An analysis published by the National Center for Health Statistics found that opioid painkillers like morphine, hydrocodone (sold as Vicodin and other brands) and oxycodone (Percocet and other brands) were involved in more than 40 percent of drug poisonings in 2008. These drugs were implicated in more poisoning deaths than heroin or cocaine.

Opioid analgesics accounted for 14,800 of the 36,500 fatal drug poisonings in 2008. About 12,400 people died after taking other kinds of drugs, and for 25 percent of the cases where drugs were listed as a cause of death, no specific drug was mentioned.

There were considerable variations in rates of drug poisoning by age. The rate was highest among 45- to 54-year-olds, and people under 24 had the lowest rates of any group except those over age 65.

Non-Hispanic whites had higher rates of death from drugs than Hispanics, and rates among African-Americans were lower than both.

In 30 states, poisoning is the leading cause of injury death. New Mexico, West Virginia, Alaska, Nevada and Utah have the highest rates in the country.

The lead author of the study, Margaret Warner, a statistician with the federal agency, said that a multifaceted approach to solving the problem was needed, analogous to the various steps taken to improve traffic safety. Equipment improvements and law enforcement have combined to sharply reduce the rate of car crash deaths since 1980.

“The C.D.C. is doing some prevention work,” she said. “The Food and Drug Administration is looking at different regulations they can impose, and the Office of National Drug Control Policy is not just focusing on interdiction, but using a public health approach as well.”

According to the article, more than five million Americans in 2009-10 reported using pain relievers without a prescription or only for the feeling they caused.

According to federal figures, treatments for the abuse of prescription painkillers has risen 430 percent over the last 10 years. Now four companies are studying a new pain reliever that is said to be 10 times more powerful than Vicodin, and addiction experts are concerned about the potential of further abuse.

A pure version of the addictive ingredient hydrocodone is included in Zohydro, which is a timed-release drug intended for use in treating moderate to severe pain.

According to CBS News, hydrocodone is listed among the group of drugs including morphine, oxycodone, codeine, heroin, and methadone. These drugs are all chemically similar to opium.

April Rovero, the president of the National Coalition Against Prescription Drug Abuse said, according to an Associated Press report on Fox News, “I have a big concern that this could be the next OxyContin.” The Drug Enforcement Agency said oxycodone has become the most-abused medicine in the United States, and hydrocodone is right behind. Drug abusers found they could beat the timed-release by crushing the pills.

Zogenix, a company from San Diego, wants to begin marketing Zohydro in early 2013. Their chief executive, Roger Hawley, claims Zohydro will be safer than Vicodin because Vicodin contains acetaminophen, which can hurt the liver through high doses, according to Mail Online. Also, the drug companies are saying patients will be watched closely because they have to return to their doctors for every refill they may need.

The other three companies doing the research, Perdue Pharma, Cephalon, and Egalet will be developing their own versions of the product.

The commissioner of the Food and Drug Administration on Friday revoked the approval of the drug Avastin as a treatment for breast cancer, ruling on an emotional issue that pitted the hopes of some desperate patients against the statistics of clinical trials.

The commissioner, Dr. Margaret A. Hamburg, said that clinical trials had shown that the drug was not helping breast cancer patients to live longer or to meaningfully control their tumors, but did expose them to potentially serious side effects like severe high blood pressure and hemorrhaging.

“Sometimes, despite the hopes of investigators, patients, industry and even the F.D.A. itself, the results of rigorous testing can be disappointing,” Dr. Hamburg told reporters Friday. “This is the case with Avastin when used for the treatment of metastatic breast cancer.”

Avastin will remain on the market as a treatment for other types of cancers, so doctors can use it off-label for breast cancer. But insurers might no longer pay for the drug, which would put it out of reach of many women because it costs about $88,000 a year.

Federal officials said on Friday that Medicare would still provide coverage for the drug’s use in breast cancer, though the government plans to “monitor the issue and evaluate coverage options.”

Medicare is obligated to pay for off-label use of cancer drugs that are listed in certain references, like the one published by the National Comprehensive Cancer Network, an organization of major cancer hospitals. In July a committee of breast cancer specialists from those centers reaffirmed that Avastin should remain listed as “an appropriate therapeutic option for metastatic breast cancer.” A third of the committee members had financial ties to Genentech, according to Dr. Hamburg’s memorandum.

Many breast cancer specialists say that Avastin does appear to work very well for some patients, and some advocates have said the drug should be left on the market for the sake of those patients. But Dr. Hamburg said there was no way to determine in advance who those patients were, so many women would use the drug. “The evidence does not justify broad exposure to the risks of this drug,” she wrote.

From the American Association for Justice news release.

Pfizer’s smoking cessation drug Chantix carries too many risks and should only be tried when other treatments fail, researchers said.

Chantix was eight times more likely to be linked with a reported case of suicidal behavior or depression than other nicotine replacement products, such as the nicotine patch, they said.

The findings contradict two studies released last month by the Food and Drug Administration that showed Chantix (sold as Champix outside the United States) did not increase the risk of being hospitalized for psychiatric problems such as depression.

The agency at the time acknowledged that those studies were flawed because they were too small to identify rare events and they only captured cases that were severe enough to land people in the hospital

“Our study contradicts the implications of a recent review by the FDA showing no difference in psychiatric hospitalizations between varenicline and nicotine replacement patches,” said Dr. Curt Furberg, professor of Public Health Sciences at Wake Forest Baptist Medical Center, co-author of the study published online in the Public Library of Science journal PLoS One.

