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Showing posts sorted by relevance for query drugs. Sort by date Show all posts

Friday, July 20, 2012

Workers Compensation Pharmaceuticals Targeted For Reform

Ritalin
Ritalin (Photo credit: Wikipedia)
An insurance based research organization, the Workers Compensation Research Institute (WCRI), has published a report concerning newly adopted State regulations limiting the prices paid for doctor-dispensed drugs (repackaging) and comparison costs between prescription medication and similar, less costly, over-the-counter (OTC) drug costs. WCRI also reports on the costs between brand-name drugs and generic prescriptions.

The study examines the results of a change to the California statute that has become a model for many other states. Critics of the regulations express concern that many patients will not get needed medications if they do not get them at the physicians’ offices.

The study, Physician Dispensing in Workers’ Compensation, examines physician dispensing before and after a 2007 change in the California statute that governed the prices paid to physician-dispensers. Prior to the statutory change, physicians typically charged much higher prices than pharmacies for the same medication. For example, for the most common drug, Vicodin®, physicians were paid $0.85 per pill compared to $0.43 for pharmacies—nearly double the price. After the reforms, physicians were paid $0.52 per pill compared to $0.48 for pharmacies. After the law changed, physicians were paid prices for prescription medications that were similar to those paid to pharmacies for the same medication.

This study finds that:

· physician-dispensed drugs became increasingly common in most states that permit physician dispensing;

· prices paid for physician-dispensed drugs were often substantially higher than if the same drugs were dispensed by a retail pharmacy;

· prices paid to dispensing physicians rose rapidly for medications that were commonly dispensed by physicians, while the prices paid to pharmacies for the same drugs changed little or fell.


One of the chief concerns expressed by supporters of physician dispensing (in California and in other states) was that doctors would stop dispensing needed prescriptions when it became less profitable. However, the California post-reform experience shows that physicians continued to dispense prescriptions, even when the prices paid were lower. Before the reforms, 55 percent of all prescriptions were dispensed at physician offices. Three years after the reforms, 53 percent of all prescriptions in California were physician-dispensed so patients had similar access to physician dispensed medications, but at a much lower cost.

Robert Ceniceros, a reporter for Business Insurance, reported, "...But critics contend such price regulations may discourage doctors from dispensing drugs and discourage patients from getting the prescription drugs they need."



The report also examines several other concerns expressed by supporters of physician dispensing. One is that spending on prescription drugs might increase if a California-type reform were adopted. They argue that physicians almost always dispense less expensive generic versions of drugs, while pharmacies dispense both brand names and generics. The study found that for the specific medications commonly dispensed by physicians, generics were almost always dispensed by both physicians and pharmacies. In many states, when generic drugs were dispensed, physician-dispensers were paid much higher prices per pill than pharmacies for the same prescription.

The data used for this study include nearly 5.7 million prescriptions paid under workers’ compensation for approximately 758,000 claims from 23 states over a period from 2007/2008 to 2010/2011. The 23 states in this study represent over two-thirds of the workers’ compensation benefits paid in the United States. These states include Arkansas, Arizona, California, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, New York, North Carolina, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, and Wisconsin. Several of the states in this study (Arizona, California, Georgia, South Carolina, and Tennessee) recently adopted reforms aimed at reducing the prices of physician-dispensed drugs.



Related Blogs on drugs and workers' compensation
Jul 12, 2012
Prescription drugs have become an increasingly important issue in workers' compensation law. Their use in workers' compensation claims has resulted in both a major direct financial cost to the system, and has had .
Jun 20, 2012
As state workers' compensation reformers continue to be sidetracked with alleged prescription drug pain-killer abuse, the US Congress has entered the fray with proposed Federal legislation. It has been reported today by ...
May 04, 2012
To use the prescription drug abuse issue to attack workers' compensation generally is merely sidetracking the real problem with the medical delivery system which is the global denial of compensability of workers' ...
Mar 30, 2011
Many states, including Wisconsin, hold that if an injury results from intoxication (by alcohol or drugs) benefits are not denied, but reduced (usually by 15%) as an employee safety violation, but intoxication is not evidence of a ...

