Asthma Meds - Asthma Meds Draw FDA Scrutiny

The Food and Drug Association has sifted the data on a handful of asthma meds such as GlaxoSmithKline's Serevent and Advair, Novartis and Schering-Plough's Foradil, and AstraZeneca's Symbicort and found out a link between the drugs and a higher risk of asthma-related side effects. Already these drugs, known as long acting beta-agonists, carry a "black box" warning that they may boost the risk of asthma-related death. The FDA has asked these drug makers for clinical data on the meds. Compared with treatment with other asthma drugs, this class of meds is associated with a greater risk of asthma-related death, asthma-related intubations, and asthma-related hospitalization.

The FDA will continue its safety review to determine if there is a link between the asthma medications and mood or behavior changes. The medicine inside these rescues inhalers — the albuterol that promptly opens airways during an asthma attack — isn't changing. But the chemicals used to gust that drug into your lungs are. Very soon all albuterol inhalers must be power-driven by the more eco-friendly chemical HFA, or hydrofluoroalkane.

But the new inhalers cost more for the disappearing generic CFC inhalers. Patients can face a learning curve. HFA inhalers must be used in a different way than the old-fashioned kind. The medicine feels and tastes unusual, sometimes frightening new users despite doctors' assurance that it works just as well.

Calls from parents uncertain how to use the new inhalers, or even what they are, have increased as more drug stores run out of CFC-powered inhalers and involuntarily switch people who'd been expecting a mere refill. The alteration shouldn't be a surprise. The Food and Drug Administration has long warned about its coming, and lung specialists have spent the past year lessening many of the nation's 20 million asthma patients as well as millions of emphysema victims who also use albuterol to ease breathing.

Some patients may with determination be buying up cheaper CFC inhalers before the sales ban. Albuterol inhalers are for emergency, for quick relief from wheezing. Patients also need every day medication to control their asthma and thwart flare-ups. The new inhalers haven't been accepted by all patients suffering from asthma and it may take time for them to overcome this change. Doctors are assuring their patients that these new inhalers are far more better than the previous ones but it is completely on the patients and their psychological thinking if they will readily accept it or not.

The FDA is giving a second glance at the safety of three asthma drugs used for kids: GlaxoSmithKline's Serevent and Advair, and Novartis' Foradil. Serevent and Advair contain the vigorous ingredient salmetrol. This so-called beta agonist helps to foil asthma attacks in most kids, but paradoxically enough can cause harsh attacks in a small number of children that can be fatal. FDA staff is recommending a formal review of the data on salmetrol sp as to avoid harsh results amongst children.

The FDA has enquired the makers of several beta agonist drugs for more data from clinical trials so they can further increase the safety of these drugs when used to treat asthma. Once the data is collected, the agency can convene an advisory panel to evaluate the safety risks. In 2005, FDA had informed the healthcare professionals and patients that the drugs might increase the risk of worsened wheezing in some patients.

• John Palsson
• 27/03/2009, 10:59 AM
• 0 Comments