Gov't Panel seeks Blackbox Warning for MRI Drugs

MRI imaging drugs from GE Healthcare (GE.N) and Covidien (COV.N) appear linked to a higher risk of a potentially fatal skin disease for some patients than similar products.

'A majority of the Food and Drug Administration panel felt current data showed GE's Omniscan and Covidien's Optimark were associated with a higher risk of nephrogenic systemic fibrosis (NSF) for patients with severe kidney disease, panel chairman Robert Harrington said.' Source.

Nephrogenic systemic fibrosis (NSF) or nephrogenic fibrosing dermopathy is a rare and serious syndrome that involves fibrosis of skin, joints, eyes, and internal organs. Its cause is not fully understood, but it seems to be associated with exposure to gadolinium (which is frequently used as a contrast substance for MRIs) in patients with severe kidney failure. It does not have a genetic basis.

In NSF, patients develop large areas of hardened skin with fibrotic nodules and plaques. Flexion contractures with an accompanying limitation of range of motion can also occur. NSF resembles scleromyxedema at the histologic (microscopic) level; it shows a proliferation of dermal fibroblasts and dendritic cells, thickened collagen bundles, increased elastic fibers, and deposits of mucin.

A black box warning is a notice on the packaging of a prescription drug which warns patients and prescribers that the drug has potentially dangerous side effects. This warning system is primarily used by the Food and Drug Administration (FDA), an American regulatory agency which oversees the safety of pharmaceuticals produced and sold in the United States. Other national regulatory agencies may use different systems to indicate that drugs are potentially dangerous.

When a drug receives a black box warning, it means that studies on the drug have suggested that it can have dangerous or even deadly side effects. Black box warnings are often added retrospectively as the result of information about a drug which has been uncovered in the course of routine usage. When doctors start reporting high levels of dangerous side effects for a prescription drug, the FDA may hold a review to decide whether or not the drug requires a black box warning.

The “black box” in “black box warning” refers to the bold black border which is drawn around the warning. The border is designed to draw attention to the warning, and to offset it from other information which may be present in pharmaceutical packaging. Thanks to widespread public awareness of the implications of a black box warning, a black box on drug packaging serves as an alert that the drug is dangerous even before people read the text of the warning.

OsmoPrep Lawsuits Filed

Four plaintiffs filed a complaint in North Carolina claiming that the use of a Salix Pharmaceuticals drug led to kidney damage.

The case revolves around the drug OsmoPrep, which is used to cleanse the intestines in preparation for a colonoscopy. A statement claims the parties sustained a variety of serious kidney injuries and that some of the injuries resulted in the need for dialysis. The statement says that the medical name for the plaintiffs’ condition is called acute phosphate nephropathy.

The U.S. Food and Drug Administration placed a “black box” warning – the most severe admonition possible – on OsmoPrep in December 2008. The FDA said that OsmoPrep and another Salix bowel cleanser, Visicol, carry the risk of kidney damage.

Source here.

Twitter: Value for your Law Practice?

Image via CrunchBase

I just completed my first year using Twitter.com. Twitter is -- reduced to its most basic - a real time scroller (like the ones you see on FOX News and CNN) for the goings on in life - news, rumors, gossip, etc. That holds true today. The news on Urban Meyer's resignation came to me via Tweet on my iPhone.

I had heard and read from many who said Twitter was an "absolute must" for a law firm or lawyer. After one year, I can't say it's a must. I am able to assess it and make these conclusions:

1.Twitter as a breaking news source: Quite good. I follow Anderson Cooper and others. On Twitter you were able to get a near ring-side seat for events ranging from the attacks in Mumbai to the ridiculous balloon boy.

2.Twitter for expanding your blog's visibility: For me, this one gets a partial grade of a C, as I think it's to be developed. This blog is ranked highly among lawyer blogs in terms of popularity (even in my niche). Twitter has given my blog a little push when I 'tweet' about a new blog post. Increasing my visibility as a lawyer is of course a goal. Where the end result for me and my firm's visibility is Google results. I have seen a small uptick.

3.Twitter for gaining new clients or potential clients:I practice consumer law - helping those who were injured because someone else was at fault in some act. I can tell you that Twitter had zero effect in developing clients. I first started - naively to be candid - to believe that Twitter would be mechanism for business development. Not so. In the future? Maybe. Just not now for me at least. If you're a personal injury lawyer who has actually developed clients from Twitter, I want to hear from you. If you're a personal injury lawyer, you make a mistake if you think Twitter will increase your client base.

