Important Updates
Medical News is always being released for consumers and medical professionals. As I come across these articles, I will post them here. They may be about drug recalls, drug alerts, therapies that need special attention etc. Things that could be a matter of life or death at times for patient.
Airway anastomotic dehiscence associated with use of sirolimus immediately after lung transplantation ( Source: Transplantation 2003, 75(9): 1437-1443, Melissa King-Biggs, Jordan Dunitz, Soon Park, Kay Savik, Marshall Hertz
This study was designed as a single center, consecutive case study of lung transplant recipients treated with sirolimus, tacrolimus and prednisone. A total of 15 subjects were enrolled in the study. Within 6 months, significant airway complications occurred in four subjects, three of whom died. At that point, the investigators terminated enrollment in the study. The study population was compared retrospectively with a group of 83 consecutive lung recipients treated with cyclosporine (64) or tacrolimlus (19), mycophenolate mofetil, and prednisone. This confirmed an increased incidence of airway dehiscence and reduced survival in the sirolimus-treated patients. Sirolimus treated patients had a low incidence of acute rejection.
From Wyeth: Warning Regarding Bronchial Anastomotic Dehiscence including fatal cases
Dear Health Care Provider, Wyeth wishes to inform you about important safety information regarding the use of Rapamune in de novo lung transplant patients. Wyeth has recieved post marketed reports of bronchial anastomotic dehiscence, including fatal cases, in patients treated with Rapamune in combination with tacrolimus and corticosteroids. The safety and efficacy of Rapamune as immunosuppressive therapy has not been established in lung transplant patients, and there, such use is not recommended. (Source: Medwatch, March 2003)
Advanced Respiratory applauds Medicare's adoption of a nationwide coverage policy for The Vest airway clearance system
New coverage policy will help patients with cystic fibrosis, bronchiectasis and other respiratory conditions breathe easier
ST. PAUL, Minn., June 16, 2003 - Advanced Respiratory, manufacturer and distributor of The Vest™ airway clearance system, today reported that Medicare has adopted a nationwide coverage policy for the use of durable medical equipment that provides high-frequency chest wall oscillation (HFCWO) therapy.
The coverage policy applies to patients with cystic fibrosis and bronchiectasis, and, on a case-by-case review, patients with other respiratory diseases or conditions.
"We applaud Medicare's decision, as it will have tremendous impact on the health and quality of life of Medicare patients who are fighting to breathe," said Elden Russell, president and CEO of Advanced Respiratory. "With The Vest system, patients can easily and effectively remove trapped secretions from their lungs. This leads to easier breathing, less infections and hospitalizations, and improved health." Medicare is one of over 1,100 insurers that pay for The Vest system.
The Vest system is a small and powerful, but gentle medical device - employing HFCWO technology - used in patients' homes to provide airway clearance therapy. Approximately the size of a portable audio system, the device consists of an inflatable vest attached to an air-pulse generator.
The generator rapidly inflates and deflates the vest, compressing and releasing the chest wall 5-20 times per second to create airflow within the lungs. Its gentle pressure moves trapped mucus from the smaller airways in the lungs to the larger airways, where it can be removed through coughing or suctioning. The action also works to thin thick secretions, making them
easier to clear.
Advanced Respiratory Inc., headquartered in St. Paul, Minn., is the privately-held manufacturer and distributor of The Vest airway clearance system. For more information about the types of patients that could benefit from The Vest system, Advanced Respiratory and its products and services, visit the company's Web site, www.thevest.com.
Contact: Kerstin March, Advanced Respiratory, 651.234.1633
RAPAMUNE SAFETY ALERT : FROM HTTP://WWW.RAPAMUNE.COM
As with all immunosuppression, there is an increased risk of developing
infection or malignancies. Only doctors experienced in immunosuppressive
therapy and management of kidney transplant patients should use RAPAMUNE.
Patients receiving RAPAMUNE should be managed in appropriate medical
facilities. The doctor who is responsible for immunosuppressive therapy
should have complete information necessary for patient care.
While taking RAPAMUNE and cyclosporine, you will need to have periodic
blood tests to check your blood cholesterol and triglycerides. Your
doctor may recommend treatment if your blood cholesterol or triglycerides
become too high. In patients taking RAPAMUNE with cyclosporine, increased blood creatinine levels have been observed, indicating a decrease in
kidney function. Because of this, your doctor will be checking your blood
creatinine level and may adjust your medications. You should also be
aware that many prescription and nonprescription drugs can affect your
kidney. Always check with your doctor before taking any new medications.
Women of childbearing potential should use effective birth control prior
to initiation of RAPAMUNE therapy, during RAPAMUNE therapy, and for 12
weeks after RAPAMUNE therapy has been stopped.
Lung Transplantation: The use of RAPAMUNE has been associated with
breakdown of the airway connections in newly transplanted lung patients,
in most cases leading to death. The safety and efficacy of RAPAMUNE in
lung transplant patients have not been established, and therefore, such
use is not recommended.
Specific side effects associated with RAPAMUNE include high cholesterol,
high triglycerides, decreased blood platelets, anemia, impaired wound
healing, high blood pressure, abnormal liver function tests, rash, acne,
joint pain, diarrhea, swelling, and low potassium. If you experience any
side effects, contact your doctor or transplant surgeon.
