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

FDA to offer guidance to companies on marketing drugs for unapproved uses

From CBC News:
The U.S. government on Friday proposed guidelines for how pharmaceutical companies can use medical journal articles to market drugs for unapproved uses.

The Food and Drug Administration guidelines, criticized by some legislators as too lenient, have been eagerly anticipated by drug and device companies like Pfizer Inc. and Medtronic Inc. that often use medical literature for marketing.

Companies are not allowed to market products for "off-label" uses, or those that have not been cleared by the FDA as safe and effective. However, under a law that expired in 2006, the agency made an exception for reprints of medical journal articles, which sales people often give to physicians. ...more

FDA Faults Drug Plants

This article references pharmaceuticals being made in Puerto Rico for the U.S. market. While it's not mentioned in this article, many of these plants are producing medications for the Canadian market as well.

From the Houston Chronicle:
The first warning sign came when a sharp-eyed worker sorting pills noticed that the odd blue flecks dotting the finished drug capsules matched the paint on the factory doors.

After the flecks were spotted again on the capsules, a blood-pressure medication called diltiazem, the plant began placing covers over drugs in carts in its manufacturing areas.

But the factory owner, Canadian drug maker Biovail Corp., never tried to find out whether past shipments of the drug were contaminated _ or prevent future contamination, according to U.S. regulators.

Thirteen of the 20 best-selling drugs in the United States come from plants on this island. But an investigation by The Associated Press has found dozens of examples over four years of lapses in quality control in the Puerto Rican pharmaceutical industry, which churns out $35 billion of drugs each year, most of it for sale as part of the $300 billion market in the U.S.

An AP review of 100 pages of Food and Drug Administration reports shows even modern drug plants here under the watch of U.S. regulators have failed to keep laboratories sterile and have exported tainted pills. ...more

Quit-smoking drug linked to serious psychiatric side-effects: FDA

From the Canadian Press:
The U.S. Food and Drug Administration issued a public health warning Friday about a highly touted smoking cessation drug after it was linked to potentially serious neuropsychiatric symptoms.

Adverse effects have been reported in relation to the prescription medication Chantrix (varenicline), which is sold in Canada under the brand name Champix, including changes in behaviour, agitation, depressed mood, and suicidal thoughts and behaviour.

The FDA has requested that Pfizer, the drug's manufacturer, add the new safety information to the warnings and precautions section of the medication's prescribing information or labelling. The agency also is working with Pfizer to finalize a medication guide for patients.

"Chantix has proven to be effective in smokers motivated to quit, but patients and health-care professionals need the latest safety information to make an informed decision regarding whether or not to use this product," Dr. Bob Rappaport, director of the FDA's division of anesthesia, analgesia and rheumatology products, said in an advisory. ...more

US FDA: 'Bio-identical' hormone claims unsupported

This warning has to be considered a negative for compounding pharmacists in general, even if they aren't involved in the "bio-identical" hormone debate.

From Reuters:
U.S. health officials warned seven pharmacy operators on Wednesday that their claims about the safety and effectiveness of "bio-identical" hormones were false, misleading and not supported by medical evidence.

The pharmacies claimed their hormone products were superior to approved menopause therapies and could be used to prevent and treat serious conditions such as Alzheimer's, strokes and cancer, the Food and Drug Administration said.

"FDA is concerned that the claims for safety, effectiveness, and superiority that these pharmacy operations are making mislead patients, as well as doctors and other health care professionals," an agency statement said.

Drugmaker Wyeth, which sells FDA-approved hormone replacement therapy, had petitioned the agency to take action against makers of bio-identical hormones. ...more

FDA Warns On Severe Bone, Muscle Pain With Bone Drugs

From CNN:
The U.S. Food and Drug Administration Monday advised doctors and patients about the possibility of severe and sometimes incapacitating bone, joint or muscle pain linked to popular drugs used to treat osteoporosis and other bone-thinning diseases.

Although a discussion of severe musculoskeletal pain is included in the prescribing information for all of the drugs, the agency said, "the association between bisphosphonates and severe musculoskeletal pain may be overlooked by healthcare professionals."

The drugs - sold under several brand names including Fosamax, by Merck & Co.; Boniva, by Roche Holding AG; Zometa and Reclast, by Novartis AG; and Actonel, by Procter and Gamble Co. - are known as bisphosphonates. ...more

Health Canada issues warning against two stomach treatments

From Canada.com:
Health Canada is telling parents not to use two natural products for treating upset stomachs in infants and children because of potential bacterial contamination.

Baby's Bliss Gripe Water, apple flavour, 26952V, is a natural health product given to babies to "ease stomach discomfort and gas often associated with colic, hiccups and teething," Health Canada said in an alert to consumers.

The product is distributed by MOM Enterprises, Inc. in California and is sold in a 118.26 millilitre plastic bottle in a cardboard carton. The label reads: Baby's Bliss Pediatrician Recommended Gripe Water Apple Flavor.

The U.S. Food and Drug Administration found the product contains the parasite cryptosporidium which can infect the gastrointestinal tract. "Infections due to cryptosporidium may cause watery diarrhea, abdominal cramps, vomiting and, in some cases, death," Health Canada said. ...more

Improper use of fentanyl pain patches linked to more deaths: FDA

From CBC News:
U.S. health officials say improper use of patches that emit the painkiller fentanyl is still killing people.

Today's warning from the U.S. Food and Drug Administration is the second concerning the powerful narcotic in two years.

