Government declines to withdraw tramadol from the market
Government declines to withdraw tramadol from the market
JAKARTA (JP): The Ministry of Health has played down demand
from the Indonesia Health Consumer Empowerment Foundation to
withdraw analgesic tramadol from the market and list the drug as
a synthetic narcotic to ensure stricter control.
The ministry's Director General for Drug and Food Control
Sampurno said on Monday that at the moment the ministry has no
plans to change the tramadol classification from a strong drug to
a synthetic narcotic.
He said even the U.S. Food and Drug Administration, known for
its strict control over drugs, and the World Health Organization
did not classify tramadol as a narcotic.
"There should be a strong reason (for such a demand),"
Sampurno told The Jakarta Post by phone. "We should also take
into account the international standard."
The ministry, he said, has imposed stricter controls over
illegal sales of strong drugs outside pharmacies.
"So, don't be confused between a drug's category and its
control. We do control drugs here," said Sampurno, adding that
the ministry had just summoned 20 drug manufacturers, calling for
their accountability over widespread sales of illegal strong
drugs.
But he added that he was not willing to be trapped in
prolonged controversy over tramadol.
"Let's allow only those from the medical profession, such as
pharmacologists or the medical association, talk about it,"
Sampurno said.
Last week, the foundation raised its demand via the mass media
-- the second one after an earlier failure to obtain a response
from the ministry -- that the government withdraw tramadol and
list it as a synthetic narcotic.
Citing medical literature, Tramadol Systemic, the foundation's
chairman, Marius Widjajarta, said that: "It has been estimated
that the analgesic potency of tramadol is one-tenth that of
morphine."
"Tramadol can cause opioid dependence and may potentially be
abused. Tolerance development, drug seeking behavior and craving
have been associated with the use of tramadol."
If tramadol is categorized as a narcotic it would be
prescribed by doctors under stricter control. Doctors and
pharmacies selling the drug would be obligated to report its
sales to the ministry every month.
At present, the ministry categorized tramadol as a strong drug
which is available upon prescription without obligation to report
its sales to the ministry. But in reality, tramadol can be
obtained from sidewalk drug vendors.
Prescribed tramadol is used for the management of moderate to
moderately severe pain, such as to treat pain following
orthopedic and gynecological procedures, including caesareans.
Marius disclosed on Monday that following the foundation's
request, a ministry expert had requested the organization submit
literature being used to back up its claims. He declined to name
the expert.
"They (the ministry) say that our literature is not
reliable ... I can't understand why," Marius told the Post.
He revealed that the foundation used medical references, such
as Internal Medicine and MIMS -- a list of drugs released by drug
producers. It also consulted Law No. 22/1997 on narcotics.
He further disclosed that the drug's producers have classified
tramadol as a narcotic with analgesic potency.
The foundation also released on Monday 17 of tramadol's brand
names. They are Bellatram, Dolana, Dolsic, Forgesic, Katrasic,
Orasic, Radol, Seminac (not Feminax as published in this page
last Wednesday), Simatral, Tradonal, Tradosik, Tradyl, Tramal,
Traumasik, Trunal DX, Tugesal and Zumatram.
When asked for the foundation's next move, if the ministry
refused its demand again, Marius said it would request the
ministry release statements refuting the medical literatures as
"false".
"It's confusing how the ministry keeps insisting that our
literature is not reliable, while at the same time doctors and
even medical students use them," Marius said. "So, if the
ministry said that the books are not dependable, they need to
clarify it." (ste)