News Briefs

FDA issues public health advisory for aprotinin injection (Trasylol)

The Food and Drug Administration (FDA) has issued a Public Health Advisory alerting doctors who perform heart bypass surgery, and their patients, that aprotinin injection (Trasylol), a drug used to prevent blood loss during surgery, has been linked in two scientific publications to higher risks of serious side effects including kidney problems, heart attacks, and strokes in patients who undergo artery bypass graft surgery.

Aprotinin is the only product approved by the FDA for the prevention of perioperative blood loss and the need for blood transfusion among patients undergoing coronary artery bypass graft surgery.

The FDA advises health care providers to be aware of the following:

  • Physicians who use aprotinin should carefully monitor patients for the occurrence of toxicity, particularly to the kidneys, heart, or central nervous system and promptly report adverse event information to Bayer, the drug manufacturer, or through the FDA Medwatch program.
  • Physicians should consider limiting aprotinin use to those situations in which the clinical benefit of reduced blood loss is essential to medical management of the patient and outweighs the potential risks.

The FDA is evaluating the studies more closely, along with other scientific literature and reports submitted to the FDA through the MedWatch program, to determine if labeling changes or other actions are warranted. The agency also anticipates convening an advisory committee meeting in 2006 to discuss the existing data about the risks and benefits of aprotinin, and if additional safety measures need to be taken.

For more information, visit www.fda.gov/cder/drug/infopage/aprotinin/default.htm.

FDA revises format of prescription drug information

The FDA has revised the format of prescription drug information, commonly called the package insert, to give health care professionals clear and concise prescribing information.

Revised for the first time in more than 25 years, the new format requires that the prescription information for new and recently approved products meet specific graphical requirements and include the reorganization of critical information so physicians and pharmacists can find the information they need quickly.

Some of the most significant changes include:

  • A new section called Highlights to provide immediate access to the most important prescribing information about benefits and risks. Highlights typically will be a half-page in length and will provide a concise summary of information about specific areas including: Boxed Warning, Indications and Usage, and Dosage and Administration; and will refer the health care professional to the appropriate section of the Full Prescribing Information. In addition, drug makers will be required to include a list of all substantive recent changes made within the year.
  • A Table of Contents for easy reference to detailed safety and efficacy information.
  • The date of initial product approval, making it easier to determine how long a product has been on the market.
  • A toll-free number and Internet reporting information for suspected adverse events to encourage more widespread reporting of suspected side effects.

In addition, the Full Prescribing Information has been reorganized to give greater prominence to the most important and most commonly referenced information. As a result of feedback from two national physician surveys, the Indications and Usage and the Dosage and Administration sections are moved to the beginning of the Full Prescribing Information.

The addition of a new Patient Counseling Information section also places greater emphasis on the importance of communication between professionals and patients. If the FDA has approved patient information for a prescription drug, it will be printed at the end of the label immediately following the Patient Counseling Information section or will accompany the label so it can be easily shared.

For additional information, please visit CDER’s web site: www.fda.gov/cder/regulatory/physLabel/default.htm.

Current influenza viruses resistant to amantadine, rimandatine

The Centers for Disease Control and Prevention (CDC) in Atlanta has issued a health alert recommending that amantadine and rimandatine not be used for the treatment or prophylaxis of influenza in the United States during the 2005-06 influenza season.

Evidence is showing that a high proportion of currently circulating influenza A viruses in this country are resistant to these medications, the CDC says. Instead, the agency says oseltamivir or zanamivir should be selected during this period if an antiviral medication is used for the treatment and prophylaxis of influenza. Amantadine still should be used to treat the symptoms of Parkinson’s disease, another of its indications.

A recent report on the global prevalence of adamantane-resistant influenza viruses showed a significant increase (from 1.9% to 12.3%) in drug resistance over the past three years, the CDC says. In the United States, the frequency of drug resistance increased from 1.9% in 2004 to 14.5% during the first six months of the 2004-05 influenza season.

For the 2005-06 season, 120 influenza A (H3N2) viruses isolated from patients in 23 states had been tested at CDC through Jan. 12, 2006; 109 of the isolates (91%) contain an amino acid change at position 31 of the M2 protein, which confers resistance to amantadine and rimantadine. Three influenza A (H1N1) viruses have been tested and demonstrated susceptibility to these drugs. All influenza viruses from the United States that have been screened for antiviral resistance at CDC have demonstrated susceptibility to the neuraminidase inhibitors.

