Social Tonics Not Safe

Health Canada warns against use of 'social tonics' which contain drugs

Health Canada is urging consumers not to use products sold as "social tonics" by the company Purepillz, saying they contain unauthorized drugs.

The department says four products that go by the names "Peaq", "Freq", "PureRush", and "PureSpun" are promoted on the company's website as safer legal alternatives to street drugs.

But they contain compounds that reportedly have effects like amphetamines and the drug MDMA, and can't be legally sold in Canada this way.

Health Canada says the products can cause hallucinations, convulsions and slowed breathing.

They can increase body temperature and blood pressure, dilate pupils and increase euphoria, alertness and paranoia.

Health Canada says it has repeatedly asked Purepillz to remove the products from the market and is taking enforcement action because the company has not complied.

he products contain benzylpiperazine (known as BZP) and 3-trifluoromethylphenylpiperazine (3-TFMPP), compounds that require a drug identification number (DIN) before they can be legally sold in Canada.

Health Canada says BZP and 3-TFMPP have no therapeutic uses and while BZP is frequently claimed to be a "natural" substance, it is not a natural health product.

Health Canada says it is carrying out an assessment to determine whether it would be appropriate for these substances to be regulated under the Controlled Drugs and Substances Act
Source: CBC.ca

Pharma Execs Guilty of Misleading Public

The maker of the powerful painkiller OxyContin and three of its current and former executives pleaded guilty Thursday to misleading the public about the drug's risk of addiction, a federal prosecutor and the company said.

Purdue Pharma LP, its president, top lawyer and former chief medical officer will pay US$634.5 million in fines for claiming the drug was less addictive and less subject to abuse than other pain medications, U.S. Attorney John Brownlee said.

The plea agreement settled a national case and came two days after the Stamford, Conn.-based company agreed to pay $19.5 million to 26 states and the District of Columbia to settle complaints that it encouraged physicians to overprescribe OxyContin.

"With its OxyContin, Purdue unleashed a highly abusable, addictive, and potentially dangerous drug on an unsuspecting and unknowing public," Brownlee said. "For these misrepresentations and crimes, Purdue and its executives have been brought to justice."

Privately held Purdue learned from focus groups with physicians in 1995 that doctors were worried about the abuse potential of OxyContin. The company then gave false information to its sales representatives that the drug had less potential for addiction and abuse than other painkillers, the U.S. attorney said.

Ken Jost of the Justice Department's Office of Consumer Litigation said this case should put pharmaceutical companies on notice that they won't be able to get away with breaking the law to make a profit.

"The things that they plot in their boardrooms, the things that they do behind closed doors will not stay behind closed doors," Jost said. "We have the people, we have the resources. We'll take the time and we'll take the effort to find out what they did and how they did it."

Purdue Pharma said it accepted responsibility for its employees' actions.

"During the past six years, we have implemented changes to our internal training, compliance and monitoring systems that seek to assure that similar events do not occur again," the company said in a news release.

OxyContin, a trade name for oxycodone, is a time-release painkiller that can be highly addictive. Designed to be swallowed whole and digested over 12 hours, the pills can produce a heroin-like high if crushed and then swallowed, snorted or injected.

From 1996 to 2001, the number of oxycodone-related deaths nationwide increased fivefold while the annual number of OxyContin prescriptions increased nearly 20-fold, according to a report by the U.S. Drug Enforcement Administration. In 2002, the DEA said the drug caused 146 deaths and contributed to another 318.

The U.S. attorney said the guilty pleas were entered Thursday morning in U.S. District Court in Abingdon, southwest of Roanoke. In an unusual move, Brownlee said, company chief executive officer Michael Friedman, general counsel Howard Udell and former chief medical officer Paul Goldenheim each pleaded guilty to a misdemeanour count of misbranding the drug. Of the total fine, $34.5 million was levied on those three.

The fines will be distributed to state and federal law enforcement agencies, the federal government, federal and state Medicaid programs, a Virginia prescription monitoring program and individuals who had sued the company. About $5 million will go toward a six-year company program to monitor compliance with the agreement.

When he took office in 2001, Brownlee said, his office was handling a number of cases related to OxyContin abuse, including crimes by addicts seeking to support their habits and arrests of street dealers and even pharmacists and physicians.

"But it always seemed, I think to me and to the investigators, that there was more," he told a news conference.

