HC Deb 13 December 1990 vol 182 cc466-9W
Mr. Ashley

To ask the Secretary of State for Health if Myodil still has a product licence for export; and what information he has on whether Glaxo is still exporting it.

Mrs. Virginia Bottomley

For medicinal products exported from the United Kingdom the requirements are set by the importing country. A product licence is not always required for exports.

Mr. Ashley

To ask the Secretary of State for Health (1) when Myodil was given a reviewed product licence; on what subsequent dates was the licence renewed; what evidence was presented at the time the reviewed licence was given; and what consideration was given to adverse reactions to Myodil;

(2) what clinical trials have been carried out on Myodil.

Mrs. Virginia Bottomley

A review application for Myodil was received in the early 1980s. Numerous clinical trials have been conducted with Myodil, examining its value in a number of diagnostic procedures including myelography and ventriculography. A substantial body of evidence in relation to iophendylate, the active ingredient of Myodil, has been published in well over 300 citations spanning a period of over 40 years. This included information relating to adverse reactions associated with the use of Myodil.

The review included examination of evidence that the product was of an appropriate standard of safety, quality and efficacy. A reviewed product licence, valid for five years, was granted in 1987.

Mr. Ashley

To ask the Secretary of State for Health (1) in what ways were the warnings regarding the use of Myodil drawn to the attention of doctors; and whether any steps were taken by his Department or by health authorities to ensure that no doctor giving a spinal injection of Myodil could be unaware of them;

(2) whether his Department, the Committee on Safety of Medicines or the Committee on the Review of Medicines ever issued warnings to radiologists about adverse reactions to Myodil.

Mrs. Virginia Bottomley

I know of no warnings being issued by the Department, health authorities, the Committee on Safety of Medicines or the Committee on the Review of Medicines to radiologists about adverse reaction to Myodil. Information was already available to them in package inserts and the data sheet which were updated as appropriate in the light of accumulating knowledge. It is for doctors who use a product to ensure that they are fully familiar with the benefits and the risks of any procedure or treatment.

Mr. Ashley

To ask the Secretary of State for Health what precise warnings regarding the use of Myodil and the possibility of subsequent adverse reactions were given by the manufacturer, Glaxo; what changes there have been in the warnings; and when they were made.

Mrs. Virginia Bottomley

In the package insert dated March 1972, serious adverse reactions were reported to be rare provided that a suitable technique was used; references were made to the removal of Myodil after myelography. The reactions listed included frequent headaches, sometimes severe with vomiting and photo-phobia after myelography, pyrexia, neck stiffness, low back pain and exacerbation of previous symptoms such as those of sciatica. The leaflet also referred to occasional reports of arachnoiditis and literature reports of adhesions and fibrous exudates being found on operation in patients who had at some stage undergone myelography with Myodil.

In the revised package insert dated November 1973 it was, in addition, recommended that the material be removed by aspiration after the myelography unless required for further study. Information on adverse reactions was enlarged to detail its irritant or allergenic potential. Advice was given that if low back pain persisted or previous symptoms of sciatica were exacerbated, any residual Myodil should be removed and where warranted, hydrocortisone sodium succinate injected intrathecally.

The data sheets introduced in the 1980s further emphasised the importance of removing as much Myodil as possible at the time of myelography.

Mr. Ashley

To ask the Secretary of State for Health what is the approximate number of people who have developed arachnoiditis after the use of Myodil.

Mrs. Virginia Bottomley

Myelography is often a prelude to surgery for lumbar disc disease. In consequence, it is difficult to disassociate the effects of the original disease from those of the pre-operative myelography or the surgery. The frequency of symptoms compatible with arachnoiditis varies in different publications and it is clear that there is a poor correlation between symptoms and pathology. For these reasons, it is not possible to estimate the number of people who may have developed arachnoiditis as a result of the use of Myodil.

