The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

Pfizer Makes List of Worst Corporate Evildoers

Evelyn Pringle March 6, 2006

On January 3, 2006 the Global Exchange Report named the top fourteen “Worst Corporate Evildoers” in the world for 2005. Pfizer, one of the most profitable drug companies on earth, with sales over $52 billion in 2004, made the list of Evildoers.

Pfizer’s participation in the cover-up of the deadly side effects of Bextra surely contributed to its membership. Because the drug was promoted and sold off-label for so many unapproved uses, the company made hundreds of millions of dollars in pure profits during Bextra’s short life on the market. However, experts predict that when all is said and done, the total amount of the drug’s damage to consumers will be in the billions.

Bextra belongs to the same class of drugs as Vioxx and Celebrex, known as Cox-2 inhibitors. Millions of people world-wide have taken these drugs.

It is now apparent that Pfizer knew Bextra was associated with extremely harmful side effects long before it was yanked off the market. However, Pfizer had good reason to stall its inevitable removal after Vioxx was recalled.

Bextra was on the market for about 3.5 years, but did not reach its full sales potential until Vioxx was eliminated from the competition. After the Vioxx recall, in one month alone, Bextra prescriptions went from 1.15 million in September 2004, to 1.48 million in October. All total for 2004, Pfizer generated sales of about $1.3 billion.

The marketing history of Bextra involves a train of suspicious conduct. On November 16, 2001, the drug’s original maker, Pharmacia won FDA approval for treatment of pain associated with osteoarthritis, adult rheumatoid arthritis and menstrual pain only and immediately went into overdrive promoting the drug for off-label use.

In July 2002, Pfizer acquired Bextra from Pharmacia in a $58 billion dollar deal that was not approved by the FTC until the following year in April 2003.

An FDA Talk Paper on the agency’s web site on November 15, 2002, announced new warnings on Bextra and said, “labeling is being updated with new warnings following postmarketing reports of serious adverse effects including life-threatening risks related to skin reactions – including Stevens Johnson Syndrome, and anaphylactoid reactions.”

The following month, the “Congress of California Seniors,” filed a lawsuit against Pharmacia in a Superior Court in Los Angeles, alleging the company had illegally promoted Bextra for off-label use.

According to the group, after the FDA refused a request to approve Bextra for pain related to impacted molars, Pharmacia helped fund a study that claimed Bextra could be useful in fighting acute dental pain and got it published in dental journals which led to the suit alleging secretive encouragement of ‘off label’ uses and attempting to circumvent the FDA’s refusal.

On November 2, 2003, after a year-long analysis of prescribing records, Knight-Ridder reported that more than half of Bextra pills sold were for off-label use.

About 5 months later, on March 14, 2004, Pfizer disclosed in a regulatory filing that the Justice Department was investigating the company’s marketing practices of Bextra for uses not approved by the FDA.

In October, 2004, the New England Journal of Medicine carried two editorials calling for renewed scrutiny of all Cox-2 inhibitors to assess whether the other drugs also caused heart problems.

In one editorial, cardiologist, Eric Topol, one of the first people to raise a red flag on Vioxx, from the Cleveland Clinic in Ohio, called for a government investigation into why Merck and the FDA allowed Vioxx to remain on the market for so long after its association with heart risks were revealed.

The FDA’s inaction was also noted by the Washington Post pointing out that in the late 1990s, the FDA took action when safety concerns were raised by withdrawing 10 drugs within 3 years. “But until the Vioxx withdrawal, only one other drug had been pulled since the Bush administration began, leading some to conclude that the agency had made a quiet policy change that emphasized “benefit” and sought to manage “risk” less intrusively,” the Post said on April 11, 2005.

As it turns out, Pfizer knew Bextra was every bit as dangerous as Vioxx and that the incidence of heart attack and stroke among patients using Bextra was more than 2 times that of patients taking placebos, which was revealed in a study presented on November 9, 2004, during the annual meeting of the American Heart Association in New Orleans.

Dr Curt Furberg, a professor at Wake Forest University School of Medicine, helped conduct the study and said: “Basically, we showed that Bextra is no different than Vioxx, and Pfizer is trying to suppress that information.”

On November 18, 2004, Dr David Graham, head of the FDA’s Office of Drug Safety, testified before the Senate Finance committee and listed Bextra as one of five drugs whose safety needs ”to be seriously looked at.”

On December 9, 2004, the FDA announced that Bextra would come with a new bolded warning contraindicating its use in patients undergoing coronary artery bypass graft (CABG) surgery.

