Acetaminophen doses over 325 mg might lead to liver damage

You're in pain after surgery, and your doctor prescribes you Vicodin, or maybe Percocet. But when you get home, the pain hasn't subsided and you decide to pop some Extra Strength Tylenol.

Unknowingly, you may have just taken more of the drug acetaminophen than is safe.

Don't combine aspirin and ...

Acetaminophen is often used in pain medications with opioids such as oxycodone (Percocet), hydrocodone (Vicodin) and codeine (Tylenol with Codeine).

These are called combination drugs, and the Food and Drug Administration is asking doctors to stop prescribing those that have more than 325 mg of acetaminophen per dose.

FDA warns of acetaminophen liver damage FDA: Pain meds may cause liver damage

The FDA says no data show that taking more than that amount provides enough benefit to outweigh the risk of liver damage.

"Many consumers are often unaware that many products (both prescription and OTC) contain acetaminophen, making it easy to accidentally take too much," the FDA said in a statement Tuesday.

The warning does not apply to over-the-counter drugs such as Tylenol, which contains acetaminophen. The FDA said it will address over-the-counter products in another regulatory action.

In 2011, the FDA asked manufacturers to limit the amount of acetaminophen in prescription combination drugs to 325 mg per capsule or tablet by January 2014. While more than half of the manufacturers agreed, some combination drugs with higher amounts of acetaminophen remain on the market. The federal agency says it plans to start the process of withdrawing approval of prescription combination drugs from manufacturers that have not complied.

Health risks

"Acetaminophen overdose is one of the most common poisonings worldwide," according to the National Institutes of Health.

Taking too much of this pain reliever can lead to liver failure or death.

The FDA has set the recommended maximum for adults at 4,000 milligrams per day. It's easier to reach this limit than you might think; one gel tablet of Extra Strength Tylenol, for example, contains 500 mg.

New Tylenol cap will have warning label

Consumers should not take more than the prescribed dose of any medication that contains acetaminophen, according to the FDA, and should avoid taking more than one acetaminophen product at a time. Drinking alcohol while taking acetaminophen also puts you at risk.

To find out if your medications contain acetaminophen, read the drug label or the list of ingredients in the patient information leaflet that came with your prescription. Look for the word "acetaminophen" or the letters "APAP," an abbreviation sometimes used for the drug. If you are still unsure, contact your doctor or pharmacist.

Acetaminophen may also cause serious skin reactions in some people. According to the FDA, the skin reactions are rare but can be deadly. These conditions can cause blisters, serious rashes, reddening of the skin and the detachment of the upper surface of the skin, the epidermis.

Anyone who develops these types of conditions after using acetaminophen should stop taking the product immediately and visit a doctor or emergency room. FDA issues warning about acetaminophen and skin reactions

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Source: CNN (Yan, 1/16)

Johnson & Johnson Said to Agree to $4 Billion Settlement Over Hip Implants

Johnson & Johnson has tentatively agreed to a settlement that could reach up to $4 billion to resolve thousands of lawsuits filed by patients injured by a flawed all-metal replacement hip, said two lawyers briefed on the plan.

The tentative plan, which must win court approval, represents one of the largest payouts for product liability claims involving a medical device.

A spokeswoman for the company’s DePuy Orthopaedics unit declined to comment on the possibility of a settlement. An announcement about the plan is expected in the coming days, the lawyers said.

The agreement will include those patients who have already been forced to have the device, known as the Articular Surface Replacement, or A.S.R., removed and replaced with another artificial hip, said the lawyers who spoke about the agreement only on the condition of anonymity.

Under the deal, each patient would receive about $350,000 on average in compensation, though that figure will vary depending on factors like a patient’s age and medical condition.

The precise value of the settlement is unclear because lawyers for patients are still trying to estimate how many of the 12,000 related lawsuits involve patients who had a replacement. Lawyers believe that number may be 7,000 to 8,000 cases.

The final cost of the deal to Johnson & Johnson could rise, depending on how many claimants who received the device undergo replacement operations in the future, the lawyers said. Under the plan, patients who have not had a replacement would not receive compensation, the lawyers said.

