Serevent FDA Information
FDA Drug Information Facts
SEREVENT (Salmeterol) FDA INFORMATION
The FDA issued several warnings concerning Serevent related side effects. The links below will redirect you to these warnings on the FDA website.
Quick Facts
Serevent Reference Guide
Generic Name
Salmeterol xinafoate
Date Approved
May 21, 1998
Manufacturer
Glaxo
Status
Black Box Warning 7/12/05
Approved Uses
Asthma
Serious Side Effects
Asthma-related fatalities
Related Topics
Advair
Foradil
Asthma
Defective Drugs
Diseases
Salmeterol xinafoate
Date Approved
May 21, 1998
Manufacturer
Glaxo
Status
Black Box Warning 7/12/05
Approved Uses
Asthma
Serious Side Effects
Asthma-related fatalities
Related Topics
Advair
Foradil
Asthma
Defective Drugs
Diseases
Injured by Serevent?
David Graham, the FDA researcher who questioned Vioxx's safety before it was recalled has recently raised safety concerns about Serevent. Recently a warning was added to Serevent concerning asthma-related fatalities in studies. Data from a large placebo-controlled US study that compared the safety of Serevent (Generic: Salmeterol) and a placebo showed an increase in asthma-related deaths in patients receiving Serevent. In patients taking Serevent there were 13 deaths out of 13,176. In patients taking the placebo there were only 3 of 13,179.
Serevent Label Update
The label for Serevent has been updated with a warning stating that the drug can increase the chance of severe asthma attacks that can result in death. The Food & Drug Administration (FDA) made this announcement on May 16, 2006.
If you or a loved one took Serevent and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.
SereventRSS Feed
FDA Seeks to Limit Use of Serevent, Advair, Symbicort and Foradil
Feb 19, 2010 | Parker Waichman Alonso LLP
U.S. regulators want to limit the use of Serevent, Advair, Symbicort and Foradil. The four drugs, part of a class of asthma medications known as long-acting beta agonists (LABAs), are being subjected to new restrictions, the U.S. Food & Drug Administration (FDA) has announced. These drugs are approved to treat both people with asthma or with chronic obstructive pulmonary disease (COPD). The new recommendations announced by the FDA only apply to the use of LABAs in the treatment of...
FDA Panel Wants Restrictions on Two Asthma Drugs
Dec 12, 2008 | Parker Waichman Alonso LLP
A U.S. Food and Drug Administration (FDA) panel has called for restrictions on two asthma treatments: Serevent and Foradil. Both belong to a class of drugs known as long-acting beta-agonists. Both contain a drug that relaxes muscles around airways, said WHEC TV, but may also mask symptoms that can prompt deadly asthma attacks. Although the expert 27-member panel found Serevent and Foradil drugs present greater risks than benefits and should not be used in the...
FDA Considers Heart Risks of Serevent, Foradil, Advair and Symbicort
Dec 11, 2008 | Parker Waichman Alonso LLP
One expert estimates that long-acting beta-agonists (LABAs) - a class of asthma drugs that includes Serevent, Foradil, Advair, and Symbicort - might be responsible for about 14,000 deaths, Reuters is reporting. The comments were part of a confrontational meeting between the U.S. Food and Drug Administration (FDA) and an advisory panel discussing how to handle increased risks experienced with the inhaled asthma medications called LABAs, said Reuters, LABAs are used by millions of...
Complications, Deaths Seen with Some Long-Acting Asthma Drugs
Dec 5, 2008 | Parker Waichman Alonso LLP
Some asthma drugs in a class known as long-acting beta agonists (LABA) can increase the risk of death and complications, a new Food & Drug Administration (FDA) analysis has found. The analysis looked at GlaxoSmithKline PLC's Serevent and Advair, Novartis AG's and Schering-Plough Corp.'s Foradil and AstraZeneca PLC's Symbicort.The FDA analysis was prepared for an advisory committee meeting next week that is slated to discuss the safety of the drugs, The Wall Street Journal...
Asthma Med Serevent Linked to Serious Adverse Events, Death
Jul 18, 2008 | Parker Waichman Alonso LLP
Researchers have just revealed that patients with chronic asthma who take the asthma medication Serevent—also known generically as Salmeterol—on a daily basis are at increased risk for serious adverse events, including deathThe research involved a 12-week review of 32 clinical trials that involved 62,630 patients. In addition to pointing to serious adverse events with daily Serevent use, the research findings also suggest that the collaborative use of inhaled corticosteroids...