Apotex warned as U.S. drug agency cracks down

I have not heard if Health Canada is looking into these issues on our side of the border or not...

From Reuters:
Canada's Apotex Inc could face a freeze on new drug applications in the United States as well as a ban on products entering the country after the U.S. Food and Drug Administration warned it of a number of manufacturing breaches at a Toronto factory.

The June 25 warning, which followed a late 2008 inspection of the Etobicoke, Ontario facility, cited a number of manufacturing deviations from U.S. manufacturing codes.

Among the breaches, the agency charged that Apotex did not thoroughly investigate the failure of batches of some drugs and also noted an unusual high number of rejected batches.

This, the FDA suggested in the letter, "demonstrates a lack of adequate process controls and raises significant concerns regarding the capability and reliability of (Apotex's) processes to consistently manufacture drug products meeting predetermined specifications." ...more

Health Canada, FDA warn of swine flu scams

From the National Post:
Health authorities in Canada and the United States are on high alert for Internet scams related to swine flu and are cracking down on websites that are selling unauthorized products and making illegal claims about how to prevent and treat the illness.

Health Canada and the U.S. Food and Drug Administration are tracking the websites and have issued dozens of warning letters to force the removal of offensive claims.

Among the products that have popped up online are: a pill that is purported to cure a swine-flu infection within hours; a spray that claimed to leave a layer of ionic silver on the skin that would kill the virus; fake test kits; a shampoo; nasal sprays; wall-mounted ultraviolet light machines that allegedly prevent the spread and destroy the virus; and an electronic instrument that declared its "photobionic energy" and "deeply penetrating mega-frequency life-force energy waves"would strengthen the immune system and prevent infection. The machine costs thousands of dollars. ...more

Drug regulators seek curbs on acetaminophen products

From the Calgary Herald:
American drug regulators are considering pulling some products with acetaminophen off the shelves and Health Canada is keeping a close eye on the deliberations as it also moves to warn consumers about the risk of liver damage due to an overdose of the drug.

Acetaminophen, widely used as a pain reliever and to reduce fever, is generally a safe and effective drug, according to the U.S. Food and Drug Administration, but when a patient exceeds the recommended dosage, it has been known to cause abnormalities in liver function, liver failure and death.

The FDA has made various efforts since the 1990s to stem what it calls "a public health concern," but it has been unsuccessful in reducing the number of cases of liver damage related to the drug. ..more

Health Canada weighs options as U.S. FDA adds "black box" warnings

From the Ottawa Citizen:
Health Canada is still in discussions with Pfizer Inc., about whether to add safety warnings to packages containing anti-smoking drugs that may have psychiatric side effects, including suicidal thoughts.

South of the border, U.S. health officials Wednesday ordered Pfizer Inc and GlaxoSmithKline PLC to add strong "black box" warnings on their anti-smoking drugs to highlight the risk of serious mental health problems.

Philippe Laroche, spokesman for Health Canada, said the federal agency expect to reach an agreement with the pharmaceutical giant by the end of this summer, or the fall.

"In addition to updated safety information regarding the risk of psychiatric events, new labelling will also incorporate information regarding angioedema, serious skin reactions and accidental injury," said Laroche in an email to Canwest News Service.

The U.S. warnings, which must be added to Pfizer's Champix and Glaxo's Zyban, follow more than five thousand reports of depression, hostility and other behavioural changes in the U.S., the Food and Drug Administration said. ...more

Prescription drugs: more business for Canadian online pharmacies?

From CBC News:
The U.S. Food and Drug Administration still says "don't do it." The "it" being buying prescription drugs from Canadian — or any other foreign — online pharmacy.

The official line is that if you're an American buying drugs online, you could be paying for:

* Counterfeit drugs.
* Medicine that's too strong or two weak.
* Drugs made in unsafe conditions.
* Drugs that are beyond their best-before date.

