Author Topic: Dangerous diabetes drug Avandia on sale in Kenya  (Read 3296 times)

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Offline Abdulrazzak

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Dangerous diabetes drug Avandia on sale in Kenya
« on: October 03, 2010, 01:06:39 PM »
Rosiglitazone  (Avandia)
 Rosiglitazone is an anti-diabetic drug in the thiazolidinedione class of drugs. It works as an insulin sensitizer, by binding to the PPAR receptors in fat cells and making the cells more responsive to insulin. It is marketed by the pharmaceutical company GlaxoSmithKline (GSK) as a stand-alone drug (Avandia) and in combination with metformin (Avandamet) or with glimepiride (Avandaryl). Annual sales peaked at approx $2.5bn in 2006, but declined after reports of adverse effects. The drug's patent expires in 2012.
Some reports have found that rosiglitazone is associated with a increased risk of heart attacks, but other reports have not found a statistically significant increase. Concern about adverse effects has reduced the use of rosiglitazone despite its sustained effects on glycemic controlThe drug is currently the subject of many lawsuits against GSK. Over 13,000 have been brought against the company due to the drug As of July 2010, GSK has agreed to settlements on more that 11,500 of these suits.
The drug is controversial in the U.S. Food and Drug Administration. Some reviewers concluded that rosiglitazone caused more deaths than pioglitazone (Actos) and recommended that rosiglitazone be taken off the market, but an F.D.A. panel disagreed and it remains on the market in the U.S., subject to significant restrictions.
In Europe, the European Medicines Agency recommended in September 2010 that the drug be suspended from the European market. However, patients currently taking rosiglitazone are advised to discuss alternative options during their next physician appointment.

Side-effects and contraindications
Heart disease
Some studies conclude that rosiglitazone increases fatalities from heart disease, but other studies do not.
A study in 2007, found that Avandia may increase the risk of heart attack by as much as 43%. A meta-analysis reported in May 2007 that the use of rosiglitazone was associated with a significantly increased risk of heart attack (odds ratio=1.43, (95% confidence interval, 1.03 to 1.98; P=0.03)), and an even higher risk of death from all cardiovascular diseases (odds ratio=1.64).[15] The U.S. Food and Drug Administration (FDA) issued an alert on May 21, 2007.[16] On July 30, 2007 an Advisory Committee of the Food and Drug Administration concluded that the use of rosiglitazone for the treatment of type 2 diabetes was associated with a greater risk of myocardial ischemic events (including heart attacks) than a placebo, but data from several long term, prospective clinical trials showed that when rosiglitazone was compared to metformin, or sulfonylurea, there was no difference in the risk of heart attack. This data, coupled with the meta-analysis, prompted the FDA to state that the data on the association between rosiglitazone and myocardial ischemia were inconclusive. The meta-analysis was not supported by an interim analysis of the trial designed to evaluate this, and several other reports have failed to conclude the controversy. This weak evidence for adverse effects has dramatically reduced the use of rosiglitazone, despite its important and sustained effects on glycemic control.
In 2009 the RECORD study, an open label trial published in the Lancet, found that there was no increase in cardiovascular hospitalisation or death with rosiglitazone compared to metformin plus sulfonylurea, but the rate of heart failure causing admission to hospital or death was significantly increased.
Both TZD's are contraindicated in patients with NYHA Class III and IV heart failure.
In February 2010, David Graham, the FDA's associate director of drug safety, recommended that rosiglitazone be taken off the market. Graham argued that rosiglitazone caused 500 more heart attacks and 300 more heart failures than its main competitor. At the same time, a report by the Senate Finance Committee accused GlaxoSmithKline of knowing about the drug's risks well before they became public. The report also criticized the FDA for letting clinical trials continue despite 83,000 heart attacks from 1999 to 2007 that the FDA linked to rosiglitazone. GlaxoSmithKline maintains that the drug is safe and that the Senate report did not consider scientific evidence or the company's efforts to make known its concerns to the parties involved. However, the FDA still recommends that patients continue taking it unless their doctor tells them otherwise.
In June 2010, David Graham et al. published a retrospective study of 227,571 elderly American patients, comparing roziglitazone to pioglitazone, the other thiazolidinedione marketed in the United States. The authors concluded that rosiglitazone was associated with "an increased risk of stroke, heart failure, and all-cause mortality and an increased risk of the composite of AMI, stroke, heart failure, or all-cause mortality in patients 65 years or older". The number needed to treat with roziglitazone to cause harm in one was sixty.
Stroke
Avandia has been linked to stroke. In some studies, it was found that the drug increases the risk of stroke by over 27%
A study found that Avandia increases risk of stroke more than alternative drug Actos in elderly patients.
Bone fractures
GlaxoSmithKline reported a greater incidence of fractures of the upper arms, hands and feet in female diabetics given rosiglitazone compared with those given metformin or glyburide. The information was based on data from the ADOPT trial. The same increase has been found with pioglitazone (Actos), another TZD.
[Eye damage
Both rosiglitazone and pioglitazone have been suspected of causing macular edema, which damages the retina of the eye and causes partial blindness. Blindness is also a possible effect of diabetes, which rosiglitazone is intended to treat.                                   One reportdocumented several occurrences and recommended discontinuation at the first sign of vision problems.
 Hepatotoxicity
Moderate to severe acute hepatitis has occurred in several adults who had been taking the drug at the recommended dose for 2–4 weeks. Plasma rosiglitazone concentrations may be significantly increased in patients with pre-existing hepatic impairment.

