Access To Justice

Should Avandia be pulled from the market?

That’s the key question the Food and Drug Administration (FDA) must decide as it meets this week to ponder the fate of GlaxoSmithKline’s (GSK) controversial diabetes drug, which some studies have linked to increased risk of heart attack, stroke, and death.

Two recent news reports have made Avandia’s position even tougher on the eve of this critical meeting at which an expert panel will assess the drug’s safety and recommend whether it should remain on the market.

First, The New York Times reported that an FDA reviewer last week issued a devastating critique of the clinical study used by GSK to refute safety claims lodged against Avandia.  The reviewer found that the so-called Record study failed to count at least twelve instances in which patients who used Avandia may have suffered cardiovascular problems, reports the Times. GSK stands by the study’s results, which will be part of the data reviewed by the FDA panel this week.

Meanwhile, Bloomberg News reported that a former FDA official has alleged that GSK did not share with federal regulators a study showing that Avandia might pose a greater heart attack risk than some other diabetes drugs. The allegation was made by Dr. Rosemary Johann-Liang in a deposition she gave in a lawsuit filed against GSK, according to Bloomberg. GSK took issue with Johann-Liang’s account and told the news service that no studies have proven that Avandia is dangerous.

Avandia (rosiglitazone) has come under increasing scrutiny since February, when the FDA and the US Senate released reports critical of cardiac risks associated with it. But the drug has been embattled since 2007, when a study by the Cleveland Clinic linked it to an increased risk of heart attack. The FDA issued a safety alert for Avandia that same year.

GSK has defended Avandia even as it has recently settled hundreds of lawsuits brought by patients alleging the drug caused heart attacks and other health issues.

As always, do not change any medication without first consulting your doctor.

Two new studies linking Avandia to risk of heart attacks, strokes, and other serious cardiovascular problems have reignited safety concerns and calls for regulators to pull the diabetes drug made by GlaxoSmithKline from the market, according to Bloomberg Business News.

One study (blogged recently here) found that nearly 50,000 older Americans died or experienced stroke or heart failure after taking Avandia instead of another anti-diabetes medication; the second study found that the drug would lead to harm  in one of every 52 patients taking it, reports Bloomberg.

The Journal of the American Medical Association and the Archives of Internal Medicine published the research.

GlaxoSmithKline said it stood by the drug and noted that many other studies had found the drug to be safe. The new studies will be included at an FDA meeting next month to review Avandia’s safety, according to Bloomberg.

Avandia has been scrutinized since February when the FDA and the US Senate released reports that were highly critical of cardiac risks associated with it.

GlaxoSmithKline’s diabetes drug Avandia  may be responsible for up to 48,000 heart attacks, strokes, and other serious health problems over the past decade, reports the Wall Street Journal (subscription required), citing an unpublished study by a Food and Drug Administration (FDA) scientist.

Medicare patients using Avandia (rosiglitazone ) faced greater risks of stroke (27 percent), heart failure (25 percent) and dying (13 percent), according to the study by David Graham, an FDA drug safety official and harsh critic of the drug.

The FDA is meeting in July to review the safety of the drug and will include the study as part of the data to be reviewed, reports the WSJ.

Avandia has been under increased scrutiny since February when the FDA and the US Senate released reports that were highly critical of cardiac risks associated with it. But the drug has been under siege for some time. In 2007, a study by the Cleveland Clinic linked it to an increased risk of heart attack. The FDA issued a safety alert for Avandia that same year.

Glaxo continues to defend the safety of Avandia even as it has recently settled hundreds of lawsuits brought by patients alleging the drug caused heart attacks and other health issues.

As always, do not change medications without first consulting your doctor.

News developments that we’ll be watching at Sokolove Law:

GlaxoSmithKline could face billions of dollars in potential liability from personal injury lawsuits stemming from its diabetes drug Avandia, according to a Reuters report.  The news service said that UBS cut its price target for Glaxo and estimated the company’s potential liability to range “below the midpoint of the $1-$6 billion range forecast by legal experts.” Around 13,000 lawsuits have been filed in connection with Avandia.

Last month a US Senate committee released a report saying that Glaxo knew of possible cardiac risks associated with Avandia for years before such evidence became public. Glaxo rejected the Senate report findings and said the drug is safe.