With several different websites for my firm, I will tell you that websites (and blogs) will be by far the best way to spend your time if you you hope to develop business from the web for the near future.

On this blog earlier this year, I posted what one lawyer thought of Twitter:

9 Reasons You Need Social Media Marketing in 2009. Among those are:

4. More Social = more Search.
More Search = More Customers.
More customers = More business.

That is simply not the case in the PI area.


I have switched from believing that (in my field) Twitter would work to increase my client base, to one where I decided to follow other lawyers with helpful news and information. This leads to the next item:

4. Twitter as a resource: I have been able to locate vendors and support persons thanks to Twitter. I did so by actively seeking someone to, for example, help me with service of process in a Pacific state.I was able to find a vendor for office products. Could I have used Google to accomplish the very same thing? Probably, but I wanted to see what Twitter could or could not do.

I have tried to use Twitter to refer a number of matters, and it's just not there yet. In my practice, groups like the AAJ and my state bars are the best source for me to find someone to assist on a legal matter. According to Lextweet.com, there are 5856 lawyers with some form (inactive or active) of Twitter account. One list serve I belong to has more than 7,000 member subscribers.

It's probably too early to give Twitter a ringing endorsement, and too early to pan it. For me it's one more piece of my overall business effort. The 'ground war' is going to meetings, having lunches and visits with lawyers, and joining affinity groups in my city. The "air war" is my web presence, and Twitter will likely be a part of that effort.


This is my list of items so far. I'll be updating with more items later.

Comparison of Free Online Storage Sites

I've been checking out online backup storage for my office, and I have found many possible solutions. Worth checking out is a post on Lifehacker that compares many of the sites.

Take a look here, and good luck with your selection.

Recall of Tylenol Arthritis Pain Caplets

A voluntary recall of Tylenol Arthritis pain caplets is being expanded because of consumer reports of a moldy odor.

The recall affects the 100-count bottles. The FDA says the recall is specific to bottles with the distinctive red "EZ open" cap.

It's based on consumer reports of a foul smell on the medicine associated with nausea, stomach pain, vomiting and diarrhea.

The pills’ musty odor comes from trace amounts of a chemical known as 2, 4, 6-tribromoanisole, according to the company, which is believed to be from the breakdown of another chemical in wooden pallets used to transport and store the drug

From NPR: How A Bone Disease Grew To Fit The Prescription (Fosamax)

Interesting read at NPR about Osteoporosis and Fosamax. Osteoporosis is a disease that causes bones to become thinner, more porous and break more easily. It mostly affects elderly women, who can be devastated by a fall that breaks their hip. One in five elderly women who break a hip will die within a year. Osteopenia, it turns out, is a slight thinning of the bones that occurs naturally as women get older and typically doesn't result in disabling bone breaks.

NPR writes: "This is the story of how pills for osteopenia ended up in one person's
medicine cabinet, and in the medicine cabinets of millions of women like her all over the United States.

Read it here.

FDA: No Cancer Link to Vytorin

The FDA says an extensive data review shows there's no evidence that Merck's cholesterol drug Vytorin causes cancer, a suspicion raised last year by a patient study.

Still, the Food and Drug Administration says it cannot definitively rule out whether Vytorin is linked to a higher risk of cancer or death from cancer.

The FDA says it's examined all of the data from the study that first raised the alarm about a possible risk. It also has reviewed interim data from two very large studies that are still in progress.

Source here.

Nestle Gets FDA Letter Regarding Boost

In an early December letter to Nestle, the FDA told the company that it had mislabeled its Boost drink, which comes in flavors like chocolate, vanilla and strawberry, “as a medical food for the medical condition of ‘failure to thrive’ and also for ‘pre/post surgery, injury or trauma, chronic illnesses.’”

The FDA informed that federal guidelines explain that “medical foods must be for the dietary management of a specific disorder, disease, or condition for which there are distinctive nutritional requirements and must be intended to be used under medical supervision.”



Source here.

IKEA High Chair Recall

IKEA Home Furnishings is recalling LEOPARD Highchairs sold exclusively at IKEA stores nationwide from October 2009 to November 2009. The snap locks used to secure the seat to the frame can break and allow the seat and child to drop through the frame, posing a fall hazard. Detached snap locks can pose a choking hazard.

