Putting Pain Sufferers Health at Risk

In its infinite wisdom, FDA is planning to consider Cymbalta for pain relief -

-FDA Panel to Consider Pain Indication for Antidepressant (excerpt)
Patients in the duloxetine arms were more likely to discontinue treatment because of adverse events, including nausea, sleep disturbances, dizziness, dry mouth, somnolence, constipation, and fatigue. Most of the events were dose-dependant.
Duloxetine use also appears to be associated with an increased risk of Stevens-Johnson syndrome, a skin disease that usually results from a drug reaction, as well as another form of the disease called toxic epidermal necrolysis. The FDA reviewers recommended that, if duloxetine is given the chronic pain indications, it should carry warning labels about the increased skin disease risks.
The FDA also has concerns about duloxetine's risk of serious liver toxicity, already included in the drug's labeling.
No deaths were reported during the trials.
The safety findings aren't new or unexpected and are very similar to duloxetine's current safety label, the FDA reviewers said.
The drug also carries a boxed warning for suicidality in children, adolescents, and young adults taking antidepressants for major depressive disorder and other psychiatric disorders.
"...duloxetine is not universally tolerated nor free of safety risks," wrote Eli Lilly staff in the company's briefing documents posted on the FDA's website. However, the safety profile is "well-characterized" and not any different for chronic pain patients than it is for other patients who are already using the drug.

Consider that you do encounter much higher risk with these and may other drugs used for pain relief. Lyrica for example depletes your platelets and they don't mention that in the TV ads.

You might want to learn more about natural pain relief.

from Natural Health News Search

Natural Health News: FDA and Drug Risks

Sep 07, 2008

The FDA also said it is evaluating reports of urinary retention with Eli Lilly's antidepressant Cymbalta, and skin melanoma with Biogen and Elan Corp's multiple sclerosis drug Tysabri. Biogen spokeswoman Shannon Altimari said two cases ...

Natural Health News: New Drug Approved for FMS - Read this first ...

Feb 13, 2009

When cymbalta first came out, it was the "wonder drug" that was going to end my troubles. Well, it almost ended ME altogether!!! I had horrible suicidal ideations, and I even brought home insulin and a syringe to do myself in (I'm a ...

A Fox was in the Chicken Coop: Disgraced Former FDA Official Now ...

Dec 28, 2007

In October, the FDA told Lilly to stop falsely claiming antidepressant Cymbalta produced “significantly less pain interference with overall functioning” and start mentioning its side effect of liver toxicity. ...

No Difference in Psych Drugs for Depression

Nov 18, 2008

Duloxetine (Cymbalta) * Fluvoxamine (Luvox) * Mirtazapine (Remeron) * Trazodone (Desyrel) * Nefazodone (Serzone) * Venlafaxine (Effexor) The guideline also calls for physicians to modify treatment if patients fail to respond adequately 

SSRIs Can Lead to Cataract

Jun 02, 2010

Not all SSRI antidepressants were found to increase cataract risk, although this may be because not enough people in the study were taking them for the researchers to detect a risk. Risk was found for three different antidepressants:

Suicide & Death Can Lurk In Each SSRI Pill

Jul 06, 2007

In June 2001 I posted a response to the just reported Andrea Yates case, directing my comments to the negligence of the prescribing physician for the overload of SSRI and related psychiatric drugs, including Haldol. ...

SSRI Drugs in Pregnancy Linked to Heart Abnormalities

Nov 26, 2008

Prozac use has shown that women who took the SSRI (and fluoride based) antidepressant during the first three months of pregnancy gave birth to four times as many babies with heart problems as women who did not. ...

Natural Health News: Fluoride is not a cure for mothers or babies

Mar 16, 2009

SSRI anti-depressants are based in fluoride and are endocrine disruptors. All campus shootings have been associated with people who have been taking SSRI anti-depressants, which recently have been proven - AGAIN - to be ineffective for ...

A New Look at Fibromyalgia?

If there were to be something coming from this story I'd like to see proper thyroid testing, nutritional counseling, and supplement support.

I say this because I worked for several years as a resource person for a large urban hospital FMS/CFIDS group.

I also worked with an MD and an LMP to develop and monitor a natural approach to fibromyalgia.

Guess What? Many of our group lost the FMS and the diagnosis!