The A.S.R. hip was sold by DePuy until mid-2010, when the company recalled it amid sharply rising early failure rates. The device, which had a metal ball and a metal cup, sheds metallic debris as it wears, generating particles that have damaged tissue in some patients or caused crippling injuries.

DePuy officials have long insisted that they acted appropriately in recalling the device when they did. However, internal company documents disclosed during the trial of a patient lawsuit this year showed that DePuy officials were long aware that the hip had a flawed design and was failing prematurely at a high rate.

Many artificial hips last 15 years or more before they wear out and need to be replaced. But by 2008, data from orthopedic databases outside the United States also showed that the A.S.R. was failing at high rates in patients after just a few years.

Internal DePuy projections estimate that it will fail in 40 percent of those patients in five years, a rate eight times higher than for many other hip devices.

It had been long anticipated that DePuy would try to settle the case. Of the two lawsuits that have gone to trial, the company lost one lawsuit and won the other one.

However, it was facing the start of several new trials around the country with the prospect of large damage awards. The outlines of a settlement proposal were reported Tuesday by Bloomberg News.

The hip was first sold by DePuy in 2003 outside the United States for use in an alternative hip replacement procedure called resurfacing. Two years later, DePuy started selling another version for use here in standard hip replacements that used the same cup component as the resurfacing device. Only the standard version was sold in the United States; both were sold outside the country.

About 93,000 patients received an A.S.R., about one-third of them in the United States.

Problems with the design first came to light in Australia and England just a few years after its marketing began. But DePuy officials insisted for years to surgeons who complained about that device that patient problems reflected their surgical technique rather than the implant’s design.

Last year, The New York Times reported that DePuy executives decided in 2009 to phase out the A.S.R. and sell existing inventories weeks after the Food and Drug Administration asked the company for more safety data about the implant.

The agency also told the company at that time that it was rejecting its efforts to sell the resurfacing version of the device in the United States because of concerns about “high concentration of metal ions” in the blood of patients who received it.

DePuy never disclosed the F.D.A. ruling to regulators in other countries, where it was still marketing the resurfacing version of the implant.

The head of DePuy’s orthopedic unit, Andrew Ekdahl, oversaw the introduction of the hip and was warned by a company consultant in 2008 that the implant appeared to have a design flaw, according to internal DePuy documents disclosed during a trial earlier this year.

When DePuy recalled the hip in 2010, it announced a program in which it offered to pay the medical costs of a replacement procedure.

All-metal replacement hips like the A.S.R. were once highly popular with orthopedic surgeons who believed the devices would last longer than traditional replacement devices made of plastic and metal. But the metal devices are rarely used anymore because of their high early failure rates.

While the settlement, if approved, would resolve much of the litigation against DePuy involving that device, it continues to face thousands of lawsuits involving another all-metal hip that it no longer sells called the Pinnacle.

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Source: The New York Times (Meieir, 11/12)

Rogue Dentist May Have Exposed 7,000 Patients to HIV, Hepatitis

The Tulsa Health Department is warning 7,000 patients of a local dentist's office that they could have contracted HIV, hepatitis B or hepatitis C from poor sterilization practices.

Dr. Wayne Harrington, an oral surgeon with a practice in Tulsa, Okla., is being investigated by the state dental board, the state bureau of narcotics and the federal Drug Enforcement Agency because one of his patients recently tested positive for hepatitis C and HIV without known risk factors other than receiving dental treatment.

Upon hearing of the infected patient, the Oklahoma Board of Dentistry conducted a surprise inspection of Harrington's practice on March 18, allegedly finding numerous problems, including regular use of a rusty set of instruments on patients with known infections, and the practice of pouring bleach on wounds until they "turned white."

Calls to Harrington's office were directed to an operator, who told ABC News the clinic no longer took voicemails. The operator said patients were being referred to another clinic, but did not disclose the clinic's name.

Susan Rogers, executive director of Oklahoma's Board of Dentistry, called the incident a "perfect storm." On top of his many violations in sanitary practice, the dentist was a Medicaid provider, which means he had a high proportion of patients with HIV or hepatitis, she said.

