ASK DIS: Etoricoxib : Safety Update

FDA

etoricoxib, or Arcoxia, is still not FDA approved in the United States.
Concerns about the similar structure and mechanism to rofecoxib, or Vioxx, has the FDA wary about approval for etoricoxib. Vioxx was pulled from the market in 2004 due to many adverse reports of cardiovascular complications, specifically stroke and heart attack.
In April 2007 the FDA officially rejected the application for a U.S. approval for Arcoxia.
Besides a potential for negative cardiovascular effects, other side effects for etoricoxib include nausea, stomach pain, edema in the hands and feet, bruising and dyspepsia.
Despite the lack of FDA approval, many countries find success in patients using etoricoxib

MHRA

has concluded that etoricoxib’s benefits outweigh the risks in the treatment of rheumatoid arthritis.
Furthermore, the Committee recommended extension of the indication to include ankylosing spondylitis at a dose of 90 mg once a day.
Committee recommended an update to the existing contraindication in patients with inadequately controlled hypertension to state that patients whose blood pressure is persistently above 140/90 mmHg and inadequately controlled must not receive etoricoxib.
Furthermore, high blood pressure should be controlled before starting treatment, and should be monitored for 2 weeks after the start of treatment and regularly thereafter.

NPS Australia

In July 2008 the Pharmaceutical Benefits Advisory Committee rejected an application to list etoricoxib on the PBS for osteoarthritis, concluding that there was no demonstrated need to list another COX-2 selective NSAID and that etoricoxib appears to cause more episodes of hypertension than celecoxib.
In most other respects the efficacy and safety of etoricoxib are similar to those of celecoxib. In 2 trials comparing celecoxib 200 mg once daily with etoricoxib 30 mg once daily in people with osteoarthritis, over 26 weeks etoricoxib was no worse than celecoxib at reducing pain and improving function.
The 2 drugs are likely to have similar gastrointestinal safety, although only imprecise estimates of the comparative rates of serious gastrointestinal injury (e.g. perforations, obstructions and bleeding) are available

Malaysia / Recommendation

Based on our regulatory board, Etoricoxib is still indicated and beneficial in treatment (benefit outweighs harm)
However, prescribing should be carried out based on the Indication and Contraindication and the shortest period as possible.\
based on a meta analysis, treatment with etoricoxib proved not to result in an increased risk of serious vascular events when compared with both the placebo and naproxen.

INDICATIONS

Acute and chronic treatment of the signs and symptoms of osteoarthritis (OA) and rheumatoid arthritis (RA)
The management of ankylosing spondylitis (AS)
Treatment of acute gouty arthritis
Relief of acute pain, including pain related to minor dental procedures
Relief of chronic musculoskeletal pain
The decision to prescribe a selective COX-2 inhibitor should only be made:
if non-pharmacological interventions and simple analgesic therapy i.e paracetamol have been tried and found to lack analgesic efficacy or to have unacceptable adverse effects in the individual patient; and

after assessment of the individual patient's overall risk factors for developing severe
adverse events e.g. history of cardiovascular, renal, or gastrointestinal disease

Contraindication

Hypersensitivity to the active substance or to any of the excipients
Active peptic ulceration or active gastro-intestinal (GI) bleeding.
Patients who, after taking acetylsalicylic or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors, experience bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions.
Pregnancy and lactation
Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score ≥10).
Estimated renal creatinine clearance <30 ml/min.
Children and adolescents under 16 years of age.
Inflammatory bowel disease.
Congestive heart failure (NYHA II-IV).
Patients with hypertension whose blood pressure is persistently elevated above 140/90mmHg and has not been adequately controlled.
Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease

References

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