It was first used on human subjects during the Vietnam war but due to its hallucinogenic qualities and the tendency to increase heart rate and blood pressure, it is rarely used as a primary human anaesthetic today, but is still in common use for minor surgeries. It has been used as a dissociative drug and also for the treatment of addiction.

However, according to an article published today on MinnPost.com, Ketamine, also known as ‘Special K’, ‘green’, ‘K’, ‘cat Valium’, ‘jet’, ‘super acid’, has grown from being a ‘clubbing drug’ to a primary drug of choice in many areas of the world. The MinnPost reports that it is now the primary drug of choice in Hong Kong, second in Singapore, fifth in China and growing in use in Europe and North America. Several countries have made it illegal to be in possession as a result.

It has gained in appeal because it is significantly cheaper than many drugs and the chemical ingredients for its production are easily available over the internet. There is a misconception that it is safer than other drugs but abuse can lead to severe bladder and kidney problems.

According to the U.S. Drug Enforcement Administration, Ketamine comes in a clear liquid or an off-white powder form. It can be injected, smoked, or ingested by snorting or swallowing and “Use of the drug can cause delirium, amnesia, depression, and long-term memory and cognitive difficulties. Due to its dissociative effect, it is reportedly used as a date-rape drug.” It also can result in impaired motor function and potentially fatal respiratory problems. Large doses may lead to oxygen starvation of the brain and muscles and death may occur at high doses. Like PCP, flashbacks can occur a year after use.

There has been an increase in the number of veterinary clinics being robbed specifically for their Ketamine stock.

Users describe the effects as “out of body” or “near death” experiences. The effects can last from a half-hour to two hours, but 24-48 hours are required for the user to be completely “normal” again. It is considered an addictive psychedelic.

Because of the drug’s potential to produce states in which the individual feels invulnerable and numbed to pain, accompanied with an exaggerated sense of strength, users are at the same risk associated with the “bad trips” linked to LSD. Higher doses can lead to seizures and there is a risk of passing out and asphyxiating due to vomiting.

Ketamine will cause a positive PCP on a Urine Tox Screen. But detection is difficult because it is rapidly metabolised by the body.

Ketamine, being such an essential drug in the medical arsenal, is going to remain a part of our society. Its growing use as a recreational drug needs to be recognised. And because it is so easily delivered via drinks or smoking materials to unsuspecting persons, it can lead to dangerous and deadly results.

issuesdaily staff article

http://www.minnpost.com/globalpost/2009/05/22/9024/the_globalization_of_special_k

http://en.wikipedia.org/wiki/Ketamine

http://www.usdoj.gov/dea/concern/ketamine_factsheet.html

http://www.theantidrug.com/drug_info/drug_info_ketamine.asp

issuesdaily staff article

By MATTHEW PERRONE
AP Business Writer

WASHINGTON (AP) — Federal health officials say a Johnson & Johnson drug helps prevent deadly blood clots in patients getting hip or knee replacement, but it also carries a risk of serious internal bleeding.

Johnson & Johnson and partner Bayer have asked the Food and Drug Administration to approve their once-daily pill, rivaroxaban, as an anticlotting drug to stop blood clots in legs and those that can travel to the lungs. More than 800,000 U.S. patients receive hip or knee replacements each year, and an estimated 40 to 60 percent are at risk of blood clots.

But FDA regulators said in documents posted online Tuesday that the drug carries nearly twice the risk of bleeding of Sanofi-Aventis’ Lovenox, the top-selling blood thinner used by patients receiving orthopedic implants.

On Thursday the agency will ask a panel of cardiology experts to weigh in on the drug’s risks and benefits. The FDA is not required to follow the advice of its panel, though it usually does.

After reviewing four studies with more than 12,000 patients, the FDA said major bleeding occurred in 0.4 percent of patients on the J&J; drug, compared with 0.2 percent of those taking Sanofi’s drug, known chemically as enoxaparin. The drug was Paris-based Sanofi’s biggest product last year, with sales of $3.5 billion.

“The evidence that administration of rivaroxaban could lead to bleeding events in significantly more patients relative to enoxaparin amplifies this safety concern,” states the FDA’s review, posted online Tuesday.

Regulators also voiced concerns about potential risks of liver injury or toxicity, a common side effect with blood-thinning drugs. Bayer and J&J; have proposed that the drug would be used for only two weeks by knee surgery patients and five weeks by hip surgery patients.

But the FDA is concerned doctors could use it for longer periods. The agency will ask its panelists whether there is enough information to gauge the risks of the drug over the long term.

The agency said it asked the companies to develop a lower-dose version of rivaroxaban that could be used by patients with liver or kidney problems. According to the agency, the companies “regarded this modification as unnecessary.”

