Yourlawyer.com (Plavix News)

Plavix Users Warned Not to Take Prilosec, Nexium

Wed, 18 Nov 2009 00:00:00 -0800

Prilosec and Nexium reduce the anti-clotting effects of Plavix, according to a Public Health Advisory issued by the U.S. Food & Drug Administration (FDA). As a result, patients at risk for heart attacks or strokes who use Plavix to prevent blood clots will not get the full effect of this medicine if they are also taking Prilosec or Nexium. The agency warned yesterday that patients who take Plavix should use different medications to treat acid reflux, such as Mylanta or Zantac.

Prilosec inhibits the drug metabolizing enzyme (CYP2C19) which is responsible for the conversion of Plavix into its active form (active metabolite), the FDA said. New studies compared the amount of Plavix's active metabolite in the blood and its effect on platelets (anti-clotting effect) in people who took Plavix and Prilosec versus those who took Plavix alone. A reduction in active metabolite levels of about 45 percent was found in people who received Plavix with Prilosec compared to those taking Plavix alone. The effect of Plavix on platelets was reduced by as much as 47 percent in people receiving Plavix and Prilosec together. These reductions were seen whether the drugs were given at the same time or 12 hours apart, the agency said.

Prilosec is one of a class of drugs known as Proton Pump Inhibitors (PPIs). PPIs are often prescribed to Plavix patients to minimize gastric effects such as nausea and heartburn. According to the FDA, the level of inhibition among other PPIs varies, so it is unknown to what extent other PPIs may interfere with Plavix. However, Nexium, a PPI that is a component of Prilosec, also inhibits CYP2C19 and should also be avoided in combination with Plavix.

The FDA also advised that other drugs that are potent inhibitors of the CYP 2C19 enzyme would be expected to have a similar effect and should be avoided in combination with Plavix. These include: Tagamet, Diflucan, ketoconazole (sold as Nizoral, Extina, Xolegel, Kuric), VFend, etravirine (known as Intelence or TMC125), Felbatol, Prozac, Luvox, and Ticlid.

The manufacturers of Plavix have agreed to look at other possible drug interactions with Plavix. In the meantime, the Plavix label will be updated with new warnings on Prilosec and other drugs that could interact with Plavix in the same way. When more information becomes available, the FDA will communicate any additional recommendations or conclusions on the use of Plavix.

Finally, the FDA advised patients taking Plavix to consult their healthcare provider if they are currently taking or considering taking Prilosec, Prilosec OTC or Nexium. It is also very important that patients talk with their healthcare professional about any over-the-counter drugs they are taking before starting or while using Plavix. Patients should always consult with their healthcare professional before starting or stopping any medication.

Plavix Users Should Avoid Heartburn Drugs

Thu, 07 May 2009 00:00:00 -0700

Plavix (clopidogrel) users are being warned by a group of heart experts to avoid some common heartburn drugs. HealthDay News is saying that patients taking the clot-preventing Plavix following stent implantation should stay away from PPIs, or proton pump inhibitors. Stents are implanted in artery-opening cardiac surgeries and PPIs, said HealthDay News, include drugs such as Nexium, Prevacid, and Prilosec.

According to the experts at the Society for Cardiovascular Angiography and Interventions (SCAI), the PPI-Plavix combination increases a patient’s risk for heart attack, stroke, and other cardiovascular problems, reported HealthDay News. The SCAI cited one study in which the PPI-Plavix combination was linked to significant increases: 70 percent for heart attack, 48 percent for stroke, and 35 percent for repeat heart procedures, said HealthDay News.

The SCAI said in a statement released at its annual meeting, "given the thousands of patients who receive stents each year, coupled with significant risks demonstrated in this study, SCAI recommends the use of alternative medications for gastrointestinal symptoms in patients with stents when appropriate," quoted HealthDay News. The group noted that additional research is called for and also pointed out that this recommendation refers to the older PPIs—Protonix, Nexium, Prilosec, and Prevacid—not the newer PPIs—Aciphex and Kapidex, said HealthDay News.