Nov 18, 2011
The Complex World of Workers' Compensation and Pharmaceutical Benefits. The Workers' Compensation system, designed over a century ago, was intended to provide medical benefits that were to be delivered to injured ...
Sep 14, 2011
The Top 10 Drugs Prescribed For Workers Compensation Claims. A recent study by NCCI Holdings, Inc. reports the top 10 most popular drugs prescribed for workers' compensation claims. OXYCONTIN®; LIDODERM ...
Dec 05, 2011
Workers Compensation on Drugs - Tenn Supreme Court Allows Fatal Case to Proceed. A major complaint of the failure of medicine is that sick people are sent to the pharmacy for pain relief without adequate evaluation ...
Mar 09, 2010
After an onsite review of the plan and its services, CMS determined that the plan's significant deficiencies – not meeting Medicare's requirements to provide enrollees with prescription drugs according to recognized standards ...
Mar 21, 2012
For Medicare beneficiaries stuck in the prescription drug benefit coverage gap known as the "doughnut hole," a 50 percent discount on covered brand name drugs and 14 percent savings on generic drugs. * A requirement ...

Saturday, August 3, 2013

Health Care Workers Suffer Exposures to Antineoplastic Drugs

A recent study reveals that health care workers may be suffering from occupational exposure to chemotherapy drugs while treating cancer patients.

"Antineoplastic drugs are pharmaceuticals commonly used to treat cancer, which are generally referred to as 'chemotherapy'. Several studies have shown that exposure to antineoplastic drugs can cause toxic effects on reproduction as well as carcinogenic effects. Presence of these drugs in the urine of hospital personnel has been widely studied and dermal exposure has been suggested to be the main route of exposure. 

The main focus has been on handling the concentrated drug during preparation and administration of antineoplastic drugs and several approaches have been proposed on how to control those. Handling patient excreta has been considered to be potentially harmful to nurses working with cancer patients, since antineoplastic drugs are known to be present in patient excreta (e.g. urine, saliva, sweat, faeces, vomit), but this has not been studied in great detail in occupational exposure studies. 

The identification of occupational exposure to antineoplastic drugs in sectors outside the hospital environment (i.e. veterinary medicine, home care, nursing homes and industrial laundries) showed that the number of workers potentially exposed to antineoplastic drugs is larger than previously estimated. "

Click here to read the series of articles in The Annals of Occupational Hygiene

Exposure to Antineoplastic Drugs in Two UK Hospital Pharmacy Units 
H. J. Mason, S. Blair, C. Sams, K. Jones, S. J. Garfitt, M. J. Cuschieri, and P. J. Baxter 

A Pooled Analysis to Study Trends in Exposure to Antineoplastic Drugs among Nurses 
Wouter Fransman, Susan Peelen, Simone Hilhorst, Nel Roeleveld, Dick Heederik, and Hans Kromhout 

Occupational Dermal Exposure to Cyclophosphamide in Dutch Hospitals: A Pilot Study 
Wouter Fransman, Roel Vermeulen, And Hans Kromhout 

Postulating a dermal pathway for exposure to anti-neoplastic drugs among hospital workers 
Hans Kromhout, Fred Hoek, Ruud Uitterhoeve, Roel Huijbers, Roderik F. Overmars, Rob Anzion, and Roel Vermeulen 

Occupational Exposure Limits for Therapeutic Substances 
Raymond Agius 


Read more about "occupational exposures" and workers' compensation:
Jul 12, 2013
The Occupational Safety and Health Administration today announced a new National Emphasis Program to protect workers from the serious health effects from occupational exposure to isocyanates. OSHA develops national ...
Jun 03, 2013
Chemical exposure in the workplace can have an insidious--yet devasating--effect on a worker. In a wide-ranging article, the New York Times presented an in-depth view of chemical exposure at furniture factories in North ...
Jul 19, 2013
Workers' compensation claims result from heat stress and exposure. As the Mid-West and Northeast heatwave is now soaring to records temperatures, workers should protect themselves from heat exposure. Today's post was ...

Tuesday, March 9, 2010

Citing Violations Medicare Ends Contract with Fox Insurance Company Drug Plan

The Centers for Medicare and Medicaid Services has issue an announcement of the immediate termination of Fox Insurance Company.

Members Will Be Provided Access to Drugs While Transitioning to New Plans.

The Centers for Medicare & Medicaid Services (CMS) today terminated its contract with Fox Insurance Company. After an onsite review of the plan and its services, CMS determined that the plan’s significant deficiencies – not meeting Medicare’s requirements to provide enrollees with prescription drugs according to recognized standards of care – jeopardized the health and safety of Fox enrollees. CMS found that Fox committed a series of violations, including improperly denying its enrollees coverage of critical HIV, cancer, and seizure medications. The termination of the contract is effective immediately.

