Drugs/Medical Archive

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 »

Antidepressant Guide: the Brands, the Generics & Who Makes Them

May 6th, 2010. By Kristine B

These days, there are many drugs to keep track of. It’s not just the brand name drug anymore; patients could be taking a generic equivalent. So, this week, Pleading Ignorance looks at the SSRIs and SNRIs to give you the brand name, manufacturer, generic version and the generic’s manufacturer. Consider it your one-stop cheat sheet on some of the more commonly prescribed antidepressants.

Brand name	Ingredient	Made By	Generic	Made By
Celexa (SSRI)	citalopram hydrobromide	Forest Laboratories	citalopram	Eon Labs, Inc., Aurobindo Pharma Limited, Purepac Pharmaceutical Co., Dr. Reddy’s Laboratories Limited, Corepharma LLC
Lexapro (SSRI)	escitalopram oxalate	Forest Laboratories	escitalopram	Alphrapharm
Paxil/Seroxat    (SSRI)	paroxetine hydrochloride	GlaxoSmithKline	paroxetine	Apotex, Alphapharm, Teva, Aurobindo Pharma, Zydus Pharms USA, Caraco
Prozac (SSRI)	fluoxetine hydrochloride	Eli Lilly and Company	fluoxetine	ESI Lederle (tentative approval)
Symbyax (SSRI)	olanzapine and fluoxetine hydrochloride	Eli Lilly and Company	olanzapine/ fluoxetine	Teva Pharms (tentative approval, July 17, 2007)
Zoloft (SSRI)	sertraline hydrochloride	Pfizer Pharmaceuticals	sertraline	Dr Reddy’s Labs Ltd, Teva, Genpharm, Aurobindo Pharma, Sandoz and many others
Zyprexa (atypical antipsychotic)	olanzapine	Eli Lilly and Company	olanzapine	All tentative approval: Dr. Reddy’s Labs Inc, Teva Pharms, Mylan PHarma, Sandoz, Barr Pharms, Roxane
Cymbalta (SNRI)	duloxetine hydrochloride	Eli Lilly and Company	duloxetine	No generic so far as I can tell
Effexor (SNRI)	venlafaxine	Wyeth	venlafaxine hydrochloride	Aurobindo, Mylan, Teva, Dr Reddy’s Labs Ltd, Caraco and others

The information in the chart above was found at either drugs@fda, or on the individual drug manufacturer’s website. As far as I can tell, this information is correct as of the date it was written—and it is not intended to replace the information you might receive from your doctor or medical practitioner (hey, have to say it, we’re a legal site). Talk to your doctor or pharmicist for medical advice.

Tags: Antidepressants, Celexa, Cymbalta, Effexor, Lexapro, paxil, paxil-heart-defects-newborn, Pleading Ignorance, Prozac, SSRI, Symbyax, Zoloft, Zyprexa
Posted in Drugs/Medical, Emerging Issues | 1 Comment »

Guidant Forced to Toe the Moral Line

May 1st, 2010. By Hunter West

Tuesday a federal judge in Minneapolis rejected a plea deal arrangement that would have seen Guidant, the medical device manufacturer acquired by Boston Scientific about four years ago, plead guilty to a couple of misdemeanor charges and pay a fine. A big fine, mind you—$296 million, described as the largest fine ever thrown down in front of a medical device manufacturer. The relatively small fine paid by Toyota for leading the feds down the garden path is niggly in comparison. 

But that’s not the point. Given the risks associated with playing in the medical devices sandbox, one can assume that the players plan for this sort of thing. Their revenues are staggering as it is. And a plea of guilty to two misdemeanors, when the company knowingly vended life-saving devices that were faulty and led to the deaths of at least six individuals, just seems so wrong. 

A judge agreed, and rejected the deal. Donovan W. Frank noted in his ruling that the deal allowed the company to escape accountability. 

At least there were misdemeanor charges. How often have you heard companies of any stripe pay a huge fine for a proven misdeed but admit to NO wrongdoing? 

That’s like telling a child who knowingly was responsible for bad behavior, “okay Johnny, give Mummy five bucks and we’ll forget this ever happened…” 

No parent in his, or her right mind would ever offer that deal to a child. What are we teaching them? 