This recall involves all colors of the LEOPARD highchairs sold as a seat and a frame individually. The seat and tray has an adhesive label affixed to the underside with the words LEOPARD and “Made in Italy,” an eight-digit article number and a five-digit supplier number (19589).

Consumers should return the highchairs to any IKEA store for a full refund.

Consumers can also contact IKEA at (888) 966-4532 anytime, or visit at www.ikea-usa.com. More info at www.recalls.org.

Polaris ATV Recall

Polaris Industries Inc. is recalling 2009-2010 Polaris All-Terrain Vehicles (ATVs) sold nationwide from February 2009 to November 2009. The front suspension ball joint stem can separate from the steering knuckle and cause the rider to lose steering control, posing a risk of injury or death.

This recall involves model year 2009 and 2010 Polaris Sportsman ATVs with certain VIN numbers. A list of the recalled ATVs can be found at www.recalls.org.

AstraZeneca’s Swine Flu Nasal Spray Recalled for Lower Potency

AstraZeneca Plc recalled 4.7 million doses of its nasal spray version of the swine flu vaccine after routine tests showed a decline in potency, U.S. regulators said.

The doses remain safe, and people who have already been inoculated don’t need to get vaccinated again, said Norman Baylor, director of vaccines research and review for the U.S. Food and Drug Administration. About 3,000 of the affected doses remain in warehouses, and AstraZeneca will send recall notices to clinics that may have unused vials of the vaccine.


The link is here.

Prempro Verdict: $8 Million

A Philadelphia jury in January 2007 awarded Mary Daniel compensatory damages of $1.5 million in her lawsuit against Pfizer’s Wyeth subsidiary over its Prempro menopause treatment. The panel recommended she get more than $8 million in punitive damages if an appeals court found she was entitled to such an award because of bad conduct by the company, people with direct knowledge of the figure said.

The $8 million figure was sealed pending an appeal. A judge in Philadelphia refused last month to make it public. A Pennsylvania appellate court heard arguments in Wyeth’s challenge to the verdict on Dec. 1. Wyeth wants the jury’s $1.5 million compensatory award thrown out. Daniel’s lawyers are seeking to have punitive damages added to it.

Source and more here.

Does Chelation Therapy Cause Heart Injuries?

Chelation therapy is a recognized treatment for heavy metal (such as lead) poisoning. EDTA (Ethylenediamine tetraacetic acid) is injected into the blood and binds the metals, allowing them to be removed from the body in the urine.A potent chelator of cations, especially calcium, it is FDA-approved only for rapid, emergency treatments of hypercalcemia or digitalis toxicity,and for those indications it has long been obsolete. Source.

Na2EDTA is specifically contraindicated for “generalized arteriosclerosis.” Its labeling includes a “black box” warning: “The use of this drug in any particular patient is recommended only when the severity of the clinical condition justifies the aggressive measures associated with this type of therapy." You can find the warning here: http://www.circare.org/foia2/endrate_ppi19740716.pdf



Chelation therapy is not approved by the FDA to treat coronary artery disease, but some physicians and alternative medicine practitioners use it for this purpose.

In August 2002, the National Center for Complementary and Alternative Medicine (NCCAM) and the National Heart, Lung, and Blood Institute (NHLBI), which are both components of the National Institutes of Health (NIH), announced the launch of the Trial to Assess Chelation Therapy (TACT). This placebo-controlled, double-blind study involves participants age 50 years and older who’ve had a heart attack, and is expected to reach a total enrollment of 1,950. Participants are representative of the U.S. population.

Last August, the federal Office of Human Research Protections began a probe into whether the people in the study were being fully informed of risks and adequately protected. Researchers then suspended enrollment.

The most common immediate side effects of oral chelation therapy include: skin rashes, redness and swelling, headaches, diarrhea, nausea, fainting, fatigue, joint pain, body aches, cramps and convulsions.

Kidney damage from chelation therapy has resulted in permanent damage requiring ongoing dialysis. Deaths have also occurred during chelation therapy from kidney failure and cardiac arrhythmia.

Death and permanent injury have resulted from chelation therapy, even in doctor-supervised clinical trials. The American Heart Association warns of severe and life-threatening side effects and does not endorse chelation as a treatment for heart disease.

