The American unit of Belgian pharmaceutical company UCB SA will plead guilty and pay $34.4 million to settle criminal and civil probes that it illegally promoted a drug for migraines, according to court documents filed this week.

The company will plead guilty to one count for promoting the epilepsy treatment drug Keppra, in the United States in 2004 without the necessary approval from the Food and Drug Administration, the documents filed on Wednesday said.

A court hearing is slated for Thursday, according to the Justice Department. A spokeswoman for the company said the issues occurred more than six years ago and that UCB was pleased to have resolved the matter.

(Reporting by Jeremy Pelofsky, editing by Lisa Von Ahn)

Technorati Tags: epilepsy treatment drug, Keppra

Taken in combination, two commonly prescribed drugs, the antidepressant Paxil and the cholesterol-lowering medication Pravachol, appear to significantly raise blood sugar levels, a new study finds.

The increase is most apparent — and concerning — among diabetics, whose blood sugar is already too high, the researchers noted.

“This interaction may affect as many as 1 million Americans who might be on these two drugs and who are getting a bump in their blood glucose that may be unnecessary,” said lead researcher Dr. Russ Altman, a professor of bioengineering, genetics and medicine at Stanford University.

It’s possible that the blood sugar spike triggered a diagnosis of type 2 diabetes in some patients, Altman said, “and we might have been able to avoid that diagnosis if they hadn’t been on these drugs,” he said. “That’s speculative, but it’s possible.”

Neither drug alone raises blood sugar, and the researchers said they can’t yet explain the effect of the combination. Also, combinations of other antidepressants and cholesterol-lowering drugs do not boost glucose levels. “It is not what we would call a ‘class’ effect,” Altman explained.

Paxil (paroxetine) is in a class of drugs called selective serotonin reuptake inhibitors (SSRIs), and Pravachol (pravastatin) belongs to a group of drugs called statins. “We looked at all other pairs of SSRIs and statins, and there were a couple that showed a tiny bump in glucose, but there is nothing like the bump seen with Paxil and Pravachol,” Altman said.

For the study, published online May 25 in Clinical Pharmacology and Therapeutics, the researchers used a technique called data mining, scanning large databases in hopes of finding information that, while not immediately obvious, is gleaned by combining data in a new way.

In this case, Altman’s team used data from the U.S. Food and Drug Administration’s Adverse Event Reporting System, plus data from Stanford, Harvard and Vanderbilt universities to identify associations that would not be apparent to doctors treating individual patients.

Using this method, the researchers identified 135 non-diabetic patients taking both drugs whose blood sugar increased 19 milligrams per deciliter after starting treatment. They also identified 104 diabetics whose blood sugar increased an average of 48 mg/dl while taking both drugs.

People with blood sugar levels of 126 mg/dl or higher on two tests are considered diabetic. Levels of 100 mg/dl to 125 mg/dl are considered pre-diabetic.

By extrapolating these findings to the entire United States population, Altman’s team believes that of 33 million people currently taking Paxil or Pravachol, 500,000 to 1 million take them together.

To test whether their findings were merely associations that could be explained by other factors, the researchers experimented with the drugs in mice.

The mice were exposed to the two drugs after receiving a high-fat, high-calorie diet to make them pre-diabetic. While neither drug alone increased blood sugar, together they increased blood sugar from about 128 mg/dl to 193 mg/dl, the researchers found.

“This was just like the humans in our database,” Altman said. “So, this seems to be a real biological effect. This might give us insight into mechanisms of diabetes.”

Altman cautions that people taking this drug combination should not overreact.

“People on an antidepressant should not mess with that because depression is a very serious disease,” he said. It would be reasonable to visit a physician and see if your glucose levels have been difficult to control, he said. “If it has been, then I would think the thing to change might be the statin,” he said.

Dr. Ronald B. Goldberg., professor of medicine at the Diabetes Research Institute of the University of Miami Miller School of Medicine, said this is “an interesting finding and could be clinically important.”

“People with diabetes have an increased risk of depression; they are all recommended to be on statins,” Goldberg said. “So, it may aggravate blood sugar control in people who are diabetic.”