Additional information about the prevention and control of influenza is available at www.cdc.gov/flu. Specific information regarding the use of the neuraminidase inhibitors is available at www.cdc.gov/flu/protect/antiviral. These web sites will be updated as new information becomes available.

Report: Many CAD patients don’t take drugs that could extend lives

Nearly half the coronary artery disease (CAD) patients in a seven-year study admitted they don’t consistently take beta-blockers, cholesterol-lowering drugs, and other medications that could extend their lives, researchers report in the Jan. 17 issue of Circulation: Journal of the American Heart Association.

Researchers tapped the Duke Databank for Cardiovascular Disease to analyze medication adherence among 31,750 patients who had undergone a cardiac procedure at Duke, had at least one coronary artery more than 50% blocked, or had heart bypass surgery. All patients — mostly from North Carolina and southern Virginia — reported their use of aspirin, beta-blockers, and lipid-lowering drugs in annual surveys.

Patients had to have at least two consecutive surveys returned during the study. Consistent use was defined as reporting use of medications on at least two consecutive occasions and continuing to report use through the end of the study period. Angiotensin-converting enzyme (ACE) inhibitors were reported for patients with and without heart failure. Researchers found the use of all drugs and combinations increased each year.

By 2002:

  • 83% of patients reported using aspirin;
  • 61% reported using a beta-blocker;
  • 63% reported taking a lipid-lowering drug;
  • 54% used aspirin plus beta-blocker;
  • 39% reported using all three drugs.

However, consistent use during the study period was lower. Researchers found:

  • 71% of patients said they used aspirin consistently;
  • 46% adhered to beta-blockers;
  • 44% stuck with a lipid-lowering drug;
  • 36% committed to aspirin plus beta-blocker.

Only 21% used the three consistently. Among patients who had not experienced heart failure, 39% reported using ACE inhibitors in 2002; however, consistent use was at 20%. Among patients who had experienced heart failure, ACE inhibitor use was 51% in 2002 and consistent use was 39%. Older patients, those with heart failure, smokers and diabetics were least likely to consistently take medication.

Consistent use of any of the therapies was associated with higher survival rates. An association was not found, however, among patients who used ACE inhibitors but had not experienced heart failure.

ICAP approves uniform labeling guidelines

The International Academy of Compounding Pharmacists (IACP) in Sugar Land, TX, has issued national guidelines for the labeling of custom-prepared, compounded medications by its member pharmacists. The guidelines are intended to provide patients receiving compounded medications with the most complete information possible about how to use and care for their prescriptions; to standardize labeling across all 50 states; and to help promote best practices by compounding pharmacists.

The IACP guidelines cover medications compounded for human use — both medications that are compounded in direct fulfillment of a prescription for a specific patient and those that are compounded for administration by licensed institutions and practitioners, also called "office-use compounds."

For compounds prepared in response to a prescription for a specific patient, IACP recommends affixing a label to the primary container of each compounded medication that reads: "This medicine was specially compounded in our pharmacy for you at the direction of your prescriber." IACP also recommends that its members include an insert with the compounded prescription to explain why the patient’s physician prescribed a compounded medicine and what information the patient should have received from his or her physician.

For office-use compounds, IACP is recommending the following label: "This medicine was compounded in our pharmacy for use by a licensed professional only."

The labeling guidelines can be seen in their entirety on IACP’s web site at http://www.iacprx.org/site/PageServer?pagename=Press_Releases#011706.

Serious liver toxicity reported with use of telithromycin (Ketek)

The Annals of Internal Medicine has published an article reporting three patients who experienced serious liver toxicity following administration of telithromycin (Ketek). These cases were also reported to FDA MedWatch.

While it is difficult to determine the actual frequency of adverse events from voluntary reporting systems such as the MedWatch program, the FDA says it is continuing to evaluate the issue of liver problems in association with use of telithromycin to determine if labeling changes or other actions are warranted. For the complete MedWatch 2006 Safety summary, including links to the Public Health Advisory and Q&A’s, see: www.fda.gov/medwatch/safety/2006/safety06.htm#Ketek.