ADR database


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References:
Current Problems in Pharmacovigilance 1998 aug; vol.24: 11-14

Meloxicam (Non-steroidal antiinflammatory drug)

Gastrointestinal and skin reactions

By June 1998, a total of 773 reports describing 1,339 suspected adverse drug reactions (ADRs) for meloxicam (a non-steroidal anti-inflammatory drug) had been received from the UK. The most frequently reported reactions are gastrointestinal (41 %, among which perforation, ulceration and/or bleeding), dermatological (25 %, mostly pruritus, rash and urticaria, but angioedema, photosensitivity, and bullous dermatoses, including erythema multiforme and Stevens Johnson syndrome have also been reported), neurological (mostly headache), cardiovascular (oedema and palpitations), dizziness, flushing and fatigue. The majority of the patients recovered after meloxicam was withdrawn, though 5 patients died of gastrointestinal reactions. Warnings about gastrointestinal and skin reactions have been strengthened in the product information.


References:

WHO Pharmaceutical Newsletter N° 3-4, 1997

Reviewed: 01/1998

Mefloquine (antiprotozoal)

Correct use

Mefloquine is a widely used antiprotozoal for the treatment and prophylaxis of malaria caused by P. falciparum resistant to other antimalarials. An increased incidence of neuropsychiatric effects was observed with mefloquine, leading the Irish Medicines Board to remind doctors that it should not be prescribed for prophylaxis in patients with renal or liver insufficiency, or with a history of psychoses or epilepsy. Same contraindications are already described in the Italian Product Information Sheet.
People taking mefloquine and experiencing depression, confusion, anxiety, hallucination, psychosis, sleep disorders, or abnormal thinking, should immediately report to a doctor. Nevertheless, the risks associated with a correct prophylactic antimalarial treatment are clearly outweighted by the benefits.
It must be remembered that the antimalarial prophylaxis has to be started one week before the arrival in a malaric area; a concomitant oral antityphic prophlaxis should be completed three days before the antimalaric treatment, in order to avoid a possible attenuation of the immunisation.


References:

FDA - Medwatch (may 1997)

Reviewed: 10/1997

Methotrexate (antitumoral)

Tumor lysis syndrome

Methotrexate may induce 'tumor lysis syndrome' in patients with rapidly growing tumors. Appropriate supportive and pharmacologic measures may prevent or alleviate this complication.

References:

Br J Rheumatol 1998; 37: 105-106

Reviewed: 04/1998

Drug interactions: mylosuppression

A fatal case of mylosuppresson was reported in an old patient with Rheumatoid Arthritis after the addition of trimethoprim to a treatment with low doses of methotrexate. The summatory effect of the anti-folate activity of each agent may have been further increased by the old age of the patient and his reduced renal function

References:

FDA Talk Paper june 8,1998
Roche "Dear Doctor Letter"; june 1998

Reviewed: 07/1998

Mibefradil (antihypetensive, antianginal)

Drug withdrawal

Roche voluntarily withdrew mibefradil from the market, as a result of new information about potentially harmful interactions with other drugs. This decision was based on the analysis of a three-year study in patients with congestive heart failure.
Mibefradil was launched in the USA in august 1997.

References:

Ann Emerg Med 1998; 32:263-265

Reviewed: 09/1998

Midazolam (sedative agent)

Laryngospasm

Midazolam caused laryngospasm in a 61-year-old man who was to undergo conscious sedation before cardioversion. the laryngospasm was reversed by a small dose of flumazenil, a competitive inhibitor of the benzodiazepines.
Laryngospasm is listed by the manufacturer as a rare side effect of midazolam.

References:
BMJ 1998;317:795-797

Reviewed: 01/1999

Mesalazine (NSAID)

Interstitial nephritis


Two cases of late onset interstitial nephritis induced by mesalazine (prescribed for ulcerative colitis) were reported. The first presented after at least 5 years of continuous treatment with the drug and the second after 1 year.
Renal biopsy showed considerable tubule damage and periglomerular fibrosis and inflammatory interstitial infiltrate.
Restoration of renal function was seen on withdrawal of medication.
Authors suggest a routine monitoring of renal function in such patients. An increasing number of reports suggests that this adverse drug reaction may be underrecognised and underreported.


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