Posts Tagged ‘ FDA ’

Score One for the FDA as Rest of World Finally Yanks Thelin

January 3rd, 2011. By Hunter West

Time to give credit where credit is due. And this time, the US Food and Drug Administration (FDA) got it right.

Recently it was announced, in a joint statement by Health Canada and Pfizer Canada, that Thelin (sitaxsentan) was being taken off the market in Canada, as well as every country in which it had been sold, due to risk for potentially fatal liver damage.

Never heard of Thelin? There’s a reason for that. Thelin is not available in the US. Never was. That’s because the FDA refused to approve the drug designed to treat pulmonary hypertension. In the view of the FDA, the benefits did not outweigh the risks.

In a bid to win FDA approval for marketing Thelin in this country, Pfizer Inc. launched a series of clinical trials. However, those trials have been abandoned following the deaths of three trial participants.

According to a report in the Globe and Mail, Canada’s national newspaper, liver damage was a known complication of Thelin. However, in announcing that it was abandoning further clinical trials, Pfizer noted that it had discovered a ”new potentially life-threatening idiosyncratic risk” of liver injury among patients that is difficult to predict or guard against.

Thus, there will be no further clinical trials, and Thelin will be coming off the market in Australia, Europe and Canada where it had been previously approved. Given the known risks associated with Thelin, Canadians are wondering how Thelin ever won Health Canada approval in the first place.

The FDA has been maligned, chastised, ridiculed and kicked to the curb over the appearance of lax oversight both in the approval, and ongoing supervision of drugs and medical devices. And to be sure, much of that criticism is warranted.

However, on this occasion the FDA stuck to its guns and has been vindicated. There can be Read the rest of this entry »

Tags: FDA, Pfizer, Thelin
Posted in Drugs/Medical | 6203No Comments »2011-01-03+15%3A34%3A04Hunter+West

Menaflex: Influence Peddling at the FDA

October 22nd, 2010. By Hunter West

The revelation last week that the US Food and Drug Administration (FDA) would rescind a product previously given FDA approval, is yet another example of why the FDA needs to be overhauled from the ground up and the top down.

That’s because, according to a report October 14^th in The New York Times, a medical device roundly criticized by the FDA’s own scientists and reviewers was approved by the agency largely due to political pressure (read lobbying) and the intervention of the former FDA Commissioner.

Worse, it appears as though this situation was one “of several” at the agency in which outside forces were allowed to be brought to bear over the FDA’s own good scientific counsel.

And this is the agency that ensures the drugs we take, and the medical devices we use are trustworthy?

Oh…my…God…

The issue is over Menaflex, an implantable knee patch manufactured by ReGen. According to an FDA report launched to investigate undue outside influence in its own agency, it was determined that the Menaflex product was given FDA approval in spite of the repeated, and unanimous declarations of FDA reviewers that Menaflex did not meet the criteria for approval.

It should be noted that the FDA employs a fast-track route for approval if it is determined an Read the rest of this entry »

Tags: FDA, implantable knee patch, Menaflex, NJ, ReGen
Posted in Defective Products, Drugs/Medical | 5313No Comments »2010-10-22+15%3A04%3A11Hunter+West

Giddy with Glee: FDA Got One Right with SSRI Drug

October 18th, 2010. By AbiK

Or so it appears.

A little bomb just dropped in the form of a report out in the British Medical Journal (BMJ) regarding the antidepressant drug reboxetine. Reboxetine—brand name Edronax—is one of the drugs classified as a Selective Serotonin Reuptake Inhibitor, or SSRI, and it’s manufactured by Pfizer. According to the report, data from industry-sponsored (biased?) trials that have been published in peer-reviewed journals are misleading when it comes to reboxetine’s safety and efficacy.

How did this happen? Well, according to an article over at medscape.com, the BMJ reports that “74% of the data on patients who took part in the trials of reboxetine were not published because the findings were negative and that the data that were published about reboxetine overestimated its benefits and underestimated its harm.”

Huh?

I feel like I’m sitting in a management meeting—not at LawyersAndSettlements.com mind you—where we’ve just received the results of an employee feedback survey—that happen to suck—and we’re all trying to figure out how to save face and mitigate any fallout. What to do? LIE! Or, simply be selective in what information gets revealed…

So re: reboxetine, little bothersome details like the trial revealed that there was no significant difference in remission between reboxetine and a placebo, and that reboxetine was found to be inferior to other SSRIs such as fluoxetine (Prozac), paroxetine (Paxil) and citalopram (Celexa), just never hit the light of day. Until now.

But here is what makes me giddy with glee: reboxetine had been approved for marketing in the UK, Germany and “other European countries” according to the medscape.com article….”but did not win approval in the United States.”

Looks like the FDA got one right! Can it be so…?

Tags: Celexa, Edronax, FDA, paxil, paxil-heart-defects-newborn, Prozac, Reboxetine, SSRI
Posted in Drugs/Medical | 52622 Comments »2010-10-18+21%3A17%3A38AbiK

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 | 5060No Comments »2010-09-24+18%3A50%3A00Hunter+West

Seroquel Settlements Continue…but What Drug is Next?

September 2nd, 2010. By LucyC

Seroquel Mug available at Zazzle.com

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 | 48511 Comment »2010-09-02+17%3A22%3A07LucyC