But Goldberg thinks it’s too early to change clinical practice based on this study alone. “This needs to be confirmed in a clinical trial,” he said.

Technorati Tags: blood-sugar, paxil, Pravachol, prescription drugs

Patients on heart drugs are less likely to fill their prescriptions if they have to make more trips to a pharmacy or have multiple doctors prescribing them drugs, according to a new study.

“The problem of complexity has just increased over the years as Americans are prescribed more and more medication,” Dr. Sunil Kripalani of Vanderbilt University, who wrote a commentary accompanying the study, told Reuters Health.

While the finding is not surprising, it highlights the importance of doctors and patients discussing the best way to simplify each patient’s medication regimen, the authors report in Archives of Internal Medicine.

It also shows that health insurers and pharmacies can do a better job of making things simpler for patients, they added.

Dr. Niteesh Choudhry of Brigham and Women’s Hospital and Harvard Medical School and his colleagues analyzed a database of about 2.5 million patients who were prescribed a heart medication, including cholesterol-fighting stations, in 2006 and 2007.

For 3 months, the authors tracked each of those patients to see how many medications they were prescribed — both for heart disease and other conditions — as well as how many doctors prescribed their medications, how many pharmacies they used to fill those prescription medications, and how often they visited a pharmacy.

Next, the researchers kept track of how frequently those patients filled their heart medication prescriptions over the following year.

Over those first three months, patients filled an average of eleven prescriptions for six different medications, and made five visits to a pharmacy. And during the following year, they filled an average of two-thirds of their heart drug prescriptions.

Patients who had to make more pharmacy visits and fill prescriptions from more doctors were less likely to get their heart drugs filled.

However, patients who were taking more medications actually appeared to be better about filling their heart drugs that those taking fewer — especially when they could fill all of their prescriptions during just a few pharmacy visits.

It’s not completely clear why that is, Kripalani said. However, he added, “my own suspicion is that the people who end up being prescribed more medications have little choice but to develop mechanisms for managing those medications (and they) integrate them more into their daily lives.”

To show just how complicated some patients’ medication routines can get, the authors reported that the 10 percent of patients with the most complex routines filled 23 or more prescriptions over the three months and made eleven or more pharmacy visits. They also had at least four doctors prescribing them medication.

SIMPLIFYING ROUTINES

While there’s no proof that helping patients consolidate their prescriptions means they will be better about filling them, Kripalani said that it was “reasonable for health care providers to recommend that patients try to simplify and streamline their prescription filling practices as much as possible,” as suggested by the researchers.

However, “this is a tough problem for doctors to solve themselves,” Choudhry told Reuters Health. He said the study was a “call to action” for pharmacies and health insurance companies, who may be able to make a bigger difference in simplifying patients’ medication routines.

And with more people being able to pay for their medications under health care reform, and many of them having to manage multiple prescriptions, “it means that the issues that we highlight might actually become more and more relevant,” he said.

PRESCRIBING IN THE HOSPITAL

Having a better handle on patients’ medications may also help hospitals make fewer errors when they are admitted and need a change in those drugs.

Another research letter from the same issue of Archives of Internal Medicine found that when a Veterans Affairs medical center began phasing in a computerized tool that displayed what medications patients were currently taking or had taken recently, those patients had fewer drug-related complications due to hospital doctors’ prescribing errors.

The “medication reconciliation” process also involved talking to the patient, or calling their pharmacy or doctor’s office to get a more complete picture of drug use, said Dr. Kenneth Boockvar, the study’s lead author from the James J. Peters VA Medical Center in Bronx, New York.

Drugs that patients are taking long-term are especially important to keep tabs on, he said.

Patients “often have medications they’re taking at home,” Boockvar told Reuters Health, and doctors have to determine “what those medications are, whether the patients are adherent or take the medications as prescribed, if they don’t, why they don’t take those medications as prescribed.”

He said that as these systems get implemented more fully and doctors get on board, drug-related complications — whether or not they are caused by errors — should decline.

SOURCES: http://bit.ly/lXOpXw and http://bit.ly/mFfq8X Archives of Internal Medicine, online May 9, 2011.

