Hemabate (Carboprost Tromethamine) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

The adverse effects of HEMABATE Sterile Solution are generally transient and reversible when therapy ends. The most frequent adverse reactions observed are related to its contractile effect on smooth muscle.

In patients studied, approximately two-thirds experienced vomiting and diarrhea, approximately one-third had nausea, one-eighth had a temperature increase greater than 2° F, and one-fourteenth experienced flushing.

The pretreatment or concurrent administration of antiemetic and antidiarrheal drugs decreases considerably the very high incidence of gastrointestinal effects common with all prostaglandins used for abortion. Their use should be considered an integral part of the management of patients undergoing abortion with HEMABATE.

Of those patients experiencing a temperature elevation, approximately one-sixteenth had a clinical diagnosis of endometritis. The remaining temperature elevations returned to normal within several hours after the last injection.

Adverse effects observed during the use of HEMABATE for abortion and for hemorrhage, not all of which are clearly drug related, in decreasing order of frequency include:

Vomiting Diarrhea Nausea Flushing or hot flashes Chills or shivering Coughing Headaches Endometritis Hiccough Dysmenorrhea-like     pain Paresthesia Backache Muscular pain Breast tenderness Eye pain Drowsiness Dystonia Asthma Injection site pain Tinnitus Vertigo Vaso-vagal syndrome Dryness of mouth Hyperventilation Respiratory distress Hematemesis Taste alterations Urinary tract infection Septic shock Torticollis Lethargy Hypertension Tachycardia Pulmonary edema Endometritis from     IUCD

Nervousness Nosebleed Sleep disorders Dyspnea Tightness in chest Wheezing Posterior cervical     perforation Weakness Diaphoresis Dizziness Blurred vision Epigastric pain Excessive thirst Twitching eyelids Gagging, retching Dry throat Sensation of choking Thyroid storm Syncope Palpitations Rash Upper respiratory     infection Leg cramps Perforated uterus Anxiety Chest pain Retained placental     fragment Shortness of breath Fullness of throat Uterine sacculation Faintness, light-     headedness Uterine rupture

The most common complications when HEMABATE was utilized for abortion requiring additional treatment after discharge from the hospital were endometritis, retained placental fragments, and excessive uterine bleeding, occurring in about one in every 50 patients.

REPORTS OF SUSPECTED HEMABATE SIDE EFFECTS / ADVERSE REACTIONS

Possible Hemabate side effects / adverse reactions in 37 year old female

Reported by a physician from United Kingdom on 2011-10-13

Patient: 37 year old female weighing 70.0 kg (154.0 pounds)

Reactions: Cyanosis, Hypotension, Cardiac Arrest

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Hemabate
    Dosage: 500 mg, (250 mg x 2 given as stat)
    Indication: OFF Label USE
    Start date: 2011-08-04
    End date: 2011-08-04

Hemabate
    Indication: Haemorrhage

Possible Hemabate side effects / adverse reactions in 32 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-01-17

Patient: 32 year old female

Reactions: Uterine Inversion, Muscle Necrosis, Haemorrhage, Drug Ineffective, Sepsis, Vaginal Discharge, Pyrexia, Pyometra

Suspect drug(s):
Hemabate
    Indication: Postpartum Haemorrhage

Misoprostol
    Indication: Postpartum Haemorrhage

Oxytocin
    Indication: Postpartum Haemorrhage

Syntocinon
    Indication: Postpartum Haemorrhage

Possible Hemabate side effects / adverse reactions in 22 year old female

Reported by a physician from China on 2012-05-31

Patient: 22 year old female

Reactions: Blood Pressure Increased, Dyspnoea, Drug Hypersensitivity, Rash, Headache

Suspect drug(s):
Hemabate