In the comic science fiction of Douglas Adams, the 'Hitch-hiker's Guide to
the Galaxy' bears on its cover the reassuring message, "Don't panic". That advice
would have been useful early last week after the November 6 announcement by
the United States Food and Drug Administration that it was taking steps to remove
phenylpropanolamine from drug products on the American market (PJ, November
11, p709). The FDA had made its decision in the light of research - reported
in The Journal three weeks ago (PJ, October 28, p642) - that showed a risk,
albeit a small one, of haemorrhagic stroke associated with the use of the drug.
On the morning after the FDA's announcement, Britain's national news media gave
the decision prominent coverage, with headings such as "Family cold cures linked
to strokes". In fact, the US research offers no evidence that could connect
British cold products with a risk of stroke. It is clear from the research report
that the link between phenylpropanolamine and stroke is not only a weak one
but also relates almost exclusively to the use of the drug in appetite suppressant
products that are not marketed in Britain. For cough and cold remedies, the
link is weaker still - if it exists at all. Furthermore, the evidence relates
only to cough and cold products on the US market, where they are allowed a maximum
daily dose that is 50 per cent higher than the limit for UK products.
Armed with appropriate information about the American research, community pharmacists
could have countered the British scare story by giving suitable reassurance
and advice to customers. But no guidance was offered to pharmacists until November
10, when the Medicines Control Agency, via the health authorities, sent them
a letter prepared by the Committee on Safety of Medicines after a review of
the UK situation on November 8 (see p748).
The CSM's letter explains the matter clearly. But, since the relevant facts
had been openly available from the FDA website before the panic began, the Government
and various bodies in pharmacy had had an opportunity from the start to support
pharmacists by providing them with a rapid preliminary assessment of the risk.
In the absence of such guidance, many pharmacies were constrained to join in
the general turmoil, scrambling to remove all phenylpropanolamine products from
display and offering unnecessary advice about alternative "safer" products.
Once again, we have experienced a drug safety crisis that could have been better
handled. Perhaps there is a need for a "hitch-hiker's guide" to help the profession
and the Government to cope more effectively with future drug panics.