Parker Waichman LLP

Asthma Drugs Caution on Psychiatric Problems

  Asthma Drugs to Bear Caution. Singulair  (montelukast ) and other asthma medications known as leukotriene modifiers will carry a new precaution about their association with neuropsychiatric events, the Food & Drug Administration (FDA) has announced. According to the agency, it has received reports of agitation, aggression, suicidal thinking, suicide, depression, insomnia and irritability in […]

Asthma Drugs

 

Asthma Drugs to Bear Caution. Singulair  (montelukast ) and other asthma medications known as leukotriene modifiers will carry a new precaution about their association with neuropsychiatric events, the Food & Drug Administration (FDA) has announced.

According to the agency, it has received reports of agitation, aggression, suicidal thinking, suicide, depression, insomnia and irritability in patients taking leukotriene modifiers like Singulair.

Leukotrienes are chemicals the body releases in response to an inflammatory stimulus, such as when a person breathes in an allergen.  In addition to Singulair, other leukotriene modifiers include Accolate (zafirlukast)  and Zyflo and Zyflo CR (zileuton).

Singulair and Accolate are  leukotriene receptor antagonists that work by blocking leukotrienes. Zyflo and Zyflo CR are leukotriene synthesis inhibitors which work by stopping the formation of certain substances that cause swelling, tightening, and mucus production in the airways.

All of the drugs are approved to treat asthma, while Singulair is also  approved to treat the symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of the nose), and to prevent exercise-induced asthma.

The FDA had announced in March 2008 that it was reviewing the safety of  Singulair

As we reported previously, the FDA had announced in March 2008 that it was reviewing the safety of  Singulair because of reports linking it to neuropsychiatric events, including suicidal behavior. According to a posting on the agency’s website, the FDA completed its review in April.

As part of its review, FDA reviewed post-marketing reports and also requested that manufacturers submit all available clinical trial data for the medications. According to the FDA,  the post-market reports of patients on  Singulair and similar drugs included cases of neuropsychiatric events.

Some reports included clinical details consistent with a drug-induced effect.
In the clinical trial data submitted by manufacturers, neuropsychiatric events were not commonly observed, the FDA said.

However, according to the agency, the available data were limited because the trials were not designed to look for neuropsychiatric events.   Sleep disorders (primarily insomnia) were reported more frequently with all three products compared to placebo.

The agency said on Friday that  doctors and their patients should be aware that  mental issues could arise in patients taking leukotriene modifiers and consider discontinuing the drugs if patients develop psychiatric symptoms.  Patients should speak with their doctors if they experience any neuropsychiatric symptoms.

The new information on neuropsychiatric side effects will be included as a precaution in the drugs’ prescribing information.  A precaution is a less serious safety notice than a warning.

Need Legal Help Regarding Asthma Drugs?

The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. For more information, fill out our online contact form or call 1-800-YOURLAWYER (1-800-968-7529).

[sc name=”post-footers”]

Our lawyers for Asthma drug side effects are here to help you when you need it the most.

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
My experience was very satisfactory and I achieved all my objectives in a fairly short time and thanks to my contact in that office Jorge Peniche who was very kind and efficient in our communications.
Roberto A Guzman
9 months ago
5 Star Reviews 150
The associates I dealt with, Shelly Davis & Christina Morace were extremely helpful and very pleasant to work with. They responded to my inquires in a timely fashion. They secured very favorable settlement.
John Ilardi
2 years ago
5 Star Reviews 150
I would like to thank everyone at Parker waichman who worked so hard on my case especially Jerrod Ryan my wonderful attorney who was very professional knowledgeable and very patient. SINCERE THANKS GOD BLESS YOU ALWAYS
Betty Pershae
a year ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038