The FDA knew Bextra was being widely marked for off-label use. Its December 9, Talk Paper, noted that Bextra was “not approved for use in the treatment of postoperative pain of any type;” but added: “however, FDA believes that these new findings should be made available to healthcare professionals and patients, and the bolded warning specifically contraindicates Bextra for treatment of pain immediately following CABG.”

The FDA also ordered a black boxed warning on the label stating that patients taking Bextra had reported serious, potentially fatal skin reactions, including Steven-Johnson Syndrome and toxic epidermal necrolysis.

Come to find out, as of November 2004, the FDA had received reports of 87 cases of SJS associated with Bextra. Thirty-six patients required hospitalizations, and 4 people died. Twenty involved patients with a known allergy to sulfa.

Although the other Cox-2 selective inhibitors also showed a risk for SJS, the FDA found reported cases to be greater with Bextra.

SJS is a devastating reaction affecting the skin and mucous membranes, causing severe burning, blistering and sloughing of involved tissue. SJS commonly causes blindness and results in death in 10 to 30 percent of the cases, according to a December 12, 2004 press release by the SJS Foundation.

People also develop SJS as a reaction to other commonly prescribed drugs, including antibiotics, anti-convulsants, and non-steroidal inflammatory drugs (NSAIDS), including over-the-counter drugs such ibuprofen products.

On January 26, 2005, Jean Farrell McCawley, the founder of the SJS Foundation testified before a joint meeting of the FDA’s Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee.

Ms Farell-McCawley told the panel that although SJS was referred to as a rare skin reaction, since 1995, the SJS Foundation had been notified of far more cases of the condition than those recorded by the FDA.

By one estimate, each year, SJS effects three to eight people per million in the US. However, the frequency is thought to be much higher since the FDA acknowledges that only between one and 10% of all adverse drug reactions are reported each year.

“SJS is not as rare as we are led to believe,” Ms Farrell McCawley advises. “During the winter months, we learn of 15 new cases a week, and that’s only people with Internet access,” she says.

It is hard to imagine a more severe adverse drug reaction than SJS. In the April 2005 SJS Newsletter, SrA Tanner Claybaugh published a letter describing what his sister, Mollie, went through after developing SJS as a reaction to children’s Advil.

Shortly after taking drug, Mollie developed blisters and rashes all over her body and was hospitalized. “She was put in the Intensive Care Unit (ICU) where there were countless machines keeping her alive,” SrA says.

“After about a weeks time,” he continued, “she was put in the burn unit as if she had burns from a fire, but the allergic reaction was the cause of her third degree burns.”

She was hanging on to life by a thread for weeks. “Back and forth she went,” her brother said, “from the burn unit to ICU.”

“As soon as her condition improved it worsened,” he noted. “It was always the same pattern entering ICU,” he recalls, wash your hands with warm water and soap and then put on medical mask and gloves.

“I was an 11 year old boy,” he wrote, “who had to do this just to watch my sister through a glass door of an isolation room.”

Mollie’s head had to be shaved and her skin was covered in blisters. “Her whole body was wrapped in gauze to stop the bleeding blisters,” SrA recalls.

“I remember sitting in her burn unit room watching two therapists lift her up and try to sit her in a wheelchair,” he said and described how drops of blood would fall from Mollie’s burnt flesh.

SrA says Mollie could not even scream out in pain. “All she could do is cry because her vocal cords had been burned,” he said.

After five months in the hospital Mollie was allowed to go home.

“Our living area transformed into that of a hospital room,” SrA said, “it had a ventilator for her tracheotomy, IV stand, stomach tube stand, heart rate monitor, and medications galore.”

Therapists came everyday and a nurse was always with Mollie giving her care. She required surgeries almost every other week to stretch her esophagus and the ligaments in her feet and hands. She also had cornea surgery.

According to SrA, today Mollie cannot walk, see, or talk very well. “She is fed through a stomach tube and it’s hard for her to breath,” he says.

Before SJS, Mollie was a dancer. “She was suppose to perform in the opening show for the 1996 Olympics in Atlanta,” her brother says. However, the room where she used to practice her dance moves and back flips has now become a rehabilitation center.

SrA says Mollie cannot receive any more therapy because of the healthcare budget cuts so his mother became a nurse to take care of Mollie.

SrA believes there needs to be more public awareness of the dangers associated with the drugs that cause this horrible reaction.

In January 2005, the Bextra related cardiovascular problems were back in the news when the results of two trials were released that showed the drug tripled the incidence of heart attack and stroke in coronary bypass graft surgery patients.

On February 14, 2005, the Associated Press reported that while Vioxx and Celebrex increased patients’ risk of heart attack and stroke by about 20 percent, Bextra increased the risk by 50%, citing a study by WellPoint Inc.

