed to hospitals, wholesalers, pharmacies, nursing homes, medical and dental offices, and consumers. Some were given as free samples. The swabsticks are packaged as three sticks in a white foil pouch, with the name “Moi-Stir” in green letters on the front of the pouch. The recall includes Moi-Stir Swabsticks with lot numbers A2, 1193, 1209, 1233, 1260 and 1725. The lot numbers are embossed on the pouch.
If you have swabsticks in the recalled lots, you should stop using them immediately and return them to the point of purchase. And if you know of patients who are using this product, you should warn them to stop doing so.
|MRI-Caused Injuries in Patients with Implanted Neurological Stimulators|
FDA recently issued a notification to health care professionals which warned about the possibility of serious injury if patients with implanted neurological stimulators undergo MRI exams. The injuries reported to FDA have included coma and permanent neurological damage. They were likely caused by heating of the electrodes at the tip of the leads.
Neurological stimulators include a fairly wide variety of products i.e., neuromuscular stimulators, deep brain stimulators, spinal cord stimulators, vagus nerve stimulators and peripheral nerve stimulators.
Physicians who either implant these stimulators or monitor patients who have them should warn patients that if an MRI procedure was prescribed, they should check back with the monitoring physician and make sure it can be performed safely.
In addition, radiology personnel should screen patients for the presence of implants before performing an MRI exam. It’s important to ask about both present and past implants. That's because sometimes when an implant is removed, the pulse generator is explanted but the leads remain in place in the patient. These leads can be heated by the MRI and cause a problem as well.
If the patient does have an implanted neurological stimulator, then consider consulting with the referring physician about other imaging options. If it's decided that an MRI procedure is indicated, be sure to review the labeling for the specific model stimulator, and pay particular attention to warnings and precautions. For some stimulators, the labeling may specify the types or strengths of MRI equipment that can be used. But with other stimulators, certain MRI procedures simply can't be performed.
- FDA Public Health Notification: MRI-Caused Injuries in Patients with Implanted Neurological Stimulators.
|Recall of Some Injectable Famotidine|
Bedford Laboratories, a division of Ben Venue Laboratories, is recalling one lot of Famotidine Injection, 20 mg/2 mL, because the company could not assure the sterility of the product. Famotidine injection is used in some patients with pathological hypersecretory conditions or intractable ulcers, or as a short term alternative for patients who can't take oral famotidine.
The affected lot is # 609336, with an expiration date of April 2006. This lot was distributed in August 2004 to wholesalers and distributors, and they distributed the product to hospitals. If you have any vials of this lot of Famotidine Injection, stop using it. Contact Bedford Laboratories at 1-800-562-4797 to return the product.
- FDA MedWatch Safety Alert 2005 - Famotidine Injection, 20 mg/2 mL.
- FDA Recall - Amerisource Health Services Recalls One Lot of Famotadine Injection.
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