Regular use of painkillers such as aspirin, ibuprofen and paracetamol is linked to greater risk of stroke and heart attack from higher blood pressure, research published today shows.

A wide-ranging US study has found that men who took paracetamol, aspirin or ibuprofen six or seven days a week over a two-year period were a third more likely to be diagnosed with high blood pressure than men who did not use them.

Researchers, led by Dr John Forman of the Brigham and Women's hospital in Boston, studied 16,000 men whose records they checked over a four-year period. Those who took 15 or more pills per week were 48% more likely to have high blood pressure.

The findings, published in the Archives of Internal Medicine, reiterate a 2002 study which found that commonly-used painkillers raise blood pressure in women.
More than five million Britons, including those suffering back pain, migraine or osteroarthritis take painkillers.

The US research found that those who took paracetamol six or seven days a week were 34% more likely to be diagnosed with high blood pressure, and being overweight reduced this risk. Those who took aspirin as regularly were 26% more likely to have high blood pressure. For painkillers such as ibuprofen and naproxen, the risk increased by 38%. Being overweight increased this risk.

Dr Elliott Antman, from the American Heart Association: said: "We advise physicians to start with nonpharmacologic treatments such as physical therapy and exercise, weight loss to reduce stress on joints, and heat or cold therapy," he said.

Dr Gary Curhan, who also worked on the study, said men who were advised by a doctor to take an aspirin a day to reduce the risk of heart attack and stroke should continue to take them. "The benefit outweighs the risk," he said.

Texas-based SCCI Health Services Corporation (SCCI) and its subsidiary, SCCI Hospital Ventures Inc., have paid the United States $7.5 million to settle allegations that the companies violated the Stark self-referral statute and the False Claims Act, the Justice Department announced today. SCCI, which was purchased by Triumph Hospital in 2005, operates long term acute care facilities across the United States.

The government complaint alleged that from November 1996 through at least 1999, SCCI entered into prohibited financial relationships with three physicians and paid these physicians illegal payments in violation of the Stark statute. The government further alleged that from November 1996 through at least 1999, SCCI either submitted or caused false claims to be submitted to the Medicare program, as a result of these prohibited financial relationships, in violation of the False Claims Act.

The Justice Department is committed to investigating cases that threaten the integrity of the Medicare program, especially when providers fail to abide by federal laws prohibiting the referral of Medicare patients in exchange for a fee, said Assistant Attorney General Peter D. Keisler.

The settlement resolves a civil case filed on behalf of the government on April 1, 1999 by former employees and an independent contractor who worked for SCCI Houston. Daryl Kaczymarczyk, Patricia Rocha, Michelle Pate, Michael Brigle and Theresa Taylor filed the case under the qui tam or whistleblower provisions of the False Claims Act, which authorize private parties to file lawsuits on behalf of the United States. On Oct. 2, 2002, the government intervened in the Stark Act claims as to the three physicians. The United States filed its complaint in the case on March 10, 2003. Of the total settlement amount, $1 million resolves additional allegations as to which the government did not intervene. As a result of the settlement, the five whistleblowers shared $1.7 million.

The Justice Department and the United States Attorney's Office are committed to preventing and punishing improper financial relationships between physicians and hospitals. Such relationships have great potential to adversely impact the physician's judgment and result in Medicare funds being spent on unnecessary and expensive hospital stays, said Donald J. DeGabrielle Jr., United States Attorney for the Southern District of Texas.

The case was handled by the Justice Department's Civil Division and the U.S. Attorney's Office for the Southern District of Texas, with the assistance of the Federal Bureau of Investigation.

Millions of bottles of the pain reliever acetaminophen are being recalled because they may contain metal fragments.

The recall affects 11 million bottles containing varying quantities of 500-milligram acetaminophen caplets made by the Perrigo Co. The pills were sold under store brands by Wal-Mart, CVS, Safeway and more than 120 other major retailers, the Food and Drug Administration said, some as long ago as three years. At least two chains - CVS Corp. and SuperValu Inc. started pulling the pills from store shelves Thursday.

According to the FDA, the pills included metal fragments (though the type of metal has yet to be determined),ranging in size from microdots to portions of wire one-third of an inch long.

The discovery was made during quality-control checks done after the company Perrigo, discovered its equipment was wearing down prematurely, the FDA said. Agency officials declined to say whether the metal found in the pills caused the damage or resulted from it.

According to the FDA, a company investigation turned up metal in about 200 of the 70 million pills it passed through a metal detector.

Consumers who take any of the contaminated pills could have minor stomach discomfort or possible cuts to the mouth and throat, the FDA said, adding that the risk of serious injury was remote, and as of yet there has been no immediate reports of ilness.

Acetaminophen is best known as the drug in products sold under the Tylenol brand, but it is available in typically less expensive generic versions. Acetaminophen along with aspirin and ibuprofen, is one of the most popular pain relievers available over the counter.

The recall does not affect Tylenol. Nor should the recall cause a shortage of acetaminophen, the FDA said.

Perrigo says it is the world's largest manufacturer of store-brand nonprescription drugs. The retail market for the pain relievers is worth more than $2 billion a year.

Kevin Vincent, 44, of Arlington, Va., said "If it's not something that has any chance of recurring, then I really wouldn't worry."

The 129 retailers that could potentially be affected by the recall include Wal-Mart Stores Inc. CVS, Safeway Stores and SuperValu as they sell the Perrigo-made pills under their own or other private labels.

CVS will stop selling its own brand of 500-milligram acetaminophen caplets and pull bottles from store shelves nationwide. SuperValu also began removing the pills from its Albertsons, Cub Foods and other stores, according to their spokespersons.

Molly Walsh, 21, a George Washington University student shopping at a CVS pharmacy in Washington, said she did not plan to toss any of the store-brand drugs at home, "It's still going to be cheaper and I'm still going to be broke after the recall."

The FDA did not know in which states the pills had been sold, but recommended that customers determine whether products they bought are being recalled by checking the store list on the FDA Web site, and the batch list. The batch numbers appear on the container's label.

It has not been determined where Perrigo made the pills. Its main factories are in the United States and Israel, with secondary plants in the United Kingdom, Mexico, Germany and China.

According to FDA records, Perrigo has carried out at least 32 other product recalls since 1993, as recently as May when it recalled nearly 59,000 bottles of a 500-milligram combination pain-reliever and sleep aid that contains acetaminophen because of contamination with acrylic mirror particles.

The 2006 Health Confidence Survey, released by the Employee Benefit Research Institute under the headline, "Dissatisfaction with Health Care System Doubles Since 1998," helps explain why health care is consistently ranked as one of this country's key issues.

A record percentage in the survey, 52% of Americans, are unhappy with the cost of health care. That breaks down to 6 out of ten Americans rank the U.S. health system as poor or fair. That represents a sharp increase in the number of dissatisfied health care consumers, shich includes the insured as well as the uninsured.

Survey results indicate that of the average family surveyed, 36% are facing higher medical costs, 53% contribute less to their retirement plans and save less in general, and 28% have trouble paying for basic necessities. In addition, 20% of those surveyed increased their credit card debt or borrowed money to pay the ever increasing health care bills, while others have chosen to delay getting medical care altogether (44%) or filling necessary prescriptions (22%).

The EBRI survey points out both that the problems with U.S. health care are rapidly geting worse and that solutions are needed to address the issues of excessive cost and the consequential burden of tolerating ill health that is facing the insured as well as the uninsured.

Breaking Legal News.com
Sheryl M. Jones
Staff Writer