Other observers have reported cases of hypocalcemia leading to cardiac arrhythmias and tetany; kidney damage; decreased blood clotting ability with abnormal bleeding; thrombophlebitis and embolism; hypoglycemia and insulin shock; severe vasculitis and autoimmune related hemolytic anemia, dermatitis with pruritus and generalized eczema; and extensive clumping of platelets in the blood of some patients with atherosclerosis and other chronic diseases.

M-Drol and P-Plex -Link to Liver Injuries?

Both M-Drol and P-Plex were supplements were marketed on the Internet by a company in Galveston, Texas called TF Supplements.

Some say that the main ingredients in M-Drol and P-Plex are methylated compounds known to cause liver damage. It has been claimed that the supplements were manufactured by a company called Competitive Edge Labs, a foreign corporation working in Virginia. Making and distributing the supplements is not against the law.

If you took either or both of these and have liver injuries now, call us.

Law Tech: 2009's Most Useful Tech Items

Here are tech apps/hardware that I think are "best" when it comes to helping my office in the practice and business of law:

1.iPhone- I'm old enough to remember when computers for lawyers were a rarity. In 1991 I remember an older partner literally yelling at me that "computers are for secretaries!" when he saw a PC on my desk. Could anyone today imagine practicing law without one?

I'd put the iPhone on the list of essential tools. If you don't have one, in my opinion you are at a disadvantage. Apps for it are key - Dragon dictate, access to key documents, email with PDF capability, the ability to fill out, sign and annotate any PDF document while away from the office (Zosh), and more. The blog iPhoneJD.com is a must read. If you're one of those dinosaurs who proudly proclaims that you only use your phone to make calls, well, the meteor is headed your way, and it has an Apple logo on it. If you have a smart phone like a BBerry, at least you're getting closer.


2.Speak Write: This is a transcription service. A transcript is processed by trained professionals located in the U.S. and Canada, without the use of voice recognition software. You can dictate from anywhere and receive your completed work via email, 24 hours a day, 7 days a week, in about 3 hours. Since you can dictate using a variety of methods, no special equipment or software is required; you can be signed up and dictating within minutes. Speak-write.com


3.Scansnap:


Especially for smaller firms like ours, the Fujitsu ScanSnap scanner takes the complication out of document imaging with one-touch ease of use. It's the size of a football, is sturdy (I've dropped it twice), lightning fast, and relatively inexpensive. I've taking it to document reviews and have been able to have 1000's of pages scanned while reviewing papers.



4.Google Desktop: Google Desktop is desktop search software made by Google for Mac OS X, Linux, and Microsoft Windows. The program allows text searches of a user's e-mails, computer files, music, photos, chats, and Web pages viewed.

We have indexed the documents on our servers, and now can search our "google-style" for items. Cost? Free.





5.Dual Monitors: More and more you are seeing dual monitors. I have two, and it helps a great deal. Using dual monitors allows you to eliminate scrolling and window switching. You may not even be aware of how often you are moving things around now. It’s very easy to get used to two monitors and to determine the best way for you to work with them.

On my desk, our client database and contacts are on one monitor, and my work items are on another.

I also have two 23" monitors, and that's been a great help as well.

6.RingCentral: RingCentral Office delivers a virtual PBX, VoIP phone service and IP phone as one complete system. It's cheap, and here is how I use it: I sign up for an account, and then use that number to track any google ad words buy we use. At any one time, I may have 2-4 web sites active with either google ad buys or simply as informational sites. It helps me measure the success of the site separate and apart from any emails or forms filled out. It's cheap, easy to use and yes, there's a free app for that for the iPhone. On the iPhone it looks like this:



7.Phonetag: From their site: PhoneTag automatically converts your voicemail into text and delivers it directly to your mobile phone, Blackberry, Goodlink enabled phone and/or your email account; so you can read your voicemail.

I love it.

There you have it. Email me if any of those help.

SCOTUS to review Texting Privacy Ruling

The Supreme Court has granted certiorari regaarding a federal appeals court in California that reading text messages sent on devices provided by the employer violated the worker's privacy rights and amounted to an "unreasonable search" barred by the U.S. Constitution. The case is City of Ontario v. Quon, 08-1332.

The city appealed to the Supreme Court, saying employers typically have policies in place establishing that workers have no expectation of privacy in electronic communications on employer-owned equipment.

The PDF opinion may be found here.

