From the FDA:

On July 7, 2009, the Food and Drug Administration (FDA) announced actions it was taking to reduce the risk of overdose in people who use pain medications, such as Darvon and Darvocet. These medications contain the drug propoxyphene, which is linked to death from overdoses.

FDA finds there is evidence that propoxyphene can effectively treat pain at recommended doses. But because of the drug’s potential risks, the agency is requiring manufacturers to provide more information to help physicians and patients decide whether propoxyphene is the appropriate pain treatment.

FDA Actions

• FDA is requiring manufacturers of propoxyphene-containing products to strengthen the label’s boxed warning to emphasize the risk for overdose when using these products.
• FDA is requiring manufacturers to provide a medication guide (FDA-approved information that must be given to patients with each prescription or refill) to stress the importance of using the pain drugs only as directed.
• FDA is requiring a new safety study to find out more about the effects of propoxyphene on the heart at higher than recommended doses.
• FDA is planning to work with other federal agencies, such as the Centers for Medicare and Medicaid Services and the Department of Veterans Affairs, to conduct additional studies on the safety of products that contain propoxyphene as compared to other commonly used pain medications.
• FDA has denied a citizen petition from the public interest group Public Citizen requesting a phased withdrawal of propoxyphene.
• FDA will further evaluate the safety of propoxyphene and take additional regulatory action, if necessary.

Advice for Consumers

• Be aware of all the risks associated with pain medication, including propoxyphene, when making decisions on how to treat pain. All pain medicines have side effects.
• Talk to your health care professional to decide on the appropriate pain treatment for you if you need relief from pain.  

***Update***

Press Release on the NHTSA Roadside Survey of Alcohol and Drug Use.

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From The Christian Science Monitor:

Americans seem to have finally gotten the message: It's not OK to drive while drunk. But driving on drugs appears to be another matter and a significant problem.

The National Highway Traffic Safety Agency (NHTSA) on Monday released the results of its 2007 Roadside Survey of Alcohol and Drug Use. It found that the share of Americans driving while intoxicated on weekend nights is at a low of 2.2 percent. That's down 71 percent from the mid-1970s, when the survey was first conducted. Back then, 7.5 percent of the drivers surveyed had blood alcohol-content levels higher than the legal limit.

That's the good news. But for the first time, the survey also looked at drug use late on weekend nights. It found that 16.3 percent of drivers had traces of drugs in their system, including marijuana, cocaine, and various stimulants, sedatives, antidepressants, and narcotics. But the survey's authors cautioned that it was difficult to tell from the findings whether the drivers were impaired, because traces of some drugs like marijuana can be found weeks after a chronic user has stopped taking the drug.

For years, law-enforcement officials have encountered drivers who seemed to be impaired but did not test positive for alcohol. That prompted the NHTSA to start research on how drugs can affect an individual's ability to drive safely. One issue still to be resolved is how to test for, and find a safe driving threshold for, drugs that can stay in a person's system for days or even weeks.

"We know what that threshold is for alcohol, and states have universally set 0.08 blood alcohol content as the limit," Mr. Tyson says. "We still have a lot of research to do and a lot to learn in terms of what impact drugs have on your system and at what point a driver is too impaired by drugs to be behind the wheel."

For groups like Mothers Against Drunk Driving (MADD), which has been working to get intoxicated drivers off the roads and to educate young people since 1980, the survey results on drunken driving are encouraging.

Mr. Griffin says that MADD does have "major concerns" about the number of people driving under the influence of drugs, but the group will keep its focus on drunken driving.

From The Associated Press:

LOS ANGELES (AP) — A maker of the potent anesthetic propofol found in Michael Jackson's home has been contacted by federal officials investigating the pop star's death and has recalled tens of thousands of vials of the drug after two tainted lots sickened dozens of patients.

There is no apparent connection between the bacterial contamination that prompted the recall and Jackson's death. Teva Pharmaceuticals spokeswoman Denise Bradley told The Associated Press on Tuesday.

Propofol usually is administered intravenously in hospitals to patients who need to be unconscious for surgery or other procedures.
Teva announced it was recalling two lots of propofol — 57,620 vials in all — after concluding bacterial contamination caused up to 40 patients in Florida, Arizona and Missouri to develop fevers and chills since May. Investigators believe vials were distributed nationally and are urging doctors not to use any propofol from the two lots.

FDA investigators arrived Monday at the Teva plant in Irvine, Calif., where the suspect lots were made and were looking for any irregularities in the manufacturing process, Riley said.

Investigators believe that bacteria in vials of the anesthetic released toxins into the drug which caused the fever, Srinivasan said.