Investigators from a number of state and federal agencies worked together on an investigation of Purdue Pharma and began to subpoena company records in 2002, Brownlee said.

"From these millions of records, they picked out probably 300 to 500 documents and pieced together a case," he said.

The Food and Drug Administration was part of the investigation. A spokesman for Connecticut Attorney General Richard Blumenthal said the agency had not acted on a citizen petition Blumenthal's office filed more than three years ago. The petition raised concerns about misbranding and called for stronger warnings and fuller disclosure about OxyContin's dangers.

Kim Rice of the FDA told the news conference that over time the agency has mandated increasingly stronger warnings on labels about OxyContin's abuse potential.

Source: CBC.ca

Children's Cold Medicine Investigation

U.S. investigating children's cold medicines: report

Common children's cold and cough medicines are coming under scrutiny from U.S. federal drug regulators, who say the remedies and their recommended doses have not been studied enough in children, the New York Times reported Friday.

Dr. Charles J. Ganley, a top Food and Drug Administration official, said the agency was "revisiting the risks and benefits of the use of these drugs in children," especially those younger than two years old, the paper reported.

Most over-the-counter cold and cough medicines have been insufficiently tested in children, said Ganley, the director of the FDA's office of non-prescription drug products.

"We have no data on these agents of what's a safe and effective dose in children," he told the Times in an interview.

The FDA said it could not yet determine whether new regulations would result from the safety review, according to the newspaper.

A group of pediatricians and public health officials asked the agency Thursday to bar drug manufacturers from marketing remedies such as Toddler's Dimetapp, Infant Triaminic and Little Colds to children under six.

Cold medicines killed 3 children: study

A recent study by the U.S. Centers for Disease Control and Prevention showed that in 2004 and 2005, more than 1,500 children under two had experienced serious health problems — and three died — after taking common cold medicines.

The American College of Chest Physicians last year recommended avoiding giving cough and cold medicines to children, especially young ones.

In above-normal doses, cold medicines can lead to heart arrhythmias, and some have been linked to hypertension and stroke when taken in high doses, the Times reported.

In rare cases, children have had medical problems after taking recommended doses, the article said.

The president of the Consumer Healthcare Products Association, which represents companies that sell over-the-counter cold drugs, noted that the medicines had FDA approval and had been used for decades. They should be taken only in recommended doses, association president Linda A. Suydam said.

The pediatricians who petitioned the FDA Thursday acknowledged that children's cold medicines were generally safe in recommended doses, but they said overdoses were common because many children were given more than one medicine, among other reasons.

They also questioned the drugs' effectiveness in children.

Many cold and cough drugs won FDA approval decades ago, when the agency's standards were less strict, the Times reported.

Source: CBC.ca

Drug Side Effects Report Cards - FDA

U.S. proposes 'report cards' for drugs

Last Updated: Tuesday, January 30, 2007 | 7:03 PM ET

Drug "report cards" may list any unexpected side-effects that become known within 18 months of a drug's approval, the U.S. Food and Drug Administration said Tuesday in response to criticism of the agency's drug safety oversight.

In September 2006, a panel of experts at the U.S. Institute of Medicine said the FDA needed to boost its staff, funding and power to track the safety of not only new medications, but also drugs already on the market.

The panel met after Merck & Co. pulled its anti-inflammatory drug Vioxx from the market in 2004, five years after it was approved. Long-term use of the drug was linked to an increased risk of heart attack and stroke.

The institute's report concluded that FDA officials downplayed concerns raised by safety reviewers after drugs were approved. The report also suggested the FDA did a poor job of managing scientific disagreements among staff.

In its response on Tuesday, the FDA said it was "making specific organizational and management changes to increase communications among FDA review staff and safety staff."

The response is not the final word, FDA Commissioner Dr. Andrew von Eschenbach said.

"It will be a continuous process of improvement. The initiatives we are announcing today are not the full story, nor are they the final chapter in that story," von Eschenbach told reporters in Washington.

The FDA's response includes plans to:

• Upgrade its electronic database for tracking potential side-effects.
• Create a new advisory panel on risk communication.
• Publish regular newsletters summarizing safety reviews of older drugs, including any emerging issues that do not include information the agency considers confidential.

The response came days before U.S. senators are to introduce legislation for drug safety changes.

Source: CBC.ca