Data on nearly 17,000 Plavix users—who took the drug for over one year following stent implantation—were analyzed, said HealthDay News, citing Eric J. Stanek, senior director of research at drug distributor Medco Health Solutions. The team found that the incidence of cardiovascular events was 51 percent greater in patients taking the Plavix-PPI combination over those on Plavix alone, said Stanek, according to HealthDay News. "Considering all the available evidence, PPI use should be limited in patients taking clopidogrel, based on the physician's judgment," Stanek said.

PPIs are often prescribed to Plavix patients to minimize gastric effects such as nausea and heartburn. Since Plavix and PPIs are metabolized by the same liver enzyme, a PPI can reduce Plavix’s benefits, explained HealthDay News. Also, early studies linked the PPI-Plavix combination to increased cardiac risk and the U.S. Food and Drug Administration (FDA) issued an alert on this recently, said HealthDay News.

In past reports, we have discussed PPIs such as Prilosec and Nexium and that the FDA had investigated a suspected link between cardiac trouble and PPIs. Also, because such drugs may be overly effective at stopping stomach acid production, they have also been know to raise pneumonia, bone loss, and fracture risk; this, by over 40 percent in patients on long-term use.

A Canadian study of PPIs such as Aciphex, Nexium, Prevacid, Prilosec, and Protonix and osteoporosis-related fractures revealed a link between long-term PPI use and the increased risk for such fractures of the hip, wrist, or spine. It remains unclear how PPIs might increase fracture risk, but some experts believe it may be related to the medications’ stomach acid inhibiting qualities.

Tysabri, Plavix Sponsored Link Promotions Criticized

Mon, 06 Apr 2009 00:00:00 -0700

The makers of Tysabri and Plavix have been warned about internet ads for the drugs. According to the Food & Drug Administration (FDA), the Tysabri and Plavix ads fail to provide required safety information.

According to a report on Reuters.com, the makers of the drugs have been directed to rectify the problems with the ads. They must submit a written response by April 9 stating whether they intend to comply.

The Tysabri and Plavix ads in question appear as sponsored links on internet search engines, like Google. In a March 26 letter to Biogen Idec, the maker of Tysabri, the FDA says sponsored links for Tysabri "make representations and/or suggestions about the efficacy of Tysabri, but fail to communicate any risk information associated with the use of this product."

Tysabri was taken off the market by the FDA in 2005 after three patients in clinical trials developed progressive multifocal leukoencephalopathy (PML), an often deadly brain disease. But the drug was reapproved in 2006, although it was subject to restrictions. Tysabri is now available only to patients with relapsing multiple sclerosis (MS) or Crohn's disease (CD) who are enrolled in the risk minimization plan called the TOUCH Prescribing Program. Under the TOUCH Prescribing Program, every Tysabri-treated patient is closely monitored and followed for the occurrence of PML and other serious opportunistic infections.

A letter to Sanofi-Aventis voiced similar criticism over sponsored links for Plavix, an anti-clot drug. "By omitting the most serious and frequently occurring risks associated with Plavix, the sponsored links misleadingly suggest that Plavix is safer than has been demonstrated," the letter said. Plavix is known to increase the risk of serious bleeding.

According to The Wall Street Journal, a total of 14 drug makers received warning letters about sponsored links for 48 drugs. GlaxoSmithKline was warned about sponsored links for several of its drugs, including the diabetes drugs Avandia, Avandamet and Avandaryl, the blood pressure medicine Coreg, Avodart for enlarged prostate and the breast cancer drug Tykerb. Pfizer received a letter criticizing its sponsored links for the anti-smoking drug Chantix, and its arthritis drug Celebrex.

The other companies that received letters are: Johnson & Johnson, Forest Laboratories Inc., Cephalon Inc., Bayer AG, Novartis AG, Merck & Co., Eli Lilly & Co., Roche Holding AG, Genentech Inc., and Boehringer Ingelheim Pharmaceuticals Inc., the Journal said.

Of the drugs cited by the warning letters, the Journal said 19 carry black box warnings - the FDA's strongest safety notice - about potential side effects.

A spokesperson for the FDA told The Wall Street Journal that the agency hasn't contacted any of the search engines where the ads have appeared because the FDA doesn't contact third parties that carry ads, even if violate agency rules.

