asked the Secretary of State for Social Services if he will publish in the Official Report the letter sent to doctors and pharmacists by the Committee on Safety of Medicines warning them of the risk to babies under six months arising from the use of the dicyclomine drugs, Merbentyl and Ovol; and what action he has taken to warn mothers of the risks related to these drugs available without prescription.
The letters to doctors and pharmacists advising them that Merbentyl Syrup (dicyclomine hydrochloride) is contra-indicated in infants under six months of age were issued by the licence holder for Merbentyl Syrup and not by the Committee on Safety of Medicines. I have arranged for copies of these letters to be placed in the Library. The only other dicyclomine product for infants on the market, Ovol Colic Drops, is no longer indicated for infants under three months and may be dispensed only under the supervision of a pharmacist, who is well placed to explain the licensed indications to purchasers.
asked the Secretary of State for Social Services what evidence for the safety of Merbentyl was provided for the Committee on Safety of Medicines by Merrell Pharmaceuticals when it sought a product licence for the drug.
Data in support of an application for a product licence are presented to the licensing authority in confidence. However, the licence-holder has agreed to the disclosure of data presented in support of their application for a licence for the use of Merbentyl Syrup in the treatment of infant colic. Their data, which are all available in published form, showed the safety record of the product in a total of 1,000 patients including 261 babies with infant colic. The studies are by Illingworth published in the Lancet on 19 December 1959,
| Product | Licence | Status | Whether on the market | |
| Kolanticon Wafers | Product licence of right | Lapsed | No | |
| Kolanticon Tablets | — | Product licence granted | 11 April 1983 | No |
| Kolanticon Gel | Product licence of right | Product licence granted | 29 July 1982 | Yes |
| Kolantyl Tablets | Product licence of right | Product licence granted | 20 April 1982 | No |
| Kolantyl Gel | Product licence of right | Product licence granted | 10 December 1982 | Yes |
| Merbentyl Tablets | Product licence of right | Product licence granted | 27 September 1982 | Yes |
| Merbentyl Syrup | Product licence of right | Product licence granted | 13 July 1983 | Yes* |
| Merbentyl with Phenobarbitone Tablets | Product licence of right | Lapsed | No | |
| Merbentyl with Phenobarbitone Syrup | Product licence of right | Lapsed | No | |
| Debendox | Product licence of right | Lapsed | No | |
| Ovol Colic Drops | Product licence granted | 25 February 1972 | Yes* | |
| Diarrest Syrup | Product licence granted | 26 February 1981 | Yes | |
| Infacol Syrup | Product licence granted | 26 June 1981 | No | |
| Wyovin Tablets | Product licence of right | Lapsed | No | |
| Abacid-Plus Suspension | Product licence of right | Lapsed | No | |
| * Indicated for treatment of babies. | ||||
asked the Secretary of State for Social Services if he will detail the evidence considered by the Committee on Safety of Medicines which led it to warn of the risks to babies under six months arising from the use of the drug dicyclomine; when the committee issued its warning; how many adverse reaction reports it had received and when it received them; on how many previous occasions the committee has assessed the safety of dicyclomine; and with what result.
The Committee on Safety of Medicines has not issued such a warning as explained in
by Grunseit published in Current Medical Research and Opinion in 1977, by Ribero published in Folha Medicine in 1973, by Nobre published in Hospital (Rio) volume 67 1965, by Guerro published in the Phillipines Journal of Paediatrics in 1953 and by Pakula published in Post Graduate Medicine in 1952.
asked the Secretary of State for Social Services if he will set up an inquiry into the possibility of an association between cot deaths and the use of drugs containing dicyclomine.
No. There is no prima facie evidence of a causal link to warrant such an inquiry.
asked the Secretary of State for Social Services when drugs containing dicyclomine first appeared on the British market; which ones were given product licences of right, and which were fully tested; how many have been withdrawn since the licensing system began; and how many were still on the market when the Committee on Safety of Medicines issued its recent warning of risks for babies of under six months.
I understand that products containing dicyclomine were first marketed in the United Kingdom in the early 1950s but we do not have detailed information about this marketing. The table shows products containing dicyclomine which were granted product licences of right as well as those which have been granted full product licences. The table also shows that the licences for six products have been allowed to lapse, another six are on the market and a further three products have licences but are not currently on the United Kingdom market. Only two products on the market are indicated for babies.my other reply to the right hon. Member today. The committee has received 36 reports of adverse reactions associated with products containing dicyclomine for use in babies, as follows:
| Year | Number of reports |
| 1969 | 1 |
| 1973 | 1 |
| 1976 | 1 |
| 1977 | 1 |
| 1978 | 1 |
Year
| Number of reports
|
| 1980 | 1 |
| 1981 | 1 |
| 1982 | 1 |
| 1983 | 10 |
| 1984 | 17 |
| 1985 | 1 |
The committee has considered the safety of products containing dicyclomine on many occasions including for the treatment of infant colic on two occasions. In May 1983 the committee advised the licensing authority that Merbentyl Syrup should be granted a product licence for use in the treatment of irritable colon and infant colic. In July 1984 the committee considered adverse reaction reports relating to apnoeic attacks in babies associated with the use of dicyclomine products. Although the committee noted that no evidence had been identified which established a casual link between dicyclomine and apnoeic attacks it asked its secretariat to pursue the matter. This was done and after discussions with the manufacturer of Merbentyl Syrup the company agreed to delete the indications of the product for the treatment of infant colic.
Following discussions with the manufacturer of Ovol Colic Drops, the only other product currently on the market containing dicyclomine hydrochloride which is indicated for infants, the company agreed to delete the indication for the treatment of colic in infants under three months.
asked the Secretary of State for Social Services if he is able to estimate the annual use of drugs containing dicyclomine, and the likely number of times it has been given to babies during the years it has been on the British market.
The manufacturers estimate that in the United Kingdom around 74 million doses of liquid products containing dicyclomine were sold in 1984, of which some 12 million doses were for babies. We do not have enough information to make an estimate for the 30-year period since the product became available here.