The immediate termination will not impact or delay access to drugs for the more than 123,000 Medicare beneficiaries currently enrolled in Fox plans. Beginning tomorrow, all enrollees will obtain their drugs through LI-NET, a program run by Medicare and administered by Humana, to ensure that beneficiaries receive their Medicare prescription drugs. Fox enrollees will be able to choose a new Medicare prescription drug plan through May 1, 2010. Current enrollees who do not choose a plan will be enrolled into a new plan by Medicare.
“The immediate termination of Fox as a Medicare prescription drug plan demonstrates our commitment to protecting the health of some of their most vulnerable enrollees from getting necessary drugs, in some cases life-sustaining medicines. CMS’s immediate action was essential to protect members’ health and safety – an integral part of our contract with all Medicare beneficiaries,” said Jonathan Blum, acting director of CMS’ Center for Drug and Health Plan Choices. “Fox enrollees also need to know that they are not losing their drug coverage and will continue to have access to needed medicines. We will be sending letters explaining the steps we are taking to ensure they continue to get their medicines. They can also call 1-800-MEDICARE or their local state health insurance assistance programs if they have questions.”

CMS issued an enrollment and marketing sanction to Fox on Feb. 26, 2010, because the organization was not following Medicare’s rules for providing prescription drug coverage to its enrollees. After an onsite audit, which ran between March 2 and March 4, CMS found Fox’s problems persisted and it continued to subject its enrollees to obstacles in getting needed and, in many cases, life–sustaining medicines. CMS also found that many of the obstacles were in place to limit access to high-cost drugs, which could have led to enrollees’ clinical needs not being met. In many cases, Fox enrollees were required to have unnecessary and invasive medical procedures before they were able to obtain drugs. Fox was unable to satisfactorily address these compliance concerns and furnish medicines to its Medicare enrollees.

Among the audit findings CMS found include:

· Failing to provide access to Medicare prescription drugs benefits by imposing unapproved prior authorization and step therapy criteria that made it more difficult for beneficiaries to get drugs that are protected by law.

· Not meeting the plan’s appeals deadlines,

· Not complying with Medicare regulations requiring enrollees to be transitioned to new drugs at the beginning of the new plan year.

· Failing to notify enrollees about prior authorization and step therapy determinations as required by Medicare.

According to CMS auditors, Fox was unable to satisfactorily address compliance concerns cited in the enrollment and marketing sanction and meet contractual obligations to provide medicines to Medicare beneficiaries enrolled in their plans.

“We take our oversight role of Medicare prescription drug plans seriously,” said Blum. “We review and take action on all complaints received about Medicare health and drug plans and will take appropriate and immediate actions wherever necessary.”

CMS encourages Medicare prescription drug plan enrollees having concerns with access to drug coverage to contact 1-800-MEDICARE (1-800-633-4227) or the state health insurance assistance program (SHIP) to help get them resolved. Medicare enrollees, their families and their caregivers can contact a SHIP near them by visiting:http://www.medicare.gov/Contacts/staticpages/ships.aspx

# # #

NOTE: States in which the Fox plan was available were: Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Louisiana, Maryland, Missouri, North Carolina, New Jersey, New York, Nevada, Ohio, Pennsylvania, South Carolina, Texas and West Virginia.

Wednesday, April 16, 2014

Prices Soaring for Specialty Drugs, Researchers Find

Workers' Compensation insurance covers the FULL cost of prescription drugs.Today's post was shared by The New York Times and comes from www.nytimes.com

Even as the cost of prescription drugs has plummeted for many Americans, a small slice of the population is being asked to shoulder more and more of the cost of expensive treatments for diseases like cancer and hepatitis C, according to a report to be released on Tuesday by a major drug research firm.
The findings echo the conclusions of two other reports released last week by major pharmacy benefit managers, which predicted that spending on so-called specialty drugs would continue to rise.
The report, by the IMS Institute for Healthcare Informatics, also found that consumers’ use of health care — visits to the doctor, hospital admissions and prescription drug use — rose in 2013 for the first time in three years, mainly because of the improving economy, it said.
“Following several years of decline, 2013 was striking for the increased use by patients of all parts of the U.S. health care system,” Murray Aitken, executive director of the IMS Institute, said in a statement. He noted that the spike came before the Affordable Care Act, which has helped provide health insurance to millions of new customers, fully went into effect.
But even as consumers became more confident about spending money on health care last year, the report found that a divide is developing between those with medical conditions that can be treated with cheap generic drugs, and those with rare and often more serious diseases that can come with breathtaking price tags.
More than...
[Click here to see the rest of this post]