Plavix, Heart Burn Drug Combo Risky for Stent Patients, Study Says

Wed, 12 Nov 2008 00:00:00 -0800

Taking Plavix along with certain heartburn medications could be dangerous to stent patients. According to a recent analysis of a database kept by pharmacy benefits manager Medco Health Solutions Inc, the combination of Plavix and proton pump inhibitors, such as Nexium, places these patients at a greater risk of heart attack, stroke and other dangerous health problems than those who took Plavix alone.

Plavix is used to prevent blood clots after a recent heart attack or stroke, and in people with certain disorders of the heart or blood vessels. The medication keeps the platelets in the blood from coagulating to prevent unwanted blood clots that can occur with certain heart or blood vessel conditions.

Proton pump inhibitors are used to treat chronic heartburn. In addition to Nexium, other prescription proton pump inhibitors include Protonix and Prevacid.

The Medco study followed more than 16,000 patients in the database from 2005 to 2006. Of the patients inthe study, 9,862 patients were taking Plavix alone;and 6,828 patients were taking Plavix and a proton pump inhibitor.

All patients in the study had been implanted with a wire-mesh tube - a stent - to prop open arteries after they have been cleared of plaque. The study tracked whether they had been hospitalized for heart and circulatory problems within a year of the stent being implanted.

Of those who had not had a previous heart attack, only 21.2 percent of patients experienced a serious event within a year of their stent surgery. That number rose to 32.5 percent among those who took Plavix and a proton pump inhibitor.

Of those who did have a previous heart attack, 39.2 percent were hospitalized for a serious heart or circulatory event. For those taking only Plavix, only 26.2 percent did.

The database did not include patients who took over-the-counter proton pump inhibitors. Medco's chief medical officer and lead researcher on the study, Robert Epstein, told the Associated Press that the percentage of those who experienced a serious event would likely be even higher if such drugs were included in the study.

"Considering the widespread use of these two medications, this important research adds to a growing body of evidence raising questions about their concurrent use and suggests further research is needed," Epstein said in press release announcing the study's findings.

According to The Wall Street Journal, a study published in the journal Circulation in 2003 showed that nearly 30 percent of Plavix patients don't process the drug effectively. The Medco study could be an important clue as to why. People on Plavix are often prescribed proton pump inhibitors because Plavix has been linked to a higher risk of ulcers.

For Plavix to work, it must first be converted to its active form by a liver enzyme. The Medco researchers said proton pump inhibitors According to the Medco researchers, these drugs interfere with the liver enzyme, thereby reducing the amount of Plavix that is converted to an active form.

Two Studies: Similar Results, No Benefits from Stroke Drugs

Thu, 28 Aug 2008 00:00:00 -0700

Two recently-released, separate studies on medications used in the prevention and treatment of stroke both question the benefit of blood pressure medicine and a popular blood thinner for use in the prevention of stroke recurrence. In the first study, patients who were taking the blood pressure drug Micardis (telmisartan) were no less likely to have another stroke than those patients who were taking a placebo. The second study found that when aspirin was combined with the anti-platelet drug Persantine (dipyridamole), the combination also performed no better than the standard anti-clotting treatment Plavix (clopidogrel)for reducing the chance of stroke.

"We found no evidence that either of the two treatments was superior to the other in the prevention of recurrent stroke," said Ralph Sacco of the University of Miami. Sacco led the study. "Even though, in science, you always strive to find a superior treatment, in this case it gives us options for treatment depending on the patient and their response to the different medications." Both research papers were released online by the New England Journal of Medicine and were based on the “Profess" study. The Profess study reviewed data from 20,332 patients from 695 medical centers located in 35 countries.

The drug clopidogrel is a Bristol-Myers Squibb drug that is marketed under the brand name Plavix. Boehringer Ingelheim GmbH makes dipyridamole and markets that drug under the brand name Persantine.

Stroke kills about five million people worldwide every year and suffering from high blood pressure increases the risk of stroke. Also, when a patient survives a stroke, that person experiences an eight percent increased likelihood of suffering from another stroke within one year.