Technorati Tags: heart drugs, medications, prescription routines

Pfizer Inc posted disappointing revenue for Lipitor pharmacy and other medicines, exposing the risks the world’s biggest drugmaker faces if it sells better-performing units like its nutritional products business.

Pfizer is widely expected to divest one or more of its four non-core units, allowing it to focus on growth from promising new medicines.

But that may take time. New Chief Executive Ian Read said in an interview that Pfizer will provide rough outlines by year’s end on what it might sell or spin off, and could take until early 2012 to develop full-fledged plans.

There will be no “Big Bang” this year, he said, noting that other units that could be gradually divested include Pfizer’s consumer health business and animal health unit. He said the best use of proceeds would likely be to buy back company shares.

“We need to focus on the fact that we’re an innovative pharmaceutical company and that is 85 percent of our revenue base today. And we need to get that right,” Read told Reuters. “I don’t think diversification for diversification’s sake gives you a premium” in your stock price.

Many investors fear Pfizer will be far too big to deliver strong profit growth once Lipitor and other top prescription drugs lose their exclusive marketing status in the next few years.

“Pfizer is most likely to sell its nutritionals business and could get as much as $7 billion for it, which could be used to buy back more company shares,” said Morningstar analyst Damien Conover. He said a sale of the consumer products business was somewhat less likely, but could fetch $6 billion.

But it may not be simple to give up the non-core businesses, which have helped offset anemic drug sales, especially since Pfizer laboratories have not produced a new best-seller since introducing Viagra pharmacy more than a decade ago.

The company is pinning its hopes on new medicines for rheumatoid arthritis, lung cancer and stroke now in advanced clinical trials.

Pfizer shares closed down 2.8 percent at $20.44 after gaining more than 10 percent since early February, when Read announced plans to streamline Pfizer. The company turned over the reins to him in December after the abrupt departure of Jeffrey Kindler.

A GAMBLE ON DRUGS

Cholesterol fighter Lipitor, Pfizer’s biggest product, led drug sales lower in the first quarter. Its revenue tumbled 13 percent to $2.39 billion due to generic competition in overseas markets, foreshadowing the drug’s even worse plight once it loses U.S. patent protection in November.

In all, the company earned $2.22 billion, or 28 cents per share, in the first quarter. That compared with $2.03 billion, or 25 cents per share, a year earlier, when Pfizer took charges for its late 2009 purchase of U.S. rival Wyeth.

Earnings were 60 cents per share, excluding special items and the Capsugel business that is being sold. Analysts on average expected 59 cents, according to Thomson Reuters I/B/E/S.

Results benefited from a weaker dollar that boosted the value of sales abroad, new products obtained by the purchase of King Pharmaceuticals and a sharply lower tax rate.

Large U.S. rivals also topped first-quarter forecasts, helped by a weaker dollar and cost cuts, with Merck & Co Inc and Bristol-Myers Squibb Co posting the biggest profit beats.

Pfizer revenue of $16.5 billion was a bit lower than a year earlier and trailed Wall Street expectations of $16.63 billion. Prescription drug sales fell 2 percent to $14.2 billion.

Sales of animal-health products — mainly for livestock and pets — jumped 16 percent to $982 million. Sales of consumer products, including Centrum vitamins and painkiller Advil, rose 12 percent to $745 million. Nutritional product sales rose 3 percent to $470 million.

Pfizer, which has bought three of the largest U.S. drugmakers over the past decade, has already slimmed down its operations considerably. Three months ago, Read vowed to slash the company’s research budget by up to $2 billion, to between $6.5 billion and $7 billion, eliminating thousands of jobs.

The move pleased investors by allowing Pfizer to stick to its 2012 profit forecast, which calls for earnings similar to what it reported for 2010.

In early April, Pfizer announced plans to sell Capsugel, the world’s largest maker of hard capsules, to private equity firm KKR & Co for $2.38 billion. The deal will enable Pfizer to make up to $2 billion in share repurchases this year beyond its previous plans for $5 billion.