In April 2005, Pfizer finally took Bextra off the market at the request of the FDA. At the same time, the FDA told Pfizer to include a black box warning on Celebrex.

In a prepared statement, Pfizer reported that the FDA said Bextra’s risk to the heart was not distinguishable from other drugs and that it was the skin reaction that led to the decision.

The FDA advisory said it “concluded that the overall risk versus benefit profile is unfavorable and has requested that Pfizer, the manufacturer of Bextra, voluntarily withdraw Bextra from the market.”

The FDA explained that the request to recall the drug was based on:

1) The lack of adequate data on the cardiovascular safety of long-term use of Bextra, along with the increased risk of adverse CV events in short-term coronary artery bypass surgery (CABG) trials that FDA believes may be relevant to chronic use.

2) Reports of serious and potentially life-threatening skin reactions, including deaths, in patients using Bextra. The risk of these reactions in individual patients is unpredictable, occurring in patients with and without a prior history of sulfa allergy, and after both short- and long-term use.

The FDA also cited a lack of any demonstrated advantages for Bextra compared with other NSAIDs and instructed patients taking Bextra to contact their physicians and consider alternative treatments.

At the same time, FDA officials said all painkillers in the category known as “nonsteroidal anti-inflammatory drugs,” or NSAIDS, would have to carry stronger warnings about risks of heart attack, stroke, ulcers, internal bleeding or skin reactions, the Philadelphia Inquirer announced on April 9, 2005.

The warnings affected dozens of medications sold by prescription, as well as over-the-counter, with worldwide sales of at least $18.7 billion, according to the British pharmaceutical research firm Lead Discovery.

The drugs included Wyeth’s biggest-selling over-the-counter product Advil, which had sales of $620 million in 2004, Wyeth spokesman Doug Petkus told the Inquirer.

Teva Pharmaceutical’s ibuprofen, diclofenac and naproxen were included as also McNeil’s biggest-selling NSAID Motrin.

A report in the San Francisco Chronicle on February 27, 2005, said the “painkillers Vioxx, Celebrex and Bextra may go down in history as a classic example of the danger posed by aggressive industry promotion of prescription drugs to both patients and doctors.”

“In 2003,” the report said, “their manufacturers spent more than $1.5 billion to promote the drugs through television spots, print ads and pitches to doctors,” the report wrote.

And the $1.5 billion turned out to be a sound investment because by 2003, combined sales of the 3 drugs topped $5.3 billion, according to IMS Health, a pharmaceutical information and consulting company.

People who helped derail this deadly money train by standing up to the giant drug makers responsible for marketing this class of drugs often end up with a bitter pill. In the third civil lawsuit against Vioxx, Dr Topel gave testimony against Merck in a deposition and less than a week after his videotaped testimony was played in a Houston courtroom, he lost his title as chief academic officer of the Cleveland Clinic’s medical college.

On December 10, 2005, Dr Topol told the New York Times he was fired as a result of going up against Merck and said in part:

“The hardest thing in the world is just trying to tell the truth, to do the right thing for patients, and you get vilified. No wonder nobody stands up to the industry.”

But the icing on the cake for the Cox-2 inhibiter saga came on December 2, 2005, when Gooz News ran an article titled, “Pricey Pain Pills No Better at Reducing Tummy Distress.”

“It looks like the billions spent on expensive new Cox-2 inhibitors,” Gooz said, “was wasted – and not just because Vioxx was the likely cause of tens of thousands of heart attacks among its users.”

Citing a report in the British Medical Journal that day, Gooz said that “Cox-2 inhibitors do not reduce the gastrointestinal side effects of over-the-counter pain pills like ibuprofen.”

“This was the whole rationale for justifying the drug industry’s massive investment in this new class of medicines,” Gooz noted, “since they don’t reduce pain any more effectively than older pain pills.”

Filed under: 2006, Bextra, NSAIDs, Pfizer, SJS, Truthout

SJS – Called A Fate Worse Than Death

Evelyn Pringle January 29, 2006

Until Susie Orme developed Stevens Johnson Syndrome, it was a condition she read about in medical textbooks and a difficult topic to study for on her postgraduate exams. Susie is a doctor and as such, she was able to diagnose her own SJS.

However, “no amount of training could prepare me for the pain ahead,” she said.

Susie’s SJS was a reaction to the anticonvulsant drug lamotrogine. It started with a headache. Susie thought she had the flu and that it would pass and went to bed.

When she awoke her mouth was ulcerated and her eyes had become swollen, blotchy and painful. Within 24 hours her lips had sloughed off and she began to spit rotting flesh and blood from her mouth. Her genitals were swollen and sore and it was agonizing to urinate.