But a J&J; spokesman said the company “is actively working with the FDA on this issue to assure the best balance of benefit and risk.”

The FDA also said the companies declined to design a risk minimization strategy for their drug, or a plan to help doctors and patients use the drug safely. But the company said it has submitted a number of plans to reduce the drug’s risks, including education and outreach programs.

The agency will have to weigh rivaroxaban’s risks against its promise as a lifesaving medication.

In four studies of knee and hip replacement patients, rivaroxaban cut the risk of blood clots or death in half, to 0.6 percent, compared with 1.3 percent for patients taking Lovenox.

Rivaroxaban is one of several new anticlotting drugs designed to be safer and more effective than older treatments. One mainstay of anticlotting treatment, Coumadin or warfarin, requires patients to undergo frequent blood tests because a too-high or too-low dose can lead to strokes or dangerous bleeding.

“If we look at our program, we believe we have a very effective drug with a very positive benefit risk profile,” J&J; Vice President Peter Wildgoose said in an interview last week.

J&J; is studying the drug in more than 60,000 patients for additional uses, including stroke prevention and treatment of coronary artery disease.

If the drug is approved, Johnson & Johnson’s Ortho-McNeil business will sell the drug in U.S., while Bayer HealthCare AG will have marketing rights in other countries.

Shares of New Brunswick, N.J.-based J&J; fell $1.18, or 2.3 percent, to $49.56 in morning trading.

Copyright 2009 The Associated Press.

By TOM MURPHY and MARLEY SEAMAN
AP Business Writers

INDIANAPOLIS (AP) _ Drugmaker Eli Lilly & Co. cleared another legal cloud hanging over its top-selling drug Zyprexa when it announced a $62 million settlement Tuesday, but several other storms are still brewing for the antipsychotic medication.

Lilly agreed to pay 32 states and Washington, D.C., to resolve an investigation into the company’s marketing practices.

Attorneys general from several states had accused Lilly of marketing Zyprexa for off-label uses and inadequately disclosing the drug’s side effects to health care providers, the same claims made in reams of other litigation against the drugmaker.

Lilly was accused of marketing the drug for pediatric care, for use at a high dose and for the treatment of dementia, according to a statement from the Indiana attorney general’s office. Doctors are free to prescribe drugs for uses not approved by the FDA, but drug companies cannot market them for those situations.

The company did not admit wrongdoing in the settlement.

Tuesday’s settlement will be divided among the states and the district based on population, said Greg Zoeller, Indiana’s chief deputy attorney general. Indiana, for instance, will receive $1.6 million.

Lilly also agreed to several mandates that will last until 2014, well beyond Zyprexa’s patent expiration in 2011. The company agreed to avoid making false, misleading or deceptive claims about the drug and not to promote it outside FDA-approved uses.

The drugmaker also agreed to give its medical staff, not the marketing staff, ultimate responsibility for approving the content in “all medical letters and medical references regarding Zyprexa,” according to the Indiana attorney general’s statement.

“The one thing that’s really key here is they’ve agreed to have a much more transparent system,” Zoeller said.

However, Lilly spokesman Phil Belt said many of the items his company agreed to were things it either already did or was in the process of doing.

“There’s no admission of wrongdoing, there’s no dramatic changes in the way we’re doing business,” he said.

He said Lilly agreed to the settlement to avoid being wrapped up in litigation and other things it deems counterproductive to drug development.

“We think its better for Lilly, better for patients, better for prescribers to have this kind of activity behind us,” he said.

Lilly said it will take a related charge of 4 cents per share in the third quarter for the settlement.

The states involved in Tuesday’s settlement are Alabama, Arizona, California, Delaware, Florida, Hawaii, Illinois, Indiana, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Missouri, Nebraska, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington and Wisconsin, as well as the District of Columbia.

Zyprexa rang up $4.8 billion in sales last year. But Lilly also has settled more than 31,000 product liability claims against the drug since 2005, shelling out more than $1.1 billion in the process.

Last year, Lilly paid $15 million to settle a lawsuit with the state of Alaska in March. The drugmaker still faces litigation with 11 states, generally involving consumer protection issues or Medicaid reimbursement. These cases are separate from the settlement announced Tuesday.

Those states include Arkansas, Connecticut, Idaho, Louisiana, Mississippi, Montana, New Mexico, Pennsylvania, South Carolina, Utah and West Virginia.

The U.S. Attorney’s office for the Eastern District of Pennsylvania also is investigating Zyprexa marketing.