(Reporting by Ransdell Pierson and Lewis Krauskopf; editing by Lisa Von Ahn, Maureen Bavdek editing by Andre Grenon)

Technorati Tags: Lipitor, Pfizer, prescription drug, top drugs, Viagra

The Supreme Court ruled on Tuesday that a group of large pharmaceutical companies cannot be sued by a California county for allegedly overcharging for prescription drugs in violation of federal law.

By an 8-0 vote, the justices overturned a U.S. appeals court ruling that the county with its medical facilities could sue because it was a direct beneficiary of the pricing agreements between the federal government and the companies.

Santa Clara County, which operates a number of hospitals or health clinics that receive federal funds, filed the lawsuit in 2005 for alleged overcharges dating back to 2001.

The county claimed the drug manufacturers violated a 1992 federal law that requires them to give the same discounts to federally funded medical facilities under the Medicaid program as those under standard pricing agreements between the federal government and the companies.

A federal judge initially dismissed the lawsuit and ruled only the federal government, which signed the Medicaid agreements with the companies, had the right to enforce it.

The appeals court disagreed, reinstated the lawsuit, and ruled the county can seek reimbursement of excess payments.

“Recognizing the county’s right to proceed in court could spawn a multitude of dispersed and uncoordinated lawsuits” by outside parties, Justice Ruth Bader Ginsburg wrote in the unanimous opinion.

The court also noted that if the suits were allowed to proceed, secret pricing information could be revealed in violation of the law governing the Medicaid program.

“This ban on disclosure is a further indication of the incompatibility of private suits with the statute Congress enacted,” the opinion said.

The companies in their appeal told the Supreme Court that the appeals court ruling threatened to disrupt the $30 billion Medicaid program for outpatient prescription drugs.

Among the companies appealing were Pfizer, Merck & Co Inc, AstraZeneca, GlaxoSmithKline, Bristol-Myers Squibb and Bayer.

The Obama administration supported the companies.

Justice Elena Kagan did not participate in the case. She previously served as U.S. solicitor general.

The Supreme Court case is Astra USA v. Santa Clara County, No. 09-1273.

(Reporting by James Vicini, editing by Matthew Lewis)

Technorati Tags: drugmakers, Medicaid, prescription drugs

In people with heart disease, the use of blood pressure-lowering medications can be beneficial, even in those who don’t have high blood pressure, new research suggests.

The study found that when people without high blood pressure were given blood pressure drugs, their risk of congestive heart failure, stroke, all-cause mortality and a combination of cardiovascular disease outcomes were reduced.

“If someone has had a previous heart attack or other cardiovascular event, and their blood pressure is in the normal range, they’re still at risk of future cardiovascular events. There may be an additional benefit to giving an anti-hypertensive medication to these folks,” said study author Angela M. Thompson, a doctoral research fellow in the department of epidemiology at Tulane University School of Public Health and Tropical Medicine in New Orleans.

“Current treatment recommendations advise treatment when the blood pressure is over 140/90 mm/Hg, but our study shows that you can obtain benefits even when the blood pressure is below that,” Thompson explained.

In fact, the risk for cardiovascular disease begins at 115 mm/Hg of systolic pressure (the top number on a blood pressure reading), according to background information in the study.

In addition, in adults 55 years and older, the lifetime risk of developing hypertension is more than 90 percent, the study noted.

The study, which was funded by Tulane University and the National Institutes of Health, was published in the March 2 issue of the Journal of the American Medical Association.

Cardiovascular disease is the leading cause of death in the United States, according to background information in the study. About 54 percent of strokes and 46 percent of heart disease cases occur in people who have blood pressure levels in the normal range, the study reported.

The current study is a meta-analysis of 25 reports that were selected from a pool of 874 studies. The selected studies included almost 65,000 people without high blood pressure, and three-quarters of the study participants were men. All had a history of heart attack or other cardiovascular disease.

Most of the study volunteers were taking blood pressure medications known as beta blockers or angiotensin-converting enzyme (ACE) inhibitors, two commonly used classes of drugs for lowering blood pressure.

The researchers found that people taking blood pressure medications had a 23 percent reduced risk of stroke, a 29 percent reduced risk of congestive heart failure and a 15 percent reduction in the risk of a combination of cardiovascular events. In addition, the risk of cardiovascular mortality was reduced by 17 percent, and the risk of all-cause mortality dropped by 13 percent in those taking these medications compared to those who weren’t on the drugs.

