FDA Notifications

Nutrition management essential for HIV infection

A special supplement to Clinical Infectious Diseases (CID), a journal of the Infectious Diseases Society of America (IDSA), contains a special report on current issues related to nutrition management and HIV infection.

The supplement is a collaborative work of more than 50 authorities representing a wide range of expertise in conjunction with five federal agencies: the Health Resources and Services Administration, the FDA, the Centers for Disease Control and Prevention, the National Institutes of Health, and the Department of Veterans Affairs.

Nutrition is an important, but often overlooked aspect of HIV disease management. John Bartlett, of the Johns Hopkins University School of Medicine, states in the supplement’s introduction: "Modern management of HIV infection now requires substantial expertise in dealing with nutritional issues and access to this expertise, despite the fact that there have been virtually no guidelines that specifically target the nutritional care of the HIV-infected population. This report on the nutrition management and concerns of HIV infection is consequently most welcome as timely, authoritative, and greatly needed."

Integrating Nutrition Therapy into Medical Management of Human Immunodeficiency Virus is available to IDSA members at www.journals.uchicago.edu/cgi-bin/contents?CID+v36nS2. To subscribe to CID or to order single copies of the supplement, go to: www.journals.uchicago.edu/CID/order1.html.

FDA approves Fuzeon, the first fusion inhibitor

The first drug in a new class of HIV/AIDS treatments for HIV-infected adults and children with advanced HIV infection has been approved by the FDA.

The FDA approved Fuzeon (enfuvirtide, also known as T-20) March 15, for use in combination with other anti-HIV medications to treat advanced HIV-1 infection in adults and children ages 6 years and older.

The FDA’s approval of Fuzeon is the first, worldwide, of a new class of drugs known as "fusion inhibitors." Fusion inhibitors interfere with the entry of HIV-1 into cells by inhibiting the merging of the virus with the cellular membrane, the first step in viral infiltration. This inhibition blocks HIV before it enters the human immune cell.

Combination therapy using multiple medications is used to effectively treat HIV infection. However, a significant percentage of patients with chronic HIV have developed infection resistant to many existing medications.

Because of its unique mode of action, Fuzeon may be active against HIV that is resistant to currently available classes of anti-HIV drugs.

Fuzeon, administered twice daily as a subcutaneous injection (under the skin), can be used as part of a treatment regimen in patients for whom there are limited options.

It only should be used in patients who have used other anti-HIV medications and show evidence of ongoing viral replication.

The FDA based its approval on an analysis of six months of data from two ongoing clinical studies of Fuzeon involving approximately 1,000 patients. The data from this analysis showed that the addition of Fuzeon to a combination of other antiretroviral medications reduced viral load in the blood, a measure of HIV infection, more than the use of the combination of medications alone.

Fuzeon was studied in 35 pediatric patients from the age of 6 years to 16 with pharmacokinetic data from 18 of these patients.

The long-term effects of Fuzeon are not known at this time, but are being evaluated by ongoing clinical studies.

The approved labeling for Fuzeon warns physicians to carefully monitor patients for signs and symptoms of pneumonia.

Although bacterial pneumonia was not common in clinical study participants, more patients treated with Fuzeon developed bacterial pneumonia than did patients who did not receive Fuzeon. Patients receiving Fuzeon are advised to seek medical evaluation immediately if they develop signs or symptoms suggestive of pneumonia, such as cough with fever, rapid breathing and shortness of breath.

In addition, Fuzeon can cause serious allergic reactions, and local skin reactions at the site of injection.

Symptoms of reaction

Symptoms of a serious allergic reaction with Fuzeon can include trouble breathing, fever with vomiting and a skin rash, blood in urine, and swelling of the feet. Patients taking Fuzeon should contact their healthcare provider right away if they experience any of these symptoms.

Local skin reactions from Fuzeon injections are common, occurring in almost all patients, and may be painful. Patients must be careful that their skin does not become infected at the site of injection. It is important to follow the injection instructions that come with the medication to lower the chances of getting an injection site infection.

Patients should call their health care provider if there are signs of infection at the injection site such as drainage, increasing heat, swelling, redness, or pain.

Because of the molecular complexity and difficulty of manufacture, it is possible that demand for Fuzeon may exceed supply at launch. The sponsor is working with HIV physician and patient groups to develop a progressive launch plan and will carefully manage allocation of Fuzeon.

Roche Pharmaceuticals of Nutley, NJ, has licensed the product from Trimeris Inc. of Durham, NC, and will distribute Fuzeon.

FDA uncovers counterfeit Procrit

The FDA has uncovered the existence of contaminated counterfeit Procrit, also known as epoietin alfa. Procrit is used to stimulate the production of red blood cells in humans to treat severe anemia and is indicated for some people with anemia related to treatment for HIV/AIDS.

As a result of investigative review and laboratory testing performed by the FDA, and in cooperation with Ortho Biotech Products, L.P. in Bridgewater, NJ, health care providers and consumers are being alerted to the existence of three lots of counterfeit product labeled as Procrit (epoetin alfa):

P007645 — 40,000 units/mL, expiration date 10-2004

P004677 — 40,000 units/mL, expiration date 02-2004

P004839 — 40,000 units/mL, expiration date 02-2004

The firm is issuing the warning to health care providers and others in a letter (also posted on its web site — listed at the end of this article) because counterfeit Procrit has been found to be contaminated with bacteria, and therefore, represents a significant potential hazard to consumers. In addition, FDA testing has demonstrated that some counterfeit product contains no active ingredient.

The FDA urges health care providers and patients alike to check the packaging and vials very carefully before using this product. Anyone finding counterfeit product should not use it, should quarantine it, and should immediately contact FDA’s Center for Biologics Evaluation and Research at (800) 835-4709, prompt #1, then prompt #5, and Ortho Biotech at (800) 325-7504, prompt #2.

In the performance of its responsibilities to assure the safety of products it regulates, the FDA regularly conducts investigations and testing to identify and remove from the market counterfeit, tampered, or otherwise unsuitable products.

The FDA supports the activities of legitimate manufacturers, in cooperation with the agency, to inform the public about counterfeit products and how to identify them. The FDA is committed to continued vigilance in rooting out counterfeiting activity and alerting the public to the existence of counterfeit product.

The FDA says physicians, pharmacists, nurses, and patients should carefully examine all Procrit packaging and vials before use. Additional details concerning the counterfeit product, including identifying characteristics and photographs to help identify possible counterfeit product are available on Ortho’s web site at www.procrit.com/counterfeit/letter.html.