It was because of these data, telmisartan—which Is sold under a variety of brand names—was prescribed to half the study volunteers; that study was let by Salim Yusuf of McMaster University, Ontario, Canada. Telmisartan is sold as Boehringer Ingelheim's Micardis or Pritor and Bayer Schering Pharma’s Kinzal brands.

After two and a half years of study follow-up, the researchers found that 8.7 percent of the patients taking telmisartan suffered another stroke as compared to 9.2 percent of patients suffering another stroke in the placebo group. The less-than-one-percent increase was described as insignificant. The drug, which is an angiotensin-receptor blocker, had no effect on the risk of heart attack, or other major cardiovascular events, or diabetes.

Among volunteers receiving Plavix, 8.8 percent in the Plavix group suffered an additional stroke versus 9 percent of the patients in the aspirin-dipyridamole combination group. Also, the risk of major bleeding was similar in both groups. "Furthermore, there was no significant difference between the two treatments in the risk of fatal or disabling strokes," the researchers wrote.

Drs. David Kent and David Thaler of the Tufts University School of Medicine in Boston agreed the findings were confusing. The study was funded by drug maker Boehringer Ingelheim.

Taking Plavix With Aspirin Proves Risky

Sun, 12 Mar 2006 00:00:00 -0800

People taking the blood thinner Plavix on top of aspirin to try to prevent heart attacks, as many doctors recommend, now have good reason to stop.

The drug combination not only didn't help most people in a newly released study, but it unexpectedly almost doubled the risk of death, heart attack or stroke for those with no clogged arteries but with worrisome conditions like high blood pressure and high cholesterol.

"They actually were harmed," said Dr. Eric Topol. "This was a trial to determine the boundaries of benefit, and it did. You don't use this drug for patients without coronary artery disease."

He and Dr. Deepak Bhatt of the Cleveland Clinic led the study, which involved 15,603 people in 32 countries. Topol has since left the clinic and is at Case Western Reserve University in Cleveland.

Results were reported Sunday at an American College of Cardiology conference whose organizers issued an "expression of concern" saying the drug's maker, Sanofi-Aventis SA, told some stock analysts the results of the study in advance, in violation of the conference's embargo policies.

However, Sanofi spokesman Michel Joly denied the claim Sunday, saying the company provided no results in advance.

Aspirin's ability to prevent heart attacks in men is legendary but it does little for their risk of stroke. In women, aspirin wards off strokes but only reduces heart attack risk in those 65 or older. Adding Plavix to aspirin for people being treated for a heart attack cuts their risk of a second one or death.

For these reasons, doctors thought the drug combination might prevent "heart attacks waiting to happen" in people with very clogged arteries or lots of risk factors like heavy smoking, diabetes and high cholesterol.

They gave everyone in the study low daily doses of aspirin plus Plavix or a dummy pill and looked at how they fared more than two years later.

Adding Plavix made little difference for the group as a whole except for slightly reducing hospitalizations. But for the 20 percent with no signs of heart disease, the drug combination proved dangerous. Heart-related deaths almost doubled, from 2.2 percent of those taking only aspirin to 3.9 percent of those who added Plavix.

The only people even modestly helped by adding Plavix were those with established heart disease. Their risk of heart attack, stroke or death was about 7 percent versus 8 percent for those taking aspirin alone.

Specialists said this was not enough to justify recommending the drug in light of the overall findings of no benefit.

The cost and risks of Plavix don't justify expanding its use for prevention, Dr. Marc Pfeffer of Brigham and Women's Hospital in Boston and Dr. John Jarcho of the New England Journal of Medicine write in an editorial in the journal, which will be published along with the study results in the April 20 issue.

"Plavix should not be used for prevention," said Dr. Elizabeth Nabel, director of the National Heart, Lung and Blood Institute. "Aspirin alone is sufficient."

The study was paid for by Sanofi and Bristol-Myers Squibb, which sell Plavix in the United States for about $4 a pill. Outside the U.S. the drug is sold as Iscover. Many of the researchers have ties to the companies or others that make heart drugs.

Also at the conference, the third study in roughly a year confirmed that a different strategy to prevent heart attacks folic acid and vitamin B supplements doesn't work.