Harrington and his staff told investigators that he treated a "high population of known infectious disease carrier patients," according to a complaint filed by the Oklahoma Board of Dentistry.

He allegedly allowed unlicensed dental assistants to administer medication, according to the complaint. These assistants were left to decide which medications to administer, and how much was appropriate.

Drug cabinets were unlocked and unsupervised during the day, and Harrington did not keep an inventory log of drugs, some of which were controlled substances. One drug vial expired in 1993.

"During the inspections, Dr. Harrington referred to his staff regarding all sterilization and drug procedures in his office," the complaint read. "He advised, 'They take care of that. I don't.'"

Harrington allegedly re-used needles, contaminating drugs with potentially harmful bacteria and trace amounts of other drugs, according to the complaint. Although patient-specific drug records indicated that they were using morphine in 2012, no morphine had been ordered since 2009.

The instruments for infected patients was given an extra dip in bleach in addition to normal cleaning methods, but they had red-brown rust spots, indicating that they were "porous and cannot be properly sterilized," according to the complaint.

The Tulsa Health Department said Harrington's patients will receive letters by mail notifying them of the risk and steps to obtain free-of-charge testing. While 7,000 patients may have been exposed, Joseph Perz, an epidemiologist with the U.S. Centers for Disease Control and Prevention, said it's "extremely rare" to see dental transmission of HIV and hepatitis B or C. In July 2012, 8,000 Coloradans were notified that their dentist had reused needles, potentially exposing them to the blood-borne viruses. But not a single case was identified, according to the CDC.

Dental transmission is not impossible, however. Perz cited a dental fair three years ago in which hepatitis B was transmitted between patients. In July 2012, more than 1,800 veterans who received dental care at a St. Louis VA Medical Center were warned that improper cleaning of dental tools may have exposed them to HIV and hepatitis.

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Source: Good Morning America (Lupkin, 3/29)

Mass. pharmacy recalling some compounded products

BOSTON— A Massachusetts pharmacy issued a voluntary recall Monday of some of its sterile compounding products after "foreign matter" was found in drug vials during an unannounced inspection by state and federal officials.

Pallimed Solutions Inc., of Woburn, was also ordered by the state board of pharmacy to stop all sterile compounding activities until further notice.

Most of the recalled items were used to prepare erectile dysfunction treatments for patients who have difficulty taking drugs orally. The company said fewer than 800 patients were involved.

The company described the recall as a precautionary measure and said it had received no reports of any illnesses or injuries. It also said it would continue with nonsterile compounding.

The Massachusetts Department of Public Health said it requested the recall after a joint inspection on Friday by the state pharmacy board and the U.S. Food and Drug Administration.

"The cease and desist was issued after foreign matter was observed in vials of injectable drugs," the Department of Public Health said in a statement.

Pallimed also was ordered to place all its compounded sterile products into quarantine while the investigation continued.

The company said there was no indication the products were tainted or unsafe. The state also said there were no reports of any patient harm. A message was left with the FDA.

Massachusetts stepped up unannounced inspections of compounding pharmacies after a deadly fungal meningitis outbreak last year was linked to an injectable steroid produced at another Massachusetts company, New England Compounding Center.

That outbreak was responsible for 720 illnesses in 20 states, including 48 deaths, according to the most recent update from the Centers for Disease Control and Prevention.

Framingham-based NECC ceased operations in October and surrendered its license to the Massachusetts board.

Pallimed Solutions is a 7-year-old company that does business as Pallimed Pharmacy and has about 15 employees, according to its website. It said it regretted any impact on customers and that patient safety was its top priority.

"By undertaking this recall action, Pallimed will move forward to ensure that our products always meet the highest standards of safety and customer expectations," the company said in its statement.

On Nov. 27, the state ordered Pallimed to temporarily stop production of sildenafil citrate — the active ingredient in Viagra — for human use after inspectors found it had been prepared with improper components. The company said those issues were administrative in nature and had been resolved, and Monday's announcement was unrelated.

The state said the earlier order was still in place, pending the board's acceptance of a corrective plan.