Related Articles:
Dec 18, 2013
A major international pharmaceutical company has made a major change in strategy for the sale of prescription drugs. Part of the change was induced by the economics of litigation and the threat additional lawsuits. Today's ...
Jul 12, 2012
Prescription drugs have become an increasingly important issue in workers' compensation law. Their use in workers' compensation claims has resulted in both a major direct financial cost to the system, and has had .
Jun 18, 2013
The CDC latest statistics show close to 40,000 drug overdose deaths each year in the United States, more than half of which involve prescription drugs. Deaths in which opioids are used now exceed deaths involving heroin ...

Thursday, July 12, 2012

The High Price of Drugs: Upscale Pricing By Doctors

Source: NY Times
"Rules in some states that govern workers’ compensation insurance allow doctors to charge many times what pharmacies charge for some drugs when dispensed in their offices."


Nov 18, 2011
Prescription drugs have become an increasingly important issue in workers' compensation law. Their use in workers' compensation claims has resulted in both a major direct financial cost to the system, and has had ...

Jun 20, 2012
As state workers' compensation reformers continue to be sidetracked with alleged prescription drug pain-killer abuse, the US Congress has entered the fray with proposed Federal legislation. It has been reported today by ...
May 04, 2012
To use the prescription drug abuse issue to attack workers' compensation generally is merely sidetracking the real problem with the medical delivery system which is the global denial of compensability of workers' ...
Mar 30, 2011
Many states, including Wisconsin, hold that if an injury results from intoxication (by alcohol or drugs) benefits are not denied, but reduced (usually by 15%) as an employee safety violation, but intoxication is not evidence of a ...
Sep 14, 2011
The Top 10 Drugs Prescribed For Workers Compensation Claims. A recent study by NCCI Holdings, Inc. reports the top 10 most popular drugs prescribed for workers' compensation claims. OXYCONTIN®; LIDODERM ...

Sunday, January 5, 2014

Video: AAJ President Discusses Generic Drugs

Today's post was shared by Take Justice Back and comes from www.takejusticeback.com


Nearly 80 percent of all prescriptions in the U.S. are filled with the generic version of a drug.  The price tag can be appealing, but taking a generic drug can also have dangerous consequences because generic drug manufacturers are not accountable for the safety of drugs they produce.Accountability is a key incentive to ensure drug companies monitor and adequately warn patients about the safety of drugs. Despite what many may think, the FDA does not test drugs, but instead relies on testing provided by the drug companies.  FDA approval of a drug does not guarantee safety.  In the above video, American Association for Justice President Burton LeBlanc talks about the accountability imbalance between generic drugs and name-brand drugs and how the lack of accountability can put consumers at risk. “What you may not know is that unlike brand-name manufacturers, generic drug manufacturers cannot be held accountable if their drugs injure or kill Americans. And we all know too well, if no one is accountable, no one is safe,” LeBlanc said. To view the video in its entirety, click here. Here’s where you can help. Join the growing number of over 20,000 consumers who have already signed a petition calling on the FDA to restore accountability. Safety is an issue that can’t be overlooked. 
[Click here to see the original post]

Tuesday, June 24, 2014

Warning Unheeded, Heart Drugs Are Recalled

More problems with generic drugs. Today's post was shared by The New York Times and comes from www.nytimes.com

For years, Dr. Harry Lever, a cardiologist at the Cleveland Clinic, has been warning nearly anyone who would listen of his growing suspicions about generic versions of a widely used heart drug, Toprol XL.

Patient after patient, he said, would visit his office complaining of chest pains or other symptoms after switching from the brand-name version, made by AstraZeneca, to a generic product, often one made in India. When he switched them back to the brand — or to another generic — the symptoms disappeared, he said. Dr. Lever wrote a letter outlining his concerns to the Food and Drug Administration in 2012, and this year, he traveled to Washington to try to get the attention of Congress.

Dr. Lever could not prove that the generic drugs were to blame. “You see enough people and you get a feel, but it’s anecdotes,” he said in an interview Monday. “It’s not science.”