New criteria proposed for diagnosing fibromyalgia

ScienceDaily (2010-06-06) -- The American College of Rheumatology is proposing a new set of diagnostic criteria for fibromyalgia that replaces the tender point test with a rating system that includes common symptoms such as fatigue, sleep disturbances, and cognitive problems, as well as pain. ... > read full article

Chili Counters Pain

Natural Health News has about nine articles that include cayenne. You'll find more here on our original domain, on line since 1991.

Learn more

To me it is interesting that news of the well known - for a very long time - benefits of cayenne as a pain remedy reports as if no one has ever heard of this benefit.

But in case you've been in the dark on this wonderful substance for pain, here's the newest -

Studying chilli peppers is helping scientists create a new type of painkiller which could stop pain at its source.

And if you'd like to get some of our great cayenne ointment, just send us an email for more information and ordering.

Pfizer hedging its bets? UPDATE

Today Pfizer agrees to pay out $894 million to settle lawsuits over Celebrex and Bextra. Other NSAIDS still show a link to heart disease but this is one of the most readily preventable health conditions we know of and other posts on this blog give you some of that data. For pain and inflammation there are many excellent natural remedies as well as one of the natural products I use from time to time that has been tested at Dana Farber.

$894 million deal ends pain of Pfizer's lawsuitsBy Linda A. Johnson, Ap Business Writer
17 October, 2008
TRENTON, N.J. – Drug giant Pfizer Inc. has reached an $894 million deal to end most of the lawsuits over its two prescription pain relievers, the popular Celebrex and a similar drug, Bextra, no longer on the market.

The world's biggest drugmaker said Friday it has agreements in principle to end more than 90 percent of personal injury lawsuits brought by people claiming the pills caused heart attacks, strokes or other harm.

The settlement includes roughly 7,000 personal injury cases, mainly plaintiffs who took since-withdrawn Bextra, said plaintiff attorney Perry Weitz. He represents nearly 2,000 claimants, about 10 percent of them relatives of people who died.

"It gives Pfizer closure and the claimants their money sooner, rather than later or never at all," Weitz said.

Pfizer hopes to finalize claims covered by the settlement, which now includes up to 92 percent of plaintiffs, by year's end. It also hopes to include many of the remaining claimants in the settlement and will fight any remaining personal injury suits with court motions or at trial, General Counsel Amy Schulman told The Associated Press.

"I don't think either side has an interest in protracting this," Schulman said in an interview.

Weitz said plaintiff lawyers will "have issues" with Pfizer "if their claimants aren't paid before the end of the year."

In early trading, Pfizer shares were down 47 cents, or 2.8 percent, at $16.50.

Schulman said the deal comes after two important court rulings — one by a New York state judge overseeing many of the state-level personal injury cases and the other by a federal judge in San Francisco coordinating pretrial steps in federal lawsuits over the drugs.

"We teed up some pretrial motions for a court ruling on whether there was significantly reliable evidence that would allow an expert to testify as to whether there was an increased risk of heart attack and stroke at the most common dose," 200 milligrams, Schulman said. Both judges ruled that was not the case, she said.

The proposed deal also would end suits by insurers and patients seeking to recover what they spent on Bextra and Celebrex, as well as claims by 33 states and the District of Columbia that Pfizer improperly promoted Bextra.

Out of the total settlement, $745 million will go to settle personal injury cases, $60 million will cover settlements with attorneys general in the 33 states and the District of Columbia, and $89 million will cover consumer fraud class action cases over reimbursement for money spent on the two drugs. Two additional states, Louisiana and Mississippi, still have pending cases regarding Pfizer's promotion of the drugs.

New York-based Pfizer withdrew Bextra from the market in 2005, a year after Merck & Co. withdrew its Vioxx, a similar drug.

The Vioxx withdrawal, which triggered an avalanche of lawsuits against Merck, also raised concerns about the safety of other medicines in the same class, called Cox-2 inhibitors. They were heavily touted by their makers as superior to traditional nonsteroidal anti-inflammatory drugs, or NSAIDs, such as ibuprofen, because they block an enzyme involved in promoting inflammation but — unlike NSAIDs — don't block an enzyme that protects the stomach from bleeding and other side effects.

Other NSAIDs, such as ibuprofen and naproxen, have also been linked to increased heart risks.

Celebrex is the only Cox-2 inhibitor that the Food and Drug Administration has allowed to remain on the U.S. market.

Attorney Christopher Seeger, a member of the plaintiffs steering committee, said he'll "have no problem recommending" the settlement to the roughly 400 clients he represents.

"We're very satisfied with the deal," Seeger said.

