Include your return address and telephone number on all communications. Your Representative will want to know that the correspondence is from a person in his or her district. Address your letter as follows:
You may wish to include the following information in your letter and provide details of your experience:
My child experienced an adverse reaction to Singulair. In August 2009, a precaution about neuropsychiatric side effects was added to Singulair's label. This was the result of a year-long safety review by the FDA.
Since Singulair was approved in 1998, it's label has been updated numerous times to include the following psychiatric side effects: bad/vivid dreams, irritability, restlessness (added in 2001), agitation including aggressive behavior, insomnia, hallucinations (added in 2002); tremor (added March 2007), depression (added April 2007), suicidal thinking and behavior (addded October 2007), anxiousness (added February 2008), hostility and somnambulism (added August 2009). The most recent additions are disturbance in attention and memory impairment.However, these side effects are not required by law to be listed in the Consumer Medication Information for Singulair voluntarily provided by pharmacies.
It has come to my attention that CMI is neither regulated nor approved by the FDA. In 1995, the FDA proposed a regulation to set specific goals regarding the distribution and quality of medication information provided to consumers (60 FR 44182; August 24, 1995). Specific goals of the regulation included a target that by the year 2000, 75% and by 2006, 95% of new prescriptions dispensed would include useful written information for patients.
Before the regulation could go into effect, Public Law 104-180 was enacted. While the law adopted the goals of the 1995 proposed rule, it prohibited the FDA from taking regulatory steps specifying uniform content under the assumption that private‐sector initiatives were able to meet the goals, which the FDA was charged with evaluating. Currently the FDA's role, as set forth by Congress, is to encourage the private sector to provide this information, supply companies with the necessary guidance and evaluate private sector progress.
A study released by the FDA, Expert and Consumer Evaluation of Consumer Medication Information - 2008: www.fda.gov/cder/news/CMI/final_report.pdf found that CMI does not consistently provide easy-to-read, understandable information about the use and risks of medications.
It is crucial that consumers receive complete, correct, and up to date information about medication side effects from pharmacies. Because there is no regulated system for communicating side effects added to a medicaton's label to physicians and other healthcare providers, they may not have this information to share with patients, and parents of patients, when they write prescriptions.
Lack of side effect knowledge may result in unnecessary suffering from medication side effects, misdiagnosis with additional medical conditions, hospitalization, increased medical costs for patients (and the government when patients are on Medicare/Medicaid), educational problems, and unemployment.
CMI should be regulated by the FDA. At the very least, a regulation should be put in place requiring CMI to list all side effects present on a medication's FDA approved label and direct consumers to a reliable database of additional medication information, such as the National Library of Medicine's Dailymed website: www.dailymed.nlm.nih.gov. Additionally, there needs to be a regulated system to communicate updated medication side effect information directly to physicians and other healthcare providers.