Now, Dr. Lever is feeling a sort of sad vindication. Two large Indian manufacturers, Wockhardt and Dr. Reddy’s Laboratories, have announced recalls over the last two months totaling more than 100,000 bottles because their products were not dissolving properly — therefore probably not working as they should. The drug is a beta blocker that treats high blood pressure and heart ailments.

The recalls are the latest in a string of recent problems involving generic drugs, especially those made in India. Wockhardt, for example, is now banned from exporting drugs to...
[Click here to see the rest of this post]

Related articles

Knee Replacement Medical Device Recalled (workers-compensation.blogspot.com)
FDA Warns Zithromax / Zmax Antibiotics Potential Risk of Fatal Heart Rhythms (workers-compensation.blogspot.com)
FDA warns of rare but serious risk of heart attack and death with cardiac nuclear stress test drugs Lexiscan (regadenoson) and Adenoscan (adenosine) (workers-compensation.blogspot.com)
Doctors Say Heart Drug Raised Risk of an Attack (workers-compensation.blogspot.com)
FDA Closes Down Illegal On-Line Pharmacies (workers-compensation.blogspot.com)
Video: AAJ President Discusses Generic Drugs (workers-compensation.blogspot.com)

Wednesday, December 18, 2013

The Selling of Prescription Drugs: A Major Change in Sales Strategy

A major international pharmaceutical company has made a major change in strategy for the sale of prescription drugs. Part of the change was induced by the economics of litigation and the threat additional lawsuits. Today's post is shared from NPR.org.

Doctors talking up drugs to other doctors has been quite lucrative for pharmaceutical companies — and the physicians who moonlight as their salesmen.

Drugmakers learned long ago that deputized doctors were effective pitchmen. A doctor paid by a company to give a dinner speech or to chat over lunch with colleagues can go a long way toward changing their prescribing habits.

But now drug giant GlaxoSmithKline says it's going to stop paying doctors to speak about drugs or diseases to people with the power to write prescriptions or influence those who do. Doctors will still be able to earn money from Glaxo through research collaborations and consulting agreements.
The company will also stop paying sales reps based on sales targets. Historically, Glaxo and other companies have tied reps' compensation to changes in the prescriptions written by doctors they call on.
The changes "are designed to bring greater clarity and confidence that whenever we talk to a doctor, nurse or other prescriber, it is patients' interests that always come first," Glaxo CEO Andrew Witty said in a statement.

Glaxo says the new approach will be implemented in all the countries it operates in by early 2016.
Some of the changes, such as the shift in sales rep pay, got rolling in the U.S. a few years ago. In 2011, Deirdre Connelly, Glaxo's U.S. president, talked about decoupling rep pay from prescriptions in a speech that acknowledged that "our industry lost its way."

Why is Glaxo making these changes now? Well, the company has been rocked by allegations of ethical missteps and worse. There's been a bribery investigation in China. And last year, a settlement of alleged health care fraud involving the marketing of some drugs in the U.S. The settlement included a restrictive corporate integrity agreement with the federal government.

Before The Prescription, Ask About Your Doctor's Finances
But CEO Witty told The New York Times the shift wasn't related to events in China or anything else in particular. Instead, he said, the changes are part the company's effort "to try and make sure we stay in step with how the world is changing. We keep asking ourselves, are there different ways, more effective ways of operating than perhaps the ways we as an industry have been operating over the last 30, 40 years?"

There are some other reasons it might be more palatable for Glaxo, and perhaps other companies, to dial back marketing now. There are fewer new drugs being launched for mass markets — think cholesterol-fighters, antidepressants and blood pressure pills. And more doctors' offices and hospitals have restricted interactions between physicians and the drug industry.
Also, public scrutiny of these relationships has been increasing year by year. In 2014, a plank of the Affordable Care Act will bring even more sunshine to bear. Makers of drugs and devices will have to make public what they pay doctors.

"Many people have wondered, what difference will it make?" asked Susan Chimonas, a research scholar at the Center on Medicine as a Profession at Columbia University. "Will it clean up practices, or just allow the status quo to continue so long as there is transparency? Glaxo's move is giving us an early answer — and reason for optimism," she told ProPublica. "The saying about sunlight being the best disinfectant — that's exactly what we're seeing here. The sunshine law is working."
….
Jon L. Gelman of Wayne NJ is the author NJ Workers’ Compensation Law (West-Thompson) and co-author of the national treatise, Modern Workers’ Compensation Law (West-Thompson). For over 4 decades the Law Offices of Jon L Gelman  1.973.696.7900  jon@gelmans.com  have been representing injured workers and their families who have suffered occupational accidents and illnesses.

