South Africa: Viagra gets go-ahead, Stampede expected as miracle sex pill is launched in SA this week
Sunday Times [South Africa]
28 February 1999
LAURICE TAITZ
THE wonder sex drug Viagra will be launched in South
Africa this week after the Medicines Control Council
finally approved the marketing of the pill on Thursday
night.
Since April, the council has refused to give the
miracle anti-impotence pill the green light because
of concerns about 130 deaths linked to the drug in
the US dating from March last year.
Pharmacists canvassed yesterday expect a huge
demand for the drug when it hits the shelves, but
the council has insisted on stringent safety measures
for its use in South Africa.
Council chairperson Dr Helen Rees confirmed that
the controversial drug had been given the
go-ahead. "The matter was discussed, and the
launch will happen soon," she said yesterday.
Viagra manufacturer Pfizer was told on Friday of
the council's decision. Company spokesman Dr
Koanji Sebati said: "We are very pleased that we
have reached agreement with the council."
The drug has been stored in warehouses in South
Africa since October, when approval for its
registration was given and then suddenly
withdrawn.
Pfizer is now preparing to supply the drug to
pharmacies, where it could go on sale as early as
this week.
Sebati said its availability was dependent on how
quickly the company could place new package
inserts and get the drug to wholesalers and retailers.
Pfizer has complied with requests from the council
to ensure the safe use of the drug and has begun
undertaking safety measures including:
Countrywide educational meetings on erectile
dysfunction;
Letters to doctors and pharmacists informing
them on when to prescribe the drug;
Labelling which complies with international
standards, including a requirement that a thorough
cardiovascular assessment be carried out on
potential patients before the drug is prescribed;
A patient information leaflet warning about
possible negative drug interactions and advising
against use if the patient has a heart condition; and
A letter informing doctors and pharmacists of
changes to the package insert and their safety
responsibilities.
The package insert has been rewritten twice to
comply with the council's recommendations.
The company has also recently launched an
education programme for pharmacists and
emergency room workers around the country.
Once Viagra is on the market Pfizer will begin
monitoring the drug's use.
The high number of deaths linked to Viagra raised
questions of whether the US Food and Drug
Administration approved the drug too quickly - it
took just six months.
Critics of the FDA said that by July the
administration had received 77 reports of deaths
and yet it took the company and the FDA more
than four months to agree on a new, more stringent
warning label, which was issued in November.
The drug comes with a warning that Viagra should
not be prescribed for men taking nitrates to treat
angina or chest pain, as the combination can cause
a sudden lowering of blood pressure, possibly
triggering a heart attack.
However, the sex act itself could be responsible for
many of the deaths as men suffering from
impotence may have had an undiagnosed heart
condition and may not have been used to the
exertion of intercourse.
In an article in the SA Medical Journal this month,
product manager Sam Nkulashe described the last
few months as a "traumatic time". He said the
company had lost about R20-million in expected
sales revenue since May.
Sandton pharmacist Trevor Charters said he
expected the demand for the drug to be
"enormous".
"When the hype first started we had calls every day
asking when we were getting Viagra. It has died
down, but we still get at least a call a day," he said.
A Viagra tablet will sell for between R70 and R110
for three strengths: 25mg, 50mg and 100mg.
suntimes.co.za |
