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US regulators have approved new “black box” warning labels for GlaxoSmithKline's controversial diabetes drug Avandia.
The warnings, the strictest that prescription drugs can carry in the US, emphasise the drug may trigger congestive heart failure and that patients should be monitored closely by physicians.
The drug’s labelling already contained similar warnings but the new ones will be significantly more prominent.
The warning is also applicable to other drugs in the same class that help patients with type 2 diabetes control their levels of blood sugar. They include Actos manufactured by Japan’s Takeda.
The move may help end some of the uncertainty surrounding Avandia following an investigation by America’s Food and Drug Administration into the possible increased risk of heart problems associated with the drug.
News of the investigation led to a fall in sales of Avandia of up to 40 per cent in the US.
However, the new warnings regarding congestive heart failure are separate from other fears that Avandia may also lead to ischaemic heart attacks.
A review of Avandia and a possible increased risk of heart attacks is ongoing, the FDA said.
Shares in GSK fell from £12.62 to £12.44 in early trading.
GSK has been scrambling to head off a crisis of confidence in the drug since the New England Journal of Medicine published a report in May claiming that the drug increased the risk of heart attacks by 43 per cent. The report has been criticised by other scientists.
GSK is considering cutting or redeploying its sales force as sales of Avandia plummet.
Last year Avandia contributed £1.4 billion to GSK's total turnover of £23.3 billion in 2006.
The company employs 30,000 salespeople, including 9,000 in the US.
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I'm a pharmacy student in my 3rd year of the PharmD program, and today I presented a clinical seminar for school entitled, "Is Rosiglitazone (Avandia) Safe for Use in Cardiovascularly-Compromised Patients?" I think that the object of each physician should be to CLOSELY monitor patients who possess a necessity for a TZD, for potential adverse cardiac outcomes. Pharmacists are more readily accessible to the patient and are more able to identify and address important monitoring parameters, chiefly increased weight gain. The severity of this, in turn, can be relayed back to the PCP by the pharmacist, facilitating a feedback system that may help assign the patient the need for more frequent follow-up appointments with the PCP to assess the potential for adverse cardiac outcomes. PCPs should be aware that we as pharmacists are aware of the issues and parameters that should be magnified in practice, and that we're here to help and guide to the best treatment efficacy for the patient.
Alex, Athens, Georgia
If regulators only focused on whether there was a risk of heart attack, there would be no drugs to treat diabetes.
According to oficial US statistics (2005), 20.8 million peopleâ7 percent of the populationâhave diabetes.
Diabetes was the sixth leading cause of death listed on U.S. death certificates in 2002. According to death certificate reports, diabetes contributed to a total of 224,092 deaths.
Heart disease and stroke account for about 65 percent of deaths in people with diabetes. Adults with diabetes have heart disease death rates about 2 to 4 times higher than adults without diabetes. The risk for stroke is 2 to 4 times higher among people with diabetes.
To deprive patents access to Avandia and other similar drugs would be irresponsible.
Chris Johnson, London,
I am amazed that a drugs manufacturer can issue a drug with side effects which can cause heart failure/heart attacks. Avandia should be withdrawn from the market. Is this a case of Money rules, the patient comes second.
D Fowler, Chalfont St. Peter, Buckinghamshire U.K.