Posts Tagged ‘ Byetta ’

Criminal Medicine: Best Defense, Sadly, is a Good Offense

October 6th, 2010. By LucyC

If finding the right medication feels a bit like a minefield lately, it’s no wonder.

It’s not been a banner time for Pharma—these past few years. So many drugs and medical products in general seem to be linked with serious, if not life-threatening adverse events. You may recognize some of the names on the hit parade: drugs such as Accutane and a possible link with inflammatory bowel disease (IBD); proton pump inhibitors (antacid drugs) and increased risk for hip fractures; Reglan and its link with Tardive Dyskinesia; Byetta—a diabetes medication linked with kidney failure… 

And of course no list would be complete without Avandia—another diabetes medication—and its infamous association with serious, sometimes fatal cardiovascular events. 

Oh—there’s also allegations surrounding the class of antidepressants known as SSRIs and links with newborn heart defects. In fact the list is exhaustive.  

And to be clear, it’s not just drugs. Products such as the DePuy metal hip replacement are also in trouble. DePuy is currently facing a class action lawsuit over failure rates seen with its ASR acetabular cup. DePuy, which is owned by Johnson & Johnson, has also had global product recalls.

Gadolinium is another one. It’s a clear, non-radioactive chemical compound used with patients undergoing magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA). In 1988 the FDA approved gadolinium as a contrast agent to provide a clearer picture of organs and tissues. Since that time, more than 200 cases of Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) have been linked to the product. 

This week, news out on Bloomberg indicates that the powers that be at Pfizer Inc, ‘failed to properly warn doctors and consumers that its Prempro menopause drug could cause Read the rest of this entry »

Tags: Accutane, Avandia, Byetta, DePuy, DePuy Orthopaedics Metal Hip Replacement, Drugs, Gadolinium, Medical, Norian SRS, Prempro, Proton Pump Inhibitors, Reglan, SSRI
Posted in DePuy ASR Hip Recall, Drugs/Medical | No Comments »

FDA vs Attorneys: Who Really Protects Us?

September 27th, 2010. By janem

There’s always some whining going on about how much money lawyers make from pharmaceutical class actions. But do those whiners ever think about how safe we would be were it not for the lawyers, lawsuits and the courts? Let’s add advocacy and consumer groups too—their actions have also kept us safe from dangerous drugs and their side effects.

Relying on the FDA for post-market surveillance once it has approved a drug reminds me of this old adage: Close the stable door after the horse has bolted. All too often it takes consumers and their attorneys—like a band of Davids against the Goliath drug company—to resolve adverse drug events that occur by underhanded tactics such as off-label promotion and false advertising.  Case in point: the diabetes drug Byetta.

The FDA received reports of adverse health events (kidney problems and pancreatitis) from Byetta users since the beginning of 2005 but they did diddly squat until last November, when in their infinite wisdom, finally said, “Byetta can heighten the risk of kidney problems, including kidney failure, in people suffering from type 2 diabetes.” But not before attorneys were filing class action lawsuits against the manufacturer.

And what about Avandia? In 2007, a report in the New England Journal of Medicine, linked Avandia to a 43 percent increased risk of heart attack, and more than 700 lawsuits—with GlaxoSmithKline agreeing to a $60 million settlement. Yet it took the FDA until September 2010 to severely restrict sales of the drug (sales have been completely suspended in Europe).

And let’s consider Zyprexa. Class action lawsuits alleged that the manufacturer, Eli Lilly and Co., negligently made, marketed and sold Zyprexa without properly warning of the risks prior to June 6, 2007. Eli Lilly paid out approximately $1.5 billion to settle civil and criminal claims alleging illegal marketing—promoting the drug for use in seniors with dementia when it is not approved for that use.

As well, Eli Lilly paid millions of dollars to settle claims alleging the increased risk of diabetes and related health problems, but the settlement does not imply liability or wrongdoing, so are we safer as a result? The drug is still sold, but with the labeling clearly showing diabetes-related side effects. But Zyprexa treats psychosis—how many people with schizophrenia or bi-polar disorder are going to read the label? Attorneys have taken the drug company to court; now isn’t it up to the FDA to take the drug off the market? Or at the very least, the agency should be more diligent with post market surveillance.

Tags: Avandia, Byetta, Zyprexa
Posted in Drugs/Medical | 2 Comments »

Point of Byetta Study? Warning is Still Needed

July 13th, 2010. By AbiK

Despite a recent study that puts into question the link between Byetta and pancreatitis, I was looking back over Byetta’s history as it relates to FDA labelling. For some background, Byetta came on the market in 2005—to treat patients with type-2 diabetes—and some reports indicate that over 10 million Byetta prescriptions have been written since 2005.

But since 2005, there have been some other interesting (or should I say “disturbing”) developments with Byetta as well. According to the FDA, between April 28, 2005 and December 31, 2006, there were 30 domestic reports of acute pancreatitis in patients who were taking exenatide (the generic name for Byetta). Clearly feeling that thirty such cases within the span of just under two years was perhaps worth raising an eyebrow, the FDA responded with some additional Byetta warnings. Here’s what happened:

October, 2007: the FDA mandated that Amylin and Eli Lilly include stricter, more prominent warning labels about possible Byetta side effects on Byetta’s packaging; the new Byetta warnings included acute pancreatitis.

August, 2008: the FDA issued an alert to healthcare providers regarding six additional cases of necrotizing or hemorrhagic pancreatitis among Byetta patients. Two of those six cases resulted in death.

November, 2009: Between April, 2005 and October, 2008, the FDA had received 78 reports of problems with kidney function in patients using Byetta. Some cases occurred in patients with pre-existing kidney disease or in patients with one or more risk factors for developing kidney problems. Based on this, the FDA issued new safety information on Byetta to include a warning of possible kidney function problems a a side effect.

Now, while I surely don’t believe the FDA is incapable of error or misjudgement (we only have to look to Avandia this week to question such), it does seem that when the number of reports Read the rest of this entry »

Tags: Byetta, FDA, Kidney Function, Medco, Pancreatitis
Posted in Drugs/Medical | 4 Comments »