Committee on Safety of Medicines

In the United Kingdom, the Committee on Safety of Medicines (reporting to the Minister of Health) regulates drug safety and development under the Medicines Act... 

Committee on Safety of Medicines (CSM) Cornell Legal Library... 

By the time that an application for a product licence is ready, a certain amount of evidence on the safety of the drug will be available. In a review of product licence applications to the Committee on Safety of Medicines (CSMs), Rawlins and Jefferys presented data on the number of patients who were available for the assessment of safety and efficacy (Table 15.5). When it is considered that many of the patients included would have been in short-term clinical trials (up to 28 days), and that other trials would have been conducted on formulations and doses that were different from those recommended in the product licence application, then the relevant numbers are substantially reduced. 

Grahame-Smith DG. Report of the adverse reactions working party to the Committee on Safety of Medicines. London Department of Health and Social Security, 1983. 

Professor AC Frazer was appointed to succeed Sir Derrick but imfortimately he died shortly thereafter. During 1969, therefore. Professor EF Scowen succeeded Professor Frazer as the Chairman of the Committee. In June 1970, the membership of the Committee was revised to correspond with that of the then newly established (under section 4 of the Medicines Act 1968) Committee on Safety of Medicines (CSM). The full... 

The relevant advisory committees with a remit for medicines for human use established under the Medicines Act 1968 were the Committee on Safety of Medicines (CSM), set up in June 1970 (SI 1970/1257) under the Chairmanship of Professor EF Scowen and the British Pharmacopoeia Commission (BPC), also set up in June 1970 (SI 1970/1256) under the Chairmanship of Dr F Hartley (later Sir Frank Hartley). The Veterinary Products Committee (VPC), chaired by Professor CSG Grunsell (with a remit for... 

Medicines Commission. Annual Report for 1971. Her Majesty s Stationery Office, London, 1972. Committee on Safety of Medicines. Report for the year ended 31 December 1971. Her Majesty s Stationery Office, London, 1972. 

The full data package was submitted and assessed by assessors from each of the three disciplines. The Committee on Safety of Medicines and its sub-committees then considered their assessment report. If the decision was positive then a certificate was issued. If the decision was negative, then the applicant had the same appeal rights as those that apply to a marketing authorisation application (see Section 17.8.1). 

The agreement between the Committee on Safety of Medicines and the ABPI on the use of the black triangle is that ... 

Promotional material must not include any reference to the Medicines Commission, the Committee on Safety of Medicines, the Medicines and Healthcare products Regulatory Agency, the Medicines Control Agency or the licensing authority, unless this is specifically required by the licensing authority. 

The Committee on Safety of Medicines (CSM) was established in 1970 under section 4 of the Medicines Act 1968. Its Terms of Reference are ... 

Smith, C.C., Bennett, P.M., Pearce, H.M., Harrison, P.I., Reynolds, D.J., Aronson, J.K. and Grahame-Smith, D.G. (1996) Adverse drug reactions in a hospital general medical unit meriting notification to the Committee on Safety of Medicines. British Journal of Clinical Pharmacology, 42, 423—429. 

In the early 1990 s, the Committee on Safety of Medicines of the United Kingdom concluded that the risks of treatment with triazolam at the licensed doses (0.25 and 0.125 mg) outweighed the benefits. The United Kingdom and a few other countries banned triazolam primarily because of persistent reports of adverse reactions. As of 1992, France, Spain, and New Zealand suspended the 0.25-mg dose of triazolam but allowed continued marketing of the 0.125-mg dose, whereas Canada and Japan lowered the recommended starting dose for nonelderly insomniacs to 0.125 mg. 

In Britain, the medical community was alerted to the risks by an editorial in the British Medical Journal in 1971, but it was only in 1973 that the Committee on Safety of Medicines advised against the use of diethylstilbestrol during pregnancy (21). In Britain, drugs were commonly not labelled with information about their contents, nor with warnings of risk until well into the 1990s thus, patients were kept in ignorance. No measures have yet been taken in Britain to alert the public to the need for medical surveillance of women who have been exposed to diethylstilbestrol in utero. 

Currently one must ask why the particular risk of the third-generation contraceptives was identified so late. These third-generation products had been in development since the late 1970s and the first had been marketed in 1981-82, some 14 years before the Committee on Safety of Medicines issued its statement. Could society not have done better and thereby reduced the risks to which women were exposed There are two principal answers, both of them at least partly in the affirmative. 

England that the Committee on Safety of Medicines had written to prescribers in 1995 stating that three unpublished studies on the safety of combined oral contraceptives in relation to venous thromboembolism had indicated about a two-fold increase in the risk of such conditions compared with the preceding generation of products. This issue of a two-fold increase became crucial to the case. For reasons of causation, as the Judge put it, the claimants had accepted the burden of proving that the increase in risk was not less than two-fold. 

The authors reported that two other cases of metformin-associated lactic acidosis with concurrent NSAID therapy have been reported to the Committee on Safety of Medicines in the UK. Indometacin can impair kidney function and may have done so in this case. Phenformin can cause tubular damage and oliguria in animals (145) and so it is conceivable that metformin-induced renal damage may also have contributed. 

In Great Britain, all SSRI antidepressants, except fluoxetine, have been banned for use in treating depression in children. The main concern surrounded suicidality that was increased with SSRIs in general, including fluoxetine (Committee on Safety of Medicines, 2003). 

Great Britain s Committee on Safety of Medicines (CSM 1988) recommended that benzodiazepines should not be used alone to treat depression or anxiety associated with depression. Suicide may be precipitated in such patients. ... 

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