New first-line treatment available
In addition to diet and exercise, the FDA approved rosiglitazone maleate plus glimepiride tablets (Avandaryl) for use in improving glycemic control in patients with type 2 diabetes mellitus. The treatment is approved for those who are already receiving rosiglitazone plus a sulfonylurea or who aren't adequately controlled on either drug alone.
The medication will be available as a 4-mg dose of rosiglitazone with 1-, 2-, and 4-mg doses of glimepiride. Studies showed that treatment with Avandaryl plus a sulfonylurea significantly reduced mean fasting plasma glucose and hemoglobin A1c compared with placebo plus a sulfonylurea or sulfonylurea uptitration. The drug was also shown to be effective for long-term glycemic control.
Source: Waknine Y. FDA approvals: Avelox, Avandaryl, Trileptal. Available at: http://www.medscape.com/viewarticle/518278?rss. Accessed February 11, 2006.
Beware of falsely elevated glucose readings
The FDA has notified healthcare providers of the potential for life-threatening falsely elevated glucose readings in patients who have received parenteral products containing maltose or galactose, or oral xylose, and are then testing blood glucose using glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) based glucose monitoring systems.
According to the FDA, there have been reports of inappropriate administration of insulin and consequent life-threatening/fatal hypoglycemia in response to erroneous test results obtained from patients receiving parenteral products containing maltose. Cases of true hypoglycemia can go untreated if the hypoglycemic state is masked by false elevation of glucose readings.
The GDH-PQQ method of glucose determination is nonspecific for glucose and, in the presence of maltose, xylose, or galactose, may yield falsely elevated glucose readings.
Visit http://www.fda.gov/medwatch/safety/2005/safety05.htm#maltose for more detailed information, including a preliminary listing of U.S. products that may cause glucose test interference.
I.V. insulin aspart available
The FDA approved I.V. administration for insulin aspart (recombinant) and human insulin (recombinant) injections (Novolog and Novolin R), allowing I.V. injection of the two products under medical supervision in a clinical setting to achieve glycemic control.
Previously, recombinant insulin aspart and human insulin were indicated for subcutaneous administration to control hyperglycemia in patients with diabetes.
Close monitoring of glucose and potassium levels is recommended because of the rapid onset of action of I.V.-administered insulin and the potential for fatal hypoglycemia and hypokalemia.
Source: Waknine Y. FDA approvals: Hyzaar, Levemir, NovoLog/Novolin R. Available at: http://www.medscape.com/viewarticle/515620. Accessed February 11, 2006.
CDC recommends pertussis vaccination for adults
Adults from 19 to 64 years of age should be vaccinated against pertussis to stop its spread among infants, recommends an advisory panel for the Centers for Disease Control and Prevention (CDC). The agency's advisory committee on immunization unanimously approved the recommendation because pertussis is becoming more common, particularly among teenagers. Adult vaccination can stop the spread of infection among infants, who are especially vulnerable to pertussis. The advisory panel recommends that healthcare providers give the booster to adults who haven't had a booster in 10 years. Providers should also administer the booster to adults in close contact with an infant less than 12 months of age, ideally at least 1 month before beginning close contact.
In 2004, over 25,000 cases of pertussis were reported across the country, a sharp increase from previous years.
The committee currently advises that infants receive the diphtheria tetanus acellular pertussis (DTaP) vaccine at 2-month intervals after birth, followed by a fourth dose about 1 year later and a booster between the ages of 4 and 6 years. However, immunity lasts only between 5 and 10 years.
A rising number of cases among middle school and high school students prompted the CDC to recently recommend that adolescents between 11 and 18 years of age receive the DTaP vaccine in place of the previously recommended diphtheria tetanus booster, a recommendation now extended to adults.
Source: CDC. Advisory Committee on Immunization Practice Recommends Adult Vaccination with New Tetanus, Diphtheria and Pertussis Vaccine (Tdap). Available at: http://www.cdc.gov/od/oc/media/pressrel/r051109.htm. Accessed February 11, 2006.
Children respond to hepatitis A vaccine
The FDA approved an expanded indication for hepatitis A vaccine (Havrix), allowing its use in children aged 12 months and older. Previously the vaccine was approved for use in children and adolescents aged 2 to 18 years.
Researchers based approval on data from a clinical trial of the vaccine in more than 1,000 healthy children, which demonstrated the vaccine's safety and effectiveness and showed that it retained its efficacy when administered concomitantly with Haemophilus b tetanus toxoid conjugate vaccine.
Source: GlaxoSmithKline's Havrix (hepatitis A vaccine, inactivated) now approved for use in children aged 12 months and over. Available at: http://www.gsk.com/ControllerServlet?appId=4&pageId=402&newsid=661. Accessed February 11, 2006.
New PCA pump available
Medtronic's Personal Therapy Manager (PTM) has been approved for use with the company's SynchroMed II implantable system. This allows for patient-activated delivery of provider-programmed, supplemental doses of preservative-free morphine sulfate sterile solution in the treatment of chronic, intractable pain. Previously, PCA-pump patients received a constant dose of pain medication that had been preset by a healthcare provider using a programmer.
The system is used to treat all types of severe chronic pain by delivering small, controlled amounts of medication to the intrathecal space.
The PTM is a hand-held device about the size of a cell phone. Patients use the PTM by pressing a button, which triggers the delivery of medication after the device software verifies that the "lockout interval," or length of time the patient no longer receives additional doses of medication, has elapsed.
Source: New Personal Therapy Manager (PTM). Available at: http://www.PTM.medtronic.com. Accessed February 11, 2006.
Telemetry affected by electromagnetic interference
The FDA has issued a public health notification about an increased risk for electromagnetic interference in any medical telemetry system operating in the 460 to 470 MHz frequency band after December 31, 2005.
The transmitters operating under new licenses in this frequency band can interfere with medical telemetry systems, leading to lapses in patient monitoring and missed alarm events, putting patients at risk. The interference won't be limited to urban areas. Any medical facility in the vicinity of a mobile radio could be affected. In January, the Federal Communications Commission began issuing new licenses for mobile radio transmitters to operate in the 460 to 470 MHz band.
The FDA provides a list of recommendations that will assist practitioners at http://www.fda.gov/cdrh/safety/111605-wmts.html.
FDA flags clarithromycin
A study showing a higher death rate among heart disease patients a year after taking clarithromycin (Biaxin) has led the FDA to issue an alert. The CLARICOR study, published in the British Medical Journal, reported on data from over 4,300 Danish heart disease patients who took the antibiotic clarithromycin or a placebo for 14 days. Within 3 years of treatment, 9.8% of patients who took clarithromycin died, compared with 7.8% of those who took a placebo. There were no differences in death rate until a year after surgery.
Abbott Laboratories, the maker of Biaxin, said the study results were a random finding that was at odds with decades of other research. Previous studies of the medication and similar drugs haven't detected any increases in deaths.
The FDA hasn't recommended any changes in use of the drug based on the study's findings. The alert is a preliminary analysis. The FDA has discussed the findings with the Danish Medicines Agency and the FDA's recommendation is consistent with that of the Danish agency. The FDA is attempting to obtain more information regarding the study and its findings. For more information, view the alert on the FDA's Web site, http://www.fda.gov/cder/drug/infopage/clarithromycin/default.htm.