Her overriding memory is one of excruciating pain, Susie recalls, “of feeling that my body was burning and that someone had poured acid into my eyes.” The pain was so extreme that even morphine provided limited relief.

As the SJS progressed, Susie appeared as badly on the outside as she felt on the inside. “I no longer looked like a human being,” she said, “it was terrible for my family to watch me suffer and awful for me to know that the staff who cared so well for me were also physically shocked and repulsed when they saw me.”

“I felt utterly beaten by this awful disease,” Susie recalls. “Each time I closed my eyes the eyelids stuck together and had to be painstakingly bathed apart by the nurses,” she said. Her eyes hurt so badly and her vision became so poor that Susie remembers fearing for her eye sight more than death.

A year has now passed since she acquired SJS, and Susie says that she is recovering but has not yet recovered.

Even after the acute SJS phase is over, its after effects can last a lifetime. For instance, the nailbeds on Susie’s hands are permanently damaged.

She continues to get corneal abrasions due to in-growing eyelashes and her eyes are still very bothered by bright light. Susie’s tear ducts have been permanently damaged and she says, “using artificial tears has become as routine as breathing.”

Overall Susie remains optimistic. “By some miracle considering the severity of my illness,” she notes, “I can see and if I wear sunglasses can manage to do most things without too much pain.”

“My face looks unfamiliar due to the scarring of my eyelids,” Susie said, “but does not look as disfigured as I envisaged it might.” There is scarring on her genitals and initially it was difficult to have sex but with patience this problem is now better, she says.

“At the start of this terrible disease it feels as if there is no hope,” Susie recalls. But she wants other people with SJS to know that there is hope and that with time, patience, and determination, they too “can overcome this terrible illness and its consequences.”

Adverse reactions to prescription and over-the-counter drugs are one of the leading causes of death in the United States. Yet, because there is no mandatory reporting system for post marketing adverse affects, less than one percent of events are ever reported to the FDA.

For this reason, no one can provide an accurate number of the cases of Stevens Johnson Syndrome in the US. Described in many drug package inserts as a “serious skin condition,” SJS is in most cases a devastating allergic reaction to a drug and has been described as “a fate worse than death.”

According to experts, SJS causes the immune system to turn on itself to rid itself of the offending drug, in effect burning the patient from the inside out. SJS often causes blindness and results in death in 10 to 30% of the cases.

SJS is characterized by an extremely painful blistering skin rash, peeling skin, and blistering sores in the mucous membranes including the mouth, throat, eyes, nostrils, and anal and genital areas. In the most severe forms of the disease, the skin peels off in sheets from large areas of the body, much like with severe burn injuries.

Although SJS continues to be listed as a rare condition and is virtually unheard of by most people, it is becoming much more common. The February 15, 2005 Pittsburgh Post-Gazette, reported that there are between 600-2,000 cases in the US each year.

With more than 40 percent of Americans taking at least one prescription drug (2004 CDC report), the potential for the deadly adverse drug reaction is increasing, according to a SJS Foundation warning in the December 13, 2004 Business Wire.

The Stevens Johnson Foundation was founded as a resource for SJS victims and their families. Its mission is to provide support services, and compile and distribute information about SJS to the public and medical professionals. It also works to promote awareness of the symptoms of SJS so that a quick diagnosis can be made.

“SJS is not as rare as we are led to believe,” said Jean McCawley-Farrell, president of the Foundation. “As prescription drug use increases, we are being contacted by increasing numbers of people,” she adds.

“During the winter months,” Jean reports, “we learn of 15 new cases a week, and that’s only people with Internet access.”

Experts agree that recognition of early symptoms followed by prompt medical attention is crucial in minimizing the long-term effects of SJS. Symptoms include:

Rash, blisters, or red splotches on skin
Persistent fever
Blisters in mouth, eyes, ears, nose, genital area
Swelling of eyelids, red eyes
Conjunctivitis
Flu-like symptoms
Recent history of having taken a prescription or over-the-counter medication

Dr Bernard Cohen, MD, of John Hopkins Hospital, is a pediatric dermatologist and advisor to the SJS Foundation, and says, “typically, the reaction begins within the first two weeks of taking the drug.”

Experts usually distinguish between three forms of the disease Dr Cohen explains, “a milder form called Erythema Multiforme Minor, or EM, Stevens Johnson Syndrome, SJS, and TENS, or Toxic Epidermal Necrolysis Syndrome, the most severe form.”

“With EM, which can be recurrent, there will be lesions on the distal extremities [lower legs and arms] and in the mouth; there is little mucous membrane involvement, however.

“With SJS, which is usually not recurrent, there are usually blistering ulcerations of the cornea, mouth, rectum, genitalia, skin, and urethra, usually accompanied by a high fever and generalized weakness.