The FDA says there's nothing wrong with buying online, as long as the website is located in the United Prescription drugs being measured out.States, is licensed by the state board of pharmacy where the site is operating, has a licensed pharmacist on hand to answer your questions and requires a prescription from a doctor who is licensed to practice in the United States. ...more

Ban diabetes drug Avandia: consumer group to FDA

From CBC News:
The diabetes drug Avandia should be banned over its risks of heart and liver damage, a U.S. consumer group urged.

In a petition filed with the U.S. Food and Drug Administration on Thursday, the group Public Citizen called for the Type 2 diabetes drug, whose generic name is rosiglitazone, to be pulled from the market.

Last week, the American Diabetes Association and a European counterpart unanimously advised doctors against using Avandia in updated treatment guidelines.

"The FDA is in possession of clear, unequivocal evidence that (Avandia) causes a wide variety of toxicities," Public Citizen said in its petition.

"Many of these are life-threatening, such as heart attacks, heart failure (and) liver failure."

In November 2007, GlaxoSmithKline Inc., the manufacturer of rosiglitazone, updated its prescribing information in consultation with Health Canada after a study published in the New England Journal of Medicine reported a 43 per cent higher risk of heart attack for those taking rosiglitazone compared to people taking other diabetes drugs or no diabetes medication at all. ...more

Cold medication not for kids under 4, U.S. companies say

From Canada.com:
As drug companies in the United States put new warning labels on cold and flu medication for children under four years old, a Canadian manufacturer of children's medicine, said it would not follow suit.

Major U.S. pharmaceutical companies announced Tuesday they would change labels on cough and cold medicines to warn consumers not to give the products to children under four, said the Consumer Healthcare Products Association, a group representing the American producers of over-the-counter kids medicine.

"After consulting with the Food and Drug Administration, the leading manufacturers of these medicines are voluntarily transitioning the labelling on oral (over-the-counter) pediatric cough and cold medicines to state "do not use" in children under four years of age," it said in a statement.

However, Johnson & Johnson Canada said no such warnings will be put on the Canadian products yet.

"At this time the initiatives in the U.S. don't affect our products in Canada," said spokeswoman Tina Peyregatt. "We have been in continuous talks with Health Canada on the same topic but at this time we have not arrived at a decision." ...more

Sale of cough, cold medicines for children under 6 reviewed

From CBC News:
Banning over-the-counter cough and cold medicines for children under six might drive parents to resort to adult medicines, a U.S. health official said in weighing a recall of products to fight runny noses, hacking and congestion.

Some pediatricians and consumer groups are seeking a ban on the sale of the cough and cold medicines for children, saying the value of the products remains unproven and they are potentially risky.

At a public hearing Thursday, officials with the U.S. Food and Drug Administration agreed there is a lack of solid evidence to support the use of the pediatric cough and cold medicines, especially in those aged two to six.

But if parents turn to adult medicines, the results could be worse, said Dr. John Jenkins, head of the U.S. Food and Drug Administration's Office of New Drugs. ...more

India's Ranbaxy hit by reports of Canada drug review

From AFP:
Shares of Indian generics giant Ranbaxy hit an 18-month low Tuesday on reports Canada was looking into the safety of the firm's drugs as well as on fears about its revenue outlook, analysts said.

Ranbaxy shares have been under pressure since the US Food and Drug Administration blocked imports of over 30 of the New Delhi-based company's drugs last week, saying they failed to meet manufacturing standards.

On Tuesday, India's business daily Mint quoted the Canadian health ministry as saying a "regulatory letter" was sent to Ranbaxy Pharmaceuticals Canada requesting an action plan and a response to the FDA's move.

The company, which is being bought by Japan's Daiichi Sankyo in a deal valued at up to 4.6 billion dollars, closed down 11.05 percent or 38.35 rupees at 308.85 rupees, its lowest level since March 2007.

"We're not responding to any media reports," said a spokesman for Ranbaxy when asked about the Canadian letter. ...more

U.S. posts drugs under safety probe

The FDA Top 20 watch list is located here. Commonly used drugs on this list includes heparin, insulin, nitroglycerin, oxycodone, and quetiapine among others.

