Posts Tagged ‘ FDA ’

Children’s Motrin: Another Example of a Toothless FDA

September 24th, 2010. By Hunter West

A controversy emerged this week over an alleged agreement between the US Food and Drug Administration (FDA) and Johnson & Johnson subsidiary McNeil HealthCare over a ‘soft’ recall of Children’s Motrin and other products that were thought to be defective due to lax GMP (Good Manufacturing Practice) at one of McNeil’s facilities. 

The allegation, if true, suggests that one arm of the FDA doesn’t know what the other is doing. It also appears to suggest—again—that so long as the FDA does not have the mandate to force a drug company to conduct a recall, or do anything it doesn’t want to, for that matter, the federal drug regulator is like a tiger without teeth. 

As for the drug companies, it appears as if they subscribe to the credo, “don’t ask permission, beg forgiveness.” 

According to documents and testimony at a congressional hearing this week, the FDA had decided that Motrin product, which had been identified as defective due to GMP problems at the facility where it was manufactured, should be subject to a Class 2 recall. 

There are various levels of recall identified by the FDA, with a Class 1 as the most serious. The latter is urged if there is a problem that could lead to serious health effects or even death. Class 2 is suggested if the problem could cause temporary, or medically reversible adverse health consequences. 

Further, a Class 3 is issued if a product defect is not likely to cause serous health consequences at all. 

Then there’s the ‘market withdrawal,’ which according to CNN Money on Tuesday is not a recall Read the rest of this entry »

Tags: Children's Motrin, FDA, J&J, Johnson & Johnson, McNeil
Posted in Drugs/Medical | No Comments »

Seroquel Settlements Continue…but What Drug is Next?

September 2nd, 2010. By LucyC

During the past few weeks we have seen AstraZeneca (AZ) settle some 17,500 Seroquel lawsuits—give or take. That puts them about two thirds of the way through a staggering 26,000 cases currently pending against them. So far the estimated amount of those settlements is around $198 million, according to media reports. That certainly isn’t chump change. But then the drug reportedly did about $4.9 billion in sales last year. You do the math. 

According to a report on Bloomberg, AZ is still facing “at least 8,000 cases in both state and federal courts.” The cases allege that the drug, which was approved by the federal Food and Drug Administration for treatment of schizophrenia and mania associated with bipolar disorder, causes—or at least is associated with—the onset of diabetes. All the settlements so far have been negotiated out of court, so this week it was decided to give AZ a little more time to see if they could finish the job—settle all the outstanding cases—without having to go to court. We’ll see. 

The average amount of the settlements per case is around $11,000. I wonder how much diabetes medication that buys?

But it seems that Seroquel isn’t the only drug associated with the development of adverse Read the rest of this entry »

Tags: FDA, Janumet, Januvia, Seroquel
Posted in Drugs/Medical | 2 Comments »

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 | 2 Comments »

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 | No Comments »

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 | No Comments »