Navigation Links
FDA Announces Possible Safety Concern for HIV Drug Combination
Date:2/23/2010

Review of data indicating life-threatening heart abnormality underway

SILVER SPRING, Md., Feb. 23 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today announced preliminary data suggesting that Invirase (saquinavir) in combination with Norvir (ritonavir) may have potentially important adverse effects on the heart.

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

When used together, the drugs may cause prolongation of the QT and PR intervals on an electrocardiogram. Prolongation of the QT interval may lead to a condition known as torsades de pointes, an abnormal heart rhythm. Prolongation of the PR interval may also lead to an abnormal heart rhythm known as heart block. With torsades de pointes or with heart block, 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.

Review of the data is ongoing. Preliminary findings suggest that some patients using Invirase and Norvir may be at an increased risk for heart abnormalities leading to irregular heart rhythms. For example, the risk for torsades de pointes may be increased in patients who are also using medications known to cause a heart disturbance called QT interval prolongation. The risk may also be increased in patients who have a history of QT interval prolongation.

Patients using Invirase should talk to their health care professional about any questions or concerns they have about Invirase. 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 that was first approved in 1995. Invirase is used in combination with Norvir and other antiretroviral medicines to treat HIV in adults. Invirase does not cure HIV infection, may not prevent you from developing HIV-related illnesses, and may not prevent you from spreading HIV to other people.

This early communication is in keeping with FDA's commitment to inform the public about ongoing safety reviews of drugs. FDA will communicate its findings to the public as soon as the review is complete.

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

For more information:

FDA Drug Safety Communication: Ongoing safety review of Invirase (saquinavir) and possible association with abnormal heart rhythms

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm201221.htm

Drugs@FDA

http://www.fda.gov/Drugs/default.htm

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

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration

Back to top

RELATED LINKS
http://www.fda.gov/

'/>"/>

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

Related medicine technology :

1. Microfluidics International Corporation Announces Fourth Quarter and Year-End 2009 Financial Results
2. Jiangbo Pharmaceuticals Announces Conference Call to Discuss Results for Its Second Quarter of Fiscal Year 2010
3. Adamas Pharmaceuticals Announces In Vitro Data Demonstrating TCAD Therapy is More Potent Than Double Combinations or Monotherapy Against Drug-Resistant Flu Strains
4. Ethicon Endo-Surgery Announces Agreement with Hologic Inc. To Resolve Patent Disputes
5. Pioneer(R) Surgical Technology, Inc. Announces New CTO
6. Jazz Pharmaceuticals Announces FDA Acceptance of its New Drug Application for JZP-6 (sodium oxybate) for the Treatment of Fibromyalgia
7. Echo Therapeutics Announces Significant Product Development Milestone: The Completion of Next Generation Electronic Components for Its Revolutionary, Patented Symphony(TM) tCGM System
8. Transdel Pharmaceuticals Announces Management Reorganization
9. Solta Medical, Inc. Announces Fourth Quarter 2009 Results Release Date and Conference Call
10. Hollis-Eden Announces Name Change to Harbor BioSciences, Inc. and Ticker Symbol Change to HRBR
11. Sunridge Announces Marketing Roll Out of PNT in the Dominican Republic
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... Pa. , June 23, 2016 Bracket ... will launch its next generation clinical outcomes platform, Bracket eCOA ... Meeting held on June 26 – 30, 2016 in ... the first electronic Clinical Outcome Assessment product of its kind ... Booth #715. Bracket eCOA 6.0 is a flexible ...
(Date:6/23/2016)... and INDIANAPOLIS , June ... receiving a Lilly Diabetes Tomorrow,s Leaders Scholarship is any ... scholarship winners, announced today online at www.diabetesscholars.org ... type 1 diabetes stand in the way of academic ... supported the Foundation,s scholarship program since 2012, and continues ...
(Date:6/23/2016)... , June 23, 2016 Revolutionary ... Oticon , industry leaders in advanced audiology ... of Oticon Opn ™, the world,s first internet ... possibilities for IoT devices.      (Photo: ... introduces a number of ,world firsts,: , ...
Breaking Medicine Technology:
(Date:6/27/2016)... , ... June 27, 2016 , ... "FCPX editors can ... inside of Final Cut Pro X," said Christina Austin - CEO of Pixel Film ... Final Cut Pro X users can now reveal the media of their ...
(Date:6/27/2016)... ... June 27, 2016 , ... A revolution is underway. ... transport experience for the millions of people who require these medical transport services ... industry through the use of technology. Now, SmartEMS has put forth an industry-changing ...
(Date:6/26/2016)... ... 2016 , ... On June 10-11, 2016, A Forever Recovery, a holistic treatment ... Longest Breakfast Table in Battle Creek, MI, where the rehabilitation facility is located. This ... of the world’s leading providers of cereal and other breakfast foods. Its residents often ...
(Date:6/26/2016)... NC (PRWEB) , ... June 26, 2016 , ... Brent Kasmer, a legally blind and ... to be personalized through a fitness app. The fitness app plans to fix the two ... currently only offer a one size fits all type program , They don’t ...
(Date:6/25/2016)... ... 2016 , ... Austin residents seeking Mohs surgery services, can now turn to ... Dr. Russell Peckham for medical and surgical dermatology. , Dr. Dorsey brings specialization to ... fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was under the direction of ...
Breaking Medicine News(10 mins):