FDA looks into Singulair, risks of suicidal thoughts

[Celebration]

http://www.usatoday.com/money/industries/health/2008-03-27-suicide-link_N.htm

The Food and Drug Administration is investigating anecdotal reports that people who use Singulair, the popular asthma and allergy drug, are at greater risk for suicidal thoughts and suicide.

Singulair is a pill prescribed to treat asthma and hay fever symptoms such as sneezing and a nose that is stuffy, runny or itchy. It blocks an inflammation pathway in the body that can cause both asthma and allergy symptoms.

It was approved for treating asthma in 1998 and to treat seasonal allergy symptoms in 2003.

In the past year, drugmaker Merck (MRK) of Whitehouse Station, N.J., has added tremors, depression, suicidal thinking and behavior, and anxiety to the list of possible adverse side effects it gives doctors about the drug.

[HysteryDiagnosis]

1. Another option:

You can find authentic pycnogenol at GNC, Vitaminshoppe, and most reputable health food stores across the country.


1: J Med Food. 2001 Winter;4(4):201-209.Click here to read Links
Pycnogenol((R)) in the Management of Asthma.
Hosseini S, Pishnamazi S, Sadrzadeh SM, Farid F, Farid R, Watson RR.

College of Public Health and School of Medicine, The University of Arizona, 1501 N. Campbell Ave., Tucson, AZ 85724.

Asthma is characterized as a chronic inflammatory process. Pycnogenol((R)), a bioflavonoid mixture extracted from Pinus maritima, is known to scavenge free radicals while possessing antioxidant and antiinflammatory properties. The objective of this study was to evaluate the efficiency of this agent in a randomized, double-blinded, placebo-controlled, crossover study in patients with varying asthma severity. Twenty-six patients who fulfilled the American Thoracic Society criteria for asthma were enrolled in the study. Medical history, physical examination, blood sample analyses, and spirometric values were obtained at baseline, 4 weeks, and 8 weeks. The patients were randomly assigned to receive either 1 mg/lb/day (maximum 200 mg/day) Pycnogenol or placebo for the first period of 4 weeks and then crossed over to the alternate regimen for the next 4 weeks. No adverse effects were observed related to the study drug.

Within the contingent of 22 patients who completed the study, almost all responded favorably to Pycnogenol in contrast to placebo.

Pycnogenol treatment also significantly reduced serum leukotrienes compared with placebo. The results of this pilot study indicate that Pycnogenol may be a valuable nutraceutical in the management of chronic asthma. We recommend that further clinical trials be conducted in larger groups of asthmatics to establish its efficacy.

PMID: 12639402

1: J Asthma. 2004;41(8):825-32.Links
Pycnogenol as an adjunct in the management of childhood asthma.
Lau BH, Riesen SK, Truong KP, Lau EW, Rohdewald P, Barreta RA.

Division of Microbiology and Molecular Genetics, Department of Biochemistry and Microbiology, School of Medicine, Loma Linda University, Loma Linda, California 92350, USA. [e-mail]

A randomized, placebo-controlled, double-blind study involving 60 subjects, aged 6-18 years old, was conducted over a period of 3 months to determine the effect of Pycnogenol (a proprietary mixture of water-soluble bioflavonoids extracted from French maritime pine) on mild-to-moderate asthma. After baseline evaluation, subjects were randomized into two groups to receive either Pycnogenol or placebo. Subjects were instructed to record their peak expiratory flow with an Assess Peak Flow Meter each evening. At the same time, symptoms, daily use of rescue inhalers (albuterol), and any changes in oral medications were also recorded. Urine samples were obtained from the subjects at the end of the run-in period, and at 1-, 2-, and 3-month visits. Urinary leukotriene C4/D4/E4 was measured by an enzyme immunoassay. Compared with subjects taking placebo, the group who took Pycnogenol had significantly more improvement in pulmonary functions and asthma symptoms. The Pycnogenol group was able to reduce or discontinue their use of rescue inhalers more often than the placebo group. There was also a significant reduction of urinary leukotrienes in the Pycnogenol group.

The results of this study demonstrate the efficacy of Pycnogenol as an adjunct in the management of mild-to-moderate childhood asthma.

PMID: 15641632

[dropkickpa]

2. My allergies would be unmanageable without it

I take other things for my allergies too, but singulair was the thing that pushed me from "miserable, but not as much as before" to actually comfortable for the first time in years, if not ever. I've finally hit on a combination of drugs that allow me to function normally and actually feel good most of the time.

As with everything, you have to balance side effects and benefit, and everyone reacts differently to things, so while most may not get any side effects, some may, and they need to evaluate the benefit/risk for themselves. In the trials prior to approval, depression was NOT a reported effect. It was only after a much larger population started using it that this effect was reported by users.

[trotsky]

3. Oh look, the evil, corrupt, useless, under-the-control-of-bigpharma FDA...

is investigating (and REPORTING) on a possible side effect of a common drug!

If the FDA simply exists to rubber-stamp products and protect the drug industry, why do they publicize and conduct these investigations for us?

I've said it before and I'll say it again, thank goodness that with evidence-based medicine, at least there is a system in place to report side effects, investigate them, and remove a drug from the market if necessary.

[flamingyouth]

4. I've been on Singulair for two years.

It's helped my asthma tremendously. In fact, under normal circumstances I hardly even have an asthma attack anymore. (I've been battling the flu and bronchitis complications for the past few weeks and that's been another story...) I haven't had any side effects but sometimes I do have trouble sleeping, although I can chalk that up to about 1,000 other possible causes.