Source Pravda.Ru

FDA Scrutinizes Side Effects of Asthma Drug

The Food and Drug Administration announced Thursday it is conducting a safety review of the asthma drug Xolair after data from an ongoing study suggested an increased number of heart attacks and strokes among patients who use it.

The drug, made by Genentech and co-marketed by  was approved in 2003. The study, which started in 2004 and is slated to end in 2012, was mandated by the agency as part of its post-approval process, CNN reports.

The data from the trial was supplied to the FDA by Genentech, the maker of Xolair. The trial includes some 5,000 patients taking the drug and an additional 2,500 patients who are not using Xolair, according to the FDA.

Xolair, which is given by injection, is used for those people whose asthma is not controlled by inhaled corticosteroids.

Currently, the FDA is not telling people using Xolair to stop taking the drug. However, the agency believes patients and doctors should be aware of potential problems when taking the drug, including the possible risk of heart attack and stroke, Pediatric SuperSite reports.

Meanwhile a spokeswoman for South San Francisco-based Genentech said the company and partner Novartis are "committed to patient safety," and will continue gathering safety information about the drug. No changes are planned for the drug's labeling, The Associated Press reports.

Comments
Russian Defense Minister speaks about war with Ukraine, US and fight for Crimea
Russian Defense Minister speaks about war with Ukraine, US and fight for Crimea
Russian Defense Minister speaks about war with Ukraine, US and fight for Crimea
Ukraine dreams of what it can do to Crimea after winning war with Russia
Default more likely to hit American, rather than Russian economy
The Sham called Democracy
The Sham called Democracy
Russian woman killed when hanging out naked of moving car in Dominican Republic
Pilot shares his impressions after flying Su-57 fifth-generation fighter
Russian government prepares to get rid of US dollar in economy
Putin in Austria: Europe doesn't like Russia very much, but it is fed up with USA too
US-Russian confrontation: War is peace, freedom is slavery
Details of Putin-Merkel surprise meeting unveiled
Russia's long-range Bastion system follows USS Carney in Black Sea waters
The insane idea in Germany: "pedophilia normal love"
US sanctions to kill Russian banks and sovereign debt?
Will Smith tells of his trip to Russia in a video
Why Russia continues investing in US public debt
USA and Turkey: The elephant kicks the barking pug aside
In Ukraine, human organs don't stink
US-Russian confrontation: War is peace, freedom is slavery