“TENS involves the entire skin and mucous membrane; the skin literally sloughs off of the person’s body.”

Dr Cohen advises. “Care must be taken to prevent staph infections of the skin from taking hold,” he said. “Intravenous fluids to prevent dehydration are a must, as the person is usually unable to eat or drink due to the mouth blisters,” he notes.

Some of the lasting complications of SJS that have been reported include blindness, dry-eye syndrome, arthritis, lung damage, asthma, photophobia, chronic obstructive pulmonary disease, loss of nail beds, scarring of the esophagus and other mucous membranes, and chronic fatigue syndrome.

As a physician, Susie Orme says she tells anyone who will listen about SJS. “If I prevent one of my colleagues from writing an unnecessary script and prevent one case of SJS it will have been worthwhile,” she notes.

The most frequently implicated drugs with SJS are antibiotics, anti-convulsants, and non-steroidal anti-inflammatory medications. SJS can be caused by these types of drugs:

painkillers
rheumatoid arthritis
antibiotics
drugs for bi-polar disorder
non-steroid anti-inflammatory drugs (NSAIDS)
barbiturates
anticonvulsants
sulfa antibiotics
penicillins

SJS has been reported as caused by these specific medications

Bextra
Arava
Remicade
Ibuprofen
Daypro
Children’s Motrin
Advil
Topamax
Lamictal
Allopurinol
Phenytoin
Carbamazepine

Why certain drugs cause SJS is still not fully understood. However, it is generally accepted that patients with known allergies to sulfa-based drugs have a greater chance of acquiring the conditions. Examples of sulfa-based antibiotics include:

Penicillins
Tetracycline
Doxycycline
Amoxicillin
Ampicillin
Zithromax/azithromycin
Beta-Lactams
Ciprofloxacin

Proper labeling of drugs is crucial to helping medical professionals and consumers recognize and understand adverse reactions such as SJS. Too often, drugs have sulfa components, but are not labeled as sulfa drugs.

Back on December 9, 2004, the FDA ordered new warnings for Pfizer’s Bextra. The warning identified Bextra as containing sulfa, and said that patients taking the drug had reported serious, potentially fatal skin reactions.

As of November 2004, the FDA had received reports of 87 cases of severe skin reactions in association with Bextra. Twenty of the cases involved patients with a known allergy to sulfa and four of the patients died.

The agency noted that Cox-2 inhibitors, such as Celebrex, and other anti-inflammatory drugs, such as naproxen and ibuprofen, also had a risk for serious skin reactions, but said that the reported rate of the side effect was greater with Bextra.

The FDA also told Pfizer to notify doctors of the risk. On October 15, 2004, Pfizer sent a letter to physicians informing them of the SJS risks associated with Bextra and advised that the skin reaction had lead to hospitalizations and deaths.

Five months later, on April 7, 2005, in a startling move, the FDA went against its own advisory committee’s recommendation to allow Bextra to remain on the market and told Pfizer to remove it, in large part due to its associated risks of SJS.

In addition, the agency ordered Black Box warnings about the risk of SJS on over-the-counter NSAID drugs, such as children’s Motrin and Advil. The FDA’s decision to mandate the strongest warning a label can carry, followed two pediatric cases of SJS where one 9-year-old child died, and another 7-year-old girl became blind after using over-the-counter NSAIDs.

Medical professionals advise patients who have suffered a drug-related case of SJS to avoid the offending drug, and all other drugs in the same class. They also recommend that immediate relatives of SJS victims avoid the same drugs as hypersensitivity has been known to be genetically linked.

Filed under: 2006, Bextra, NSAIDs, Scoop, SJS

Risk Of Harm From Motrin Aleve Advil – Better Odds In Crap Shoot

Evelyn Pringle July 1, 2006

Complications from non-steroidal anti-inflammatory drugs, or NSAID, have been linked to 103,000 hospitalizations and more than 16,000 deaths per year in the US, according to a study published in the American Journal of Therapeutics.

A lack of information, experts say, is the root cause of the lack of concern over the health risks associated with NSAIDs. A report in the January 16, 2005, Science Daily said: “More people die each year from NSAIDs-related complications than from AIDS and cervical cancer in the United States.”

Experts say the risk of their many adverse effects increase and vary depending on the patient’s age, dosage, and duration of use. NSAIDs include:

Ibuprofen (Advil, Motrin, Nuprin).
Naproxen (Aleve, Naprosyn).
Indomethacin (Indocin).
Ketoprofen (Orudis).
Piroxicam (Feldene).

