Drugs/Medical Archive

Has Tylenol had its Day in the Sun?

November 12th, 2009. By janem

Bayer is likely seeing its Tylenol sales drop these past few weeks after the FDA finally took aim at acetaminophen over-the-counter (OTC) products and the media made it headlines.

Many consumers are loyal to certain brands and I’ve taken my fair share of Tylenol over the years, but for me, Tylenol’s had its day in the sun. What’s most disturbing is that the FDA has known since at least 1977 that severe liver damage can occur as a result of acetaminophen overdose. Back then,  their advisers recommended explicit warnings not to exceed the dose or take acetaminophen for more than 10 days, but the FDA never took action.

So now the agency is making up for lost time and warning people that taking a few extra Tylenol pills here and there, thinking OTC meds are safe, could result in acetaminophen toxicity. Isn’t that like shutting the barn door after the horse has bolted? Since 1977!

And the German drug maker (with HQ in New Jersey) may soon take a dive in profits-there’s a new kid on the block touting a safe alternative to acetaminophen.

BioElectronics Corp. recently completed an acetaminophen comparison study and its results will be announced next Monday, November 16. Their timing is ripe to introduce ActiPatch and Allay, alternatives to Tylenol and other acetaminophen products.

“We believe this is important research especially considering the many health concerns expressed by the U.S. Food and Drug Administration relative to Tylenol, NSAIDs and other over the counter pain medications,” said Andrew Whelan, CEO of BioElectronics, Corp. ” We look forward to reviewing the full study data and submitting it to FDA in support of our current pending 510(K) applications and additional applications we plan to file in the future.”

In the meantime, no doubt consumers are studying labels on OTC meds more carefully these days, especially after the FDA’s recent announcement about the dangers of acetaminophen overdose in children’s meds. The FDA committee has insisted that all children’s and infant’s acetaminophen products be sold at the same concentration, simplifying dosing instructions. Currently the labels are confusing– there are several different strengths of liquids, chewables, and “Junior” tablets that give dosage instructions by weight and age.

What I find mind-boggling is how Bayer has controlled OTC pain meds for so long while there are safer alternatives.

Tags: acetaminophen overdose, tylenol
Posted in Drugs/Medical | 1 Comment »

Quaid Twin Fiasco: It’s All in the Label

November 12th, 2009. By Hunter West

This past September Hospira was approved for a heparin product that features, according to its web site, an ‘enhanced label design.’ Among the features of the label design are, “vibrant label colors to each strength, simplified text and increased font for dosing information, and differentiated warning labels”.

Sounds pretty basic. A hospital is a high-stress environment. Decisions have to be made quickly and accurately with split-second timing. Often there are parents, or loved ones in the room panicking. And while doctors and nurses are trained to focus on the task at hand and resist becoming distracted by any outside force that may take away from the direct relationship between practitioner and patient, the fact remains that people are human and things can get confusing.

Thus, the labeling of medication in such an obvious fashion as to ensure that the wrong medication, or strength is not fed to the wrong individual seems pretty obvious. In a quiet room without distraction a practitioner has the opportunity to carefully size up the vial and the label before injecting the substance into his patient.

However hospitals—and especially the ER—are far from quiet. There are a thousand-and-one things going on at once as you reach for that vial. Did I check the label? Oh, I’m sure I did. This is the right stuff…

For Kimberly and Dennis Quaid, it turned out to be the wrong stuff. Read the rest of this entry »

Tags: Baxter, Dennis Quaid, Heparin, Hospira
Posted in Drugs/Medical, Emerging Issues | 1 Comment »

Merck in the Middle of Statin Drug Soap Opera

November 9th, 2009. By AbiK

The latest flurry of statin drug-related news could substitute for your afternoon t.v. soap fix—except there’s a very real-life drama being played out. It’s full of intrigue and false promises. Who knew that the anti-cholesterol drug market could offer so much, and yet so little at the same time?