From The Washington Post:

Legal experts and prosecutors are concerned about the results of last month's U.S. Supreme Court ruling that requires lab analysts to be in court to testify about their tests. Lab sheets that identify a substance as a narcotic or breath-test printouts describing a suspect's blood-alcohol level are no longer sufficient evidence, the court ruled. A person must be in court to talk about the test results.

The opinion, written by Justice Antonin Scalia, has prosecutors and judges shaking their heads in disgust and defense lawyers nodding with satisfaction at the notion that the Constitution's Sixth Amendment guarantee that defendants "shall enjoy the right . . . to be confronted with the witnesses against him" is not satisfied by a sheet of paper.

"This is the biggest case for the defense since Miranda," said Fairfax defense lawyer Paul L. McGlone, referring to the Supreme Court ruling that required police to inform defendants of their Fifth Amendment right against self-incrimination. He said judges "are no longer going to assume certain facts are true without requiring the prosecution to actually put on their evidence."

States and counties across the country handle evidence differently, so the problems caused by the ruling vary widely. But many jurisdictions have a similar issue: Crime labs that test drug and DNA samples face huge backlogs even when scientists and analysts do not have to testify. If the workers are taken out of the labs to appear in court, those backlogs will grow.

In drug cases, more than 1.5 million samples are analyzed by state and local labs each year, resulting in more than 350,000 felony convictions, national statistics show. "Even if only 5 percent of drug cases culminate in trials, the burden on the states is oppressive," a group of state attorneys general wrote in a brief for the case.

The percentage of cases going to trial could well go up if defense lawyers think that bringing lab analysts to court will help their cases. Lawyers also could go to trial with the hope of a dismissal if the analyst cannot be there.

In Prince George's County, lab analysts testify regularly, but the volume of cases is so great that "we still are not able to process all the drug cases," State's Attorney Glenn F. Ivey said. "There's a triage going on in court cases. Some marijuana cases don't get tested, and we end up throwing them out."

Then there are the big rural states, where crime labs are hours away from many county courthouses. "It'll have a huge impact," said Ladd Erickson, state's attorney in McLean County, N.D. "It's not volume as much as it is distance. For some counties, round trip is going to be 10 to 12 hours to testify" for the lab analyst to travel to court.

Burns said 42 states and the District are affected by the Supreme Court case, Melendez-Diaz v. Massachusetts.

The court might be looking to blunt the impact. It has agreed to hear an Alexandria case that could provide prosecutors with an escape hatch from the requirement of bringing lab analysts to court. The court will rule on whether Virginia's law requiring the defense to provide advance notice when it wants the lab analyst to testify is constitutional. But a ruling on that case probably will not come until next year, and many lawyers believe Virginia's law is deficient.

In Manhattan, a unique situation in the medical examiner's office could result in disaster for homicide cases, Chief Assistant District Attorney Mark Dwyer said. The personnel turnover in the medical examiner's office is so great that the pathologist who performs an autopsy on a victim often is not still employed there 18 months later, when the case goes to trial. So the accepted practice in courts has been to admit the autopsy report without any testimony by the person who determined the cause of death, Dwyer said.

In addition, New York's DNA lab uses an assembly line approach in which as many as 12 people have roles in breaking down and analyzing a piece of evidence for traces of DNA, Dwyer said. "We would be extremely concerned if the [Melendez] issue extended into DNA analysis and autopsy reports," he said. "That would have a major and negative impact on the ability to process serious cases."

In drunken driving cases, Fairfax also faces a problem. In most DWI cases, the county uses breath-test technicians stationed in the jail to perform the blood-alcohol tests rather than the arresting officers so the entire 1,300-officer force does not have to be trained on the machines. But there are only a few dozen technicians in Fairfax processing about 4,000 DWI cases a year. Training Virginia's largest police force on the machines is not feasible financially, spokeswoman Mary Ann Jennings said.

"I think the effect of this could be very, very bad for public safety," said Fairfax Commonwealth's Attorney Raymond F. Morrogh. "If we are not able to use this evidence, which is reliable, but it's excluded because we can't get the technician here, the guilty will go free. It's a real challenge for us to deal with it." Fairfax is asking for continuances in any case with a Melendez-Diaz challenge. Loudoun County also is asking for continuances.

On Friday, state Sen. Ken Cuccinelli (R-Fairfax), a candidate for attorney general, called for a special session of the General Assembly to amend Virginia's law. His proposal would require defendants to provide advance notice that they object to a lab analysis, and then prosecutors would have enough time to bring in the technician.