Friday, June 28, 2013

FDA Closes Down Illegal On-Line Pharmacies

Operation Pangea VI combats online sale and distribution of unapproved prescription medicines 

The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 9,600 websites that illegally sell potentially dangerous, unapproved prescription medicines to consumers. These actions include the issuance of regulatory warnings, and seizure of offending websites and $41,104,386 worth of illegal medicines worldwide.


The action occurred as part of the 6th annual International Internet Week of Action (IIWA), a global cooperative effort to combat the online sale and distribution of potentially counterfeit and illegal medical products. As part of this year’s international effort – Operation Pangea VI – the FDA’s Office of Criminal Investigations, in coordination with the United States Attorney's Office for the District of Colorado, seized and shut down 1,677 illegal pharmacy websites. The effort ran from June 18 to June 25, 2013.

Many of these websites appeared to be operating as a part of an organized criminal network

that falsely purported its websites to be “Canadian Pharmacies.” These websites displayed fake licenses and certifications to convince U.S. consumers to purchase drugs they advertised as “brand name” and “FDA approved.” The drugs received as part of Operation Pangea were not from Canada, and were neither brand name nor FDA approved. These websites also used certain major U.S. pharmacy retailer names to trick U.S. consumers into believing an affiliation existed with these retailers.

Friday, July 10, 2015

FDA Strengthens NSAIDs Warnings: Chance of Heart Attack & Stroke

The U.S. Food and Drug Administration (FDA) is strengthening an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke. 

Based on the FDA's comprehensive review of new safety information, it is requiring updates to the drug labels of all prescription NSAIDs. As is the case with current prescription NSAID labels, the Drug Facts labels of over-the-counter (OTC) non-aspirin NSAIDs already contain information on heart attack and stroke risk. The FDA will also request updates to the OTC non-aspirin NSAID Drug Facts labels.

Patients taking NSAIDs should seek medical attention immediately if they experience symptoms such as chest pain, shortness of breath or trouble breathing, weakness in one part or side of their body, or slurred speech.

NSAIDs are widely used to treat pain and fever from many different long- and short-term medical conditions such as arthritis, menstrual cramps, headaches, colds, and the flu. NSAIDs are available by prescription and OTC. Examples of NSAIDs include ibuprofen, naproxen, diclofenac, and celecoxib (see Table 1 for a list of NSAIDs).

The risk of heart attack and stroke with NSAIDs, either of which can lead to death, was first described in 2005 in the Boxed Warning and Warnings and Precautions sections of the prescription drug labels. Since then, we have reviewed a variety of new safety information on prescription and OTC NSAIDs, including observational studies,1 a large combined analysis of clinical trials,2 and other scientific publications.1 These studies were also discussed at a joint meeting of the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee held on February 10-11, 2014.

Based on the FDA's review and the advisory committees’ recommendations, the prescription NSAID labels will be revised to reflect the following information:


  • The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID. The risk may increase with longer use of the NSAID.
  • The risk appears greater at higher doses.


It was previously thought that all NSAIDs may have a similar risk. Newer information makes it less clear that the risk for heart attack or stroke is similar for all NSAIDs; however, this newer information is not sufficient for us to determine that the risk of any particular NSAID is definitely higher or lower than that of any other particular NSAID.

NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease. A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied.

In general, patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke following NSAID use than patients without these risk factors because they have a higher risk at baseline.

Patients treated with NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs after their first heart attack.

There is an increased risk of heart failure with NSAID use.

In addition, the format and language contained throughout the labels of prescription NSAIDs will be updated to reflect the newest information available about the NSAID class.
Patients and health care professionals should remain alert for heart-related side effects the
entire time that NSAIDs are being taken. The FDA urges you to report side effects involving
NSAIDs to the FDA MedWatch program, using the information in the “Contact FDA”
box at the bottom of the page.