From CBC News:
Health officials in the U.S. on Friday began publishing a quarterly list of prescription drugs under investigation for potential side-effects, with the aim of keeping doctors and patients better informed.

The drugs are under review based on complaints from the public. Inclusion on the list does not mean the U.S. Food and Drug Administration has concluded the drug is dangerous, officials stressed, but that safety reviewers think the reported problem needs to be looked at more closely.

The first report of 20 drugs under review was released Friday. All of the drugs, except one, are approved for use in Canada. Health Canada's website includes similar warnings about the drugs.

"My message to patients is this: Don't stop taking your medicine," said Dr. Janet Woodcock, who heads the FDA's Center for Drug Evaluation and Research.

"If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently." ...more

FDA to Revise Rules For Cold Medications Meant for Children

From the Washington Post:
The Food and Drug Administration yesterday announced plans to revise standards for over-the-counter cough and cold medications for children, a step that could lead to removing the popular products from the market.

In response to rising concerns that the products are ineffective and could be unsafe, the agency said that, for the first time in decades, it will revamp the criteria that have allowed the products to remain on drugstore shelves.

"Modern science has advanced since, and this is an opportunity to apply modern science to evaluate these products," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.

As the first step in that process, the agency will hold a special hearing Oct. 2 to begin to consider a series of questions, including: What types of studies should be done to evaluate the products? Should the products remain available without a prescription? How should the doses be determined? Should products that combine different ingredients remain available? ...more

F.D.A. Weighs Training to Dispense Narcotics

I can`t imagine this ever happening, but it`s an interesting idea...

From the New York Times:
Should doctors be required to undergo special education in order to prescribe powerful narcotics? The Food and Drug Administration may soon recommend that they do so, though such a move would most likely prove controversial.

“I think it is a good idea, and it is something we are considering,” said Dr. Bob Rappaport, the director of the division of Anesthesia, Analgesia and Rheumatology Products at the F.D.A. But the agency itself does not have the authority to take such a step, Dr. Rappaport said.

Typically, state medical boards, rather than the federal government, impose licensing requirements on doctors, including the type of continuing education they must receive. A few states, including California, now provide doctors with education about the treatment of pain patients. But nationally, state medical boards have shown little interest in mandating added training in the use of potent pain medications or in screening patients for those prone to drug abuse.

Pain experts say they support increased education for doctors, but some fear that mandatory training may harm pain patients by limiting the number of doctors prescribing such drugs. ...more

Company asks pharmacists, hospitals to return drug

So far, there has been no news that any of these products were distributed in Canada.

From the Seattle Post Intelligencer:
A New Jersey company is asking pharmacists and hospitals to return all prescription drug products made at one of its facilities because it did not pass health authorities' standards.

A Food and Drug Administration inspection at the Little Falls, N.J., facility of Actavis Totowa LLC "revealed operations which did not meet the FDA's or Actavis' standards for good manufacturing practices," according to a company statement issued Friday. ...more

Wyeth and Amgen bolster fatal infection warning on skin drug

From CNN:
Drugmakers Wyeth and Amgen Inc. have bolstered warnings about tuberculosis and other life-threatening infections on the label of their skin-disorder drug Enbrel.

The new boxed warning, the most serious a drug can carry, indicates patients taking the drug have contracted infections that led to hospitalization and death. The same language previously appeared in bolded text, which is considered a less serious warning.

Infections included tuberculosis, a disease which attacks the lungs, as well as bacterial sepsis, which can cause severe fever and inflammation. ...more

FDA cites 62 reports of possible heparin deaths

From Reuters:
U.S. regulators have received 62 reports of deaths during the last 15 months of patients who were treated with the blood-thinner heparin and suffered allergic reactions or low blood pressure, the Food and Drug Administration said on Tuesday.

Those are the problems that prompted Baxter International Inc to recall most of its heparin products in February. ...more

Drug Makers Near Old Goal: A Legal Shield

From the New York Times:
For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood clots and strokes, according to internal company documents.

But because the Food and Drug Administration approved the patch, the company is arguing in court that it cannot be sued by women who claim that they were injured by the product — even though its old label inaccurately described the amount of estrogen it released.

This legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now appears to be on the verge of success, lawyers for plaintiffs and drug companies say.

The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts. The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted. ...more

FDA, Health Canada probing possible suicide link with allergy drug Singulair

From the Canadian Press:
U.S. and Canadian drug regulators are investigating the popular allergy medication Singulair in response to reports of mood changes, suicidal behaviour and suicide in patients.

The U.S. Food and Drug Administration said Thursday it is reviewing a handful of such patient reports and has asked Singulair's maker, Merck & Co., to dig deeper into its data for more evidence of possible links to suicide.

Meanwhile, "patients should not stop taking Singulair before talking to their doctor," the FDA said in a statement, adding that doctors should monitor patients for suicidal behaviour and mood changes.

Health Canada is also investigating a possible link between Singulair and suicidal behaviour, said spokesman Paul Duchesne, noting that consumers should see their doctors if they have concerns about taking the prescription drug.

He was unaware of any reports of suicide among Canadians taking the medication.

The FDA said it has not established a "causal relationship" between Merck's drug and suicidal behaviour. The review was prompted by three to four suicide reports it has received since last October, an agency spokeswoman said. ...more

FDA reviews safety of HIV drugs from Glaxo, Bristol-Myers after heart attack risks

From the Canadian Press:
The Food and Drug Administration said Thursday recent data show patients taking HIV drugs from GlaxoSmithKline and Bristol-Myers Squibb may have increased risk of heart attack.

FDA said data pooled from a 33,000-patient study of HIV patients showed those taking Glaxo's Ziagen and Bristol-Myers' Videx had a greater chance of heart attack than patients on other medications.

Labelling changes could be needed for the drugs, FDA said, though it stressed it is still working with incomplete data. The agency does not have information on heart attack risks of two other drugs in the class of virus-fighting medications. ...more

Drug recall puts overseas inspections in spotlight

From the Globe and Mail:
A major U.S. recall of a blood-thinning drug linked to a Chinese factory last week is prompting new questions over the ability of government and industry to ensure the safety of drugs made with ingredients from China.

China has become one of the world's largest suppliers of pharmaceutical ingredients, but the country's questionable safety reputation, combined with reports of death and serious illness associated with Chinese products in the past year, has convinced some experts and industry members that North American governments need a more aggressive approach to overseas inspections and safety checks.

The issue has reached a boiling point in the United States in recent days after Baxter International Inc. expanded its nationwide recall of heparin, a blood thinner, amid reports it had been linked to 19 deaths and hundreds of illnesses. The affected products are not sold in Canada.

The U.S. Food and Drug Administration said this week that the problems may be the result of a counterfeit ingredient from China that was used in the drug. U.S. health officials had never inspected the Chinese factory owned by U.S.-based Scientific Protein Laboratories LLC where some of the raw heparin ingredients were processed. When U.S. inspectors finally visited the plant last month, they found evidence of and quality-control and hygiene problems. ...more

FDA warns Duluth about presciption importation from Canada

From the Rochester (Minn.) Post Bulletin:
The Food and Drug Administration has warned the city of Duluth that a program to import prescription drugs from Canada and save money for city workers is unsafe and most likely violates federal law.

In a letter to Duluth Mayor Don Ness, the FDA warned that any packages sent to employees would likely be detained by U.S. Custom and Border Protection.

Ness, who inherited the program from former mayor Herb Bergson, said he would keep because it would continue to save the city taxpayer money on health costs -- up to $2 million a year, he said.

"If the FDA cannot give a definitive answer that this is illegal, that demonstrates the question is still out there," Ness told the Duluth News Tribune . "I'm hopeful that the federal government will address their own policy that seems to be designed to protect the profit margins of drug companies at the expense of the American citizen."

Importing prescription drugs from Canada has been hotly debated in Minnesota and the country the last few years. Gov. Tim Pawlenty was one of the first governors in the nation to implement a drug import program, and his administration has joined numerous government entities in ignoring similar letters from the FDA. ...more