Has cough and sore throat been reported in connection with Celebra (celecoxib)?/nThe question conce

Fråga: Has cough and sore throat been reported in connection with Celebra (celecoxib)?

The question concerns a 50-year-old man being treated with Imacillin (amoxycillin; dose unknown) for respiratory tract infection. His symptoms in the form of cough and sore throat worsened after starting treatment with Celebra (celecoxib) 200 mgx1 and improved upon discontinuation of celecoxib.

Sammanfattning: In an extensive literature search we found five reports of coughing and sore throat in connection with celecoxib, which have been reported to the Swedish Adverse Drug Reaction Committee (SADRAC). In the present case there was a temporal relationship and a positive dechallenge which suggests a possible causal relationship.

Svar: In an extensive literature search covering Medline, Embase, Drugline and major pharmacological handbooks, we found no data concerning celecoxib and cough or sore throat.

In Swedis (1) we found however, five case reports concerning respiratory tract adverse reactions and celecoxib. The first case, a 46-year-old man was prescribed celecoxib for arthritis. A few days later, he developed a sore throat. Fourteen days after starting celecoxib he developed a generalised rash. He stopped treatment with celecoxib and recovered two days later.

The second patient was a 41-year-old female patient who was also taking celecoxib for suspected fibromyalgia. After seven days of treatment, she experienced a feeling of swelling in the throat, a slight cough and swallowing difficulties. She stopped celecoxib and improved after one day. She made a rechallenge, but after the second tablet a similar reaction developed, which also disappeared after drug discontinuation.

The third case was a 49-year-old woman who was being treated with celecoxib 100 mgx2 for arthrosis. The first dose was taken in the evening. She woke up the same night with coughing, dyspnoea and meteorism. Symptoms disappeared one day after withdrawing the drug.

The fourth patient was a 73-year-old woman with a history of myocardial infarction, six months coughing and tiredness on exercise. Celecoxib was prescribed after menisectomy. Postoperatively her tiredness worsened and she developed dyspnoea. Treatment with celecoxib was discontinued after 10 days and symptoms largely disappeared.

The fifth case was a 68-year-old woman with a medical history of hypertension, angina pectoris, rheumatic disorder, habitual coughing for many years, hypercholesterolemia and levothyroxyin substituted hypothyroidism. She was treated with celecoxib. Some time later (unspecified), the patient was hospitalised because of productive, severe cough and chest pain. She was treated with nitroglycerine infusion, paracetamol, dextropropoxyphene or morphine, all with poor effect. Treatment with celecoxib was then discontinued and symptoms declined.

Regarding other non-steroidal antiinflammatory drugs (NSAIDs) including cox-2 inhibitors, there are 217 adverse drug reaction reports in SWEDIS including six coughing (three by celecoxib and three by other NSAIDs), 14 rhinitis (by other NSAIDs) and ten pleuritis (by other NSAIDs).

In the WHO database, there are 39 reports (33 coughing and six haemoptysis) concerning respiratory system and celecoxib (2). Details of these cases are missing and proper evaluation cannot be made.

In FASS 2000 (3), pharyngitis, rhinitis, sinusitis and cough are listed as common or less common adverse drug reactions of celecoxib. This information is based on adverse events, regardless of causality, occurring in two percent or more of patients receiving celecoxib from 12 controlled studies conducted by the manufacturer in patients with arthritis that included a placebo and/or a positive control group (4). Similar adverse reactions are not mentioned in FASS under other cox-2 inhibitors or non-steroidal anti-inflammatory drugs.

We recommend this case be reported to the Swedish Adverse Drug Reaction Committee (SADRAC).