Navigation Links
New Label Changes for Commonly Prescribed HIV Drug Invirase
Date:10/21/2010

SILVER SPRING, Md., Oct. 21 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today announced that new safety information has been added to the label for the HIV antiviral drug Invirase (saquinavir), describing potentially life-threatening side effects on the heart when used with Norvir (ritonavir), another HIV antiviral medication.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

In February 2010, the agency warned patients and health care professionals that when used together, the two drugs could cause prolongation of the QT and PR intervals--indicators of heart rhythm activity seen on an electrocardiogram.

Prolongation of the QT interval may lead to a condition known as torsades de pointes, an abnormal heart rhythm. With torsades de pointes, patients may experience lightheadedness, fainting or abnormal heart beats. In some cases, torsades de pointes may progress to a life-threatening irregular heart beat known as ventricular fibrillation.

Prolongation of the PR interval may also lead to an abnormal heart rhythm known as heart block. With heart block, patients may experience lightheadedness, fainting or abnormal heartbeats.

The FDA is also requiring a medication guide for patients using Invirase that will describe these potential risks. Patients at greater risk of developing one of the serious heart events described above include those with underlying heart conditions or those that have existing heart rate or rhythm problems.

"These heart conditions could potentially be life-threatening and we want to assure that health care providers and patients are adequately informed of the risks," said Edward Cox, M.D., M.P.H, director, Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research. "Patients should talk to their doctor if they have any concerns about their treatment. Certain drugs may interact with Invirase and increase the risk of developing these side effects, so patients should be sure to tell their doctor about other medicines they may be taking, including non-prescription medicines, vitamins, and herbal supplements."

Patients and health care professionals should report any side effects from the use of Invirase to the FDA's MedWatch program: http://www.fda.gov/safety/MedWatch/default.htm

Invirase is an antiretroviral medication first approved in 1995, and used in combination with Norvir and other antiretroviral medicines to treat HIV in adults. Invirase does not cure HIV infection, may not prevent development of HIV-related illnesses and may not prevent the spread of HIV to other people.

Invirase is marketed by San Francisco-based Genentech, a subsidiary of the Roche Group. Norvir is marketed by Abbott Laboratories based in Abbott Park, Ill.

For more information:

FDA: Drug Safety Communication: Invirase labels now contain updated risk information on abnormal heart rhythms

http://www.fda.gov/Drugs/DrugSafety/ucm230096.htm

HHS: AIDS News and Resources

http://www.aids.gov/

Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Amgen to Review Results From TREAT and Propose Updates to ESA Labeling for Chronic Renal Failure Patients at an FDA Advisory Committee Meeting Today
2. Lead Plaintiffs Attorney In Forest Pharmaceuticals Case Says $313 Million Award Is Tip of the Iceberg of Future Off-Label Marketing Lawsuits
3. MAP Pharmaceuticals Announces All Non-Asthmatic Patients Complete Treatment in Open-Label Trial and Completion of Treatment in QT Trial for LEVADEX™ Clinical Program
4. Phase 3 Open-Label Study Comparing Tapentadol Extended Release Tablets to Oxycodone Controlled Release Tablets Published by Pain Practice
5. Teva Admits to Making False Statements in US Gianvi™ Label and Agrees to Corrective Measures
6. FRC Urges FDA to Reject New Abortion Drug Falsely Labeled as an Emergency Contraceptive
7. FDA Updates U.S. Product Labels for LABA-Containing Medications Including AstraZenecas SYMBICORT
8. GSK Announces Revised Product Labels for Serevent® and Advair®
9. FDA Approves Labeling Change for Vyvanse(R) (lisdexamfetamine dimesylate) Capsules CII to Include Supplemental Data Demonstrating Significant Efficacy at Two Hours Through 14 Hours After Administration in Adults with ADHD
10. Two Johnson & Johnson Subsidiaries to Pay Over $81 Million to Resolve Allegations of Off-Label Promotion of Topamax
11. Pharmaceutical Giant AstraZeneca to Pay $520 Million for Off-Label Drug Marketing
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/10/2016)... Inc. (Vanda) (NASDAQ: VNDA ), today announced financial ... year ended December 31, 2015. --> ... for Vanda with the continued growth of HETLIOZ in ... for Non-24," said Mihael H. Polymeropoulos, M.D., Vanda,s President ... product portfolio builds on this success and underscores Vanda,s ...
(Date:2/10/2016)... --> --> This press release is intended for U.S. ... Japan .  --> A separate press release has been prepared for ... continues to strengthen its presence in ... continues to strengthen its presence in Japan ... to strengthen its presence in Japan ...
(Date:2/10/2016)... A new report from business intelligence provider GBI Research - Alzheimer,s ... will more than double from just under $5 billion in 2014 to an ... 11%. Canada , France , ... , the UK, and Japan , and will primarily be ... Canada , France , Germany , ...
Breaking Medicine Technology:
(Date:2/10/2016)... ... 2016 , ... LaserShip, a regional parcel carrier that services the eastern U.S., ... last Friday in order to aid in the Flint water crisis. In 2014, LaserShip ... located in Clio, only 15 miles away from Flint. , “We have deep roots ...
(Date:2/10/2016)... ... February 10, 2016 , ... As part of its ongoing ... February 2016. Each webinar features a dynamic expert and thoughtful presentation to give ... patients and facilities. Both events are free to attend, but registration is ...
(Date:2/10/2016)... ... 10, 2016 , ... The Wickman Agency in Garland, TX ... local community. Pledging to select a new beneficiary every 60 days, the agency ... goal is to bring community awareness to important local causes by forming campaigns ...
(Date:2/10/2016)... ... ... Dr. Jessica Barron, of Barron Family Dental in Thornton, Colorado , is ... the North Metro Denver area. The new dental practice focuses on comfort where patients ... the most relaxing environment. , While some dental visits can create anxiety for patients, ...
(Date:2/10/2016)... ... ... Gout is like no other joint pain. It strikes suddenly, like flicking on ... redness. It is triggered by the crystallization of uric acid within the joints. It ... to the February 2016 issue of Harvard Men's Health Watch. , The large joint ...
Breaking Medicine News(10 mins):