These lower homocysteine, a blood substance that can make arteries stiffen and clog.

Dr. Eva Lonn of McMaster University in Hamilton, Ontario, and colleagues gave 5,522 people with clogged arteries or diabetes these vitamins or phony pills for five years. Homocysteine dropped in people given the supplements, but not the risk of heart attack or death. Vitamin takers suffered slightly fewer strokes than the others, but they also were more likely to be hospitalized for chest pains.

America's Top-Selling Prescription Drugs – a Who's Who of Blockbusters

Sat, 04 Mar 2006 00:00:00 -0800

According to a recent article in Forbes.com (2/27/06) that was based on figures obtained from IMS Health, a healthcare information company, the top 20 prescription drugs in the U.S. in 2005, with combined sales of $64.6 billion, were as follow:

1.    LIPITOR – Pfizer – Treats high cholesterol: $8.4 billion

2.    ZOCOR – Merck –Treats high cholesterol: $4.4 billion

3.    NEXIUM – AstraZeneca – Treats heartburn: $4.4 billion

4.    PREVACID – Abbott & Takeda – Treats heartburn: $3.8 billion

5.    ADVAIR DISKUS – GlaxoSmithKline – Treats asthma: $3.6 billion

6.    PLAVIX – Bristol-Meyers Squibb & Sanofi-Aventis – Treats heart disease $3.5 billion

7.    ZOLOFT – Pfizer – Treats depression: $3.1 billion

8.    EPOGEN – Amgen – Treats anemia: $3.0 billion

9.    PROCRIT – Johnson & Johnson – Treats anemia: $3.0 billion

10.    ARANESP – Amgen – Treats anemia: $2.8 billion

11.    ENBREL – Amgen & Wyeth – Treats rheumatoid arthritis: $2.7 billion

12.    NORVASC – Pfizer – Treats high blood pressure: $2.6 billion

13.    SEROQUEL – AstraZeneca – Treats schizophrenia: $2.6 billion

14.    EFFEXOR XR – Wyeth – Treats depression: $2.6 billion

15.    ZYPREXA – Eli Lilly – Treats: schizophrenia: $2.5 billion

16.    SINGULAIR – Merck – Treats asthma and allergies: $2.5 billion

17.    PROTONIX – Wyeth – Treats heartburn: $2.4 billion

18.    RISPERDAL – Johnson & Johnson – Treats schizophrenia: $2.3 billion

19.    NEULASTA – Amgen – Treats chemotherapy side effects: $2.2 billion

20.    REMICADE – Johnson & Johnson – Treats rheumatoid arthritis: $2.2 billion

Drug-eluting Stents May Cause Allergic Reactions

Fri, 30 Dec 2005 00:00:00 -0800

Drug-eluting stents have greatly reduced the risk of repeat blockage of heart arteries, but researchers from Northwestern Memorial Hospital have found that in some patients, the stents can cause allergic reactions that can have serious consequences. They stress that physicians and their patients should be aware of this potential and know the symptoms. The findings have been published online will be published in the January 3rd issue of the Journal of the American College of Cardiology.

"This paper provides evidence for the first time that instances of allergic reactions, presumably to the polymer in the stent, can occur. In some instances, these events have serious consequences- including stent closure and subsequent death," says one of the study's authors, Charles Bennett, MD, an epidemiologist and oncologist at Northwestern Memorial Hospital and professor of medicine at Northwestern University's Feinberg School of Medicine. Dr. Bennett developed and directs the Research on Adverse Drug/Device Events And Reports (RADAR) Project, which compiles information from reports submitted to the U.S. Food and Drug Administration's (FDA) database as well as reports by drug companies and independent researchers throughout the world. RADAR has previously successfully identified a large number of serious drug reactions associated with 15 commonly used drugs.

For this study, RADAR investigators from 10 centers around the country reviewed 5,783 reports available from April 2003 through December 2004 for hypersensitivity-like reactions associated with drug-eluting stents. From these reports, researchers identified 17 cases of hypersensitivity reactions that were classified as probably or certainly caused the stent, four of which resulted in death. Symptoms included rash, difficulty breathing, hives, itching and fevers. They also concluded that the polymer coating on the stent itself is the most probable cause of hypersensitivity in the majority of cases rather than the medications the stent is coated with.

