Navigation Links
FDA Probing Possible Link Between Asthma Drug and Suicide Risk

Singulair, top-selling drug for teens, under review by U.S. agency and manufacturer Merck

THURSDAY, March 27 (HealthDay News) -- The U.S. Food and Drug Administration said Thursday it was investigating the possibility of an increased risk of mood changes and suicidal behavior among those who take the highly popular asthma drug Singulair.

Singulair is the number one-selling drug among people aged 17 and younger. Last year, it posted sales of $4.3 billion, making it Merck & Co.'s top-selling product, according to the Associated Press.

In issuing its statement, the FDA stressed that asthma patients should not stop taking Singulair without talking to their doctor first.

Both Merck and the FDA noted that the two have been working together over the past year to determine the scope of the problem and to make appropriate labeling changes to reflect the potential risk of mood changes and suicidal behavior among Singulair users.

"Suicide has been reported to us only in post-marketing experience in anecdotal reports that come to the company," George Philip, head of Merck's Singulair development program, told Bloomberg News. The company declined to say how many suicides have been reported, saying only that it is a "very small number" relative to the amount of people taking the drug.

The company also released a statement Thursday that detailed the ongoing review.

"Singulair has been marketed in the U.S. for 10 years and millions of patients have been prescribed Singulair in the U.S. and around the world. Merck voluntarily updated the worldwide product label for Singulair in October 2007 to include 'suicidal thinking and behavior' and included similar changes to the patient product information," the company said in its statement. "These actions were based on a very limited number of post-marketing adverse event reports that Merck has received. Since that time, Merck has worked with the U.S. Food and Drug Administration to provide further clarity in the product label as well as to further communicate this information to physicians."

Over the past year, Merck has updated prescribing information for the drug to include information on several adverse events including tremor, depression, suicidality (suicidal thinking and behavior) and anxiousness, according to the FDA. And Merck plans to convey recent labeling changes in face-to-face meetings with prescribers and also in patient leaflets.

The FDA has asked Merck to look at Singulair study data for more information about suicidality and suicide. The agency itself is reviewing post-marketing reports of adverse events.

In its statement, Merck detailed the nature of those adverse events. "In a cumulative analysis recently provided to the FDA of Merck's randomized, double-blind, placebo-controlled clinical trials, which included over 11,000 adults and children in over 40 studies who were treated with Singulair, there were no reports of suicidal thoughts or actions and no completed suicides in the patients who received Singulair," the statement read. "Additionally, in a cumulative analysis recently provided to the FDA of Merck's randomized, double-blind, clinical trials that compared Singulair with other active agents to treat asthma [which included over 3,900 adults and children who were treated with Singulair and over 3,400 who were treated with other asthma therapies], there was one patient who attempted suicide who received Singulair, and there were three patients who attempted suicide who received other asthma therapies [including inhaled corticosteroids and long-acting beta-agonists]."

The FDA noted it was also looking into whether other related drugs, such as Accolate, Zyflo and Zyflo CR need to be investigated as well.

"Due to the complexity of the analyses," the FDA said, it anticipates that it may take up to nine months to complete the ongoing evaluations.

Experts pointed out that, in the meantime, asthma sufferers need to determine with their doctors whether Singulair is the best choice of treatment for them.

"[Patients need] to define what they're taking it for," said Dr. David Weldon, director of the Allergy and Pulmonary Lab Services at Scott & White in College Station, Texas. "In some instances, patients may be prescribed Singulair by itself for management of their asthma, and the expert panel guidelines recommend inhaled steroids as the drug of choice for management of asthma as the first line. So if they're still having problems with asthma, they should check with their prescribing physician regarding this."

Weldon added that he has not seen any increase in psychiatric problems with the drug, but that some patients had complained of nightmares after starting on Singulair.

The drug, a leukotriene receptor antagonist that targets part of the body's inflammatory process, is prescribed to treat asthma and the symptoms of allergic rhinitis, as well as to prevent exercise-induced asthma.

More information

Visit the FDA for more on this emerging issue.

SOURCES: David Weldon, M.D., assistant professor, internal medicine, Texas A&M Health Science Center College of Medicine and director, Allergy and Pulmonary Lab Services, Scott & White, College Station; March 27, 2008, statement, U.S. Food and Drug Administration; Bloomberg News; Associated Press

Copyright©2008 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Fairbank Farms Voluntarily Recalls 85% Ground Round Beef Patties Sold Fresh from Shaws Due to Possible Health Risk
2. M.D. Anderson-led team reports possible key to autoimmune disease
3. AHRQ and FDA to Collaborate in Largest Study Ever of Possible Heart Risks with ADHD Medications
4. Possible safer target for anti-clotting drugs found
5. Jefferson researchers uncover new evidence of prolactins possible role in breast cancer
6. Why it is impossible for some to just say no
7. Saving Millions of Childrens Lives Is Possible
8. Mayo Clinic Proceedings article explores possible link between obesity and viral infections
9. Mayo Clinic reports possible new therapy for patients with platinum-resistant ovarian cancer
10. Help for California Fire Evacuees Possible Through Partnership for Prescription Assistance
11. Mayo Clinic study points to a possible biomarker for colon cancer in people 50 and under
Post Your Comments:
Related Image:
FDA Probing Possible Link Between Asthma Drug and Suicide Risk
(Date:10/13/2015)... ... 2015 , ... Tempe Dental Care, a leading Tempe dentists’ office, celebrates offering ... dentistry for more than 5 years. A leading cause of emergency room visits, ... treatment is not timely. , Sedation dentistry provides an anxiety-free dental ...
(Date:10/13/2015)... ... ... According to an ESPN report published on October 1, Chicago ... him in the left eye during the first day of practice for the season ... of setbacks, including a knee injury that has interfered with his ability to stay ...
(Date:10/13/2015)... ... October 13, 2015 , ... ... developed valuable new strategies for enrolling and serving insurance consumers who do not ... health insurance and pay monthly premiums. In “Health Plan Engagement Strategies: The ABCs ...
(Date:10/13/2015)... ... October 13, 2015 , ... Just under three months ... eMarketing Concepts began a $1 promotion – effectively offering all of their services for ... within weeks the company was flooded with phone calls from interested buyers. As a ...
(Date:10/13/2015)... ... , ... The Bill Howe Family of Companies is an award winning HVAC ... remediation services. Family-owned and operated for 35 years, they have maintained value, ethics and ... two years in a row from the Union Tribune Reader’s Poll, a Healthiest Company ...
Breaking Medicine News(10 mins):
(Date:10/13/2015)... , Oct. 13, 2015  Asterias Biotherapeutics, ... with the UK-based Cell Therapy Catapult to advance ... Asterias, allogeneic dendritic cell immunotherapy. Under the agreement, ... manufacturing processes for AST-VAC2 to support advanced clinical ... --> --> The Cell ...
(Date:10/12/2015)... , Oct. 12, 2015 Given ... it is quite challenging to deliver an ophthalmic drug effectively ... overcome for a successful ocular drug delivery. These include dilution ... the lymphatic system of conjunctiva and drug permeation issues with ... the drug, in topical eye drops, is lost due to ...
(Date:10/12/2015)... Use this report to: - Learn about ... medical membrane devices market. - Analyze the present and ... membrane devices market including hemodialyzers, membrane oxygenators, intravenous infusion ... - Gain information on newly approved products, recalls and ... this report to: - Learn about the performance, the ...
Breaking Medicine Technology: