FDA Patient Safety News: Show #16, June 2003

Expanded Use for HPV Test

FDA recently approved the expanded use of a laboratory test to detect human papillomavirus, or HPV, in the uterine cervix. HPV infection, which is transmitted sexually, is a risk factor for cervical cancer. The test, called the HC2 High-Risk HPV DNA test, is manufactured by Digene Corp. FDA had previously approved this product as a follow-up test for women who had abnormal Pap tests. The product is now approved to be used along with the Pap test on any woman over age 30. Although it’s an adjunct to Pap screening, it’s not intended to substitute for Pap screening.

The approval specifies women over 30 because of the higher risk of cervical cancer in this age group. Although the rate of HPV infection in women under 30 is relatively high, most infections in this age group are short-lived, and women under 30 rarely develop cervical cancer. On the other hand, women over 30 have fewer HPV infections, but cervical cancers are more likely to occur in older women.

There are several things patients should understand about the HPV test. First, they should know that having the virus increases the risk of cervical cancer. But they should also understand that HPV infections are common, that most of them resolve on their own, and that only a very small proportion of these infections lead to cancer. In other words, a positive HPV test can provide useful information for the woman and her physician, but it doesn't necessarily mean that cancer is going to develop. On the other hand, patients should understand that a negative pap smear and HPV test can't assure that things won't change. Infections or cellular abnormalities could develop in the future, which is why continued screening is important.

The American Cancer Society has an excellent web site that explains HPV and its possible health effects in Iay terms. It's called “What Women Should Know about HPV and Cervical Health.” It's a good place to send patients for more information.

Additional Information:

American Cancer Society: What Women Should Know About HPV and Cervical Health.
http://www.cancer.org/docroot/CRI/content/CRI_2_6x_What_Every_Woman_Should_Know_About_Cervical_Cancer_and_the_Human_Papilloma_Virus.asp


Urgent Market Withdrawal of GYNECARE INTERGEL Solution

Now for an alert about a product that's been voluntarily withdrawn from the market. The product is the GYNECARE INTERGEL Adhesion Prevention Solution, and it's used to reduce post-surgical adhesions in patients undergoing open, conservative gynecologic surgery.

Adverse event reports associated with this solution have included late-onset post-operative pain and repeat surgeries following the onset of pain, non-infectious foreign body reactions, and tissue adherence. In some patients, a residual material was observed during the repeat surgery.

GYNECARE Worldwide, a division of Ethicon, Inc. is urging customers to immediately stop using the INTERGEL Adhesion Barrier Solution, and return all remaining product and samples to the company.

GYNECARE is taking this action while it completes an assessment of the experience with the device. Part of the assessment will include adverse events associated with off-label use, for example in laparoscopy and non-conservative surgical procedures such as hysterectomy.

Additional Information:

FDA MedWatch Safety Alert: 2003 Safety Alerts for Drugs, Biologics, Medical Devices, and Dietary Supplements (INTERGEL Adhesion Prevention Solution).
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm169519.htm


New Cautions on Beta Interferons for MS

The prescribing information for three brands of beta interferon now contains new and strengthened warnings, cautions and information on adverse reactions. Beta interferon is used to treat multiple sclerosis, where it's intended to slow the progress of the disease and reduce the frequency of exacerbation. The products are Avonex, manufactured by Biogen Incorporated, Betaseron, manufactured by Chiron Corporation, and Rebif, manufactured by Serono, Inc.

Some of the new information is based on reports of psychiatric effects among patients treated with beta interferon, including depression and suicidal ideation. Some patients developed psychiatric disorders for the first time, including psychosis. Others experienced a worsening of existing psychiatric conditions. The labeling now contains a cautionary note about using beta interferon in patients with depression, mood disorders, or other severe psychiatric symptoms.

There have also been reports of anaphylaxis, decreased blood counts, autoimmune disorders and liver damage in patients treated with beta interferon. And so the labeling now advises monitoring patients for signs of blood abnormalities, hepatic injury and possibly autoimmune disorders.

Additional Information:

Product Approval Information - Licensing Action for Betaseron.
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080486.htm


New Cautions on Beta Interferons for MS

The prescribing information for three brands of beta interferon now contains new and strengthened warnings, cautions and information on adverse reactions. Beta interferon is used to treat multiple sclerosis, where it's intended to slow the progress of the disease and reduce the frequency of exacerbation. The products are Avonex, manufactured by Biogen Incorporated, Betaseron, manufactured by Chiron Corporation, and Rebif, manufactured by Serono, Inc.

Some of the new information is based on reports of psychiatric effects among patients treated with beta interferon, including depression and suicidal ideation. Some patients developed psychiatric disorders for the first time, including psychosis. Others experienced a worsening of existing psychiatric conditions. The labeling now contains a cautionary note about using beta interferon in patients with depression, mood disorders, or other severe psychiatric symptoms.

There have also been reports of anaphylaxis, decreased blood counts, autoimmune disorders and liver damage in patients treated with beta interferon. And so the labeling now advises monitoring patients for signs of blood abnormalities, hepatic injury and possibly autoimmune disorders.

Additional Information:

Product Approval Information - Licensing Action for Rebif.
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080737.htm


Expanded Use for HPV Test

FDA recently approved the expanded use of a laboratory test to detect human papillomavirus, or HPV, in the uterine cervix. HPV infection, which is transmitted sexually, is a risk factor for cervical cancer. The test, called the HC2 High-Risk HPV DNA test, is manufactured by Digene Corp. FDA had previously approved this product as a follow-up test for women who had abnormal Pap tests. The product is now approved to be used along with the Pap test on any woman over age 30. Although it’s an adjunct to Pap screening, it’s not intended to substitute for Pap screening.

The approval specifies women over 30 because of the higher risk of cervical cancer in this age group. Although the rate of HPV infection in women under 30 is relatively high, most infections in this age group are short-lived, and women under 30 rarely develop cervical cancer. On the other hand, women over 30 have fewer HPV infections, but cervical cancers are more likely to occur in older women.

There are several things patients should understand about the HPV test. First, they should know that having the virus increases the risk of cervical cancer. But they should also understand that HPV infections are common, that most of them resolve on their own, and that only a very small proportion of these infections lead to cancer. In other words, a positive HPV test can provide useful information for the woman and her physician, but it doesn't necessarily mean that cancer is going to develop. On the other hand, patients should understand that a negative pap smear and HPV test can't assure that things won't change. Infections or cellular abnormalities could develop in the future, which is why continued screening is important.

The American Cancer Society has an excellent web site that explains HPV and its possible health effects in Iay terms. It's called “What Women Should Know about HPV and Cervical Health.” It's a good place to send patients for more information.

Additional Information:

CDRH Consumer Information on: Digene Hybrid Capture 2 High-Risk HPV DNA Test.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm082556.htm



FDA Patient Safety News is available at www.fda.gov/psn