Drugs (Hansard, 14 April 1993)

§ Dr. Mawhinney

The information requested on the potential drug safety hazards investigated by the Medicines Control Agency is as follows:

The six drug classes

Non-steroidal anti-inflammatory drugs (NSAIDs). These drugs, used to treat arthritis, can cause rare cases of meningitis of a non-infective origin, and in some patients, kidney damage. The findings of investigations into these issues were published in Current Problems No. 32, issued in October 1991.

Angiotensin Converting Enzyme (ACE) inhibitors. Anaphylactoid reactions can occur when patients on ACE inhibitors, undergo renal dialysis with a particular type of dialysis membrane. The findings of an investigation into this issue were published in Current Problems No. 33, issued in February 1992.

Beta-agonists. Following concerns regarding a possible association between the use of beta-agonists in the treatment of patients with asthma and an increase in asthma mortality and morbidity, a Working Party was set up by the Committee on Safety of Medicines to review information on the safety of beta-agonists in asthma patients. They concluded that available evidence did not support a causal link between beta-agonist use and death from asthma. The findings of the Working Party were published in a report published in early 1992, and summarised in Current Problems No. 33, issued in February 1992.

Radiographic contrast media. Concerns have been expressed in Europe regarding the comparative safety of intravascular use of high- and low-osmolar contrast media. After review of the data it was concluded that there was no convincing evidence to suggest a difference between these types of media with respect to life-threatening or fatal reactions. The review has been published in Pharmaceutical Medicine 1993, 7; 47–55.

Quinolones. These antibiotics can cause convulsions in patients with or without a history of epilepsy; this reaction can also be induced by an interaction between these antibiotics and non-steroidal anti-inflammatory drugs. The findings of an investigation into this issue have been published in Current Problems No. 32, issued in October 1991.

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Cephalosporins. These antibiotics can cause rare cases of pseudomembraneous colitis, a severe inflammatory condition of the colon. The findings of an investigation into this issue have been published in Current Problems No. 32, issued in October 1991.

The 10 drug substances

Gadolinium. Concern was raised from in vitro studies that gadolinium (Magnevist), a radiographic contrast medium, could affect viral infectivity. After review of the data it was concluded that the findings were unlikely to have relevance to the in vivo use of the agent.

Vitamin K. Concern arose from epidemiological studies reporting an association between intramuscular administration of vitamin K to newborn babies and the subsequent development of childhood cancer. After review of the studies the Committee on Safety of Medicines concluded that there was insufficient evidence to support the conclusions reached in the study. A letter was sent to all doctors by the Chief Medical Officer and the Chief Nursing Officer in December 1992 informing them about this matter. This issue is being kept under review.

Terodiline. This drug, used in the treatment of urinary incontinence, can cause rare but serious disturbances of cardiac rhythm. As a result of an investigation into this issue, the Chairman of the Committee on Safety of Medicines wrote to all doctors, dentists and pharmacists in July 1991, informing them of their findings. Following further reports of such reactions, the drug was withdrawn voluntarily by the pharmaceutical company. The findings of the review of the data were published in Current Problems Number 32, issued in October 1991.

Triazolam (Halcion). This drug is used in the short-term treatment of severe insomnia. Following a review of the data by the Committee on Safety of Medicines (CSM) this drug was withdrawn from the market in the United Kingdom in October 1991 and all doctors, dentists and pharmacists were informed by a letter from the Chairman of the CSM. The manufacturer of Halcion has appealed against the proposed action to revoke the product licences for Halcion, this matter is still under appeal.

Atenolol. Concern was raised by an epidemiological study which revealed that men receiving antenolo, had a higher death rate from cancer than those receiving diuretic or placebo. On review of the data it was concluded that it was unlikely that atenolol treatment was causally associated with increased cancer mortality in men and no action was considered necessary. This issue has been kept under review and the decision has been lent further support by two further studies which failed to find an association between alenolol treatment and increased cancer mortality.

Fenfluramine and dexfenfluramine. These drugs can cause the rare but serious adverse effect of pulmonary hypertension. The findings of an investigation into this issue were published in Current Problems Number 34, issued in June 1992. An epidemiological study is underway to investigate this matter further.

Carbimazole. This drug, used in the treatment of hyperthyroidism, can cause rare cases of serious white blood cell disorders. The findings of an investigation into this issue were published in Current Problems No. 32, issued in October 1991.

Flecainide. This drug, used in the treatment of cardiac rhythm disorders, can cause rare long-term adverse effects on the eyes, lungs or nervous system. The findings of an investigation into this issue were published in Current Problems No. 31, issued in June 1991.

Omeprazole. This drug, used in the treatment of peptic ulcers, can cause skin rashes, diarrhoea and headache, which can be severe. The findings of an investigation into these side effects were published in Current Problems No. 31, issued in June 1991.

Flucloxacillin. This antibiotic can cause jaundice. The findings of an investigation into this issue were published in Current Problems No. 35, issued in November 1992.

Copies of all the publications referred to will be placed in the Library.