Facts about non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs)
• NSAIDs are a class of medicines available by prescription and over-the-counter
(OTC). They are some of the most commonly used pain medicines.
• NSAIDs are used to treat pain and fever from medical conditions such as arthritis,
menstrual cramps, headaches, colds, and the flu.
• Examples of NSAIDs include ibuprofen, naproxen, diclofenac, and celecoxib.
See Table 1 for a list of non-aspirin NSAIDs.
Additional Information for Patients and Consumers
• Non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance
of a heart attack or stroke, either of which can lead to death. There are a large
number of studies that support this finding, with varying estimates of how much
the risk is increased, depending on the drugs and the doses studied. These serious
side effects can occur as early as the first weeks of using an NSAID and the risk
may increase the longer you are taking an NSAID.
• The risk appears greater at higher doses; use the lowest effective amount for the
shortest possible time.
• Seek medical attention immediately if you experience symptoms such as:
• Chest pain
• Shortness of breath or trouble breathing
• Sudden weakness or numbness in one part or side of the body
• Sudden slurred speech
• Many medicines contain NSAIDs, including those used for colds, flu, and sleep,
so it is important to read the labels and avoid taking multiple medicines that
contain NSAIDs.
• Patients who take low-dose aspirin for protection against heart attack and stroke
should know that some NSAIDs, including those in over-the-counter (OTC)
products such as ibuprofen and naproxen, can interfere with that protective effect.
• Read the patient Medication Guide you receive with your NSAID prescription. It
explains the risks associated with the use of the medicine. You may access
Medication Guides by clicking on this link.
• Read the Drug Facts label before taking an OTC NSAID. Talk to your health care
professional or pharmacist if you have questions or concerns about NSAIDs or
which medicines contain them.
• Report side effects from NSAIDs to the FDA MedWatch program, using the
information in the "Contact FDA" box at the bottom of this page.
Additional Information for Health Care Professionals
• Non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased
risk of serious cardiovascular thrombotic events, including myocardial infarction
and stroke, either of which can be fatal. There are a large number of studies that
support this finding, with varying estimates of how much the risk is increased.
Estimates of increased risk range from 10 percent to 50 percent or more,
depending on the drugs and the doses studied. This risk may occur as early as the
first weeks of treatment and may increase with duration of use.
• Remain alert for the development of cardiovascular adverse events throughout the
patient’s entire treatment course, even in the absence of previous cardiovascular
symptoms.
• Inform patients to seek medical attention immediately if they experience
symptoms of heart attack or stroke such as chest pain, shortness of breath or
trouble breathing, sudden weakness or numbness in one part or side of the body,
or sudden slurred speech.
• Encourage patients to read the Medication Guide for prescription NSAIDs and the
Drug Facts label for over-the-counter (OTC) NSAIDs.
• Based on available data, it is unclear whether the risk for cardiovascular
thrombotic events is similar for all non-aspirin NSAIDs.
• The increase in cardiovascular thrombotic risk has been observed most
consistently at higher doses.
• The relative increase in serious cardiovascular thrombotic events over baseline
conferred by NSAID use appears to be similar in those with and without known 
cardiovascular disease or risk factors for cardiovascular disease. However,
patients with known cardiovascular disease or risk factors had a higher absolute
incidence of serious cardiovascular thrombotic events due to their increased
baseline rate.
• To minimize the risk for an adverse cardiovascular event in patients treated with
an NSAID, prescribe the lowest effective dose for the shortest duration possible.
• Some NSAIDs, including those in OTC products such as ibuprofen and naproxen,
can interfere with the antiplatelet action of low dose aspirin used for
cardioprotection by blocking aspirin’s irreversible COX-1 inhibition.
• Report adverse events involving NSAIDs to the FDA MedWatch program, using
the information in the "Contact FDA" box at the bottom of this page.

Data Summary
FDA reviewed a meta-analysis of randomized clinical trials of cardiovascular and upper
gastrointestinal events with non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs),
conducted by the Coxib and traditional NSAID Trialists’ (CNT) Collaboration of the
Clinical Trial Service and Epidemiological Studies Units at Oxford University.2

We also reviewed observational studies and other scientific publications in the medical literature.1

The findings of these studies were discussed at a joint meeting of the Arthritis Advisory
Committee and Drug Safety and Risk Management Advisory Committee held on
February 10-11, 2014 (for complete safety reviews, background information, and minutes
of this meeting, click here).