A January 2003, Over-the-Counter Pain Medication Study, by the National Consumer League, determined that NSAIDs make up the largest share of the OTC pain medication market. About 110 million Americans who take OTC pain medications take NSAIDs most often. In fact, the study found, Americans are twice as likely to take NSAIDs than they are to take acetaminophen-based products including Tylenol.

There are also many OTC products that contain ibuprofen such as: Advil Cold And Sinus, Advil Cold, Advil Allergy Sinus, Children’s Advil Allergy Sinus, Ibuprohm Cold and Sinus, Sine-Aid IB, Children’s Motrin Cold.

Products that contain naproxen include Aleve, Naprosyn, Anaprox, Anaprox DS, EC-Naproxyn, Naprelan, and Naprapac (copackaged with lansoprazole)

A study published in the June 27, 2006, journal, Circulation, was the fifth study in a little over a year to claim that NSAIDs cause heart problems. The researchers in Circulation say NSAIDs can greatly and quickly increase the risk of death in persons who have already had one heart attack.

Dr Gunnar Gislason, from the Gentofte University Hospital in Hellerup Denmark, and colleagues gathered the medical records from the Danish National Patient Registry on 58,432 patients 30 and older who had survived a heart attack between 1994 and 2002.

They then examined the Danish Registry of Medicinal Product Statistics for information regarding prescriptions of NSAIDs, their dosages, and how long they were prescribed.

With high daily doses of NSAIDs, the study found the likelihood of dying was doubled or quadrupled depending on the specific drug, and the risk of another heart attack went up 22% to 89%.

“In addition,” Dr Gislason told Heartwire on June 21, 2006, ”the average time of treatment in our study was just one month, so it appears that even short courses of these drugs are dangerous in patients with known heart disease.”

“This is not just a problem associated with chronic treatment,” he said.

The study found any use of ibuprofen upped the risk of death by 1.5-fold, and high doses (over 1,200 milligrams a day) increased the risk by 2.2-fold. Diclofenac increased the death risk by 2.4-fold, and at high doses the increase was 4.4-fold.

Experts advise that these risks are not small for heart attack survivors. They amount to one patient harmed for every 24 patients who took diclofenac, and one in every 45 patients who took ibuprofen.

A year ago in June 2005, a British study of more than 9000 people who had suffered a previous heart attack found NSAIDs increased the risk of another heart attack by between 24% to 55%.

In that study published in the June 2005, British Medical Journal, researchers at the University of Nottingham identified 9,218 patients across England, Scotland and Wales, who had suffered a heart attack for the first time, over a specific 4-year period, with ages ranging from 25 to 100.

The researchers examined the prescribing patterns, and took into account other risk factors such as age, smoking habits, and obesity, and found that for patients prescribed the drugs in the three month immediately before the heart attack, the risk increased when compared to patients who had not taken the drugs. With ibuprofen, the risk increased by 24% and with diclofenac the risk increased by 55%.

According to the researchers, given the high prevalence of the use of the drugs by elderly people with an increased risk of heart attack due to age, the findings have considerable implications for public health.

Enough “concerns exist to warrant a reconsideration of the cardiovascular safety of all NSAIDs“, they said.

In the May 23, 2006 online version of the journal, Heart, researchers reported that taking NSAIDs could increase the risk of heart failure among the elderly by almost a third.

For this study, researchers from the Spanish Centre for Pharmacoepidemiologic Research in Madrid reviewed the medical records of 228,660 patients beginning on January 1, 1997, and followed the patients until the end of 2000.

Dr Consuelo Huerta and colleagues compared NSAID use among 1,396 patients between the ages of 60 and 84, who were hospitalized for non-fatal heart failure and a random sample of 5,000 subjects.

Of the patients admitted to the hospital, 14% were on NSAIDs at the time of their admission compared to 10% of randomly selected patients. Over half of those admitted to the hospital were in the age group of 70 to 79.

The research team determined that taking NSAIDs increases the risk of getting heart failure by 30%, after other factors are taken into consideration. The results mean that for every 1,000 people aged 60 to 84, taking NSAIDs leads to one extra hospital admission.

But according to the researchers, the number could rise to 3 among older patients with other health problems such as diabetes, high blood pressure or kidney failure. “Even a small increase in the risk can translate into a significant disease burden in the general population,” the researchers noted.

They point out that their findings are compatible with those of other studies indicating that NSAIDs aggravate heart failure symptoms, leading to more hospitalization for susceptible patients, such as those with a history of cardiovascular disease or a previous heart failure.

And finally, on June 3, 2006, researchers in another study from the Clinical Trial Service Unit at the University of Oxford, together with colleagues from the University of Rome, published in the British Medical Journal, determined that ibuprofen doubles the risk of a heart attack in patients who take it at high doses over a long period of time.