"It is important to keep the findings in perspective," says Charles J. Davidson, MD, an author on the paper and medical director of the Cardiac Catheterization Lab at the Bluhm Cardiovascular Institute of Northwestern Memorial Hospital and professor of Medicine at Northwestern University's Feinberg School of Medicine. "Drug-eluting stents are a life-saving advance used by hundreds of thousands of people that have greatly reduced the risk of restenosis. We are in no way recommending they be used less, but we do think that health professionals should be vigilant in watching for this problem."

Another concern, say the authors, is that in many instances, blame for the allergic symptoms is placed on other medications that treat their heart conditions, such as Plavix and anti-platelet agents, and these are discontinued. Premature discontinuation of Plavix can increase the risk of dangerous blood clots.

"Physicians should be cognizant that allergic reactions to the polymers in drug eluting stents can occur and all such events should be reported to the FDA. Six months after the approval of the first drug-eluting stent, the FDA issued a letter to physicians identifying 50 hypersensitivity cases associated with drug-eluting coronary artery stents, but retracted an assertion of causality a month later. That retraction may have been premature," says Dr. Bennett.

The paper also concludes that further research is warranted to better understand this risk and to develop a skin test to identify people who might be at high risk for hypersensitivity to drug eluting stents.

Study Finds Heart Attack Survival Rate Increased when Plavix is added to Standard Medical Care and Aspirin

Sun, 06 Nov 2005 00:00:00 -0800

The most recent issue of The Lancet contains the results of a large study in which the clot-preventing drug Plavix (clopidogrel) was added to the standard hospital care given to heart-attack patients.

While aspirin is routinely used in the emergency treatment of heart attack, Plavix is not.

The study was done in China and involved some 45,800 patients treated within 24 hours of the onset of a heart attack at 1,250 hospitals. Half of the subjects were given the standard treatment (including aspirin) while the other half was also given Plavix.

The group that received clopidogrel had a 7% lower death rate as well as a 14% lower incidence of second heart attacks during the treatment period (28 days or discharge whichever was shorter). Overall, the Plavix group had a 9% lower rate of repeat heart attacks, stroke, and death from heart attack.

In addition to these favorable results, there was no increase in excessive bleeding, a potentially dangerous problem that was feared with the combining of aspirin and Plavix.

Clopidogrel has already been shown to reduce deaths and other heart problems by 50% in heart-attack patients taking the drug before, rather than during, an angioplasty. Plavix is also used for patients with unstable angina or those undergoing the insertion of an arterial stent.

The study is seen as an excellent reason to standardize the use of Plavix as a routine part of the care given to heart-attack patients as soon as they are hospitalized.

The researchers estimate that based on the annual worldwide figure of 10 million heart attacks, the use of Plavix could save some 5,000 lives each year while also preventing the same number of heart attacks and strokes.

Plavix Side Effects Lawsuit Ulcer Lawyer

Sun, 06 Nov 2005 00:00:00 -0800

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Injured By Plavix?

A study to be published in the New England Journal of Medicine found that patients taking Plavix (Generic: Clopidogrel bisulfate), a popular and expensive antistroke drug, experience more than 12 times as many ulcers as patients who take aspirin plus a heartburn pill. Up to half of those now taking Plavix do so because their doctors assume that Plavix is safer on the stomach than aspirin, said Dr. Francis K. L. Chan, the study's lead author. The American College of Cardiology and the American Heart Association recommend that heart and stroke patients at risk of developing ulcers be given Plavix instead of aspirin.

The new study suggests that the guidelines should be changed, and that many of those who are taking Plavix should consider switching to aspirin plus a heartburn pill, Dr. Chan said. Dr. Chan found 320 patients whose ulcers had healed and gave half of them Plavix and half of them aspirin plus Nexium, a heartburn pill. Thirteen of the patients taking Plavix, or 8.6%, experienced renewed ulcer bleeding during the year while just one, or 0.7%, of those taking aspirin and Nexium had an ulcer bleed.

If you or a loved one took Plavix and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.