Govt warns use of ginkgo biloba

JAKARTA (JP): Directorate General for Food and Drug Control (POM) has reprimanded producers of medicines with ginkgo biloba for providing consumers with inadequate information on the substance.

The companies have been asked to withdraw all advertisements of their products which are considered misleading.

POM director general Sampurno said on Thursday that pharmaceutical firms did not attach clear contra indications on the label of their products, explaining possible side effects resulting from improper use of the medicines.

"Healthy people should not consume ginkgo biloba since it is likely to cause side effects when mixed with other medication," Sampurno told The Jakarta Post.

The side effects include etisthaxis (under skin bleeding) and nose bleeds.

There have been reports of 11 cases of side effects from ginkgo biloba in Germany and France, Sampurno said.

"Of the cases, seven were caused by taking ginkgo with other medication, such as anti-proavulan (commonly used as an anticoagulant) or oral contraception. The rest were caused purely by the use of ginkgo biloba," he said.

In Indonesia, ginkgo biloba is commonly used in traditional medication but no single case of side effects such as nose bleeding has been recorded here, Sampurno added.

Ginkgo biloba is a substance which has been consumed for over 1,000 years in China and has also been used worldwide as a medicine that can enhance blood flow.

Based on various research, the substance has more benefits than disadvantages, Sampurno said.

The substance can cure people who have problems with blood flow and exhibit symptoms of declining memory, concentration problems or vertigo.

To date no country has withdrawn the substance from the market.

The Indonesian Consumer Foundation (YLKI), however, demanded that stern measures be imposed to irresponsible pharmaceutical companies who mislead people for suggesting children consume ginkgo biloba.

"It's obvious that the ministry of health is ignorant for permitting such advertisements on the use of ginkgo biloba," Zoemrotin K. Soesilo told the Post.

"It is difficult to control since drugs in Indonesia are distributed all the way down to cigarette kiosks. So what's the guarantee that people will have safe medicine with adequate labeling of contra indications?" she remarked.

Sampurno said that misleading advertising such as the use of ginkgo biloba in the brand medicine of Cerebrovit was pulled out a month ago.

"We do not tolerate misleading advertising. Pharmaceutical business is one of the most regulated industries in the world because it directly concerns people and therefore it's obliged to tell the truth," he said.

Unlike the case of phenylpropanolamine (PPA), ginkgo biloba is a traditional substance that has been used for a long time.

Zoemrotin also remarked that medicines which contain PPA must be withdrawn from public distribution.

"I'm not sure that such PPA medication or drugs can be processed to meet standard procedures in such a short time, which is only three to four months," she said.

The ministry of health has given a four month period of transition for producers of medicines which contain PPA to change their contra indication labels and warnings.

"It has also instructed that PPA content in each tablet be reduced from 25 milligrams to 15 milligrams, with the maximum use of 60 milligrams per day," Sampurno said, adding that based on research 15 milligrams of PPA has shown therapeutic effects.

There are 189 brands of flu and cough medicines containing PPA produced by 79 pharmaceutical firms in the country.

Prolonged use or an overdose of PPA can cause hemorrhagic stroke.

Actually the use of PPA is considered safe if it does not exceed 75 milligrams per day for adults and 37.5 milligrams per day for children between six and 12 years of age, Sampurno said.

"Medicines containing PPA are not recommended for children under six or for pregnant women, except by doctor's advise," Sampurno asserted.

"Therefore, we have to be objective and not create unnecessary public concern. Unlike in the United States which has revoked PPA where it was misused to suppress appetite, Indonesia as well as England and Australia only use PPA as a decongestant.

"PPA is even used in dosages of 100 milligrams in England."

An overdose of PPA can cause elevated blood pressure and interact adversely with other medication. The substance can worsen patients with diabetes, glaucoma or those with kidney or liver problems. (edt)