Sibutramine and Sildenafil Banned From Traditional Medicine

The Health Ministry of Malaysia has banned the sale, distribution and consumption of traditional medicine manufactured by Etumax Corporation Sdn Bhd as they were found to contain sibutramine and sildenafil, which are prohibited items for medicine classed as traditional medicine. Sibutramine is an agent for the treatment of obesity while the citrate salt of sildenafil can be used an oral therapy for erectile dysfunction (VIAGRA). Thus, it must be prescribed by doctor and not used as an ingredient of a "power" beverages.

Its Pharmaceutical Services Division senior director Eisah A. Rahman said the products used the brand names of “Phyto Shape”, “Tongkat Ali Power”, “Tongkat Ali Power Plus” and “Etumax Eurycoma Active Plus”.

She said medicine containing sibutramine and sildenafil can only be prescribed by a doctor or obtained from pharmacies with a doctor’s prescription.

“The public should not use traditional medicine products with sibutramine as its use without supervision of a doctor can lead to adverse effects like high blood pressure and faster heartbeat.

“The use of sildenafil without a doctor’s prescription can lead to low blood pressure and have serious implications like a heart attack,” she said in a statement here today.

As such, she advised anyone with stocks of the products to stop selling, distributing or consuming them with immediate effect.

Offenders can be charged under of the Drug Control and Cosmetic Regulations 1984 whereby they can be fined a maximum of RM25,000 or jailed not more than three years or both, if convicted for the first time.

For subsequent offences, offenders can be fined a maximum of RM50,000 or jailed up to five years or both while offending companies can be fined up to RM50,000 for the first offence and up to RM100,000 for subsequent offences.

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Quick medical facts about Sibutramine

Sibutramine (trade name Meridia in the U.S. and Canada, Reductil in Europe and most other countries), usually as sibutramine hydrochloride monohydrate, is an orally administered agent for the treatment of obesity, as an appetite suppressant. It is a centrally-acting serotonin-norepinephrine reuptake inhibitor structurally related to amphetamines, although its mechanism of action is distinct. Sibutramine can substantially increase blood pressure and pulse in some patients. Therefore all patients treated with sibutramine should have regular monitoring of blood pressure and pulse.

The following side effects are infrequent but serious and require immediate medical attention: cardiac arrhythmias, paresthesia, mental/mood changes (e.g., excitement, restlessness, confusion, depression, rare thoughts of suicide).

Sibutramine is sometimes advised to help with losing weight if you are obese or overweight. Doctors have guidelines as to when it can be used.

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Quick medical facts about Sildenafil

Sildenafil citrate, sold as Viagra, Revatio and under various other trade names, is a drug used to treat erectile dysfunction and pulmonary arterial hypertension (PAH). It was developed and is being marketed by the pharmaceutical company Pfizer. It acts by inhibiting cGMP specific phosphodiesterase type 5, an enzyme that regulates blood flow in the penis. Since becoming available in 1998, sildenafil has been the prime treatment for erectile dysfunction; its primary competitors on the market are tadalafil (Cialis) and vardenafil (Levitra).

In clinical trials, the most common adverse effects of sildenafil use included headache, flushing, dyspepsia, nasal congestion and impaired vision, including photophobia and blurred vision. Some sildenafil users have complained of seeing everything tinted blue (cyanopsia).

Sildenafil also reduces the pressure in the pulmonary artery in a serious condition called pulmonary arterial hypertension.

Sildenafil is used for the treatment of erectile dysfunction of either organic (medical condition) or psychogenic (psychological) cause and for pulmonary arterial hypertension.