A group of insurance companies, unions and others are suing Lilly for billions of dollars, saying the drugmaker charged too much for Zyprexa and marketed the drug for off-label uses. A federal judge has recommended that Lilly settle that case and last month granted the plaintiffs class-action status.

All told, Lilly still faces about 185 product liability lawsuits involving 1,185 plaintiffs, according to its latest quarterly statement.

Lilly shares rose more than 3 percent to $39.73 in trading Tuesday.

Copyright 2008 The Associated Press.
Summary

By RICARDO ALONSO-ZALDIVAR
Associated Press Writer

WASHINGTON (AP) _ A top government health official rejected the idea of an immediate ban on cough and cold medicines for young children, saying it might cause unintended harm.

Food and Drug Administration officials at a public hearing Thursday said they need to gather more data on whether over-the-counter remedies are safe and effective for children ages 2-6.

The FDA is also worried that a ban — as sought by leading pediatricians’ groups — might only drive parents to give adult medicines to their youngsters.

“That is a concern for us,” said Dr. John Jenkins, who heads the FDA’s Office of New Drugs. “We do not want to do something that we think will have a positive impact, only to have an unintended negative. That could be an even worse situation.”

With a new cold season coming, pediatricians are urging the government to demand a recall of over-the-counter cough and cold medicines for children younger than 6. The effectiveness of the medicines in children was never scientifically established, critics say, and problems with the drugs send thousands of kids to the emergency room every year.

“When a treatment is ineffective, its risks — unless zero — always exceed its benefits,” Dr. Michael Shannon of Children’s Hospital in Boston told the FDA panel.

The FDA this year warned against giving OTC cold medicines to children younger than 2. At that time, officials said they expected to decide by spring on recommendations for youngsters up to 11. Now the agency is seeking more advice from doctors, industry and consumers — and officials are not giving a timetable for a decision.

U.S. families spend at least $286 million a year on such cough and cold remedies for children, according to the Nielsen Co. market research firm. In any given week the medicines are used by an estimated 10 percent of all children, with the biggest exposure among 2- to 5-year-olds, a recent Boston University report found.

But colds usually clear up on their own after a few days. Many doctors say rest and plenty of fluids are what it takes to get over a cold.

The industry says OTC medicines have been used for decades in treating kids’ colds and are safe for those older than 2. Nonetheless, manufacturers are planning to carry out new studies involving the most common ingredients in the medications. The companies voluntarily stopped selling cough and cold medicines for babies and toddlers last fall.

FDA advisers said that was not enough and recommended that the drugs not be used for children younger than 6. An expert panel said children older than 2 could keep taking the medications while studies are undertaken to settle scientific questions about safety and effectiveness.

It turns out that when the FDA set standards for cough and cold medicines some 30 years ago, no separate studies were done for kids.

Cough and cold medicines send about 7,000 children to hospital emergency rooms each year with symptoms ranging from hives and drowsiness to unsteady walking. Low doses of a medicine are not likely to cause a problem; the main risk comes from unintentional overdoses.

The same ingredients usually are found in different products. For example, giving a child a cough syrup and a decongestant could inadvertently lead to an overdose.

The Consumer Healthcare Products Association, which represents the manufacturers, says preventable errors are the problem, not the safety of the ingredients in the medicines. The industry is starting an educational campaign aimed at parents, doctors and day care providers on the importance of following directions and storing medicines in places where kids cannot get at them.

“The data clearly show a majority of adverse events are direct result of misuse of our products,” said Linda Suydam, who heads the industry group.

Baltimore health commissioner Dr. Joshua Sharfstein sought to reassure FDA officials worried about unintended consequences if the government moves to restrict the medications and parents start dispensing adult drugs to their preschoolers. Sharfstein said the state of Maryland saw an immediate benefit after OTC cough and cold remedies for tots were removed from store shelves last fall. Calls to poison control about problems with the medicines involving children younger than 2 dropped by 40 percent, from 99 to 60, in the first six months of this year when compared with 2007. Calls involving children 2 to 6 also dropped, but by much less.

“The feared increases in poisonings simply did not happen,” said Sharfstein. “In fact, the opposite occurred.”

Copyright 2008 The Associated Press.

By LINDA A. JOHNSON
AP Business Writer

TRENTON, N.J. (AP) _ Florida has joined eight other states in suing drugmaker Merck & Co. over what the state alleges was deceptive marketing of its former prescription painkiller Vioxx.

In a lawsuit brought by Florida Attorney General Bill McCollum, the state is seeking restitution for all money spent by state health programs on Vioxx, plus interest.

Florida’s Medicaid program alone spent more than $80 million on Vioxx, once a blockbuster arthritis treatment, between 1999 and 2004. Merck pulled Vioxx from the market four years ago after its own research showed the pill doubled risk of heart attack and stroke.

