British Columbia CA – Jeffrey Baglot developed a large ulcer that eventually perforated and required surgery to be repaired, following the use of the powerful anti-inflammatory drug. He was prescribed Ketorolac by Dr. Clasina Fourie (Abbotsford Regional Hospital, BC) during a flareup of his Crohn’s disease in 2011.
Within days, he developed an ulcer at the beginning of his small intestine. The two-centimetre ulcer ultimately ruptured and needed to be surgically repaired. Baglot ended up in another hospital for more than two months.
Baglot, now 33, thought he was going to die.
“My body was shutting down,” he testified in B.C. Supreme Court last year.
Baglot initiated the lawsuit against Dr. Fourie and won. She was ordered to pay nearly $900,000 in damages on Jan. 31.
Justice Diane Cheryl MacDonald said Fourie’s “negligence has had a devastating impact on Mr. Baglot’s life.”
“Today Mr. Baglot is totally disabled, homebound and isolated. Without the prescribing error, I find that it is more likely than not that Mr. Baglot would have continued to have Crohn’s disease but that he would have worked and been a contributing member of society,” MacDonald said.
Review of SAFETY considerations when prescribing Ketorolac
Concern over the high incidence of reported adverse effects with ketorolac trometamol has led to its withdrawal in some countries while in others its permitted dosage and maximum duration of treatment have been reduced. The recommended maximum duration for parenteral therapy is 2 days in the UK; if required, patients should be transferred to oral therapy with another analgesic. In the USA it is recommended that the maximum combined duration of use of parenteral and oral ketorolac should not exceed 5 days. Complications associated with Ketorolac misuse include potential kidney failure, liver damage and gastrointestinal bleeding. There’s also increased risk of heart attack and stroke.
WARNING
Ketorolac tromethamine, a nonsteroidal anti-inflammatory drug (NSAID), is indicated for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level. Oral ketorolac tromethamine is indicated only as continuation treatment following IV or IM dosing of ketorolac tromethamine, if necessary. The total combined duration of use of oral ketorolac tromethamine and ketorolac tromethamine injection should not exceed 5 days.
Ketorolac tromethamine is not indicated for use in pediatric patients and it is NOT indicated for minor or chronic painful conditions. Increasing the dose of ketorolac tromethamine beyond the label recommendations will not provide better efficacy but will increase the risk of developing serious adverse events.
GASTROINTESTINAL RISK
Ketorolac tromethamine can cause peptic ulcers, gastrointestinal bleeding and/or perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Therefore, ketorolac tromethamine is CONTRAINDICATED in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation, and in patients with a history of peptic ulcer disease or gastrointestinal bleeding. Elderly patients are at greater risk for serious gastrointestinal events.
CARDIOVASCULAR THROMBOTIC EVENTS
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
Ketorolac tromethamine is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
RENAL RISK
Ketorolac tromethamine is CONTRAINDICATED in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion.
RISK OF BLEEDING
Ketorolac tromethamine inhibits platelet function and is, therefore, CONTRAINDICATED in patients with suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding.
Ketorolac tromethamine is CONTRAINDICATED as prophylactic analgesic before any major surgery.
HYPERSENSITIVITY
Hypersensitivity reactions, ranging from bronchospasm to anaphylactic shock, have occurred and appropriate counteractive measures must be available when administering the first dose of ketorolac tromethamine injection.
Ketorolac tromethamine is CONTRAINDICATED in patients with previously demonstrated hypersensitivity to ketorolac tromethamine or allergic manifestations to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).
INTRATHECAL OR EPIDURAL ADMINISTRATION
Ketorolac tromethamine is CONTRAINDICATED for intrathecal or epidural administration due to its alcohol content.
RISK DURING LABOR AND DELIVERY
The use of ketorolac tromethamine in labour and delivery is CONTRAINDICATED because it may adversely affect fetal circulation and inhibit uterine contractions.
CONCOMITANT USE WITH NSAIDs
Ketorolac tromethamine is CONTRAINDICATED in patients currently receiving aspirin or NSAIDs because of the cumulative risk of inducing serious NSAID-related side effects.
SPECIAL POPULATIONS
Dosage should be adjusted for patients 65 years or older, for patients under 50 kg (110 lbs.) of body weight and for patients with moderately elevated serum creatinine. Doses of ketorolac tromethamine injection are not to exceed 60 mg (total dose per day) in these patients.
DOSAGE AND ADMINISTRATION
Ketorolac Tromethamine Tablets:
Ketorolac tromethamine tablets are indicated only as continuation therapy to ketorolac tromethamine injection, and the combined duration of use of ketorolac tromethamine injection and ketorolac tromethamine tablets is not to exceed 5 (five) days, because of the increased risk of serious adverse events.
The recommended total daily dose of ketorolac tromethamine tablets (maximum 40 mg) is significantly lower than for ketorolac tromethamine injection (maximum 120 mg).
Excerpts:
- CBC News
- MARTINDALE – The Complete Drug Reference
- DailyMed – FDA-approved label information