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Cipla Will Not Withdraw Pill Despite Request

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Original Post Date: 2010-10-21 Time: 18:00:02  Posted By: News Poster

By Tamar Kahn

Cape Town – Generic drug maker Cipla Medpro says it has no plans to withdraw its fat-fighting pill Ciplatrim from the market, despite the voluntary recall last week of Abbott’s Reductil and Ectiva, which contain the same active ingredient, sibutramine.

Abbott and its distributor, Aspen Pharmacare, last week agreed to the Medicines Control Council’s (MCC’s) request that they withdraw Reductil and Ectiva after a large European trial found that sibutramine increased the risk of heart attacks and strokes in high-risk patients.

The study, the Sibutramine Cardiovascular Outcomes Trial (Scout), included 10000 patients, most of whom had underlying cardiovascular disease and were not eligible to receive the drug under current labelling.

The Scout study prompted the European Medicines Agency to conduct a review of the safety of medicines containing sibutramine. In January, it ordered such drugs to be withdrawn, saying their benefits as a weight- loss aid “do not outweigh the cardiovascular risks”.

Earlier this month, the US Food and Drug Authority recommended patients stop using Abbott’s sibutramine product, branded Meridia in the US, saying it “may pose unnecessary cardiovascular risks to patients” and asked Abbott to voluntarily withdraw the drug, which it did.

“Quite frankly, we can’t understand Abbott’s take on sibutramine,” Cipla Medpro CEO Jerome Smith said yesterday .

“We have a different take … We believe the product is safe if used in the right patient, determined by the package insert,” he said.

Mr Smith said Cipla Medpro had requested a meeting with the MCC, which regulates the sale of medicines in SA. The company had opinions from “a top cardiologist and pharmacologist” and “had not had one complaint” about Ciplatrim. The drug was not a significant contributor to Cipla’s bottom line, he said.

MCC registrar Mandisa Hela declined to comment on Cipla’s decision to continue selling a drug containing sibutramine, saying that the council “was engaging” with generic manufacturers. “This was a voluntary withdrawal.”

The MCC would issue a statement once it had concluded its discussions with the generic drug makers, she said. Ms Hela said several generic versions of sibutramine were registered with the MCC, but as far as she could recall Cipla was the only firm that had taken such a product to market.

Aspen Pharmacare’s head of strategic trade, Stavros Nicolaou, estimated about 40000 patients were using legal sibutramine products for weight loss.

SA’s anti-obesity drug market was worth R97m in the year to August, he said, citing ex-factory data from research firm IMS. Sibutramine products were worth R40m, of which Ciplatrim generated R25m, Reductil R11,7m and Ectiva R3,3m, he said.

Global sales of Abbott’s sibutramine product reached 80m in the first nine months of this year, according to Bloomberg, but its withdrawal would have a negligible financial effect on Aspen, said Mr Nicolaou.

“The product presents less than 0,1% of Aspen’s South African turnover. Practically, Abbott are mainly responsible for the withdrawal. Patients have other obesity treatment options available,” he said.

“On the balance of the benefit of the risk and given that the product has been withdrawn by the European Union Regulatory Authority and voluntarily withdrawn in the US and Australia, we felt the responsible thing was to voluntarily withdraw (in SA).”

Abbott registered Reductil and Ectiva in SA in 1999, and for the past two years the drugs have been distributed by Aspen.

There are many illegal weight- loss products on the market that contain sibutramine. Earlier this year the MCC suspended the sale of sibutramine-containing Simply Slim because it had not been registered.

Original Source: Business Day (Johannesburg)
Original date published: 20 October 2010

Source: http://allafrica.com/stories/201010200786.html?viewall=1