What are possible side effects?
Side effects are undesirable conditions/health consequences that occur while using a medicine. These may or may not be associated with the use of the medicine itself. It is Janssen’s responsibility to determine whether a side effect is associated with the medicine.
Possible side effects can be any of the following:
- Signs and Symptoms, such as skin rash, weight loss, shortness of breath, headache, dizziness, nausea, back pain, burning sensation, blurred vision, hair loss, allergic reactions (such as skin redness, swelling, or tightness in the throat);
- Diseases, such as hypertension (high blood pressure), diabetes, or infection;
- Abnormal Test or Laboratory Findings, such as high cholesterol, low potassium, a decreased platelet count, or abnormal x-ray or electrocardiogram;
- Any other Undesirable Condition/Health Consequence that happens while using a medicine, such as injuries (e.g. skin cut, broken tooth or cut gums), drug dependency/abuse/misuse, or birth defects.
Thus, it is important to monitor your health for any side effects while you are taking a medicine, however minor they may seem to you, and report these changes to your health care professional or via the provided instructions below on “How to Report a Side Effect or Product Quality Complaint”.
Why report a side effect?
Reporting side effects helps health authorities (like the US Food and Drug Administration, European Medicines Agency, Health Canada, etc.) and companies like Janssen ensure that their medicines are safe for use. Health authorities approve new medicines for use based on demonstration of effectiveness and safety in clinical trials. This ensures that the benefits of a medicine outweigh its risk of harm to patients. However, clinical trials often include a limited number of patients with certain characteristics (age, weight, sex) over a short period of time and sometimes do not include the range of individuals who may use these medicines to treat their condition.
When a medicine is approved, larger groups of people may use it for longer periods of time than what has been studied in clinical trials. Because individuals respond differently to medicines, not all side effects are detected in clinical trials. Although a single report of a side effect doesn’t necessarily change the benefit/risk ratio for a medicine, multiple reports of the same side effect could change it. Pharmaceutical companies (like Janssen) and health authorities closely monitor safety information on their medicines for as long as the medicine is marketed in any country of the world to ensure that a medicine’s benefits continue to outweigh its risks, and to communicate any new risks to patients and healthcare professionals. For these reasons, if you experience a side effect while taking a Janssen product, it is important that you report it to Janssen and your health care professional. Your support enables Janssen to protect patient safety by providing accurate and up-to-date safety information on Janssen products.
Product Quality Complaints
What are product quality complaints?
Product quality complaints include quality issues that could occur before the product reaches the patient.
Product quality complaints can include any of the following:
- Packaging, labeling or filling issues, such as missing or defective components (e.g. broken bottle, defective cap, illegible written information, overfilled or underfilled vial or suspicion of tampering, etc.);
- Physical characteristics, such as a change in color, volume or clarity of the product (e.g. there are small particles or flakes appearing in what is supposed to be a clear liquid);
- Device malfunction, which occurs when a device fails to perform as intended (as claimed and specified in the labelling for the device). Examples include an insulin pump delivering an unwanted infusion, or a pre-filled syringe leaking such that a full dose is missed.
Why report a product quality complaint?
A product quality complaint provides valuable feedback to Janssen on its products (medicines and delivery systems) that can contribute to the protection of consumers and patients. Your support in reporting a product quality complaint enables Janssen to quickly identify problems that may occur in the design, manufacturing, transportation, or any other activity that could contribute to a product quality issue, and in turn take the necessary corrective action(s). Some examples of corrective actions include making a change to the manufacturing process, redesigning the product packaging, or in some instances issuing a recall that results in pulling some or all of the product off the market.
How to Report a Side Effect or Product Quality Complaint
Reporting a Side Effect or Product Quality Complaint
If you would like to report a side effect or product quality complaint to Janssen, please use the telephone contact or e-mail address for the country where the product was prescribed or purchased.
At a minimum, please provide the name of the medicine or product and a description of the side effect or product quality complaint. To help Janssen process the side effect or product quality complaint report quickly and effectively, please provide the following information (if available):
- Reporter information: Your name and contact information (you can also choose to report anonymously).
- Consumer or patient information: Information about the consumer or patient, such as age or age group (e.g. child, adult), gender, diseases or conditions the consumer or patient may have (for product quality complaints, a patient or consumer may not be involved).
- Product name: The branded or generic name of the Janssen medicine or product.
- Side effect or product quality complaint description: Describe the side effect or product quality complaint in as much detail as possible (including batch number, if available). Please provide any relevant dates or periods of time (e.g., the amount of time from when the patient began taking a medication until the side effect occurred and description of product quality complaint).
How will Your Report be Used?
After your information is reviewed, you may be contacted by Janssen for clarification or additional details. All reports (side effects or product quality complaints) are analyzed by Janssen and then entered into a global database that the company maintains for as long as the medicine or product is on the market in any country. Your information is very helpful to Janssen as it helps other patients who use our medicines. The safety information is reviewed, scientifically evaluated by qualified professionals, and an assessment of the data is conducted regularly to determine if there are any new side effects/product quality complaints associated with the medicine or product and to quantify and/or better characterize side effects that are already known. Whenever a new risk is identified, Janssen communicates those risks to patients and healthcare professionals and may take other actions as needed to ensure the safety of the patients who use Janssen products.