Asthma Drugs Too Dangerous For Kids: FDA

[Hannah Bell]

// December 5th, 2008 // 5:24 pm

In an advance of an advisory committee meeting next week, FDA staffers are recommending approval be withdrawn for several asthma meds known as long-acting beta agonists, or LABAs, for children younger than 18 years old, due to an increased risk of asthma-related deaths and attacks (back story here and here on FDA concerns and requests for more data).

The drugs include Glaxo’s Advair and Serevent, AstraZeneca’s Symbicort and Novartis’ Foradil, which Schering-Plough markets in the US. The FDA staffers, in fact, also urge yanking approval of Serevent and Foradil for asthma in people of all ages and question whether LABAs should still be approved for treating ashtma (these are the FDA briefing materials). Serevent and Foradil contain LABAs only, while Advair and Symbicort combine LABAs with an inhaled steroid.

An FDA meta-analysis of 110 trials involving 60,954 patients found the risk “was not apparent” in Advair or when a LABA was used with a steroid, according to agency documents. Kids between 4 and 11 years old appear to be at greatest risk, African Americans had elevated risks relative to other races and women had elevated risks compared with men. Advair, by the way, is Glaxo’s best-selling drug.

http://www.pharmalot.com/page/4/

[HysteryDiagnosis]

1. Life Extension Foundation Protocol, to POTENTIALLY REDUCE

the amount of medication necessary. Much more at link:


http://www.lef.org/protocols/respiratory/asthma_01.htm


Butterbur: An Herbal Approach to Asthma

Butterbur (Petasites hybridus) is a perennial shrub that has been used since ancient times to treat a variety of conditions. As far back as the 17th century, butterbur was used to treat cough, asthma, and skin wounds (MMWR 2001). Today, researchers have uncovered the mechanism of action that makes butterbur effective.

Scientists have identified and isolated the compounds in butterbur that help reduce symptoms in asthma. Called petasins, these chemicals inhibit leukotrienes and histamines, which are responsible for symptom aggravation in asthma (Thomet OA et al 2002).

So far, a few research teams have examined butterbur’s effectiveness in asthmatics, with encouraging results. In one open trial of 64 adults and 16 children and adolescents, asthma patients were treated for two months with butterbur extract, followed by an optional two-month open trial. They were measured throughout the study for the severity and frequency of asthma attacks. According to researchers, all the measured symptoms improved throughout the study, and 40 percent of patients were able to reduce their intake of traditional asthma medications (Danesch UC 2004).

Another study examined butterbur in conjunction with inhaled corticosteroid therapy. In this trial, 16 asthmatics were given butterbur or placebo while they continued their constant dose of inhaled steroid medications. Butterbur therapy, at 50 mg daily, was shown to reduce several measures of symptoms, leading researchers to conclude that butterbur is an effective adjunct therapy to corticosteroids. They called for further study of butterbur as a stand-alone therapy for mild asthmatics, who might be able to forgo their prescription medications (Lee DK et al 2004).
Antioxidant Therapy

Researchers are also finding that antioxidants have the unique power to reduce lung and bronchial damage in people with asthma. The lungs are at particular risk for oxidative damage because their primary function is the exchange of oxygen and waste gases. Antioxidants protect the body’s tissues by scavenging oxidant molecules and rendering them less harmful. Antioxidants can be ingested, as in the case of vitamin C, or produced internally, as in the case of glutathione.

Nutritional approaches, although often slow to act in advanced disease, can enhance the effect of medical therapy by interfering with the inflammatory process and reducing oxidation, thereby potentially reducing the need for higher doses of medication. However, patients should always consult a physician before changing their diet or medication therapy.

Antioxidants (vitamins C, E, and A). A number of studies have suggested that consuming antioxidants such as vitamins C, E, beta-carotene, flavonoids, selenium, and other nutrients reduces the risk of bronchoconstriction associated with asthma.

For instance, studies have shown that vitamin C and possibly vitamin E supplementation can alleviate the severity of asthma symptoms (Ford ES et al 2004; Rubin RN et al 2004; Wijnhoven HA et al 2003; Trenga CA et al 2001; Fogarty A et al 2000; Hijazi N et al 2000; Seaton A et al 2000). Dietary supplementation with vitamin C and vitamin A (the substances that give fruits and vegetables their color) has also been associated with reduced susceptibility to asthma attacks. Other studies have demonstrated that vitamin C or E supplementation may be a valuable addition to the treatment of patients with allergic rhinitis (otherwise known as hay fever) and asthma.

[mopinko]

2. butterbur is an effective adjunct therapy to corticosteroids

effective adjunct to something already proven effective on it's own. so what does that mean? this whole article is a primer on bullshit languauge.

[trotsky]

3. LEF is a "health magazine" front for a supplement pusher.

What do you expect?

[mopinko]

4. aha

get it. why don't other people see through that language?

[cosmik debris]

6. That poster believes every sales pitch he reads

Whether it is cars that run on water or herbs that make you live longer, he never doubts a sales pitch.

[mopinko]

7. i know

the reason i don't usually even bother to read here. but, i figured i would try to wade through the dreck for a while and see if it was worth it.

