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Printable Side Effect Alert

Physical and mental health is jeopardized when you are unaware of the side effects and adverse reactions associated with the medications you are taking or giving to your children.

Three factors that contribute to the lack of accurate and up to date information about medication side effects are:

(1) the lack of an FDA regulated system for immediately communicating updated medication information to consumers, physicians, and pharmacists;

(2) the lack of FDA regulation and approval of Consumer Medication Information (CMI) that retail pharmacies voluntarily provide with prescriptions; and

(3) the lack of mandatory adverse event reporting by physicians.

As consumers, we currently are not adequately empowered with the information necessary to make educated decisions about our healthcare and that of our loved ones. We do our research when we buy cars, televisions, and cellphones, but we often fail to do research when we purchase medications. We assume that our doctors have current and accurate information about the medications they prescribe. We don't question the accuracy of the Consumer Medication Information our pharmacist hands us with our prescription because we assume it is comprehensive and up to date. But this is not always the case.

Physicians and pharmacists do not always have the most current information about medication side effects. A regulated system to communicate updated medication side effect information does not exist.

The FDA (Food and Drug Administration) regulates and approves the content of medication labels, but there is no mechanism to alert physicians of changes or updates. Sometimes, pharmaceutical companies are given this responsibility.

Physicians can sign up for FDA MedWatch e-mail updates (which deliver important medication and medical product safety updates as they are issued) but they are not required to do so and may not even be aware of this service. (Consumers may also sign up for email alerts.)

Physicians may refer to manuals or web based databases for medication information, some of which may be out of date or may not contain comprehensive information. DailyMed is the US National Library of Medicine's database of standard, up-to-date information about marketed prescription drugs, including FDA approved labels.

Consumer Medication Information (CMI) is the leaflet that accompanies a prescription, usually stapled to the outside of the bag. CMI is NOT regulated or approved by the FDA and may not include all the side effects listed on a medication's label.

CMI leaflets are primarily generated electronically as part of the dispensing process. 
CMI content is determined by a small number of private vendors who sell drug information materials to pharmacy outlets though their pharmacy software vendors. 
The formatting of the CMI is then determined by pharmacies and/or their software vendors. As a result, there can be CMI leaflets with the same publisher and date of publication but with very different content and appearance.  

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 FDA was charged with evaluating. (Note: The FDA does regulate Medication Guides and Patient Package Inserts that are required with certain medications. See FDA: Types of Patient Information). 

The goals for CMI haven’t been met. A study released by the FDA Expert and Consumer Evaluation of Consumer Medication Information‐2008 found that CMI does not consistently provide easy-to-read, understandable information about the use and risks of medications.  The law says that if the goals aren’t met, FDA should ask the public for feedback on ways they think CMI can be improved so consumers will get useful information with their prescriptions.

One way FDA can do this is to ask the public to send in written comments on how the information given out at pharmacies could be more helpful for consumers. In February 2009, FDA held a public meeting of its Risk Communication Advisory Committee to discuss the study results, receive advice on ways to improve consumer medication information, and to get public feedback.

Transcripts from the Risk Communication Advisory Committee February 26-27, 2009 Meeting (Jenna Markle from Parents United submitted comments to this meeting, some of which were discussed.)

Transcripts from the Risk Communication Advisory Committee February 25-26, 2010 Meeting (Kate Miller from Parents United spoke at this meeting.)

The FDA defines an adverse reaction as any undesirable experience associated with the use of a medical product in a patient. Post-marketing adverse reactions to a drug are those that occur after a drug has already been approved and in use.

Anyone can have an adverse reaction to any medication, regardless of whether or not others have had the reaction before.

Consumers, physicians, and other healthcare providers can report adverse reactions to the FDA's Adverse Event Reporting System or pharmaceutical companies. When pharmaceutical companies receive these reports they are required to submit them to the FDA. Physicians and other healthcare providers are not required to report their patients' adverse reactions.

Adverse Event reporting is crucial. The FDA uses these reports to identify and evaluate safety concerns and re-define the benefit-risk ratios of drugs. If adverse reactions are not reported to the FDA, problems with medications can not be quickly identified and acted upon.

If you experience, or have experienced, an adverse reaction to ANY medication, PLEASE file a report with MedWatch.