miércoles, 29 de febrero de 2012

Drug Information Update- New FDA Drug Info: Drug Safety Podcasts for Healthcare Professionals

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

FDA Drug Info has posted new Drug Safety Podcasts for Healthcare Professionals. Click on the following links to read transcripts and listen to podcasts.

Important drug interactions between Victrelis (boceprevir) and ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitor drugs
Drug Safety Podcasts > FDA Drug Safety Podcast for Healthcare Professionals: Important drug interactions between Victrelis (boceprevir) and ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitor drugs
Clostridium difficile-associated diarrhea can be associated with stomach acid drugs known as proton pump inhibitors (PPIs)
Drug Safety Podcasts > FDA Drug Safety Podcast for Healthcare Professionals: <em>Clostridium difficile</em>-associated diarrhea can be associated with stomach acid drugs known as proton pump inhibitors (PPIs)

FDA Drug Safety Podcast for Healthcare Professionals: Important drug interactions between Victrelis (boceprevir) and ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitor drugs

Narrator: Welcome to the FDA Drug Safety Podcast for Healthcare Professionals from the Division of Drug Information. Today’s topic: Important drug interactions between Victrelis (boceprevir) and ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitor drugs

Steve Jackson, a pharmacist in the Division, will provide you with additional information about this Communication.

Guest Speaker: On February 8, 2012, the Food and Drug Administration issued a Drug Safety Communication notifying healthcare professionals and patients that drug interactions between the hepatitis C virus, or HCV protease inhibitor Victrelis and the ritonavir-boosted HIV protease inhibitors atazanavir, lopinavir, and darunavir, can potentially reduce the effectiveness of these medicines when they are used together.

Patients should not stop taking any of their medications without talking to their healthcare professional. Patients should contact their healthcare professional if they have any questions or concerns.

Healthcare professionals who have started patients infected with both chronic HCV and HIV on Victrelis and antiretroviral therapy containing a ritonavir-boosted protease inhibitor should closely monitor patients for HCV treatment response and for potential HCV and HIV virologic rebound.

A drug interaction study showed that taking Victrelis with Norvir in combination with Reyataz or Prezista, or with Kaletra reduced the blood levels of the HIV medicines and Victrelis in the body. FDA will be updating the Victrelis drug label to include information about these drug interactions.

Merck and Company has issued a Dear Healthcare Professional letter (PDF - 67KB)² with information about this drug interaction study.

At this time FDA recommends that Healthcare Professionals be aware that:

Drug interactions between Victrelis and ritonavir-boosted atazanavir, lopinavir, and darunavir can potentially reduce the effectiveness of these medicines when co-administered.
Healthcare professionals who have initiated Victrelis in combination with peginterferon alfa and ribavirin in HIV-HCV co-infected patients on fully suppressive antiretroviral therapy containing a ritonavir-boosted protease inhibitor should discuss these findings with those patients, and closely monitor those patients for HCV treatment response and for potential HCV and HIV virologic rebound.
Victrelis and Incivek were approved in May, 2011, each in combination with peginterferon alfa and ribavirin for treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease. Neither NS3/4A protease inhibitor is approved for treatment of patients co-infected with HIV. Drug interaction data with Incivek and ritonavir-boosted HIV protease inhibitors can be found in the Incivek drug label. Information about clinical trials in HIV-HCV co-infected patients can be found at ClinicalTrials.gov.
Adverse events involving Victrelis or HIV protease inhibitors should be reported to the FDA MedWatch program at www.fda.gov/medwatch³.

Narrator: Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. A link to this communication, including the complete Data Summary, can be found at www.fda.gov/DrugSafetyCommunications⁴. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

Related Information

FDA Drug Safety Podcast for Healthcare Professionals: Clostridium difficile-associated diarrhea can be associated with stomach acid drugs known as proton pump inhibitors (PPIs)

Welcome to the FDA Drug Safety Podcast for Healthcare Professionals from the Division of Drug Information. Today’s topic: Clostridium difficile-associated diarrhea can be associated with stomach acid drugs known as proton pump inhibitors (PPIs)

I’m Steve Jackson, a pharmacist in the Division.

On February 8, 2012, the Food and Drug Administration issued a Drug Safety Communication informing the public that the use of stomach acid drugs known as PPIs may be associated with an increased risk of Clostridium difficile–associated diarrhea, also known as CDAD. A diagnosis of CDAD should be considered for patients taking PPIs who develop diarrhea that does not improve.

Patients should immediately contact their healthcare professional and seek care if they take PPIs and develop diarrhea that does not improve.

Clostridium difficile is a bacterium that can cause diarrhea that does not improve.Symptoms include watery stool, abdominal pain, and fever, and patients may go on to develop more serious intestinal conditions. The disease can also be spread in the hospital. Factors that may predispose an individual to developing CDAD include advanced age, certain chronic medical conditions, and taking broad spectrum antibiotics. Treatment for CDAD includes the replacement of fluids and electrolytes and the use of special antibiotics.

The FDA is working with manufacturers to include information about the increased risk of CDAD with use of PPIs in the drug labels.

FDA is also reviewing the risk of CDAD in users of histamine H₂ receptor blockers. H₂ receptor blockers are used to treat conditions such as gastroesophageal reflux disease, stomach and small intestine ulcers, and heartburn. H₂ receptor blockers are marketed under various brand and generic drug names as prescription and OTC products.

Today's communication is in keeping with FDA's commitment to inform the public about the Agency's ongoing safety review of drugs. FDA will communicate any new information on PPIs or H₂ receptor blockers and the risk of CDAD when it becomes available.

At this time, FDA recommends that Healthcare Professionals be aware that:

A diagnosis of CDAD should be considered for PPI users with diarrhea that does not improve.
Patients should be advised to seek immediate care from a healthcare professional if they experience watery stool that does not go away, abdominal pain, and fever while taking PPIs.
Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
Adverse events involving PPIs should be reported to the FDA MedWatch program at www.fda.gov/medwatch².

Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. A link to this communication, including the complete Data Summary and Tables, can be found at www.fda.gov/DrugSafetyCommunications³. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.