The lawsuit alleges that “Merck’s costly promotional campaign was intended to convince purchasers that the drug was not only safe, but that they should demand it from their healthcare professionals for pain treatment,” according to a statement from the attorney general.

The suit also seeks civil penalties of up to $10,000 for each time that Merck’s advertising caused a Vioxx purchase to be made, an amount that a court would have to determine, according to a spokeswoman for McCollum.

“The company also allegedly tried to intimidate physicians and researchers who questioned the safety of Vioxx,” the statement adds.

Merck spokesman Ron Rogers said Tuesday that Merck acted responsibly.

The Whitehouse Station, N.J.-based company said in a statement that Vioxx was an effective pain reliever and that the company carefully studied the drug and consistently made results of its studies available to U.S. regulators and the medical community.

“We intend to defend ourselves against the complaint,” Rogers said.

Alaska, Louisiana, Michigan, Mississippi, Montana, New York, Texas and Utah have previously brought similar suits, as has New York City.

Except for the Texas case, all those suits currently are pending in New Orleans under U.S. District Judge Eldon Fallon, who is overseeing the bulk of the massive Vioxx litigation, according to Rogers.

The litigation includes a $4.85 billion settlement that will end about 50,000 lawsuits by people alleging Vioxx caused heart attacks or strokes. Several thousand other lawsuits filed by people claiming other types of injuries from Vioxx also are pending, and Merck faces two personal injury class-action suits in Canada and a class action suit by shareholders seeking to recover losses on Merck stock.

Merck has already paid out $58 million under a settlement reached in May to end allegations its ads for Vioxx deceptively downplayed health risks. That settlement ended investigations by 29 states and the District of Columbia and also required Merck to submit all new TV commercials for its drugs to the Food and Drug Administration for review.

Merck shares rose 53 cents, or 1.7 percent, at $32.09.

Copyright 2008 The Associated Press.

By RICARDO ALONSO-ZALDIVAR
Associated Press Writer

WASHINGTON (AP) _ With a new cold season coming, the government is trying once more to decide what to do about over-the-counter medicines for kids’ coughs and sniffles. Doctors question the drugs’ benefits and worry about their risks.

Pediatricians are urging the Food and Drug Administration, which scheduled a public hearing Thursday on the issue, to demand a recall of the medicines for children younger than 6.

“Parents should know that there is less evidence than ever to support the use of over-the-counter cough and cold medicines for young children,” said Dr. Joshua Sharfstein, Baltimore’s health commissioner. “There is nothing that is holding the FDA back from asking for a voluntary recall now of products marketed to kids under 6.”

U.S. families spend at least $286 million a year on such cough and cold remedies for children, according to the Nielsen Co. market research firm. In any given week the medicines are used by an estimated 10 percent of all children, with the biggest exposure among 2- to 5-year-olds, a recent Boston University report found.

But colds usually clear up on their own after a few days. Many doctors say rest and plenty of fluids are what it takes to get over a cold.

The FDA this year warned against giving OTC cold medicines to children younger than 2. At that time, officials said they expected to decide by spring on recommendations for youngsters up to 11. Now the agency is seeking more advice from doctors, industry and consumers.

The industry says OTC medicines have been used for decades in treating kids’ colds and are safe for those older than 2. Nonetheless, manufacturers are carrying out new studies involving the most common ingredients in the medications. The companies voluntarily stopped selling cough and cold medicines for babies and toddlers last fall.

FDA advisers said that was not enough and recommended that the drugs not be used for children younger than 6. An expert panel said older children could keep taking the medications while studies are undertaken to settle scientific questions about safety and effectiveness.

It turns out that when the FDA set standards for cough and cold medicines some 30 years ago, no separate studies were done for kids.

Cough and cold medicines send about 7,000 children to hospital emergency rooms each year with symptoms ranging from hives and drowsiness to unsteady walking. Low doses of a medicine are not likely to cause a problem; the main risk comes from unintentional overdoses.

The same ingredients usually are found in different products. For example, giving a child a cough syrup and a decongestant could inadvertently lead to an overdose.

The Consumer Healthcare Products Association, which represents the manufacturers, says preventable errors are the problem, not the safety of the ingredients in the medicines. The industry is starting an educational campaign aimed at parents, doctors and day care providers on the importance of following directions and storing medicines in places where kids cannot get at them.

But Sharfstein said Maryland saw an immediate benefit after OTC cough and cold remedies for tots were removed from store shelves last fall. Calls to poison control about problems with the medicines involving children younger than 2 dropped by 40 percent, from 99 to 60, in the first six months of this year when compared with 2007. Calls involving children 2 to 6 also dropped, but by much less.

