Posts Tagged ‘ FDA ’

Campaign for Safe Cosmetics Video – Real Issues or Just Hype?

August 17th, 2010. By AbiK

Ok, it’s now big enough and viral enough that Cosmetics Design has even reported on it…

The Story of Stuff’s latest video on youtube.com, “The Story of Cosmetics” (above, and yes, it’s eight minutes long), has already gotten over 203,000 views. It’s not only timely because it was released on July 21st, but also because it basically rides on the coattails of the recently introduced in Congress Safe Cosmetics Act of 2010. The Act states that it will give the U.S. Food and Drug Administration authority to ensure that personal care products are free of harmful ingredients.

A long time coming, yes. Heck, no one wants to put questionable ingredients or suspected carcinogens on their faces or the skin of their loved ones (I’m talking infants here, not massage lotions).

But while cosmetics industry groups—such as the Personal Care Products Council (PCPC)—have also called for more stringent controls on cosmetic ingredients, the PCPC has dubbed “The Story of Cosmetics” a “shockumentary”.

What do you make of it?

Tags: Cosmetic Ingredients, FDA, Safe Cosmetics Act
Posted in Consumer Fraud, Drugs/Medical, Personal Injury | 45962 Comments »2010-08-17+17%3A32%3A31AbiK

How the FDA Advisory Panel Vote Affects Avandia Patients

July 15th, 2010. By Kristine B

If you’re like other Avandia patients out there, you probably waited for the FDA advisory panel’s vote yesterday with some concern (or maybe you didn’t). Yesterday was the day the FDA advisory panel voted on whether or not to remove Avandia from the market. So, today we examine how the panel voted and what that means for you.

First, what you need to know about the panel. The panel is only advisory. This means that the FDA doesn’t have to follow the panel’s recommendations. Sure, it usually does, but that doesn’t mean it always will. So, all the panel can do is make recommendations. Whether those recommendations will be followed is up to the FDA.

So, what did the panel recommend? Well, depending on how you view it (and whose articles you read) Avandia was either dealt a severe blow by the FDA or won a major victory. Hunter’s Avandia post today calls it a “muted win” for GSK, which probably sums it up best.

On the question of what to do with Avandia, panel members voted as follows:

12 voted to withdraw the drug entirely

10 voted to allow it to remain on the market with strong label revisions and possible sales restrictions

7 voted to add further warnings to Avandia’s label

3 voted to allow continued sale of Avandia with no changes

1 abstained

So, there are two ways of looking at this: Either the majority of panelists (22) voted to either withdraw Avandia from the market entirely or only allow it under stronger warnings and sales restrictions, or the majority of panelists (20) voted to keep Avandia on the market rather than withdrawing it. Nothing is ever simple when it comes to pharmaceutical decisions.

What does that mean for patients taking Avandia? Right now, it doesn’t mean anything. You haven’t been told to stop taking the drug, although 18 panel members voted that they are concerned Avandia causes heart attacks (nine said they weren’t sure about the risk of heart attacks and six said they weren’t concerned about the risk of heart attacks).

So, if you’re concerned about taking Avandia, you should speak with your doctor about the risks. But don’t stop taking it without first speaking to your doctor about your concerns.

The FDA will make a decision later about whether or not to continue to allow Avandia on the market.

Meanwhile, GlaxoSmithKline has reportedly settled 10,000 Avandia lawsuits for approximately $460 million. If you think you may have an Avandia claim, your best bet is to file your claim with a lawyer who is specializing in Avandia claims.

Tags: Avandia, Avandia Lawsuit, FDA, GSK, Pleading Ignorance
Posted in Drugs/Medical, Emerging Issues | 4396No Comments »2010-07-15+16%3A06%3A56Kristine+B

A Muted Win For Avandia Manufacturer—But Stay Tuned…

July 15th, 2010. By Hunter West

So Avandia has been stayed from execution—for now—by virtue of a majority vote by an expert panel of experts brought together by the US Food and Drug Administration (FDA) that debated the drug’s safety and efficacy for two days this week. The Type 2 diabetes drug that has been under much fire for the past couple of years was further challenged by the long-awaited gathering which ended with a vote to leave Avandia, manufactured by GlaxoSmithKline (Glaxo), on the market for the time being.

But the victory for Glaxo is muted.

While the panel voted 20-12 to leave Avandia on the market, it will not likely be left alone. That’s because at least half of those voting ‘yay,’ according to the July 14^th edition of the Wall Street Journal (WSJ), tied their vote of support to increased restrictions on a drug that has already faced significant reduction of sales since 2007. Supporters of the drug who voted to keep Avandia on the market indicated after the vote that they only did so due to the lack, they said, of hard evidence with regard to potential harm.

They also said Avandia should be used only as a drug of last resort.

That’s good news for rival Actos, manufactured by Takeda Pharmaceuticals. Even though both Avandia and Actos carry black box warnings for fluid retention and the ensuing risk for heart failure, Avandia is thought to carry a greater risk for heart attack than its rival.

So much so, in fact, that the FDA directed the advisory panel to put that matter to a vote, pitting Read the rest of this entry »

Tags: Actos, Avandia, FDA, TIDE
Posted in Drugs/Medical, Emerging Issues | 4395No Comments »2010-07-15+14%3A32%3A57Hunter+West

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 | 43854 Comments »2010-07-13+21%3A11%3A30AbiK

80% of Approved US Drug Trials Done Outside US – What?!?

July 1st, 2010. By Hunter West

“As sponsors increase the number of foreign clinical trials in support of FDA marketing applications, the agency’s current method of using inspections to ensure human subject protections and data validity is becoming increasingly strained.”

- Daniel R. Levinson

A recent report by the inspector general of the Department of Health and Human Services reveals just how much pharmaceutical drug testing is going on in the shadow of foreign shores…

Eighty percent, according to Daniel R. Levinson. That’s 80 percent for trials of all drugs approved for sale in the US by the Food and Drug Administration (FDA) in 2008.

Wow.

What’s more, 78 percent of all subjects who participated in clinical trials were enrolled in foreign sites for drugs given the nod that year.

For some time now, there has been concern about the quality of drugs manufactured offshore. China comes to mind. Look at the heparin debacle of a few years ago. While there is massive incentive for drug companies to manufacture on foreign soil for the cost savings (and the better bottom line that goes along with it), the downside is that often you don’t know what you’re getting.

And now, the revelation that most drug testing is going on somewhere else.

That’s troubling, because in both cases—manufacturing and testing—the FDA lacks both the financial and staff resources to properly monitor things.

Check out some of the numbers contained in Levinson’s report, released towards the end of June and summarized in The New York Times. The FDA inspected fewer foreign clinical trial sites, than Read the rest of this entry »

Tags: Clinical Trials, Drug Approvals, FDA
Posted in Drugs/Medical | 4277No Comments »2010-07-01+14%3A47%3A29Hunter+West