Serevent Side Effects - Serevent Recall

Serevent Side Effects - Serevent Recall

When the asthma relief medication known as Serevent was approved by the FDA in 1994, the known Serevent side effects did not appear critical in nature. In fact, the Serevent side effects that were reported at the time by manufacturer GlaxoSmithKline were common to many drugs: dry mouth, mild anxiety, muscle cramps and joint pain. It was not until the FDA's concerns with the drug resulted in Glaxo conducting a 1996 study that anything serious was reported. During the study, which Glaxo cut short due to the seriousness of the health risks involved, 36 patients taking Serevent died from asthma attacks or had life-threatening attacks that are believed to be Serevent side effects.

If you or a loved one have taken Serevent and have suffered as a result of serious Serevent side effects or have concerns about a possible Serevent Recall; contact the Serevent lawyers of Ennis & Ennis, P.A. today to talk about the possibility of a Serevent lawsuit. Fill out our free, online case evalutation form or call us toll-free at: 1-800-856-6405.

While neither the FDA nor Glaxo is certain of the cause of these serious Serevent side effects, both insist that the benefits of the drug, used twice daily to help prevent and control asthma attacks, outweigh any of the potentially lethal Serevent side effects. The FDA has ordered that Glaxo include a warning regarding the Serevent side effects, both on the product packaging and in advertising. As yet, these warnings do not exist, and Glaxo has issued no projected date for the warnings to be included in ads and packaging. Meanwhile, Serevent side effects can lead to the asthma-related deaths of more than three times the number of patients who do not use Serevent. The risk of severe Serevent side effects is markedly higher for African-Americans than it is for Caucasians, and there is also a disparity in the number of deaths in patients who do not use a control drug to fight inflammation.

Serevent Warning - Black Box Warning

The Serevent Warning - black box warning was ordered by the FDA following a study in which 36 patients using Serevent to control their asthma symptoms either died or suffered life-threatening asthma attacks. GlaxoSmithKline, the manufacturer of Serevent, was directed to include a Serevent Warning - black box warning on all product packaging and in all advertising, warning potential and current patients about the lethal side effects of the drug.

The study that prompted the order for a Serevent Warning - black box warning was conducted in 1996 by Glaxo in response to FDA concerns about the asthma medication. Glaxo cut the study short once the nature of the potential side effects became obvious, but much of the data from the study is being used to determine the exact risks associated with Serevent. Of the patients in the study who had serious asthma-related incidents, several had to be intubated to open their airways, while others died. The chances for a serious attack appear to be significantly higher among the African-American population, a fact that may need to be included in the SereventWarning - black box warning. According to data from the study. More than three times the number of patients using Serevent suffered from serious asthma attacks than those patients who used an alternative medication or a placebo. The risks also seem to be increased among patients who do not use a companion drug to control inflammation.

Glaxo insists that the potential benefits of the drug outweigh any risks, and the FDA has agreed, even though it ordered the Serevent Warning - black box warning in February of 2003, simultaneously issuing a warning of its own about the complications and side effects that the drug may carry.

In 1994, the FDA approved Serevent, the brand name of a drug called salmeterol xinafoate, for the treatment of asthma, and later extended its use for the treatment of chronic obstructive pulmonary disease. Due to FDA concerns, drug manufacturer GlaxoSmithKline conducted a study in 1996 that reported a number of Serevent deaths from asthma attacks. The study was cut short by Glaxo, and the FDA issued a Serevent warning in February of 2003, stating that the risk of Serevent deaths was greater than asthma-related deaths among patients not using Serevent. Glaxo was ordered to place a Severent warning on all Serevent product packaging and in all advertising, explaining the potential risk of Serevent deaths. As of December 2003, no such warning exists on either the packaging or related advertising.

The nature and frequency of the Serevent deaths noted in the Glaxo study is alarming. 36 patients suffered life-threatening or lethal asthma attacks. Some of the patients required intubation and mechanical ventilation to survive. The risk of a Serevent death is triple the risk of an asthma-related death for patients who use an alternate medication or a placebo, although the chances of a Serevent death are decreased somewhat if the patient in question uses a companion medication to control inflammation. African-American are at a much higher risk of suffering a Serevent death than are patients of other races, although doctors are as yet unsure why this is so.

While the FDA and Glaxo both continue to insist that the benefits of Serevent outweigh all the potential Serevent risks, the fact remains that Serevent deaths are real and they continue to occur. If you or a loved one is using Serevent, you should discuss the chances of a Serevent death with your physician. Patients who believe that they are at an increased risk of Serevent death should not discontinue their use of the drug without first consulting their doctors. If a family member has been the victim of a Serevent death, or if you feel that you are in a high-risk category, contact an attorney who has experience representing the victims of Serevent deaths. You may have legal rights of which you are unaware, and compensation may be owed to you.

If you are currently taking Serevent and have concerns about its safety, you should consult with your doctor regarding your treatment options. Under no circumstances should you discontinue taking any medication, including Serevent, without first consulting with your doctor.