Category Archives: adverse events

FDA Probing Possible Link Between Asthma Drug and Suicide Risk

Posted on March 28, 2008 by continuum wellness| 3 Comments

FDA is investigating a possible association between the use of Singulair and behavior/mood changes, suicidality (suicidal thinking and behavior) and suicide. Singulair is a medicine in the drug class known as leukotriene receptor antagonists. Singulair is used to treat asthma and the symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of the nose) and to prevent exercise-induced asthma.

Over the past year, the maker of Singulair, Merck & Co, Inc., has updated the prescribing information and patient information for Singulair to include the following post-marketing adverse events: tremor (March 2007), depression (April 2007), suicidality (suicidal thinking and behavior) (October 2007), and anxiousness (February 2008).

In February 2008, FDA and Merck discussed how best to communicate these labeling changes to prescriber’s and patients. Merck plans to highlight the recent changes in the prescribing information in face-to-face interactions with prescriber’s and provide prescriber’s with patient information leaflets about Singulair. The Singulair website includes the most current prescribing information and patient information for Singulair (www.singulair.com).

FDA is working with Merck to further evaluate a possible link between the use of Singulair and behavior/mood changes, suicidality and suicide in response to inquiries received by FDA. FDA has requested that Merck evaluate Singulair study data for more information about suicidality and suicide. FDA is reviewing the postmarketing reports it has received of behavior/mood changes, suicidality and suicide in patients who took Singulair.

Due to the complexity of the analyses, FDA anticipates that it may take up to 9 months to complete the ongoing evaluations. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public.

Other leukotriene modifying medications include zafirlukast (Accolate), which is also a leukotriene receptor antagonist and zileuton (Zyflo and Zyflo CR), which is a leukotriene synthesis inhibitor. FDA is reviewing postmarketing reports it has received of behavior/mood changes, suicidality and suicide in patients who took Accolate, Zyflo, and Zyflo CR and will assess whether further investigation is warranted.

This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs.

The FDA urges both healthcare professionals and patients to report side effects from the use of Singulair, Accolate, Zyflo, and Zyflo CR to the FDA’s MedWatch Adverse Event Reporting program

Posted in adverse events, allergies, asthma, common cold, depression, drugs, FDA, mood changes, side effects, Singulair, suicide

Influenza Vaccine in Infants Younger Than 6 Months of Age

Posted on March 27, 2008 by continuum wellness| Leave a comment

This study, see below, assesses the need for infants less than 6 months old to receive influenza vaccine. The study is funded, designed and carried out by a vaccine manufacturer. Bias could be construed in the entire study.

There is on going discussion of how allergic reactions continue to rise in the population. Overuse of antibiotics is seen as a contributing factor (mind you, they were once hailed as ‘wonder drugs’), could the indiscriminate use of vaccines also be a contributing factor? The entire human race has lived without the need of vaccines at birth and throughout life at least since recorded history. Young children used to get sick and there is evidence it made them healthier. Mumps, measles, chicken pox were for the most part lived through. The body developed immunity against the ailment and life went on. Now, it is seen as a constant source of fear and on going threat. Why?
Here is the ‘study’ why healthy infants need influenza vaccine:

Safety and Tolerability of Cold-Adapted Influenza Vaccine, Trivalent, in Infants Younger Than 6 Months of Age

Timo Vesikari, MDa, Aino Karvonen, MDa, Helen M. Smith, BScb, Andrew Dunning, PhDc, Ahmad Razmpour, PhDc, Melanie K. Saville, MB, BSb, William C. Gruber, MDc and Bruce D. Forrest, MDc a Vaccine Research Center, University of Tampere Medical School, Tampere, Finland
b Wyeth Vaccines Research, Taplow, United Kingdom
c Wyeth Vaccines Research, Pearl River, New York

OBJECTIVE. Young children are at high risk for influenza-related complications. Vaccination of close household contacts is recommended to provide indirect protection to children <6 months of age. Studies have shown that live, cold-adapted influenza vaccine, trivalent, is efficacious in children. To assess the risks associated with inadvertent exposure of infants to vaccine viruses from vaccinated contacts, this study was designed to evaluate the safety and tolerability of cold-adapted influenza vaccine, trivalent, administered intranasally to healthy children 6 to <24 weeks of age.

METHODS. Healthy infants aged 6 to <16 weeks and 16 to <24 weeks, respectively, were randomly assigned to receive 2 doses of influenza vaccine, or placebo intranasally 35 ± 7 days apart. Reactogenicity events were monitored for 11 days after each dose. Other adverse events were monitored through 28 to 35 days after dose 2.

RESULTS. Of the infants aged 6 to <16 weeks, 31 received influenza vaccine and 28 received placebo, and of those aged 16 to <24 weeks, 30 received influenza vaccine and 31 received placebo. In the 6- to <16-week cohort, more influenza vaccine, recipients experienced irritability (66.7% vs 35.7%) and runny nose or nasal congestion (63.3% vs 33.3%) after dose 1 but not dose 2. There were no significant increases in any other reactogenicity events or adverse events in the vaccine recipients compared with the placebo group.

CONCLUSIONS. Although there was an increase in mild reactogenicity events in children 6 to <16 weeks of age, cold-adapted influenza vaccine, trivalent, was generally well tolerated in infants 6 to <24 weeks of age. These findings support further evaluation of cold-adapted influenza vaccine, trivalent, in infants <6 months of age.

Posted in adverse events, allergies, Health, health beliefs, health care, infants, influenza vaccine, Uncategorized, vaccination, vaccines