The study is reportedly the largest and most definitive of its kind into the effect of NSAIDs on the heart, and involves 138 trials covering 140,000 patients. The study combined the results of all trials in order to provide the most reliable estimate of the increased risk.

Two NSAIDs – ibuprofen and the prescription-only diclofenac – increased the risk of a heart attack by almost as much as the Coxib drugs like as Vioxx.

The researchers noted that most of the patients did not have pre-existing heart disease and the increased risk amounted to three extra heart attacks in every 1,000 people taking ibuprofen or diclofenac every year. Overall they increased the risk of any vascular event – heart attack or stroke – by 40%.

Experts says the growing body of evidence indicating the certainty of heart problems caused by the use of these drugs is particularly disturbing, because their use has drastically increased since Vioxx and Bextra were withdrawn from the market.

There are also a host of other serious health problems associated with taking NSAIDs that include kidney, liver, and stomach problems, particularly stomach bleeding and ulcers, and high blood pressure.

According to a study published January 3, 2005, in the American Gastroenterological Association journal Clinical Gastroenterology and Hepatology, chronic users of NSAIDs have an increased risk of bleeding and visible damage to their small intestine.

The study analyzed 43 relatively healthy patients, who used NSAIDs daily for relief of pain associated with rheumatoid arthritis, osteoarthritis, or non-specific arthritis, and a control group who did not use NSAIDs or aspirin for their arthritis symptoms.

Results show that 71% of those exposed to NSAIDs for more than 90 days had visible injury to their small intestine ranging from small erosions to severe ulcers.

“We have always known that NSAIDs can cause potentially deadly stomach complications, but the extent of the impact on the small intestine was largely unknown until now,” Dr David Graham, MD, lead author of the study told Science Daily.

According to Dr Thomas Stuttaford, in the May 26, 2006, UK Times Online, the hazards of NSAIDs “causing an exacerbation of indigestion and the gastro-intestinal complications associated with it, such as gastro-intestinal bleeding and even perforation, are well known.”

“Care is needed,” he warned, “when prescribing these drugs for patients over 65, especially if there is any history of peptic ulceration, whether gastric or duodenal, or of chronic indigestion.”

In May 2005, Web MD reported that “for people with high blood pressure, some types of nonsteroidal anti-inflammatory drugs (NSAIDs) can be risky.”

People with high blood pressure are at special risk, according to Web MD, because some of the NSAIDs reduce the blood flow to the kidneys, which filter the blood, causing them to work more slowly which causes fluid to build up in the body. As a result, the increased fluid drives up blood pressure.

In addition, if taken often enough and at a high enough dose, the Web MD article warned, “they can seriously damage the kidneys.”

“People with high blood pressure don’t know the risks of taking some of these painkillers,” Dr Nieca Goldberg, MD, a cardiologist and spokesperson for the American Heart Association told WebMD.

“They assume that anything you can buy over the counter is safe,” he said. “But these drugs are chemicals that can cause side effects.”

“When I have patients with heart disease that suddenly gets much worse,” he advised, “the first thing I ask them is if they’ve used an over-the-counter pain medicine.”

In August 2005, research published in Hypertension: Journal of the American Heart Association warned that women who consume higher doses of non-aspirin painkillers were much more likely to develop high blood pressure than women who do not use the medications.

The study was conducted to determine whether higher doses of pain relief drugs, specifically acetaminophen, NSAIDs, and aspirin, increase a woman’s risk of developing new-onset high blood pressure.

“Because high blood pressure is among the most important causes of death and disease in the United States, and analgesics are the most frequently used medications, a relationship between the two would be important from a public health standpoint,” said lead author John Forman, MD, instructor in medicine, Harvard Medical School, and associate physician, renal division, Brigham and Women’s Hospital, Boston, MA.

Researchers studied 1,903 women ages 51-77, and 3,220 women ages 34-53, who did not have high blood pressure when the studies began. They recorded information about whether the women used pain relief drugs, which type, at what dosage, and for what use, and then tracked whether the women developed high blood pressure. The NSAIDs taken were mostly ibuprofen and naproxen.

The study found that older women ages 51-77, who used an average of 400 mg of NSAIDs (2 ibuprofin tablets) or more per day were about 78% more likely to develop high blood pressure compared to older women who did not use the drugs.

Younger women ages 34-53, who used more than 400 mg a day of NSAIDs, were found to have a 60% higher chance of developing high blood pressure.

The risk of developing high blood pressure for women not taking any of the painkillers was only about 1 to 3% a year, researchers found.