Mr. Ashley

To ask the Secretary of State for Health (1) in the last full year it was available, how many spinal investigations using Myodil were carried out in national health service hospitals;

(2) what information he has regarding the approximate number of people who have been injected with the spinal dye Myodil since it was marketed to its withdrawal.

Mrs. Virginia Bottomley

This information is not held centrally.

Mr. Ashley

To ask the Secretary of State for Health if he will list the types of spinal investigations for which Myodil was used.

Mrs. Virginia Bottomley

Myodil was used for the following spinal investigations:

  1. (a) Investigation of low back pain.
  2. (b) Investigation of cervical, dorsal and lumbar disc disease and
  3. (c) Investigation of suspected compressive abnormalities of the spinal canal.

Mr. Ashley

To ask the Secretary of State for Health from what sources his Department has received information about adverse reactions to the spinal dye Myodil.

Mrs. Virginia Bottomley

The Department has received information on adverse reactions to Myodil from a variety of sources including spontaneous reports from the medical profession, published literature and from the manufacturer.

Mr. Ashley

To ask the Secretary of State for Health (1) how many yellow card reports there have been indicating a possible association between the spinal dye Myodil and the disease arachnoiditis; and when the first report was received;

(2) if he will list the adverse reactions associated with the spinal dye Myodil.

Mrs. Virginia Bottomley

The Committee on Safety of Medicines has received a total of 73 yellow card reports in association with the use of Myodil, the first one being in 1970. Arachnoiditis was mentioned in 11 reports, the first in March 1972. In addition to arachnoiditis, the reports have included meningeal reactions which were self-limiting in most cases and local reactions either due to the procedure or the dye such as lumbar pain and leg pain. It is important to stress that the report of a reaction suspected in association with the use of a drug does not necessarily imply a cause and effect relationship.

Mr. Ashley

To ask the Secretary of State for Health if he has any plans to withdraw the product licence for Myodil.

Mrs. Virginia Bottomley

Myodil was withdrawn from the market by the company for commercial reasons and the Licensing Authority has been notified of its action. There are no plans to withdraw the product licence for Myodil.

Mr. Ashley

To ask the Secretary of State for Health at what date alternatives to Myodil were first available; what they were; and what assessment was made of the degree to which they were risk free.

Mrs. Virginia Bottomley

Myodil was licensed with the following clinical indications:

  • Myelography
  • Ventriculography:
  • visualisation of the third and fourth ventricles and the aqueduct of sylvius.
  • Intra-uterine use:
  • to outline the foetus prior to intra-uterine blood transfusion.

The following is a list of products which are licensed for one or more of the same indications:

  • Isovist 190
  • Isovist 240
  • Isovist 300
  • Niopam 200 Injection
  • Niopam 300 Injection
  • Omnipaque 180 mgi/ml Injection
  • Amipaque Powder for Injection
  • Iopamidol 300 Injection

The availability of any particular drug is a matter for the companies concerned.

Every application for a product licence is considered individually and must satisfy the Licensing Authority as to its safety, quality and efficacy before a licence is granted.

Mr. Ashley

To ask the Secretary of State for Health what procedures for spinal investigation have been used following the withdrawal of Myodil; and what is their cost relative to Myodil.

Mrs. Virginia Bottomley

The procedures listed have been used for spinal investigations following the withdrawal from use of Myodil:

  1. (a) the use of water-soluble contrast media.
  2. (b) Computed tomography without and with contrast media
  3. and
  4. (c) Magnetic resonance imaging.

No costings are available relative to that of using Myodil.

Mr. Ashley

To ask the Secretary of State for Health (1) whether the Committee on Safety of Medicines has at any time discussed Myodil;

(2) whether any evidence on safety has been presented to the Committee on the Review of Medicines since Myodil was first given its reviewed product licence.

Mrs. Virginia Bottomley

Following completion of the review, it would be the Committee on Safety of Medicines rather than the Committee on the Review of Medicines which would be consulted if the known safety profile of a product changed so as to cause alarm. This has not been the case with Myodil.