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Source: WFAA (AP, 3/25)

Can Doctors Use Copyright Law To Get Rid Of Negative Reviews?

Online review sites are becoming an increasingly important catalyst to digital commerce — when it comes to shopping at local businesses, review sites like Yelp are many consumers’ first stop. Plenty of businesses don’t like the negative reviews they get, but a few thousand doctors have gone the extra mile to try to erase that bad press. Working with a company called Medical Justice, they’ve designed a system that tries to use copyright law to control and remove unflattering reviews. Now, a group of law professors are challenging that system, saying it’s illegal and against the purposes of copyright.

Medical Justice was founded in 2002, and today has about 3,000 members, located in various states and representing different medical specialties, who pay an average of $1,200 a year. The company sells membership as a batch of services, mainly centered around helping doctors that are facing medical malpractice litigation. But the Medical Justice benefit that has drawn the most scrutiny is its program of fighting “physician internet libel and web defamation.” The system works by getting patients to sign contracts that assign away the copyright in any future review they might of a doctor-to the doctor.

Why use copyright at all? A Medical Justice spokesman says the first system the company used-a simple contract doctors could give to all patients that banned reviews outright-was seen as “draconian” and the company was hunting for a more nuanced solution. Additionally, some courts have punished companies that have tried to use contracts to directly stop consumer reviews.

By having patients assign copyright in any reviews to their doctor, Medical Justice hopes to sidestep those problems. It’s also an effort to help doctors get around Section 230 of the Communications Decency Act (an “arcane nuance of cyberlaw,” according to Medical Justice’s website), the law that protects web services from getting sued over content posted by their users. When doctors send review sites a note complaining that a review is false or defamatory, the website is protected by CDA Section 230 and is unlikely to remove the review. But when the same sites receive copyright takedown notices, the law compels them to act-and act quickly. Section 230 doesn’t cover intellectual property claims, and copyright infringement has harsh legal penalties.

Medical Justice argues they’re just leveling the playing field. CDA 230 results in a skewed situation for doctors, who can be reviewed by their patients but are prevented from responding because of privacy laws, it says. “Some sites say, we don’t know if you’re telling the truth, and we don’t know if they’re telling the truth-it’s the internet, so deal with it,” says Shane Stadler, a spokesman for Medical Justice.

But a group of legal academics led by law professor and blogger Eric Goldman have big problems with this interpretation of the law. Today Goldman, together with his partner, UC Berkeley Law Professor Jason Schultz, launched a website called doctoredreviews.com. On the site, the two law professors offer their views on how patients, doctors, and review sites should deal with Medical Justice’s strategy, which they argue is likely illegal and surely unethical.

“There’s a substantial risk a court would deem [the Medical Justice copyright transfer] unconscionable,” Goldman wrote in an e-mail yesterday. Copyright takedown notices sent based on Medical Justice copyright transfers could actually expose doctors to liability, Goldman says, because there are legal penalties associated with sending false takedown notices. In a statement posted on his personal blog, Goldman wrote: “Should the website fail to curb the bad practices, we may need to reconsider more aggressive options.”

Stadler says he’s confident that Medical Justice’s use of copyright transfers is, in fact, legal, and it lets doctors defend their reputations while still letting most patients review away. “Can it be abused? Sure,” says Stadler. “Anything can be abused.” While it’s not a perfect system, most doctors use the power responsibly, he says.

Asked what he thinks of Goldman’s website, Stadler is diplomatic: “The gentleman who launched it is a real ardent advocate of total free speech-that you can say pretty much anything on the internet.”

Goldman admits to being an “ardent advocate” of CDA Section 230. “On that basis, we need to fix any legal artifices-like Medical Justice’s legal ‘hack’-that subvert Section 230′s social benefits.”

How are the review sites themselves handling the requests from Medical Justice? According to Goldman’s website, Yelp has refused to honor one doctor’s takedown notice based on an anti-review contract. Another website, RateMDs, has created a “Wall of Shame” to identify doctors who use anti-review contracts.

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Source: Paid Content (Mullin, 4/14)