Thompson said the researchers don’t know exactly how blood pressure medications lowered the risk of cardiovascular events, because this wasn’t a study designed to look at the mechanism behind the effect.

He and the other researchers reported no conflicts of interest.

Dr. Mario Garcia, chief of cardiology at Montefiore Medical Center in New York City, said the findings were “not surprising or unexpected. These drugs all have beneficial effects beyond lowering blood pressure. These drugs have already been shown to prevent events in patients with heart attacks or heart failure.”

Dr. Hector Ventura, director of cardiomyopathy and heart transplantation at the Ochsner Health System in New Orleans, said, “This study is kind of novel because they looked at people treated with blood pressure medications without hypertension. And, even in people without so-called hypertension, there might be a benefit from these prescription medications,” he said.

But, he said, there are still a lot of unanswered questions. In some cases, these medications could make blood pressure too low. And, people would likely need to be on these medications indefinitely, possibly for years. So, costs and potential side effects have to be considered, said Ventura, who wrote an accompanying editorial in the same issue of the journal.

In the editorial, Ventura concluded that the meta-analysis “demonstrates that treatment of blood pressures lower than 140/90 mm/Hg is associated with benefits for patients with [cardiovascular disease], but more clinical trial data are needed for those without CVD.”

Technorati Tags: cardiovascular disease, high blood pressure

In what is being hailed as a hallmark in health care, the U.S. Food and Drug Administration has approved Benlysta, a medication designed for treatment of lupus erythematosus. Not only is Benlysta the first new drug for lupus in more than 50 years to reach the market, but it is the first drug derived from the study of genes (genomics), reports The Wall Street Journal.

Lupus is an autoimmune disorder that affects nearly 1.5 million Americans, with women of all races nine times more likely than men to develop the disease. African Americans, Hispanics, Asians and Native Americans have a higher disease incidence than Caucasians.

The development of Benlysta has been years in the making and is the product of a joint effort between Human Genome Sciences, Inc. and GlaxoSmithKline. To date, Benlysta is the first drug to be approved by the FDA that has been developed through the 20-year-old Human Genome Sciences company.

The FDA press announcement of Benlysta’s approval states that the medication is approved for the treatment of active systemic lupus erythematosus. Two clinical studies involving more than 1,500 participants provided the FDA with evidence of the drug’s safety and efficacy.

The positive results of the drug’s use to reduce flare-ups and to allow lupus sufferers to decreases their steroid medications suggested, but did not firmly establish these results. Study results demonstrated that Benlysta does not work for the most severe forms of lupus and was only effective in 35 percent of the North American participants, according to the AP.

A troubling fact is that the medication failed to show positive results for African American study participants. The FDA has requested and Human Genome Sciences has agreed to conduct a new study to ascertain treatment and safety outcome potentials for African Americans and those of African descent.

Benlysta is administered intravenously. Many study participants experienced reactions from their IV infusions; the FDA states that pre-treatment with antihistamines “should be considered.” The most common side effects of the drug include nausea, fever and diarrhea, but there was also an increased number of deaths and serious infections in study participants who received Benlysta over the placebo drug.

Persons on Benlysta therapy should not receive live vaccines.

A medication guide must be provided to patients who are considering the use of Benlysta for treatment of their lupus so they can understand the risks involved.

This new drug may give hope to 200,000 currently diagnosed lupus sufferers and may also spur new developments in the treatment of the disease.

Technorati Tags: Benlysta, lupus erythematosus

A French father-of-two is to take GlaxoSmithKline to court on Tuesday, alleging the British firm’s drug to treat Parkinson’s disease turned him into a gay sex and gambling addict.

The 51-year-old’s lawyers say their client’s behaviour changed radically after he was first administered the drug in 2003 for the illness, which causes tremors, slows movement and disrupts speech.

Didier Jambart, a married father-of-two who says he has attempted suicide three times, claims he became addicted to Internet gambling, losing the family’s savings and stealing to feed his habit.

