Govt urged to withdraw tramadol

Govt urged to withdraw tramadol

JAKARTA (JP): The Indonesia Health Consumer Empowerment
Foundation urged the government on Tuesday to withdraw analgesic
tramadol from the market and categorize the drug as a synthetic
narcotic available only with a prescription.

The Ministry of Health has categorized tramadol as a "strong
drug". The generic drug comes in 17 brand names, including the
extremely popular Feminax, Belatram and Tramal. They can be
freely obtained without prescription.

Equipped with medical literature and Law No. 22/1997 on
narcotics, the non-governmental organization's chairman Marius
Widjajarta told the media that tramadol was a synthetic narcotic.

"It has been estimated that the analgesic potency of tramadol
is one-tenth that of morphine," he said, quoting a booklet on the
drug, Tramadol Systemic.

"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."

The foundation issued the same demand earlier this month after
it failed to obtain a response from the Ministry of Health until
taking its case to the mass media.

The ministry's director general for drugs and food
supervision, Sampurno, has stood by the government's policy of
classifying tramadol as a "strong drug", and insisted the
analgesic potency of tramadol was one-six thousandth that of
morphine -- not one-tenth as the foundation claimed.

He also said tramadol was not listed as a narcotic drug by the
International Narcotics Control Board.

Marius said he saw no reason behind the ministry's defense of
the drug's classification, saying 16 manufacturers of the drug
had classified tramadol as a narcotic with analgesic potency.

"If the directorate general wants to protect consumers, it
would be better if they immediately withdrew the drug and changed
its classification from a strong drug to a synthetic narcotic,"
Marius said.

When asked what action the foundation would take if the
ministry refused to withdraw tramadol, he said: "We would
question the credibility of the directorate general of drug and
food supervision here ... and what's behind all of this."

Sampurno could not be reached for further comment on Tuesday.

Marius said that presently, although considered a strong drug
available only by prescription, tramadol could be found not only
in pharmacies, but on offer by sidewalk vendors across the city.

He displayed the tramadol he bought from sidewalk vendors in
Central Jakarta.

Tramadol capsules were purchased for between Rp 300 and Rp 600
each and tramadol suppositories sold for between Rp 1,000 and Rp
2,000. Ampules, or small sealed glass tubes containing one dose
of a sterile medicine to be injected hypodermically, cost between
Rp 6,000 and Rp 7,000 each.

"The prices are as low as parking fees ... very cheap and easy
to get without a prescription," Marius said.

Prescribed tramadol is used for the management of moderate to
moderately severe pain. It has been used to treat pain following
orthopedic and gynecological procedures, including caesarean
sections.

He said if tramadol was listed as a narcotic, it would be
prescribed by doctors under stricter controls.

"If a drug is classified as a narcotic, doctors and pharmacies
selling the drug should report its sales to the ministry every
month," Marius said.

Unfortunately, there is no political will from the government,
particularly the ministry, to change its policy and regulate the
sale of tramadol, he said. (ste)