Drugs/Medical Archive

Alli Damage Control: Maybe it’s those extra pounds?

September 3rd, 2009. By AbiK

After recently posting about the FDA’s early communication on its safety review of Alli (aka orlistat) things seemed kind of quiet. The communication indicated that there had been reports of liver-related serious adverse events.

The Alli adverse event reports were low in numbers—especially when you consider that it was over a 9 year period. Regardless, there have been serious reports of liver injury. And once word came out about them via the FDA, Alli manufacturer GSK needed to respond.

So, GSK has begun its damage-control campaign—starting with yesterday’s press release that was carried on reuters.com with the following headline: “FDA states consumers should continue to use Alli”. That is a true statement—but it’s also standard operating procedure as far as FDA Read the rest of this entry »

Tags: Alli, Orlistat, orlistat-side-effects-orlistate-liver-damage-alli, Xenical
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Better or Worse? Avandia vs Actos Battle

August 31st, 2009. By janem

The Avandia/Actos battle has been making headlines since August 19 (BMJ.com) when a Canadian researcher suggested the oral diabetes treatment Actos is safer than Avandia. (Coincidentally, Takeda Canada announced a few days later that it reacquired the Canadian marketing rights for its Actos from Eli Lilly’s Canadian company. The drugmaker licensed the rights to Lilly under a worldwide agreement in 1999—financial arrangements were not disclosed.)

The similarities: Both Avandia and Actos belong to a class of drugs called thiazolidinediones, which are used widely to lower blood sugar in people with type 2 diabetes. In addition to an increased risk for heart failure, both drugs can also cause side effects that include weight gain and fluid retention. Both medications carry a U.S. Food and Drug Administration warning and both meds run the same risk of heart attack.

The discrepancies: Researchers found that patients taking Avandia were at greater risk of Read the rest of this entry »

Tags: Actos, Avandia
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Graphic Images on Cigarettes: What’s Wrong with this Picture?

August 28th, 2009. By AbiK

Here’s the question…

Smokers:

Will this picture make you stop buying and smoking cigarettes?

Some new federal regulations are in the pipeline for cigarette packs—graphic (and disturbing) pictures of what smoking can do to a body. Images of things like of throat cancer tumors…seriously discolored and decayed teeth…blackened lungs…tracheotomies. Apparently our friends north of the border already have similar programs in place and it’s been reported that these tactics actually work to deter folks from continuing the habit (healthfinder.gov 8/27/09).

The regulations would actually be part of the legislation that President Obama signed back in June with the Family Smoking Prevention and Tobacco Control Act. The legislation gives the FDA authority to regulate how tobacco products are marketed.

Now, I don’t defend tobacco companies—but seriously. When and where do we draw the line on Read the rest of this entry »

Tags: tobacco
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Yaz shotgun-style lawsuit

August 26th, 2009. By AbiK

So we just posted about Kerry Sims, the woman who’s recently filed a lawsuit against Bayer’s Yaz birth control pills. Ms. Sims alleges she suffered a blood clot in her lung and an infection surrounding the clot while on Yaz.

But here’s the interesting twist—the one that brings “shotgun style” to mind. In true git ’em all fashion, she’s not just suing Bayer, the maker of Yaz and Yasmin oral contraceptives, she’s also naming Walgreen’s in her suit. As reported in the Madison Record yesterday,

“In selling, Yaz/Yasmin to plaintiff, Walgreens expressly and impliedly warranted that Yaz/Yasmin was safe for its intended use, was free from manufacturing or production defects, and would perform as indicated,” Sims’s suit states.

While this is not unusual practice—i.e., to include other seemingly uninvolved or not-at-fault parties into a lawsuit—it does paint an interesting picture when the focus of the lawsuit is Read the rest of this entry »

Tags: Yasmin, Yaz
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Yaz: The Good, the Bad and the Ugly

August 26th, 2009. By LucyC

First the bad news…

Another young woman has suffered a blood clot while using Yaz/Yasmin.

Now the good news…

She is alive. Thankfully.

And apparently once she put two and two together, she got pissed off enough that she’s now suing Bayer.

Kerry Sims was prescribed Yasmin for birth control. She alleges she suffered a blood clot in her lung and an infection surrounding the clot while on the pill. The complaint reportedly alleges that between 2004 and 2008 Yaz caused in excess of 50 deaths in women taking the pill, some as young as 17. Sims maintains that had she known the risks associated with Yaz/Yasmin she would not have taken it. Those “risks” refer to the likelihood of deep vein thrombosis (DVT); pulmonary embolism (PE); gallbladder complications and gallbladder disease; stroke; heart attack and death.

And now the ugly… Read the rest of this entry »

Tags: Yasmin, Yaz
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