Spontaneous Cases Sample

“Dulcolax did not work for me, I still feel constipated. It tasted bad and it does not look like a tablet.”

1. Was the drug Ineffective?

Information was received from a 65 year old overweight woman who was on Empagliflozin which was
used by the patient for the treatment of her diabetes mellitus.

On 16-Sep-2018, the patient complained that "her blood sugar was still high" however her weight had
decreased to 4 pounds. The patient informed her pharmacist that she bought the medication without
prescription and had self-medicated herself from her condition.

Follow up was conducted on the same day and the patient had decided to have herself checked by her
physician. The patient was then diagnosed with type 1 diabetes mellitus.

1. What would be the possible events?

2. Are the events reasonable for the suspect medication?

Clinical Trial Case Sample

The patients were on clinical trial number XXXX

The subject drug was Nintedanib.

Nintedanib is indicated For Idiopathic pulmonary fibrosis

Recommended dosing: 300mg daily for early stages of IPF

Possible side effects are:

Not yet established

Medication was given to 65 year old male patient with aggravated condition of IPF.

On 18-Jan-2017, the patient started the dosing with 150 Milligrams. On 19-Jan-2017, the patient
experienced diarrhea where it was reported that "loose stools was all over". The physician decided to
treat the event with antidiarrheal agent and to reduce the dose by 150 milligram 1 in a day. The patient
recovered from diarrhea on 15-Jan-2017.

On 30-Jan-2017, the patient ipf worsened and was admitted to the hospital.

On 12-Feb-2017, the patient died due to exacerbation of condition. Autopsy was not performed.

The patient was a smoker for 13 years

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Suspect medication was given to a 54 year old female with early stages of IPF

On 23-May-2017, the patient stared taking the suspect medication at 150 Milligram, twice a day. The
patient complained of diarrhea and was given anti diarrheal agent.

The patient was still having diarrhea regardless of the medication. The physician reduced the dose to
150 Milligram once a day. Diarrhea symptoms were recovered.

On 30-November-2018, pulmonary scan was conducted which showed a great improvement from the
patients old labs.

The patient reported she could hike mountains and does not feel shortness of breath when walking.

1. With these two cases, what would be the possible adverse event of the suspect medication?

2. What stages of IPF can the drug act better?

3. What would be the better dosing regimen?

4. What are other factors from the patient that can affect the medication?
58 Year old female patient who was on Dabigatran Etexilate (anticoagulant) on 28-Jun-2018 for the
treatment of Pulmonary embolism.

On 21-Jan-1990 the patient was diagnosed with hypertension which was treated with Metropolol.

In 22-Jan-1990 the patient experience nausea.

Patient was hospitalized on 14-Feb-2018 due to stroke

On 30-Aug-2018 the patient was admitted for hip surgery.

Dabigatran Etexilate was discontinued and was restarted after the patient recovered from the surgical
procedure.

On an unknown date, the patient experienced gastrointestinal bleeding. Idarucizumab was initiated as
anticoagulant reversal therapy. The patient had recovered.

1. Identify adverse events for the medication Dabigatran.

2. Identify concomitant medications and concomitant/past disease.
3. Identify treatment received by the patient regarding the event.