___

On the Net:

Food and Drug Administration background: http://tinyurl.com/3emy54

Copyright 2008 The Associated Press.

By LINDA A. JOHNSON
AP Business Writer

TRENTON, N.J. (AP) _ Merck & Co. will start cutting checks for former users of its withdrawn painkiller Vioxx next month after announcing Thursday that it will fund a $4.85 billion settlement expected to resolve roughly 50,000 lawsuits.

The decision marks the beginning of the end of the four-year legal saga, which began when cardiovascular side effects forced Merck to pull Vioxx off the market in 2004, triggering tens of thousands of lawsuits, sullying its once-spotless reputation and forcing out its then-chief executive.

The Vioxx case has cost Merck at least $6.38 billion, including more than $1.53 billion through March 31 on legal costs for defense research and individual trials, most of which it has won.

Vioxx, which was launched in 1999, brought Merck revenue of $2.5 billion at its peak in 2003and $1.3 billion in 2004. Merck has not been disclosing revenue from prior years.

On Thursday, Whitehouse Station, N.J.-based Merck said more than 97 percent of eligible claimants — 48,550 out of 49,960 — have enrolled in the settlement program, surpassing threshold levels the company required for the deal to proceed. Therefore, Merck said that on Aug. 4 it will waive its right to walk away from the deal reached with plaintiffs’ attorneys last fall.

“I’m just glad that it’s almost over,” said Evelyn Irvin Plunkett of Palm Coast, Fla., who sued Merck in 2003 over the May 2001 heart attack death of her first husband, Richard “Dickie” Irvin. “It’s just been a long, hard fight.”

Plunkett’s family had gone through a mistrial, then lost to Merck at a retrial and won the right to a third trial before being allowed to join in the settlement. She does not know how much she will receive.

Settlement amounts can run from the minimum of $5,000 up to a few million dollars. Payments will be decided by a complicated formula that factors in how serious a claimant’s injury was, how much Vioxx was taken and how many other risk factors the person had.

“Long-term users of Vioxx who had a very severe injury will be well compensated,” said lawyer Andy Birchfield, who served on the plaintiffs’ steering and negotiating committees.

He said the number of plaintiffs participating shows the settlement is a good one.

“This is a great day for the plaintiffs injured by Vioxx who will within weeks begin to receive compensation for their injuries,” said lawyer Chris Seeger, a member of the plaintiffs steering committee coordinating the massive litigation. “I couldn’t be happier for my clients.”

“We’re very pleased to be reaching this milestone because we feel it confirms the program is a good one and a fair one,” said Ted Mayer, Merck’s chief Vioxx lawyer.

Roughly 700 more plaintiffs are considering participating, so Merck has extended the deadline for them to enroll until Oct. 30, he said. About 700 more have not been located by their attorneys.

Former Vioxx users, or their survivors, are eligible for part of the settlement if the patient suffered a heart attack, stroke or death. They must have had pending lawsuits or tolling agreements, which suspend the statute of limitations, as of Nov. 9, 2007, the date the settlement was reached.

To ensure that the settlement ended the bulk of the lawsuits, the company had required participation from at least 85 percent of eligible claimants in four groups: those who had used Vioxx for more than 12 months, had a heart attack, had an ischemic stroke or died.

Merck will put $4.85 billion into the settlement fund over time, with the first $500 million payment scheduled for Aug. 6. The company took a charge for the full $4.85 billion last year.

Eligible claimants who enrolled by March 31 and allege a heart attack or sudden cardiac death could then receive an interim payment, expected to be made by the end of August.

Interim payments to people alleging Vioxx caused an ischemic stroke are to begin in or after February 2009.

Mayer said several thousand additional claimants don’t have injuries eligible for the settlement and have been ordered by judges to produce expert reports supporting their claims.

“We expect to be making motions to dismiss a large number of those claims during the coming weeks and months,” he said.

Merck also faces about 260 potential class-action suits, alleging either harm or financial losses related to Vioxx, that still must be resolved.

Merck withdrew Vioxx from the market on Sept. 30, 2004, after its own research showed the once-blockbuster arthritis pill doubled the risk of heart attack and stroke.

U.S. District Judge Eldon E. Fallon in New Orleans, who has been coordinating much of the litigation, said it’s one of the country’s biggest multidistrict litigation cases — those assigned to one federal judge for pretrial purposes and possible settlement.

___

Associated Press writer Janet McConnaughey in New Orleans contributed to this report.

On the Web: http://officialvioxxsettlement.com

Copyright 2008 The Associated Press.