Posts Tagged ‘ FDA ’

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 »

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 | No Comments »

The Pill Turns 50 But Many Women aren’t Celebrating

May 7th, 2010. By janem

This week marks the 50^th anniversary of the birth control pill. We’ve come a long way baby! But some things haven’t changed: Even 35 years ago women were complaining about side effects, including blood clots.  Back in 1960, the pill was marketed as 100 percent safe, it would liberate women and it would even prevent divorce. Well, Bayer is still lying about its birth control pills Yasmin and Yaz, saying it is as safe as other oral contraceptives.

A few events regarding the pill have been announced this past month. On April 9, 2010 Bayer HealthCare Pharmaceuticals announced it would update its Yaz and Yasmin labels with a stronger warning, which has already happened in Europe. And Bayer has a dirty little secret: Did you know that 32,856 boxes of Yaz, at three packs per box, and 122,208 boxes of Ocella, an identical product was recalled? You won’t find that recall on its website and you have to dig deep to find it on the FDA recall list.

TIME magazine featured an article on the pill this month. Here is an excerpt:

“In 1954, John Rock, the doctor who was leading the research on the pill, expressed the breathless excitement shared by many of his colleagues: An oral contraceptive, he said, “would be the greatest aid ever discovered to the happiness and security of individual families – indeed, to mankind” because “the greatest menace to world peace and decent standards of life today is not atomic energy but sexual energy.”

Regarding pregnancy, the article says that ” 63 percent say they know little or nothing about Read the rest of this entry »

Tags: bayer-natazia-oral-contraceptive-adverse-events, Birth Control, Contraceptive, FDA, The Pill, Yasmin, Yaz
Posted in Drugs/Medical, Emerging Issues | No Comments »

Don’t Get Lipodissolve to Get that Bikini Bod

April 21st, 2010. By AbiK

The countdown is on baby! There’s about 5 weeks till the official kick-off to summer season—Memorial Day weekend—is upon us and that means millions—yes, millions—of women are doing things like dieting, jogging, zumba, spinning, tanning (fake, out of a tube, hopefully), and heading to cosmetic surgeons and medispas in hopes of seeing an improved version of themselves in the mirror. Quickly.

Unfortunately, a number of women will look to some cosmetic treatments that maybe promise a bit more than they deliver. Case in point: Lipodissolve.

The FDA recently sent out warning letters to six medical spas in the US for making false or misleading statements about lipodissolve. The statements included things like claiming lipodissolve is safe and effective; claiming lipodissolve has an outstanding safety record; and stating that lipodissolve is superior to other fat-loss procedures, including liposuction.

Lipodissolve is a cosmetic procedure that’s touted as a less-invasive cousin to liposuction. It’s liposuction, minus the suction, so to speak. Lipodissolve patients receive a series of drug injections (typically, phosphatidylcholine and deoxycholate) that aim to dissolve and permanently remove small pockets of fat from the body.

I don’t really want to know what happens once the fat “dissolves” and, like, where does it go? or what form is it in? Questions I sense have queasy-feeling-inducing answers to them. Be that as it may, I guess the fat is supposed to go someplace better than one’s saddlebags, love handles, tummy bulges, arm flaps…

So what’s the FDA’s beef? For starters, the fact that the FDA never evaluated or approved the products for use in lipodissolve. That should be your first clue that maybe you ought to be a little gun-shy around the ol’ lipo needle.

Beyond that, here’s the list of FDA issues with lipodissolve: 

• The FDA is not aware of evidence supporting the effectiveness of the substances used in lipodissolve for fat elimination
• The safety of these substances, when used alone or in combination, is unknown
• The FDA is not aware of clinical studies to support medical uses of lipodissolve

In addition, FDA has reports of unexpected side effects in people who’ve undergone the lipodissolve procedure. These side effects include:

• permanent scarring
• skin deformation
• deep, painful knots under the skin in areas where the lipodissolve treatments were injected

In terms of the warning letters that were sent out, they went to…

Monarch Med Spa in King of Prussia, PA

Spa 35 in Boise, ID

Medical Cosmetic Enhancements in Chevy Chase, MD

Innovative Directions in Health in Edina, MN

PURE Med Spa in Boca Raton, FL

All About You Med Spa in Madison, IN

The FDA has requested written responses from the companies—and they should be due by next week.

Tags: FDA, Lipodissolve
Posted in Consumer Fraud | No Comments »

Pfizer’s Secret Friend

April 9th, 2010. By Hunter West

Mom and Dad told us not to be ‘too big for your britches.’ However in the Land of Big Pharma, that basic chestnut of moral integrity need not apply… 

Remember the debacle over Bextra? Pfizer was found to have actively marketed the drug for off-label use, for things not approved by the US Food and Drug Administration (FDA), and was called to the carpet over it, paying about $2 billion in penalties. 

However, it could have been a lot worse, according to a special investigation by CNN that found Pfizer escaped the expected death knell in such cases by being permanently excluded from Medicare and Medicaid. 

Most know the story of Bextra, the Cox-2 inhibitor that Pfizer brought to the painkiller market in 2001 with big plans. Cox-2 inhibitors were thought to be safer than generic drugs.

Also more expensive, coming in at 20 times the cost of ibuprofen. 

Nonetheless, the plan was to market Bextra for acute pain, such as that experienced by patients following surgery. 

Enter the FDA, which put a noose around Pfizer’s neck when it decreed that Bextra was not safe for patients at high risk for heart attack and stroke. Thus the approval was limited to pain treatment related to arthritis and menstrual cramps. 

Undaunted, the marketing and sales arms of Pfizer—allegedly without knowledge of top executives—set to work circumventing that regulatory authority by promoting its use off-label to anesthesiologists, orthopedic surgeons, “anyone that use[d] a scalpel for a living,” according to the words of one district manager. 

There were other lapses in marketing judgment that flew in the face of regulatory decorum. In the end, by the time Bextra was Read the rest of this entry »

Tags: Bextra, FDA, Pfizer, Pharmacia, Upjohn
Posted in Drugs/Medical | No Comments »