The most surprising finding was the development of high blood pressure in women taking acetaminophen (Tylenol). Women ages 51-77 who took an average daily dose of more than 500 milligrams (one extra-strength Tylenol), had a 93% higher risk of developing high blood pressure within about 3 years. Among women 34-53 who took an average of more than 500 mg a day had a 99% higher risk, the study found.

The results of this study held up even when researchers excluded women who were taking pills for headaches, something that could itself be a result of very high blood pressure, said Dr Gary Curhan, one of the study’s authors from Harvard Medical School.

In May 2005, Web MD warned all people with high blood pressure not to use ibuprofen or naproxen, unless a doctor explicitly said they could. The drugs, Web MD advised, “can also impair the effectiveness of common blood pressure medicines like ace inhibitors (such as Lotensin, Capoten, and Vasotec) and beta blockers (such as Coreg, Lopressor, and Corgard.)”

But as it turns out, this is nothing new. According to Dr Stuttaford, in the May 26, 2006, Times Online: “Research carried out well over twenty years ago showed that the NSAIDs also had a tendency to increase blood pressure.”

“This tendency,” he said, “was more likely to be evident in those patients who had been treated with medication to reduce blood pressure.”

In addition, a 2005 study reported in High Blood Connection, found that NSAIDs also increase the risk for kidney failure, and that the risk is significantly greater for patients with hypertension.

Patients who took diuretics along with NSAIDs, the study found, had 11.6 times the risk of developing acute kidney failure compared to non-NSAID users. The relative risk for calcium channel blockers and NSAIDs was 7.8. The researchers warned that NSAIDs should be used with caution in patients with hypertension or heart failure.

Because there is no mandatory reporting system for post marketing adverse affects for drugs, only between 1% and 10% of all adverse reactions to medications are ever reported to the FDA, which means the actual number of patients harmed by NSAIDs is impossible to determine.

For this reason, the accurate number of cases of Stevens Johnson Syndrome caused by NSAIDs in the US are unavailable. Described in many package inserts as a “serious skin condition,” SJS is a devastating allergic reaction to a drug described by some as “a fate worse than death.”

SJS is characterized by an extremely painful skin rash and blistering sores in the mouth, throat, nostrils, eyes, and anal and genital areas. In the most serious cases, a patient’s skin peels off in sheets from large areas of the body, much like what happens to severe burn patients.

According to experts, SJS causes the immune system to turn on itself to rid the body of the offending drug, in effect burning the patient from the inside out. SJS results in death in 10 to 30% of the cases.

Although SJS was once a rare condition, it is becoming far more common. According to the February 15, 2005 Pittsburgh Post-Gazette, there are now between 600-2,000 new cases in the US each year.

Some of the lasting effects of SJS include blindness, dry-eye syndrome, arthritis, lung damage, asthma, photophobia, chronic obstructive pulmonary disease, loss of nail beds, scarring of the esophagus and other mucous membranes, and chronic fatigue syndrome.

Over a year ago, on April 7, 2005, the FDA asked manufacturers of OTC NSAIDs to revise their labeling to include more specific information to assist consumers in the safe use of the drugs.

“This includes,” the FDA said, “instructions about which patients should seek the advice of a physician before using these drugs, stronger reminders about limiting the dose and duration of treatment in accordance with the package instructions unless otherwise advised by a physician, and a warning about potential skin reactions.”

In the new labeling, the FDA instructed manufacturers to include: (1) more specific information about the potential CV and GI risks; (2) instructions about which patients should seek the advice of a physician before using these drugs; (3) stronger reminders about limiting the dose and duration of treatment in accordance with the package instructions unless otherwise advised by a physician; and (4) a warning about potential skin reactions.

In addition, the agency ordered Black Box warnings about the risk of SJS on all OTC NSAIDs. The FDA’s decision to add the strongest warning label available, followed two pediatric cases of SJS where one 9-year-old child died, and another 7-year-old became blind after using OTC NSAIDs.

Although experts are now saying to cut back on NSAIDs, on June 14, 2006, Wyeth began hawking its new product, Advil PM, promoting its use to battle sleeplessness “a few nights a week or more.”

According to the company’s press release, a survey conducted by the National Sleep Foundation found that almost 20% of Americans (42 million) experienced nighttime pain or physical discomfort that disrupted their sleep a few nights a week or more. In fact, it said, 68% of Americans currently are getting less than eight hours of sleep on weeknights, while the US Department of Health and Human Services recommends at least eight hours of uninterrupted sleep.

The profits up for grabs are as always obscene. According to Wyeth, 15% of Americans are turning to sleep aids, making the sleep aid market a $3.1 billion business annually in the US, of which more than $260 million can be attributed to OTC drugs.

Filed under: 2006, NSAIDs, Scoop, SJS

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