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Johannesburg – Adcock Ingram Holdings [JSE:AIP] has defended its move to merely suspend sales of three products, years after the UK and EU moved to ban similar drugs.
Hours after Adcock Ingram suspended sales of three of its products which contain dextropropoxyphene (DPP), the Medicines Control Council (MCC) ordered that all medicines containing DPP be withdrawn from the SA market.
DPP is found in Adcock’s Lentogesic, Doxyfene and Synap Forte, a popular post-operation painkiller, which is also used for back pain.
Drugs containing DPP were banned in the UK (2005) and the EU (2009) after the ingredient was linked to suicides and accidental overdoses led to deaths.
After many years of controversy, the US decided to ban medicines containing DPP in November following a study which showed it could lead to irregular heart rhythms that can be fatal.
Ten million Americans received drugs containing DPP in 2009. According to one estimate, up to 2 000 people may have died in the US due to problems with the medicine in the past five years.
In response to questions from Fin24, Adcock Ingram said there have been no reports of deaths in the more than 30 years that medicines containing DPP were available in the local market.
“In UK and Europe, the DPP-containing drugs were available on an over-the-counter basis and it is well documented that this situation led to abuse (or) overdoses.”
In SA doctors must prescribe DPP-containing drugs, which are categorised as Schedule 5.
“You cannot buy them over the counter. As such, these drugs have been well managed, lessening the chance of overdoses being taken.”
The medicines banned in the US have a different formulation compared to local medicines, and the dosages are also different.
“The recommended daily dose of Synap Forte is 400mg/day, much lower than dispensed in the US study. In other words, the dose applied in the US clinical trial (600 and 900 mg) is 50% above the prescribed amount recommended in South Africa, which is a maximum of 400 mg propoxyphene daily.”
The group says research by the Tygerberg Poison Information Centre over the past 15 months has not raised any areas of concern for the DPP-containing drugs.
“There are no incidences of suicide on this drug.”
Also, patients taking DPP-containing drugs are often on cardiac monitors. Over the years, there has been no clinical evidence of widespread electrical changes in heartbeat.
Clinical data in SA shows that there have been no reports of cardiovascular side-effects at therapeutic dosages, Adcock added.
“We are determined to do what is ethically right for patients. At the same time, we want to behave responsibly and not to cause undue alarm in the market.”
Adcock shares came under renewed pressure on Monday, following a sharp sell-off on Friday. By 14:00 on Monday, the shares were down more than 3% to R61.81.
The three medicines contributed about R200m to Adcock’s revenue of R4.4bn for the year to end-September.
Avior Research has calculated that the suspension of sales could lower the group’s earnings by 5%.