He also became a compulsive gay sex addict and began exposing himself on the Internet and cross-dressing. His risky sexual encounters led to him being raped, his lawyers said.

The behaviour stopped when he stopped taking the drugs in 2005 but by then he had been demoted in his defence ministry job and was suffering from psychological trauma resulting from his addictions, his lawyers said.

The plaintiff is seeking a total of 450,000 euros ($610,000) in damages from Glaxo, which he accuses of selling a “defective” drug, and from his neurologist for having failed to properly inform him about the drug.

The drug Requip has been known for years to have undesired side effects but a warning only appeared on its package insert in 2006, his lawyers said.

Glaxo said it did not wish to comment on the case.

Technorati Tags: addictions, psychological trauma, Requip

A cheap generic drug used to stem bleeding from heavy menstrual periods could save the lives of tens of thousands of accident victims each year and help reduce the number of deaths in combat, scientists said on Wednesday.

In a systematic review of studies on the effectiveness of tranexamic acid, or TXA, British researchers found that it reduces the risk of death in injured patients with severe bleeding by about 10 percent compared to giving no treatment.

This would equate to saving more than 70,000 lives a year if the blood clotting drug was used worldwide, they said in their study published in The Cochrane Library journal.

More than 90 percent of trauma deaths occur in low-income and middle-income countries, where access to medicines is often restricted by poorer infrastructure and fewer resources.

“TXA reduces the risk of a patient bleeding to death following an injury and appears to have few side effects,” lead researcher Ian Roberts, of the London School of Hygiene and Tropical Medicine, said in a statement. “It could save lives in both civilian and military settings.”

The findings were based on one large trial involving 20,211 patients and one small trial involving 240 patients.

Injuries are a major cause of death across the world. Every year, more than a million people die from road injuries, making traffic accidents the ninth leading cause of death worldwide.

On top of that, stabbings, shootings, land mines and other injuries kill thousands more, many of them young men.

Hemorrhage, or excessive bleeding, is responsible for about a third of trauma deaths in hospitals and can also contribute to deaths from multi-organ failure. Experts estimate that about 600,000 injured patients bleed to death worldwide every year.

A study published last year of 20,000 patients in 40 countries also found that TXA significantly cut death rates in bleeding patients. Based on those findings, researchers said TXA could save up to 100,000 lives a year, including around 13,000 in India, 12,000 in China, 2,000 in the U.S. and more in Europe.

They also said TXA, an off-patent generic medicine made by several companies and costing around $4.50 per gram, should be listed as “essential” by the World Health Organization (WHO).

SOURCE: http://bit.ly/ejucrU The Cochrane Library, online January 19, 2011.

Technorati Tags: blood drug, cheap prescription drug, tranexamic acid

A group set up by former Latin American leaders and personalities including Virgin chief Richard Branson on Monday recommended that consumers of illicit drugs should not be treated as criminals.

The Global Commission on Drug Policies felt that the prevalent repressive approach to drug abuse was failing, members said after their two-day inaugural meeting here.

The group of ex-politicians and intellectuals was set up this week to promote new ways of tackling drug abuse, following a similar regional venture in Latin America.

“You have to give up on the idea that drug consumers are criminals,” Cesar Gaviria, Colombia’s president from 1994-1998, told AFP, insisting on the need to tackle drug producing and trafficking cartels.

Colombia and Peru are the two largest sources of cocaine in the world, producing an estimated 400 tonnes of the illicit drug in 2009, according to the United Nations.

Brazil’s ex-president Fernando Henrique Cardoso, who chairs the commission, said addicts should be treated like people who are ill and offered health care.

The commission also includes Mexican former president Ernesto Zedillo, ex-EU foreign affairs chief Javier Solana and former Norwegian minister Thorvald Stoltenberg, as well as Nobel literature laureate Mario Vargas Llosa and writer Carlos Fuentes.

Branson attended the first day of the meeting, according to a source close to the commission.

The emergence of powerful drug barons in recent years has also been blamed for Mexico’s slide into bloody violence and gang wars, which left a record 15,200 people dead in 2010 alone.

Technorati Tags: drug abuse, illicit drugs