Source here.

Roman Blind Recall

The federal government - via the CPSC - has issued a recall of Roman Blinds that they could suffocate kids.

For the first time, the safety commission now recommends using only cordless window treatments in any home where children live or visit, such as a grandparent's house or day care center.


From USA Today:

HOW TO MAKE KIDS SAFER

1. Install only cordless window treatments in all homes where children live or visit, especially in children's bedrooms.

2. Move all cribs, beds and furniture away from windows.

3. If not using cordless shades, cut the ends of pull cords, so that the loop can't form a noose.

4. Don't allow cords to dangle. Wrap cords around a hook that's high off the floor out of a child's reach.

5. If using Roman shades with hidden strings on the back side, raise the shades high enough so children can't reach them.

Another Recall on an OTC Cold Remedy

The FDA reports that P&G has made a voluntary recall of specific lots of their Vicks brand nasal spray in the US, Germany and the UK.

The recall comes as a result of P&G finding the bacteria B. cepacia in these particular batches. There have been no reports of illness, and most healthy individuals should not be effected from this bacteria; however, the bacteria could cause serious illness in those with compromised immune systems such as those with Cystic Fibrosis or other chronic lung conditions.

The lot number in the US that is being recalled is 9239028831, which is for Vicks Sinex Vapospray 12-Hour Decongestant Ultra Fine Mist, 15 ml Nasal Spray.

Antidepressants May Raise Women's Stroke Risk

That, according to a report released this week.You may find the abstract at the Archives of Internal Medicine.

Older women who ingest such antidepressants may have a small but statistically significant increased risk of stroke and death compared to women not on the medications, a new study finds.

"But statistical significance can be different from clinical significance," stressed Dr. Jordan W. Smoller, an associate professor of psychiatry at Harvard Medical School, and lead author of a report in the Dec. 14 issue of Archives of Internal Medicine. "It is possible that a statistically detectable effect may not be a problem for most people." Source.

The Report's conclusion: "In postmenopausal women, there were no significant differences between SSRI and TCA use in risk of CHD, stroke, or mortality."

FDA Warning on Steris Sterilizer

The Food and Drug Administration has warned doctors and hospital administrators that a widely used surgical tool sterilizer made by Mentor-based Steris no longer has the agency's "safe and effective" stamp and should not be used.

The product, called System 1, is used to sterilize medical tools such as endoscopes, bronchoscopes and other devices. It is used in hospitals, outpatient surgical centers and some physicians' offices.

Source here.

Alka Seltzer Recall

Bayer Healthcare is recalling 100,000 packages of Alka-Seltzer cold capsules because some lack warnings of possible drowsiness. The recall applies to Alka-Seltzer Plus Day & Night Liquid Gels. Bayer blamed the label omission on human error and said steps are being taken to prevent this from happening again.

Consumers who purchased packages from lot 296939L can contact Bayer for a refund at (800) 986-3307.


I like the product, and a thumbs up for Bayer's effort to recall the product.

Dietary Supplement Recall

Atlas Operations Inc. is recalling dietary supplements for sexual enhancement sold under about 37 brand names. The products might contain an ingredient not declared on their labels. The undeclared ingredient is similar to a Food and Drug Administration-approved drug used to treat erectile dysfunction, making these recalled products not approved drugs.

The interaction of the ingredient with some prescription drugs could lower blood pressure to dangerous levels. No illnesses or incidents have been reported, according to the Pompano Beach, Fla., company.

The products are being sold as dietary supplements online and in retail stores throughout the nation. Laboratory results found that products tested from certain batches of these brands contain the undeclared ingredient: Rock Hard, 72 Hours, Stamin It, Finally On Demand, Sexual Surge, Staminil and Vierect.

The recalled products have the following numbers in the middle of their lot codes: 494, 520C, 520B, 520A, 520, 521, 705, 706, 779 or 807.

AP source here, FDA here.

Slim-Fast Recall

Image via Wikipedia

The Food and Drug Administration (FDA) has issued a nationwide recall on cans of Slim-Fast ready to drink beverages because of a possible contamination with Bacillus cereus, a microorganism that can cause infected people to suffer from diarrhea, nausea and vomiting.


The recall involves all Slim-Fast ready to drink beverages in cans, regardless of flavor, best-by date or UPC number, the FDA said. No other Slim-Fast products are affected by the recall.

