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Archive for the ‘Seroquel’ Category

TORONTO – An increase in the number of prescriptions of a powerful antipsychotic drug for conditions not approved by Health Canada is raising concern about what medical experts call lack of professional and government oversight of doctors’ prescribing practices.

Also known as off-label prescribing, the practice is believed to be the reason why the number of prescriptions for Seroquel — a drug only approved in Canada for the treatment of bipolar disorder and schizophrenia — has nearly doubled in the last six years.

According to IMS Health Canada Inc., a company that tracks the health-care industry, the number of prescriptions for the drug has risen from 4.1 million in 2008 to 7.4 million in 2013.

In Ontario alone, claim counts for Seroquel have risen from 1.8 million in 2010-11 to 2.3 million in 2013-14, according to the Ministry for Health and Long-Term Care. The annual cost of the drug to the province reached more than $47 million in 2012-13, until generic products were introduced last April, bringing the total down to $38 million.

Some experts say prescriptions for Seroquel are vastly disproportionate to the number of Canadians suffering from schizophrenia and bipolar disorder, about one per cent of the population respectively, according to the Canadian Mental Health Association.

“Often what we see is people taking this drug primarily as a sleep aid, and that’s very bad medicine and I think that it’s something that should be discouraged,” says Dr. David Juurlink, head of the division of clinical pharmacology and toxicology at Sunnybrook Health Sciences Centre in Toronto.

“I think that if doctors understood what exactly this drug was and how it worked and what its side effects were, they’d be very reluctant to prescribe it that way.”

Health Canada says some of Seroquel’s side effects can be fatal and include diabetes, hyperglycemia, constipation and intestinal obstruction, and complications from blood clots.

Off-label prescribing is not regulated by any one Canadian government body; Health Canada approves all drugs, regulations and policies regarding usage and prescribing, the provincial health ministries regulate the practice of medicine, but disciplining of doctors is handled exclusively by respective provincial regulatory bodies such as the College of Physicians and Surgeons, but only when a complaint is made.

When it comes to Seroquel and the way it should be prescribed in Canada, the answer varies depending on who you ask.

A spokeswoman for the Canadian Psychiatric Association says psychotropic medications are prescribed for “specific disorders, not for symptoms,” and that much of the off-label use is for treatment of specific symptoms such as sleep.

But Dr. Jitender Sareen, the head of the association’s research committee, says physicians prescribe medications off-label because some patients can’t tolerate the on-label drug, or it’s not available.

Off-label use does not mean inappropriate use, he said, as long as physicians inform their patients that they are using the medication off-label and explain to them its benefits and side effects.

Dr. Sareen says Seroquel prescriptions are rising because the drug has “beneficial effects” in more than psychotic illness.

“It does have side effects but if you look at the other medications that we prescribe in psychiatry for mental health problems, it is relatively safe … a small proportion of people do have difficulties with it but the reason that it’s used a lot is because people tolerate it reasonably well and it helps them with their depression, anxiety or psychosis.”

Juurlink of Sunnybrook says doctors should stick to Health Canada’s guidelines.

“This is a drug that can kill people, period. And it’s difficult sometimes to know who those people are going to be,” he says.

“When we give them to large numbers of people — hundreds of thousands or even millions of people — you’re going to harm a considerable number of patients, and I think in general drugs to help people sleep are a bad idea, and Seroquel is particularly a bad idea for that purpose.”

Health Canada says it monitors safety issues associated with the use of health products, including psychotropic drugs such as Seroquel, but adds the issue of off-label prescriptions falls under the “practice of medicine” and is provincially regulated.

Yet a Senate standing committee on social affairs, science and technology concluded in a report released in January that Health Canada could do more for drug safety as it is responsible for the post-approval monitoring of prescription drugs for both on- and off-label purposes.

The Senate committee also expressed its concern “regarding the manner by which physicians acquire information about approved prescription drugs.”

“Physicians are often unaware that they are prescribing off-label and that a lot of the knowledge that physicians have about medicines has been acquired through sales representatives from pharmaceutical companies,” the report states, adding that this practice is prohibited under the Food and Drugs Act.