The FDA blames some of the deaths on the patches being improperly prescribed to certain patients. Fentanyl should be used to control chronic pain in people already used to narcotics, such as some cancer patients. Yet the FDA has found cases where doctors prescribed it for headaches or post-surgical pain. ...more

FDA eyes 'behind the counter' drug category with greater clinical role for pharmacists

From the American Medical News:
The Food and Drug Administration is contemplating the establishment of a class of medications that would be available only after counseling from a pharmacist but without a physician's prescription. Physicians widely oppose the development, arguing that it could disrupt continuity of care and put patients at risk.

"We're concerned about patient safety," said Rebecca J. Patchin, MD, an American Medical Association trustee. "If a medication requires oversight, it should be available by prescription, and a physician should be involved in prescribing it and monitoring the patient." The AMA testified in opposition to this action at the FDA's Nov. 14 hearing on the subject.

Known as "behind the counter," this category exists in many other countries in various forms. The FDA is considering the possibility for the fourth time since the 1970s because agency officials feel the emergence of the Internet means that consumers are more informed than ever and the time may be right to make this change in the United States. ...more

FDA Hears Pros, Cons of Pharmacist-to-Patient Drug Sales

From Forbes:
During a day-long public hearing Wednesday on whether to allow certain drugs to be sold by pharmacists without a prescription, U.S. Food and Drug Administration officials listened to arguments for and against the proposal by representatives of various medical and public interest groups.

But at the day's end, the FDA officials said they weren't ready to make a decision on whether to create a new class of drugs that pharmacists could sell "behind-the-counter." And, they wouldn't speculate on a timetable for such a decision. ...more

Federal drug approvals plunge

The American and Canadian drug approval systems often share information and make similar decisions. I suspect the decrease in approvals of new products in the States has likely resulted in some of these products not being approved in Canada. Quite often, these drugs have received approval in other Western countries. Examples would include rimonabant and Arcoxia.

The pendulum has swung regarding North American drug approvals. In the wake of the Vioxx scandal, I suppose it was inevitable. But I wonder how many benficial new medications won't be approved because of the now exceedingly cautious regulatory bodies?

From CNN Money:
Federal drug approvals have plummeted by nearly a third in 2007, according to a report issued Thursday that is likely to fuel complaints that regulators are stymieing efforts to get new treatments on the market.

The Food and Drug Administration approved 59 new drugs through October, down 29 percent from the same period last year, according to a report from James Kumpel, an industry analyst at Friedman, Billings, Ramsey Group.

Significantly, the report says that the problem is not in the industry pipeline.

Kumpel said that the ratio of applications to approvals in 2007 is shaping up to hit a 13-year low. The FDA is on track to approve 60 percent of applications for new drugs this year, compared to 76 percent in 2006.

"While some pundits have argued that the pipeline [of applications] submitted to the FDA by the pharmaceutical industry has been weak in recent years, the facts dispute such claims," said Kumpel, in his report, released on Thursday.

Kumpel found an 18 percent decline in approvals of a key category of drugs - those that are in a brand-new molecular class. The FDA approved only 14 of these new drugs, which represent the most significant medical advances because they do not piggyback onto existing treatments. ...more

FDA Weighs Behind-the-Counter Drugs

I've already posted a few articles regarding the "behind the counter" issue in the States. I thought I'd add this one as well as it has some information I haven't seen elsewhere.

From WebMD:
For at least the fourth time, federal regulators are considering whether pharmacists should be allowed to regularly dispense medications without a doctor's prescription.

Three times since the 1970s, the FDA has rejected the idea of adding a new "behind the counter" class of drugs to existing prescription-only and over-the-counter medication, which can be bought with no professional supervision.

But the new class is once again on the FDA's docket, spurred in part by big drug companies looking for a new way to sell prescription products that the agency has rejected for nonprescription sales. ...more

FDA Mulls Direct Pharmacist-to-Patient Drug Sales

From the Washington Post:
Experts at the U.S. Food and Drug Administration are meeting Wednesday to hear arguments on whether or not pharmacists might someday bypass doctors and directly provide consumers with certain drugs that now require a prescription.

If this plan were to go ahead, it would create a new class of drugs that could be sold by pharmacists "behind-the-counter." Such drugs might include birth control pills, cholesterol drugs and migraine medicine, experts said. Their sales would require that patients discuss these purchases with the pharmacist first.

"We believe having certain drugs behind the counter, but available only after a consultation with a pharmacist, could significantly increase patient access," Ilisa Bernstein, the FDA's director of pharmacy affairs, told theLos Angeles Times.

Wednesday's hearing marks another chapter in the behind-the-counter saga. In 2005, the agency rejected a proposal to allow the cholesterol-lowering drug Mevacor to be sold without a prescription. At the time, however, some of the FDA's scientific advisers said it might be possible for pharmacists to sell the drug if they could help select which customers bought the pills. ...more

Bayer Stops Sales of Trasylol Globally

I think this article would be a good one to file in the memory banks. The next time American experts say there is no drug research being done in Canada, here's an example that contradicts that statement.

From the Associated Press:
Bayer AG halted worldwide sales Monday of its anti-bleeding drug Trasylol at the request of U.S. and foreign health officials pending further analysis of a Canadian study that suggests it's linked to a 50 percent higher risk of death than the other drugs in the clinical trial.

The Food and Drug Administration asked the company to stop selling the drug, used to prevent excessive bleeding during heart bypass surgery, until it could receive and review further results from the study. The study comparing the safety and efficacy of the drug with two others was recently halted.

"FDA cannot identify a specific patient population where we believe the benefits of using Trasylol outweighs the risk," said Dr. John Jenkins, director of the agency's Office of New Drugs, during a briefing Monday. ...more