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Update on Leukotriene Inhibitors

By Oguz Ozdemir

The FDA has updated their safety review of leukotriene inhibitors that include Montelukast , known as Singulair, Zafirlukast, sold as Accolate, and Zileuton, which is sold as Zyflo and Zyflo CR.

Leukotriene inhibitors are used primarily for asthma related illnesses. Singulair is used by patients who have asthma as well as those who suffer from allergic rhinitis which consists of stuffy, runny and itchy nose. Accolate and Zyflo are also used by asthma patients.

Use of these medications has been shown to cause neuropsychiatric episodes in patients who have used them to treat their asthmatic conditions. These side effects include different levels of aggression, agitation and irritability. In some cases patients have experienced abnormal dreams, hallucinations, suicidal thoughts and suicide.

The FDA requested the manufacturers of leukotriene inhibitors to report the results of their clinical trials in April 2009. They were reviewing the neuropsychiatric episodes that had been previously reported as side effects of using these drugs.

Some of the reports were consistent with these side effects even showing comparable responses as if the patients were drug induced. But the clinical trials were incomplete as they were not set up to specifically test for neuropsychiatric episodes. Insomnia was proven to be a side effect with all three medications as compared to using a placebo.

The FDA has asked doctors, patients and all healthcare professionals to be aware of the possibility of neuropsychiatric occurrences as a result of using leukotriene inhibitors. If any of these side effects does occur, the patient should advise his or her doctor and the doctor should consider subsitituting another medication in its place.

The FDA first established safety information regarding these medications in March 2008. The follow-up to this safety review was followed up in January 2009 and on June 12, 2009 the FDA requested that the manufacturers of these drugs include the precautionary information on their labels.

If you have asthma and have taken leukotriene inhibitors to treat it and have experienced any type of neruopsychiatric behavior first consult your physican to see if there is an alternate medication that you can take in its place. Whether you have used Singular, Accolate, Zyflo or Zyflo CR you may want to consult a lawyer to see if you have any recourse.

The legal team at the Napoli Bern Ripka Law Firm has extensive experience in dealing with physicians and the negligence associated with FDA drugs. You can input your information on the company's website in the Quick Contact section.

If you would rather speak with an attorney in person, call our office at 1-888-LAW IN NY. Our office is located in the Empire State building and your initial consultation is no charge. We would love the opportunity of helping you receive the compensation that you deserve as a victim of using any of the above mentioned medications without the proper knowledge of the risks and side effects that are involved with their use. Call today for your complimentary consultation.

Originally posted at InjuryBoard by Oguz Ozdemir

Full post as published by New York City Personal Injury Lawyer on July 30, 2009 (boomark / email).