In April 2010, Seroquel’s manufacturer — AstraZeneca Pharmaceuticals LP — was ordered by the U.S. government to pay $520 million to resolve allegations that the company was illegally marketing the drug for uses not approved as safe and effective by the Food and Drug Administration, such as for insomnia.

Health Canada has said that it is not aware of allegations of “similar advertising tactics” taking place in Canada.

The agency, however, told the Senate committee that it has received few complaints about the relationship between doctors and drug sales representatives, and the committee acknowledged Health Canada’s “inability to monitor the activities between physicians and drug sales representatives,” calling it essentially “unenforceable.”

AstraZeneca was not immediately available for comment.

South of the border, the Obama administration has introduced a new health-care law called Open Payments, which requires big pharma companies to disclose all payments made to doctors, from research grants to travel junkets, consulting and speaking fees. Newly released data shows the value of those payments totalled nearly $3.5 billion in the five-month period from August through December 2013.

No such law exists in Canada.

NDP health critic Libby Davies says that when it comes to off-label prescribing, the federal government is “sweeping it under the carpet.”

“It is a federal responsibility, it’s a very important responsibility and the more and more we find out about the lack of oversight and the lack of drug safety and the lack of transparency, I think Canadians are learning that we’ve got a pretty huge problem in this country.”

Davies says the New Democrats offered amendments to the newly passed Bill C-17 — or Vanessa’s Law — which included improvements to transparency and prescribing practices for off-label use, but they were turned down by the federal government.

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TORONTO – A class of drugs sometimes used to control symptoms of dementia appears to increase the risk of acute kidney injury in people who take it, a new study suggests.

 

The work looks at what are called atypical antipsychotic drugs, which are not recommended for dementia but which nonetheless are often prescribed for people suffering from it.

A number of studies have questioned use of the drugs in this population of patients, for a variety of concerns. Health Canada, the U.S. Food and Drug Administration and Britain’s drug regulatory body have all recommended that the drug not be used to control symptoms of dementia.

Despite that, the drugs —Seroquel (quetiapine), Risperdal (risperidone) and others — are prescribed to control symptoms such as aggression and agitation that are sometimes seen in dementia patients.

But there have been case reports of kidney ailments in older adults who start taking the drugs. So researchers from Lawson Health Sciences Centre in London, Ont., and the Institute for Clinical Evaluative Sciences in Toronto set out to see if there was a link between use of the drugs in this population and kidney problems.

They studied the health records of nearly 100,000 adults 65 years of age and older from Ontario who were newly prescribed one of these drugs during the period from June 2003 to December 2011. They then compared those records to nearly 100,000 people of similar ages and health status who did not take one of those medications.

The rate of acute kidney injury was essentially doubled in the group taking the drugs, said Dr. Amit Garg, a kidney specialist at Lawson Health Sciences Centre who is also a scientist at ICES.

When the researchers looked at how many people died in the first three months of taking the drug, they found 6,666 people taking the drugs died compared to 2,985 in the control group.

Garg said it is important to note these findings only pertain to older adults taking the drug for dementia. The researchers did not study their use in people who are prescribed the drugs for mental health conditions.

“They generally would be less at risk of side-effects anyway and they shouldn’t be alarmed by these data,” he said.

Garg said the findings suggest doctors should be cautious about using these drugs in this patient population, turning to them as a drug of last resort. “If there are other options that are available, really explore those.”

I

f using one of these drugs appears to be the best option for a dementia patient, the doctor should monitor the patient for signs of kidney problems.

And if someone with dementia shows up needing care for kidney ailments, doctors should ask whether the patient is taking an atypical antipsychotic. Garg said withdrawing the treatment can sometimes ameliorate the condition, though he warned that patients should not stop taking these drugs without first consulting a doctor.

The study is published in the journal Annals of Internal Medicine.

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(Reuters) – Pharmaceutical giant Pfizer is facing a mounting wave of lawsuits by women who allege that the company knew about possible serious side effects of its blockbuster anti-cholesterol drug Lipitor but never properly warned the public.

In the past five months, a Reuters review of federal court filings shows, lawsuits by U.S. women who say that taking Lipitor gave them type-2 diabetes have shot up from 56 to almost 1,000.