The company is in the process of identifying and correcting the production issue and will resume production and shipment as soon as the problem is remedied.

Consumers who have recently purchased ready to drink Slim-Fast beverages in cans are urged to discard them immediately and contact the company at 1-800-896-9479 for a full refund.

Source here.

FDA Investigating Brain Scans

Federal health regulators are investigating reports of dangerous radiation levels at two more California hospitals, following earlier unsafe medical scans at a Los Angeles facility.

The Food and Drug Administration is probing the use of CT scans at Glendale Adventist Medical Center and Providence St. Joseph Medical Center in Burbank, Calif. The brain scans are used to diagnose strokes.

For more, go here, the NYT Online.

First Gadolinium Trial Set to Begin in early 2010

On Monday a suit against Bayer Healthcare will begin in January, in front of San Francisco Superior Court Judge Curtis Karnow.

Peter Gerber's lawsuit accuses Bayer of negligently designing, testing and marketing Magnevist, a drug used to help doctors read MRIs, is one of hundreds of suits in California and elsewhere alleging that diagnostic drugs containing gadolinium have caused nephrogenic systemic fibrosis. And according to Gerber's lawyer, his suit is the first to be scheduled for trial.

Magnevist is a contrast agent used to improve magnetic resonance imaging. In 2007 the U.S. Food and Drug Administration requested that gadolinium-based agents such as Magnevist carry boxed warnings about the risk of contracting nephrogenic systemic fibrosis for patients with kidney problems.

Nephrogenic systemic fibrosis (NSF) or nephrogenic fibrosing dermopathy is a rare and serious syndrome that involves fibrosis of skin, joints, eyes, and internal organs. Its cause is not fully understood, but it seems to be associated with exposure to gadolinium (which is frequently used as a contrast substance for MRIs) in patients with severe kidney failure. It does not have a genetic basis.

In NSF, patients develop large areas of hardened skin with fibrotic nodules and plaques. Flexion contractures with an accompanying limitation of range of motion can also occur. NSF resembles scleromyxedema at the histologic (microscopic) level; it shows a proliferation of dermal fibroblasts and dendritic cells, thickened collagen bundles, increased elastic fibers, and deposits of mucin.

Most patients with NSF have undergone hemodialysis for renal failure, some have never undergone dialysis and others have received only peritoneal dialysis. Many patients have taken immunosuppressive medications and have other diseases, such as hepatitis C. Four of the five gadolinium contrast agents approved by the U.S. Food and Drug Administration have been principally implicated in NSF, including Omniscan, Multihance, Magnevist, and OptiMARK.

The first cases of NSF were identified in 1997.

Source here.

Trucking: Speed Limits to in crease

Image via Wikipedia

A new law takes effect next month increasing the speed limit for semi truck drivers from 55 to 65 miles per hour, but there are differing opinions on whether the new law is a good one.


"If everyone goes the same speed, it has to be safer," he said. "I think it's been proven other states' accident rates went down and I think it will also take a lot of pressure off the drivers. I don't think a lot of people want to go faster because of the threat of a speeding ticket."

More here.

FDA Fails to make safety changes Post Vioxx

The Food and Drug Administration still hasn't restructured its staff to better monitor drug safety, more than three years after experts recommended key changes in the wake of the Vioxx scandal.

That's according to congressional investigators who found that the FDA has yet to follow through on changes suggested in 2006 to help the agency detect problems with drugs taken by millions of Americans. Those recommendations came after the embarrassing and dangerous episode with Vioxx, a blockbuster pain drug the FDA approved in 1999, only to pull from the market in 2004 after linking it to heart attack and stroke.

More from the AP story.

Voltaren Gel (diclofenac sodium topical gel) 1% - Hepatic Effects Labeling Changes

Endo, Novartis and FDA notified healthcare professionals of revisions to the Hepatic Effects section of the prescribing information to add new warnings and precautions about the potential for elevation in liver function tests during treatment with all products containing diclofenac sodium.

In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month but can occur at any time during treatment with diclofenac. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these reported cases resulted in fatalities or liver transplantation.

Physicians should measure transaminases periodically in patients receiving long-term therapy with diclofenac. The optimum times for making the first and subsequent transaminase measurement are not known. Based on clinical trial data and postmarketing experiences, transaminases should be monitored within 4 to 8 weeks after initiating treatment with diclofenac.