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.
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