Schulman said the company's negotiations with opposing lawyers had been under way for some time but picked up in the late summer.

"Litigation can be distracting, and putting these matters behind us helps our shareholders and, most importantly, patients and doctors," Schulman said.

Weitz noted that it took four or five years to get through trials for less than 20 cases in the massive Vioxx litigation, because the court system can only handle a limited number of cases at a time.

Pfizer will take a pretax charge of $894 million to its third-quarter earnings, which it is scheduled to report on Tuesday.

Merck, based in Whitehouse Station, N.J., has begun paying a $4.85 billion settlement to end about 50,000 lawsuits brought by people claiming Vioxx cause heart attacks, ischemic strokes or death. It still faces other litigation over the former blockbuster arthritis treatment.

Copyright © 2008 The Associated Press.

Pfizer to Drop Development of Certain Drugs
by Shelley Wood, Heartwire 2008. © 2008 Medscape

October 3, 2008 (New York, NY) — Pfizer is getting out of the cholesterol-lowering game to focus on what it perceives to be more lucrative diseases, according to an internal memo obtained by Forbes [1]. And for the most part, the chosen "disease areas" don't include the heart.

In the memo, Martin Mackay, president of Pfizer Global Research & Development (R&D), informed his staff that the company plans to "exit" the fields of atherosclerosis/hyperlipidemia, heart failure, obesity, and peripheral arterial disease.

Instead, the company, whose cholesterol-lowering drug atorvastatin (Lipitor) is the world's top-selling drug, says it is turning its attention and R&D dollars to cancer, diabetes, Alzheimer's, pain remedies, and mental health as its "higher-priority areas."

The news comes in the wake of the flop of Pfizer's hoped-for new flagship, torcetrapib, a CETP inhibitor that was widely predicted to be the company's next blockbuster drug. While CV drugs have been the major moneymakers for Pfizer in recent years, those days are drawing to a close. In addition to Lipitor, which will lose patent protection in 2011, Pfizer's other major player in the CV drug arena is Norvasc (amlodipine), which came off patent in 2007.

Among the lower-priority "disease areas" where the company says it will continue working are thrombosis and transplant, the memo notes.

Contacted by heartwire, a handful of leaders for some of the major Pfizer-sponsored trials in cardiovascular disease over the past decade declined to comment on the company's announcement or speculate on what it might mean to the field of CV drug development--with one exception. Dr John Kastelein (Academic Medical Center, Amsterdam, the Netherlands), who was an investigator in the Pfizer-sponsored ASAP, TNT, and IDEAL trials, called Pfizer "a real powerhouse" in the CV drug arena.

"I kind of knew this was coming, but when you see it in print, it still hits hard," he told heartwire. "I think this is very, very significant both for the company itself and for the whole field of CV drug development. Pfizer had truly excellent people in the development arm of their company for CV and metabolic drugs, and they've contributed to this whole notion that you need more robust LDL lowering and that that's better than mild LDL lowering, which has become one of the axioms of CV prevention. And if they're stepping out now, that not only signifies their own problems, but it also signifies the problems in CV drug development, and how incredibly difficult and costly it has become to bring new drugs forward. And that's not good for patients."

Kastelein predicts that drug companies, having "lost faith" somewhat in HDL-raising therapies, will need to look more closely at anti-inflammatory drugs in the setting of coronary artery disease. "But there, the problem is, if you have no biomarkers whatsoever to do even dose-finding studies, you need to move from relatively small phase 2 trials to incredibly large, hard-outcome studies, which is taking quite a risk," he said. And that, at least for Pfizer, is too much risk.

"Everyone, not just Pfizer, is realizing that the days of the really big blockbuster drugs are over. And what is going to replace that are drugs in a class that are 10 times or 100 times more difficult to develop, so the risks are much higher. And these days, after Avandia and ezetimibe, everything is about safety. This means the FDA is forced, by public and colleague pressure, to demand even larger databases before drugs are going to market, which is of course making it more expensive. It's a cycle that's very hard to break."

Calls to Pfizer were not returned before this story was published.

Herper M. The Pfizer memo. Forbes, September 30, 2008. Available at: http://www.forbes.com/business/2008/09/30/pfizer-drug-agenda-biz-bizhealth-cx_mh_0930pfizermemo.html.

The complete contents of Heartwire, a professional news service of WebMD, can be found at www.theheart.org, a Web site for cardiovascular healthcare professionals.