Now Dangerous diabetes drug Avandia on sale in Kenya:
The controversial diabetic drug Avandia, alleged to cause heart attacks and strokes, is still available in the Kenyan consumer market, despite a three-year old report condemning its use in the Western world.
In interviews with The EastAfrican,The controversial diabetic drug Avandia, alleged to cause heart attacks and strokes, is still available in the Kenyan consumer market, despite a three-year old report condemning its use in the Western world. pharmacists, medical representatives and doctors confirmed that prescriptions for Avandia are still being offered to older patients.
The practice highlights loopholes in Kenya’s drug market as patient seek cheaper products and companies look to push sales.
In Uganda, though Avandia is registered by the National Drug Authority (NDA), it is not on the market.
GlaxoSmithKline country manager Nathan Wasolo said they registered the drug with NDA but did not import it for the Ugandan market.
Officials at NDA told The EastAfrican that they have both Avandia and Avandum a combination drug for diabetic patients. According to DA head of drug inspection David Nahamya, the drug has not been totally recalled but there was an alert in July 2010.
“We do not commonly prescribe it, we use the most common drugs that are affordable,” said Dr Charles Kiggundu of Nsambya hospital.
For almost a decade, Avandia was one of the most expensive drugs in the Kenyan market. It was introduced in the Kenyan market in 2000. Its initial cost was Ksh3,015.60 ($37.5) for a pack of 28 tablets. But between 2006 and this year, the price has dropped to Ksh788 ($9.85).
This has not stopped Public Health Minister Beth Mugo from urging healthcare providers to consider lowering costs and subsidising treatment.
Major pharmacies in Nairobi like Pentapharm, Lyntons, KAM, Pharmart, Transchem and Lemuma admit to keeping a limited stock of the drug for their elderly patients who they claim come to collect it mostly every month.
Avandia (Rosiglitazone) is a Type-2 drug. Type 2 diabetes occur mainly in people aged over 40 when their body either do not produce enough insulin (a hormone that regulates the blood sugar level) or ignores the insulin produced.
Avandia, like any other type 2 diabetic drug, works by making the cells more sensitive to insulin. This lowers the blood sugar level by allowing the insulin to enter into the cells.
A technician at KAM Pharmacy said he is aware of the controversy surrounding the use of the drug and advises patients who go to buy it from their stores to consult their doctor to prescribe an alternative drug.
Others like Troy Chemists, Inkamed, Pharmtrade and Sunus Chemists do not stock Avandia. .

Prepared By     Dr.Abdirizak H. Mohammed
                              Pharm-D



 

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