An advisory panel convened by the Food and Drug Administration (FDA) said on Friday that insulin pump problems were more likely the result of user error than device defects, according to Reuters. Insulin pumps are used by diabetics to regulate their blood sugar. A defective pump could lead to improper blood sugar levels, a potentially fatal problem. Earlier this week the FDA said there were problems with the pumps across the industry and called together a panel of outside experts to discuss ways to minimize the risk from defective pumps and to improve how pump makers report and investigate the problems.

Shoppers may want to consult with an FDA recall website before heading out to do the grocery shopping this weekend. That’s because thousands of products containing hydrolyzed vegetable protein (HVP) made by Basic Food Flavors Inc. may be contaminated by Salmonella, according to the federal agency. WebMD writes that so far there have been recalls of 56 processed foods ranging from dips to soup mixes and the list is expected to grow. No illnesses have so far been reported. Concerned consumers can go to an FDA web site to learn about recalled products. The site will be updated as new recalls are issued.

GlaxoSmithKline’s diabetes drug Avandia is in the spotlight again.

Confidential government reports say the medication can harm the heart and increase the possibility of heart attacks and heart failure in users, according to a recent New York Times (NYT) article. The Food and Drug Administration (FDA) reports say the drug should be removed from the market, writes the Times.

A Senate report quoted by the Times and released over the weekend says that GlaxoSmithKline (GSK) was aware of  possible cardiac risks associated with Avandia for years before such evidence became public.

The Senate report is the result of a two-year inquiry conducted by Sen. Max Baucus, chairman of the Senate Finance Committee, and Sen. Chuck Grassley, the committee’s ranking Republican. The two senators also asked the FDA to describe the steps it has taken to protect patients in an ongoing Avandia clinical trial since the agency has estimated that the drug caused approximately 83,000 excess heart attacks between 1999 and 2007, according a Senate press release.

GSK issued statements rejecting the conclusions of both the Senate and NYT reports and saying the drug is safe.

Avandia (generic name rosiglitazone) is prescribed to treat Type 2 diabetes. In 2007, the New England Journal of Medicine published a study warning of the possible cardiovascular risk of Avandia. Following the study, the FDA issued a warning about Avandia and GSK relabeled the diabetes medicine to flag the risk of heart failure. However, the FDA has allowed the drug to remain on the market.

As always, do not change medications without first consulting your doctor.

The maker of Poligrip today announced it will stop using zinc in three of its popular denture creams due to potential health risks associated with the ingredient, reports The New York Times.  GlaxoSmithKline will stop making and selling its Super Poligrip Original, Ultra Fresh and Extra Care products while it develops a zinc-free reformulation, according to the story.

In a statement, Glaxo calls the move voluntary and says the products are safe to use as directed. However, the company says it is taking the action “because we have become aware of potential health problems associated with the long-term excessive use of our zinc-containing denture adhesive products.”

Chronic and excessive use of denture adhesive creams have been linked by researchers to a condition called hyperzincuria, or zinc poisoning, which can lead to more serious and permanently disabling injuries including copper depletion (hypocupremia), nerve damage and even death.

The Times writes that Glaxo faces a number of lawsuits alleging nerve damage and other injuries from “high levels of zinc intake from the products.”

Healthcare professionals received a warning last week from GlaxoSmithKline (GSK) about a potential link between heart attacks and its HIV medication Lexiva.

Lexiva (fosamprenavir calcium) is prescribed with other antiretroviral drugs to treat HIV.

GSK has revised the warnings and precautions section of the drug’s prescribing Information to note that increases in cholesterol have occurred with treatment, the importance of lipids management, and a recommendation that triglyceride and cholesterol testing be performed prior to initiating therapy with Lexiva and periodically during therapy, according to the U .S. Food and Drug Administration (FDA). 

The FDA posted on its website a letter from GSK written to doctors describing the Lexiva label changes. The letter says the company is “in communication with FDA and this issue will be closely monitored.”

GSK’s updated label also alerts doctors to data presented at a medical conference last February that suggested that HIV-infected patients taking Lexiva had an increased risk of having a heart attack.