Screen smallpox vaccinees for cardiac factors

Reports of cardiac adverse events in smallpox vaccinees have resulted in recommendations that people with certain cardiac risk factors be excluded from the nation’s voluntary smallpox immunization program.

The Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices made the recommendations after holding an emergency meeting by conference call on March 28. The committee convened to discuss the cardiac adverse events reported after some smallpox vaccinations.

At the time of the meeting, 10 cases of myopericarditis had been reported among several hundred thousand members of the military, and two such cases (one of myocarditis and one of pericarditis) had been reported among civilian vaccinees. In addition, CDC had received reports of five patients with cardiac ischemic events following smallpox vaccination, including three patients with myocardial infarctions and two patients with angina. Two of the people who suffered heart attacks died.

The committee recommended that CDC exclude persons with known underlying heart disease and persons with three or more major cardiac risk factors. Therefore, CDC announced that potential vaccinees should not get the smallpox vaccine if they have been diagnosed by a doctor as having a heart condition with or without symptoms. The conditions include:

  • known coronary disease, including previous myocardial infarction and angina;
  • congestive heart failure;
  • cardiomyopathy;
  • stroke or transient ischemic attack;
  • chest pain or shortness of breath with activity; and
  • other heart conditions under the care of a doctor.

In addition, potential vaccinees should not get the smallpox vaccine if they have three or more of the following risk factors:

  • A doctor has told them they have high blood pressure.
  • A doctor has told them they have high blood cholesterol.
  • A doctor has told them they have diabetes or high blood sugar.
  • They have a first-degree relative who had a heart condition before the age of 50.
  • They smoke cigarettes now.

If someone receives the smallpox vaccine and develops chest pain, shortness of breath, or other symptoms of cardiac disease after vaccination, he or she should see a health care provider right away.

Unannounced surveys will be Joint Commission’s norm

The Board of Commissioners of the Joint Commission on Accreditation of Healthcare Organizations in Oakbrook Terrace, IL, has announced its intention to begin conducting all regular accreditation surveys on an unannounced basis beginning in January 2006. Unannounced surveys will be pilot-tested in volunteer organizations during 2004 and 2005.

The Joint Commission says its plans to introduce a substantially new accreditation process beginning in January 2004 have been widely discussed with accredited health care organizations during the past year. The proposal to transition to unannounced surveys — approved by the Board of Commissioners at its March 28-29 meeting — resulted from those discussions.

During 2004, the Joint Commission expects to initiate pilot-testing of the unannounced triennial survey process in up to 100 hospitals that have volunteered to be among the first participants. In 2005, the Joint Commission will continue to conduct voluntary unannounced surveys on a limited basis, opening up the option to all types of accredited organizations, and then will transition to a completely unannounced survey program in 2006. During this period, the Joint Commission plans to work closely with its various advisory groups, accredited organizations, and other stakeholder groups to gain their input and progressively refine the new accreditation process and smooth the transition to unannounced surveys.

The Joint Commission plans to continue to conduct random, unannounced, one-day surveys in an annual 5% sample of the health care organizations it accredits through the end of 2005. After that time, random unannounced surveys will be discontinued.

Details about the plan to introduce unannounced triennial surveys will be shared with accredited organizations in the coming months through educational programs, newsletters, and other outreach activities.

FDA warns of cancer drug misrepresentations

The U.S. Food and Drug Administration (FDA) is warning consumers and health care practitioners about misrepresentations in a SuperGen press release dated Nov. 15, 2002, regarding the company’s recently approved cancer drug, mitomycin for injection (Mitozytrex).

According to the FDA, the press release, titled "FDA approves SuperGen’s New Drug Application to Market Mitozytrex (MitoExtra)" and disseminated by SuperGen, exaggerates the efficacy of mitomycin for injection and fails to include the significant risks associated with the use of the drug. The FDA says the press release does not mention acute adverse reactions that can result from administration of mitomycin for injection, which include fever, anorexia, nausea, and vomiting. The press release also fails to disclose that mitomycin for injection is associated with more serious adverse events, such as myelosuppression and hemolytic uremic syndrome.

The agency lists several statements in the press release that it says are misrepresentations by SuperGen. In response, the Dublin, CA, company says it is carefully reviewing the FDA’s concerns and will address them. "SuperGen will take all appropriate steps to ensure that future news announcements are in compliance with all FDA regulations," the company states. SuperGen notes that the anticancer drug currently is not marketed or distributed and that at no time were any consumers or health care providers at risk.

FDA revises warnings, recalls drug

The Food and Drug Administration (FDA) recently announced that it and Biogen have revised the Warnings, Precautions, Adverse Reactions, Patient Information, and Clinical Studies sections of the prescribing information for Interferon beta-1a (Avonex). The updated safety information includes a cautionary note regarding use in patients with depression and other severe psychiatric symptoms.

Post-marketing reports of depression, suicidal ideation, and/or development of new or worsening of pre-existing psychiatric disorders, including psychosis, as well as reports of anaphylaxis, pancytopenia, thrombocytopenia, autoimmune disorders of multiple target organs, and hepatic injury manifesting as elevated serum enzyme levels and hepatitis were added to the labeling. An FDA-approved Patient Medication Guide, providing patient safety information and comprehensive instructions for patient self-administration of the drug, was added.

In addition, the FDA has announced that Tai Chien has recalled all 100-tablet bottles of Ancom Anti-Hypertensive Compound Tablets, an unapproved new drug labeled to contain several prescription drug ingredients, including reserpine, diazepam, promethiazine, and hydrochlorothiazide. The sale of a product with this combination of ingredients poses possible serious health risks including sedation, depression, and potentially life-threatening abnormalities of the blood.

This recall includes all lot codes of the product remaining on the market. Ancom Tablets were sold without prescriptions to consumers at Tai Chien’s retail establishment in New York City. Product also was sold to a distributor in Puerto Rico. At least one illness consequent to use of the drug has been reported to date.