Lawsuits began to be filed not long after the Food and Drug Administration in 2012 warned that Lipitor and other statins had been linked to incidents of memory loss and a “small increased risk” of diabetes. According to plaintiffs’ lawyers, women face a higher risk than men of developing diabetes from using Lipitor, and gain fewer benefits.

The recent spike in lawsuits followed a decision by a federal judicial panel to consolidate all Lipitor diabetes lawsuits from around the country into a single Federal courtroom in Charleston, South Carolina. Pfizer opposed the consolidation, arguing it would prompt copycat filings. The first case is scheduled to be tried next July.

Pfizer said in a statement that it denied liability and would fight the lawsuits.

It is not uncommon for a drugmaker to get hit with thousands of lawsuits over its products after the FDA orders a label change alerting users to newly found risks. Takeda Pharmaceutical, for instance, is facing more than 3,500 federal lawsuits since 2011 when the FDA ordered it to update the label on its diabetes drug Actos to warn about bladder cancer. Takeda has denied liability.

But several factors set the Lipitor diabetes cases apart from those against other drug companies. For one, Lipitor is the best-selling prescription drug of all time, racking up global sales of more than $130 billion since it went on the market in 1996. More than 29 million patients in the United States have been prescribed the drug, suggesting there is a vast pool of potential plaintiffs.

On the other hand, potentially complicating matters for plaintiffs, the FDA emphasized the benefits of statins even as it warned of the risks.

When the labelling change was released in 2012, a top FDA official underscored that the agency still stood behind the drugs: “Clearly, we think that the heart benefit of statins outweighs this small increased risk (for diabetes),” Amy Egan, a deputy director for safety at the agency’s Division of Metabolism and Endocrinology, said in a statement at the time.

Statins are a class of drugs that block the liver’s production of cholesterol to reduce the risk of heart disease. Type 2 diabetes, once known as adult-onset or noninsulin-dependent diabetes, is a chronic condition that affects the way the body metabolizes glucose.

RISKS AND BENEFITS

The seemingly mixed message from the FDA suggests that litigation will focus on two questions: how big a diabetes risk do women using Lipitor face, and whether that risk is mitigated by the drug’s cardiovascular benefits.

H. Blair Hahn of Mount Pleasant, South Carolina, the lead lawyer appointed to represent Lipitor plaintiffs in federal court, said the plaintiffs contracted diabetes as a consequence of taking Lipitor, and that women with diabetes see the length and quality of their lives reduced.

“We will ask a jury to decide what it’s worth to take five years of someone’s life,” Hahn said. He said the nearly 1,000 cases filed so far represent 4,000 women, and that the number of cases could ultimately reach 10,000 or more.

Pfizer said it believes Lipitor did not cause the plaintiffs’ diabetes. Women who are prescribed Lipitor to control cholesterol may share other risk factors that make them vulnerable to the disease, such as high blood pressure or obesity, the company said.

The Pfizer statement said there is an “overwhelming consensus” in the medical community about statins’ benefits.

BELLWETHER TRIALS

The first Lipitor trial, scheduled for next July before U.S. District Judge Richard Gergel, will be one of several so-called “bellwethers” used to gauge the strength of other cases. If Pfizer prevails, it could persuade plaintiffs to accept smaller settlements or drop cases.

Pfizer could also opt to settle before a single case is tried to avoid possible negative exposure or to prevent potentially damaging information from coming to light.

If past settlements are any guide, Pfizer’s potential exposure could be substantial. Bayer, the maker of one-time rival statin Baycol, paid $1 billion in 2005 to settle about 3,000 cases alleging the drug caused rhabdomyolysis, a disease that breaks down muscle tissue. Baycol was pulled from the market in 2001 after being linked to 31 deaths.

In 2011 AstraZeneca said it would pay $647 million to resolve most of the 28,000 lawsuits it faced alleging its antipsychotic Seroquel caused diabetes and other injuries.

Pfizer has not indicated that it has set aside any money specifically to cover potential future Lipitor judgments, according to its most recent quarterly filing with the U.S. Securities and Exchange Commission.

Michael Green, an expert in mass torts at the Wake Forest University School of Law, said he did not expect Pfizer to settle at this stage, especially given the major obstacle plaintiffs still face.

“(They) have to show they were actually harmed by this agent,” he said. “That might be hard.”

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