And yet, it appears de rigueur in big business. Do something bad, cop a plea where you don’t have to admit to anything, pay a fine for the privilege and move on. 

It is assumed that any new deal surrounding the Guidant situation involving those defective defibrillators will include a probationary structure as recommended by the judge, together with a fine. 

How big that fine will be, remains to be seen. Perhaps the same, perhaps smaller than the original. Either way it will be in the millions. 

As for where that money goes, I profess ignorance. Maybe it goes into a specific budget line, or to general revenues. A better place would be to help pay for the nation’s health care, just as fines levied to automotive manufacturers should go to fix up our roads and bridges—or finding a way to segregate massive trucks away from smaller cars, in an effort to mitigate the carnage on America’s roads when the ever-expanding rigs meet up with an increasingly-shrinking car. 

Or how about giving that money to the families of the victims? 

Sure, fines are important—even assuming big companies build that kind of thing into their business plans. The money could benefit someone, somewhere. 

But the payment of a huge fine should not prove a whitewash for moral irresponsibility. 

That’s the point the judge was making Tuesday.

Tags: guidant, medical devices
Posted in Defective Products, Drugs/Medical | No Comments »

Is Your Medical Device Under Warranty?

April 26th, 2010. By Hunter West

If you buy a car and it breaks down within the warranty period, the manufacturer fixes it. If your laptop goes wonky within the first year (usually under warranty), you ship it back and they’ll send you another one, or they undertake to fix it. 

That’s what warranties are for—to protect the consumer against substandard workmanship, faulty parts, or basically a lemon. Wear-and-tear is one thing. You can’t warrant against that. But when something fails well ahead of the best-before date, somebody is made to step up to the plate and extend some responsibility. 

Why does that not happen in the medical device industry? 

Back in January, William R. Morris had to have his artificial hip replaced after just three years. The replacement surgery cost about $50,000. Lucky for Morris, much of the bill was covered through his employer’s health insurance plan. But he figures, due to co-payments and other out-of-pocket expenses, he’s out about $10,000 for his initial replacement and two additional surgeries. 

That’s right—he’s had three replacements. The first operation in 2006 replaced the original hip his creator gave him. That one lasted less than a year—so the replacement was replaced. For a year, he told The New York Times, he felt good, but then THAT hip replacement went wonky. 

This year, he had another one. 

His first artificial hip lasted one year. His second, only three. 

They’re supposed to last 15. 

The April 3^rd edition of The New York Times reported that the manufacturer of the failed hip has Read the rest of this entry »

Tags: Medical Device, Warranty
Posted in Defective Products, Drugs/Medical, Emerging Issues | 3 Comments »

10 Things to Know about Stevens-Johnson Syndrome

April 20th, 2010. By AbiK

1. Stevens-Johnson Syndrome (SJS) is a potentially life-threatening form of adverse reaction to medication. The more severe form of SJS is called Toxic Epidermal Necrolysis (TEN). Some drugs that have been connected to SJS are Children’s Motrin, Ketek, Advil, Ibuprofen, Bactrim, Daypro, Cipro, Bextra and Dilantin.

2. While target lesions are typically associated with Stevens-Johnson Syndrome (SJS), they are not always seen. SJS symptoms include: rash, blisters or red blotches on skin; persistent fever; blisters in the mouth, eyes, ears, nose and genital area; swelling of eyelids or red eyes; conjunctivitis; flu-like symptoms;

3. The SJS disease process typically begins with a nonspecific upper respiratory tract infection. Studies show that more than half of SJS patients report a recent upper respiratory tract infection.

4. A diagnosis of either SJS or TEN is based on degree of body surface detachment (i.e., skin detachment). The classifications are as follows:

Stevens-Johnson Syndrome: Less than 10% body surface detachment

Overlapping SJS/TEN: 10% – 30% body surface detachment

Toxic Epidermal Necrolysis: More than 30% body surface detachment

5. There are approximately six cases of SJS per million persons per year. For TEN, it’s approximately 1-2 cases per million persons per year.

6. There is a correlation between the amount of body surface detachment and mortality. For SJS, studies have shown the mortality rate to be approximately 1% – 5%. If body surface detachment Read the rest of this entry »

Tags: SJS, Stevens Johnson Syndrome
Posted in Drugs/Medical | 20 Comments »