[mopinko]

5. you know

one of the things i look forward to most about a real health care system in this country is that i think this whole "alternative medicine" industry will be belly up in a year or 2. it is only alternative to being able to go to a real doctor.

[trotsky]

8. Oh there will always be a market for snake oil.

Of that I have no doubt. Look at the anti-government wackos out in the mountain west - there was that one state senator who took collodial silver and turned his skin blue. He's certainly not going to trust any treatment covered by the government!

[mopinko]

9. yeah, but it won't be the same.

not that many companies are going to be able to stay in business serving hermits in the mountains. bring it on.

[HysteryDiagnosis]

10. Heh.... now that is pretty funny....

http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6T1J-4SYCPX7-4&_user=10&_rdoc=1&_fmt=&_orig=search&_sort=d&view=c&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=9d2048108aa36ed58b2fc351e8a371bc

S-petasin and butterbur lactones dilate vessels through blockage of voltage gated calcium channels and block DNA synthesis
Purchase the full-text article



References and further reading may be available for this article. To view references and further reading you must purchase this article.

Majid Sheykhzadea, Sanela Smajilovicc, d, Ali Issaa, b, Stig Haunsoc, d, Søren Brøgger Christensenb and Jacob Tfelt-Hansenc, d, Corresponding Author Contact Information, E-mail The Corresponding Author

aDepartment of Pharmacology and Pharmacotherapy, Faculty of Pharmaceutical Sciences, University of Copenhagen, Copenhagen, Denmark

bDepartment of Medicinal Chemistry, Faculty of Pharmaceutical Sciences, University of Copenhagen, Copenhagen, Denmark

cLaboratory of Molecular Cardiology, Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Denmark

dThe Danish National Research Foundation Centre for Cardiac Arrhythmia (DARC), Copenhagen, Denmark

Received 5 March 2008;
revised 23 June 2008;
accepted 5 July 2008.
Available online 10 July 2008.

Abstract

Eremophilanlactones isolated from roots of Petasites hybridus (L.) G.M. et Sch. (Asteraceae) and S-petasin have vasodilatory effects with pD2 − log (EC50) values of 6.01 ± 0.08, 5.24 ± 0.10, 4.74 ± 0.13, and 5.43 ± 0.06 for S-petasin, the (Z)-3-methylthioacrylic ester of 2β-hydroxy-8βH-7(11)-eremophilene-12,8-olide, the angelic ester of 2β-hydroxy-8αH-7(11)-eremophilene-12,8-olide, and the angelic ester of 2β-hydroxy-8βH-7(11)-eremophilene-12,8-olide, respectively, in the mesenteric arteries. The pD2 values were somewhat lower for all compounds in aortic segments. The vasodilation was caused by a blockage of the voltage gated calcium channels. S-petasin, (Z)-3-methylthioacrylic ester of 2β-hydroxy-8βH-7(11)-eremophilene-12,8-olide, and the angelic ester of 2β-hydroxy-8αH-7(11)-eremophilene-12,8-olide displayed similar potencies in inhibiting DNA synthesis in cardiomyocytes and vascular smooth muscle cells.

Keywords: Petasites hybridus; Vasodilatation; Vascular smooth muscle cells; Cardiomyocyte
Article Outline

1. Introduction
2. Materials and methods

2.1. Drugs
2.2. Extraction and isolation of compounds 2, 3, and 4
2.3. Vessel preparation and measurement of force development
2.4. Experimental protocol

2.4.1. Experimental protocol 1
2.4.2. Experimental protocol 2

2.5. Cultures of vascular smooth muscle cells (VSMC)
2.6. Neonatal ventricular myocyte culture
2.7. DNA synthesis assay
2.8. Data analysis

3. Results

3.1. Concentration–response curves with S-petasin, compounds 2, 3, and 4 in isolated vessels
3.2. Effect of endothelium
3.3. Effect of pretreatment with thapsigargin
3.4. Concentration–response curves with extracellular calcium in KPSS-depolarised arteries
3.5. Effect of S-petasin, compounds 2, 3, and 4 on DNA synthesis in primary cell cultures

4. Discussion

4.1. Concentration–response relationships and effect on the calcium sensitivity
4.2. Role of endothelium and intracellular calcium storage site
4.3. Vessel size and potency of compounds
4.4. Effect of compounds on DNA synthesis
4.5. Summary

Acknowledgements
References



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Fig. 1. S-petasin (1) and eremophilanolides isolated from Petasites hybridus.

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Fig. 2. A and B. A: Concentration–relaxation curve of S-petasin, 2, 3, and 4 in endothelium-intact rat mesenteric arteries precontracted with KPSS (125 mM K+). B: Concentration–relaxation curve of S-petasin 2, 3 and 4 in endothelium-intact rat aortic segments precontracted with KPSS (125 mM K+).

View Within Article

[HysteryDiagnosis]

11. What it means is that if something that harms your body in

extreme ways... can be reduced in dosage by using adjunctive measures that do not harm your body.... then you have made a smart move AND have reduced the odds of falling ill from side effect A-Z.