Here’s the topline history to get you up to speed—just in case you’ve missed the last couple of months’ news on drugs like Vytorin, Zetia and Lipitor…

Zetia + Simvastatin (aka Zocor) = Vytorin 

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Vytorin + Zetia = Class Action Settlement

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Zetia + Atorvastatin (aka Lipitor) = Refused by FDA = Bad News for Merck

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Vytorin + Arbiter 6 Study (due 11/16) = Expected Bad News for Merck 

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Niaspan + Arbiter 6 Study = Expected Good News for Abbott Labs 

So what’s the deal with this Arbiter 6 thing? It’s the clinical study that was conducted—and whose results are hotly anticipated at the American Heart Association (AHA) annual scientific meeting in Orlando on November 16th—to review the efficacy of cholesterol drugs Read the rest of this entry »

Tags: Arbiter 6, Merck, statins, Vytorin, Zetia
Posted in Drugs/Medical | 3 Comments »

Vytorin Zetia Settlement…What’s in it for You?

November 6th, 2009. By AbiK

LawyersAndSettlements.com reported a while ago (Aug. 5^th precisely) about the proposed class action settlement in the Vytorin-Zetia case against Merck and Schering-Plough. 

At the heart of this case are claims that Vytorin and Zetia were marketed as being more effective than other anti-cholesteral drugs on the market (namely, those drugs in the class known as statins)—and that Vytorin and Zetia were sold at higher prices even though there wasn’t really evidence that they were more effective than less-expensive anti-cholesterol drugs. 

For consumers—aka the “Consumer Class” of the Vytorin/Zetia settlement, it means that if you were taking either of these drugs and either paid or were obligated to pay for them between November 1, 2002 and September 17, 2009, you may be eligible to participate in this settlement. Translation: you may be able to get some money back on your purchases as a result of this settlement. 

How much money?—it’s the number one question we always get about settlements. Well, as Read the rest of this entry »

Tags: Cholesterol, Merck, Vytorin, Zetia
Posted in Drugs/Medical, Settlement | 36 Comments »

Chantix and the Damage Done

October 27th, 2009. By janem

I’ve interviewed many people who’ve taken Chantix to help quit smoking. They talk about the damage it caused, not only to themselves, but their family and friends. All their stories are upsetting but just now I talked with Tim and his account is heart-wrenching.

Tim’s wife died from cancer a few months ago, but his grief is compounded by the fact that he was never able to apologize to her. “Soon after I took Chantix I was so short-tempered; I would get mad at my wife, Judy, for any little thing,” says Tim, his voice breaking. “Now that Judy is dead, I can’t say sorry for being so mean.”

“Judy and I were long-distance truck drivers, we were a team,” Tim explains. “When I got on the Chantix, we argued constantly on the truck. I just thought it was from nicotine withdrawal, but even our friends asked Judy what was wrong with me. Before Chantix, I was happy-go-lucky…

Judy could just move a pop can and I would get irate.  And I was mad at myself because I was making her so upset but I had no idea why. Sometimes I’d be driving and forget where I was. I’m talking about driving a semi. It was dangerous. It got so bad that I thought of wrecking the truck more than once, then we would both die. I just kept hurting her…

I saw an ad on TV a few weeks ago that explained how Chantix causes mood swings, suicidal thoughts and aggression. I didn’t read the Chantix warning label because my doctor said, ‘Just go ahead and try Chantix; it’s a new drug and pretty much reliable’. I guess that’s the problem with new drugs-you don’t know the side effects until it’s too late.

If I knew of the Chantix side effects, or if my doctor explained them to me, I wouldn’t have tried it. And I won’t be beating myself up now. And I’m smoking again. I’m really irate at the drug company and I’m so upset just thinking about it, knowing how much I hurt my wife.”

Tags: Chantix, chantix side effects, chantix suicide
Posted in Drugs/Medical | 5 Comments »