Based on the FDA's  comprehensive review and the recommendations from the advisory committees, we are requiring label changes to reflect the following conclusions:
• A large number of studies support the finding that NSAIDs cause an increased
risk of serious cardiovascular thrombotic events, with varying estimates of how
much the risk is increased. Estimates of increased relative risk range from 10
percent to 50 percent or more, depending on the drugs and the doses studied.
• Several observational studies found a significant cardiovascular risk within days
to weeks of NSAID initiation. Some data also showed a higher risk with longer
NSAID treatment.
• There are observational data indicating that the thrombotic cardiovascular risk
from NSAID use is dose-related. There is also some evidence of this doseresponse
effect from clinical trials of celecoxib.
• Some observational studies and the CNT meta-analysis suggested that naproxen
may have a lower risk for cardiovascular thrombotic events compared to the other
NSAIDs; however, the observational studies and the indirect comparisons used in
the meta-analysis to assess the risk of the nonselective NSAIDs have limitations
that affect their interpretability. The variability in patients’ risk factors,
comorbidities, concomitant medications and drug interactions, doses being used,
duration of treatment, etc., also need to be taken into consideration to make valid 
comparisons. Importantly, these studies were not designed to demonstrate
superior safety of one NSAID compared to another.
• There is evidence of an increased cardiovascular risk from NSAID use by
apparently healthy patients. Data from the CNT meta-analysis, individual
randomized controlled trials, and observational studies showed that the relative
increase in cardiovascular thrombotic events over baseline conferred by NSAID
use appears to be similar in those with and without known cardiovascular disease
or risk factors for cardiovascular disease. However, patients with known
cardiovascular disease or risk factors had a higher absolute incidence of excess
cardiovascular thrombotic events due to their increased baseline rate.
• The CNT meta-analysis demonstrated an approximately two-fold increase in
hospitalizations for heart failure with use of both COX-2 selective and
nonselective NSAIDs. In a Danish National Registry study of patients with heart
failure, NSAID use increased the risk of myocardial infarction, hospitalization for
heart failure, and death.
The Prospective Randomized Evaluation of Celecoxib Integrated Safety versus Ibuprofen
or Naproxen (PRECISION) trial, is a large, ongoing randomized safety trial comparing
cardiovascular event rates among patients with high cardiovascular risk who are
randomized to celecoxib, naproxen, or ibuprofen. This trial was also discussed at the
February 2014 Advisory Committee meeting and is expected to provide additional safety
information. 

Table 1. List of non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs)
Generic name Brand name(s)

  • celecoxib Celebrex
  • diclofenac Cambia, Cataflam, Dyloject, Flector,
  • Pennsaid, Solaraze, Voltaren, Voltaren-XR,
  • Zipsor, Zorvolex, Arthrotec (combination
  • with misoprostol)
  • diflunisal No brand name currently marketed
  • etodolac No brand name currently marketed
  • fenoprofen Nalfon
  • flurbiprofen Ansaid
  • ibuprofen* Advil, Caldolor, Children’s Advil,
  • Children’s Elixsure IB, Children’s Motrin,
  • Ibu-Tab, Ibuprohm, Motrin IB, Motrin
  • Migraine Pain, Profen, Tab-Profen, Duexis
  • (combination with famotidine), Reprexain
  • (combination with hydrocodone),
  • Vicoprofen (combination with
  • hydrocodone)
  • indomethacin Indocin, Tivorbex
  • ketoprofen No brand name currently marketed
  • ketorolac Sprix
  • mefenamic acid Ponstel
  • meloxicam Mobic
  • nabumetone No brand name currently marketed
  • naproxen* Aleve, Anaprox, Anaprox DS, ECNaprosyn,
  • Naprelan, Naprosyn, Treximet
  • (combination with sumatriptan), Vimovo
  • (combination with esomeprazole)
  • oxaprozin Daypro
  • piroxicam Feldene
  • sulindac Clinoril
  • tolmetin No brand name currently marketed *There are many over-the-counter (OTC) products that contain this medicine.

References

1. Food and Drug Administration [Internet]. Silver Spring, MD. FDA Briefing
Information for the February 10-11, 2014 Joint Meeting of the Arthritis Advisory
Committee and Drug Safety and Risk Management Advisory Committee. Available
from:
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM383180.pdf. Accessed December 23, 2014.

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Jon L. Gelman of Wayne NJ is the author of NJ Workers’ Compensation Law (West-Thompson-Reuters) and co-author of the national treatise, Modern Workers’ Compensation Law (West-Thompson-Reuters). For over 4 decades the Law Offices of Jon L Gelman  1.973.696.7900  jon@gelmans.com  have been representing injured workers and their families who have suffered occupational accidents and illnesses.