Clinical Monitoring Of Medication Side Effects

Health & Medical Blog

Whenever a pharmaceutical company develops a new medication, strict clinical monitoring needs to be implemented to make sure that the drug has an acceptable safety profile before it is cleared for use in the general population. Medications can cause mild side effects, and in some cases, severe or even life-threatening side effects. Here are some common and rare side effects that may be observed during the clinical monitoring phase of a new medication. 

Common Side Effects

One of the most common medication side effects is gastrointestinal upset. Certain drugs, especially antibiotics and pain medications, can lead to abdominal cramps, nausea, diarrhea, and even heartburn. While in most cases these side effects are mild, they can make some people stop taking them. If severe gastrointestinal problems are revealed during the clinical monitoring of the volunteers, the pharmaceutical company may decide to reformulate the medication so that gastrointestinal side effects are minimized.

Other common side effects that pharmaceutical companies watch for during the medication monitoring phase are skin problems, which may include rashes, hives, redness, and itching. Hormonal drugs and anabolic steroids may cause cystic acne, mood swings, hair loss, excessive hair growth, appetite changes, and extremely oily skin. Menstrual irregularities and male breast enlargement may also be seen in the clinical trial volunteers.

Severe Side Effects

While common side effects can be problematic, they are seldom severe enough for the drug companies to reformulate the drugs. Conversely, medications that have caused severe or life-threatening side effects in the volunteers may need to be completely reformulated. The pharmaceutical researchers will assess the volunteers for severe reactions such as anaphylaxis, cardiac arrhythmia, respiratory failure, hypoxia, and significant changes in the blood chemistry profile.

While these adverse reactions may occur in a certain subset of people who are allergic to one or more components in the medication, if they occur on a regular basis in those with no known allergies, the medication may not be suitable for mass distribution, and may therefore be scrapped.

If you want more information about how new drugs are evaluated and monitored before they are cleared for use in the general population, talk to your doctor. If he or she is unable to provide you with the information that you are seeking, contact a research hospital or university. The person who receives your inquiry can put you in contact with a member of a pharmaceutical research team who may be able to help you.


15 December 2020