Paidamoyo Chipunza Health Reporter
Local pharmacies have removed Brinerdin, a drug used to treat hypertension, from their shelves after it was recently recalled by its Swiss manufacturer — Novartis — to ensure compliance with regulatory standards and quality control.The withdrawal of Brinerdin from the local market came amid indications that the drug caused severe side-effects such as kidney malfunction, ulcers, stroke, heart failure and depletes vitamins.
Some hypertension patients who had been prescribed the drug said they were stunned when told by pharmacists that it had been removed from the shelves, with speculation rife among the users that the drug, which has been on the local market for sometime, was recalled because of its toxicity.
Last month, the World Health Organisation representative in Zimbabwe Dr David Okello said the prevalence rate for high blood pressure had reached 27 percent in the country.
That means there are more than two million Zimbabweans who are hypertensive. It could not be ascertained how many of these were prescribed Brinerdin, though pharmacists said the number was relatively high.
Swiss drugs-maker Novartis recently also recalled about 5,3 million bottles of other blood pressure medications and medicines that had been provided as free samples to United States physicians, citing potential contamination by a packaging chemical.
A website that seems linked to the US government, http://www.nlm.nih.gov, warns of many side-effects from reserpine, one of the active ingredients in Brinerdin.
Dizziness, loss of appetite, diarrhoea, upset stomach, vomiting, stuffy nose, headache, dry mouth and decreased sexual ability are listed as the lesser effects.
Serious side-effects include depression, nightmares, fainting, slow heartbeat, chest pain, and swollen ankles and/or feet. Some experts claim that reserpine increases the risk of breast cancer and malignancies in male reproductive and adrenal glands.
But the Medical Control Authority of Zimbabwe has downplayed why Brinerdin has been yanked off the market. MCAZ director-general Ms Gugu Mahlangu said Novartis voluntarily withdrew the drug that was registered in Zimbabwe in 1980, and has been in use since then, not because of complaints by local patients.
“The manufacturer indicated to us very recently that they will be withdrawing the product from the market voluntarily,” she said. “It is our view that the product has been overtaken by newer and more effective treatments for hypertension, leading to this marketing decision.”
Ms Mahlangu said the drug was no longer wanted on shelves of local pharmacies as in addition to the recall, it was outdated because combinations of more than two active ingredients were hardly used in managing hypertension in today’s world.
Brinerdin comprises of three active ingredients; namely, dihydroergocristine clopamide and reserpine.
“The trend moved away from combination products, although we have seen it come back in the era of ARVs, to reduce the number of tablets a patient takes,” said Ms Mahlangu.
A survey around pharmacies in Harare last week showed that most establishments were no longer stocking the drug. Once considered “illnesses of the rich”, non-pandemic diseases prevalences are increasing in populations in developing countries with hypertension, diabetes and cancers among the biggest problems.
Hypertension is often called the silent killer because a good number of the affected do not realise that they have the disease. It is a chronic medical condition in which the blood pressure is elevated or repressed, and this requires the heart to work harder than normal to circulate blood through the blood vessels.
Unmanaged high blood pressure may lead to impaired vision, severe headache, chest pain and difficulty in breathing. These problems can lead to heart attack, heart failure, stroke, kidney failure, blindness, rupture of blood vessels followed by paralysis and death.