“The FDA hospitalization studies were flawed because they could not capture most of the serious psychiatric side effects, including suicide, depression, aggression and assaults. These can be catastrophic events but do not normally result in hospitalization,” Furberg said in a statement.

CHANTIX VS ZYBAN

The new study relies on adverse events from the FDA’s Adverse Event Reporting System from 1998 through September 2010. They analyzed 3,249 reports of serious self-injury or depression linked to Chantix (varenicline), GlaxoSmithKline’s Zyban (bupropion) antidepressant that was approved for smoking cessation and nicotine replacement products.

They found that 2,925 cases, or 90 percent, of suicidal behavior or depression reported to the FDA were related to Chantix, even though the drug was only approved for four of the nearly 13 years of data included in the study.

By comparison, there were 229 cases of suicidal behavior or depression related to bupropion and 95 cases related to nicotine replacement products.

“We found that Chantix is associated with more suicidal behavior reports than any other smoking-cessation drug on the U.S. market. The risks simply outweigh the benefits,” Furberg said.

Prior studies by Furberg and colleagues have shown Chantix increases the risk of heart problems, unprovoked aggression, and sudden blackouts.

“There were reports of people driving cars and blacking out,” said Furberg. He and fellow researchers were so concerned about this side effect that they took their findings to the Federal Aviation Administration, which banned pilots from using Chantix in 2008.

Of course, tobacco use also has serious risks. It is responsible for one in five deaths in the United States each year and adds $193 billion to health care costs.

NBC Nightly News reported, “While the experts keep trying to learn more about what causes miscarriages, and how to prevent them, a new study of 47,000 women has found one more piece of the puzzle that women may want to consider, and it involves some big brand name pain relievers that are in so many of our homes in this country.” NBC added, “Some of the most popular over-the-counter pain relievers, so-called NSAIDs, could be cause for concern early in pregnancy including ibuprofen…and naproxyn.” These drugs “already carry warnings against use late in pregnancy, but the study out today from the team of University of Montreal, shows that taken early in pregnancy during the first 20 weeks, the drugs may more than double the risk of miscarriage.”

The Los Angeles Times reports in its “Booster Shots” blog, “The greatest risk was among women who had taken diclofenac, and the lowest among women who had taken rofecoxib alone.” It also notes that “some previous studies on the connection between non-steroidal anti-inflammatory drugs and miscarriage or birth defects have shown a link,” including “a 2003 study in the British Medical Journal” that linked NSAIDs “with an 80% greater risk of miscarriage,” though “a subsequent BMJ study found the data flawed.” The current study is published in the Canadian Medical Association Journal.

Medscape says that the study “analyzed associations between different types and dosages of nonaspirin NSAIDs and spontaneous abortion using conditional logistic regression, with adjustment for confounding variables,” and found “no apparent dose-response effect.”

HealthDay reports that “Individual drugs had different risks associated with them, the highest being diclofenac, which tripled the risk, naproxen (Aleve), which involved a 2.64-times increased risk and ibuprofen (Advil, Motrin), which carried about double the risk.”

Reuters adds celecoxib to the list of NSAIDS, and notes that the study also suggests that NSAIDs may interfere with prostaglandin production.

From the American Association for Justice news release.

Bloomberg News adds that Sen. Charles Grassley (R-IA) “last year tried to force institutions to detail industry ties and post them to the Internet. Instead, the rules give the schools an option to disclose ties on a request-only basis.” Director Collins called the rules “a significant change and one that will further strengthen the integrity of the really remarkable scientific community that has been conducting research with, for the most part, the highest ethical standards.”

Reuters reports that in the past, institutions had only to keep track of conflicts of interest and to tell NIH that such conflicts had been addressed and that amounts less than $10,000 had not been considered conflicts. The rules will cover approximately 2,000 institutions and 38,000 scientists. Reuters cites several cases of conflicts of interest not being disclosed in the past.

The Wall Street Journal quotes Director Collins saying that research “needs an additional layer of oversight,” and explains that not only do the rules lower the amount that counts as constituting a conflict, but broadens the definition to include financial interests of a researcher’s immediate family and any of the researcher’s professional duties.

From the American Association for Justice news release.

MedPage Today reports, “Public Citizen filed a petition with the FDA formally requesting warnings…in the form of updated labels, patient medication guides, and ‘Dear Doctor’ letters.” It also “charged that many patients are taking PPIs without a clear need for them.” Many of the side effects “are already described in the current product labels, but Public Citizen said they should receive ‘the strongest possible warning.’”

ABC reported, “Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said he hopes stricter warnings will curb unnecessary use of the drugs.” Wolfe noted that while a number of risks are on the label, the risk of dependence “is not.” Dr. Jacqueline Wolf, associate professor of medicine at Harvard Medical School, said, “It’s absolutely true that too many people are on these medications.”

From the American Association for Justice news release.

Here are a few more excerpts from the article:

More than 80 percent of the active ingredients for drugs sold in the United States are made abroad, mostly in a shadowy network of facilities in China and India that are rarely visited by government inspectors, who sometimes cannot even find the plants.

Self-interest helped drive the agreement because the industry will not only get speedier approvals of new products as part of the deal but also may avoid scandals involving tainted medicines, which tend to hurt confidence in the entire industry.

At its present pace, the Food and Drug Administration would need more than 13 years to inspect every foreign drug plant exporting to the United States. Some plants have never been inspected, which saves them huge sums in cleanup and other compliance costs — an important reason that drug manufacturing is disappearing from the United States and that tainted-drug scandals occur.

In one infamous case, Chinese manufacturers deliberately substituted a cheap fake for the dried pig intestines used to make the blood-thinning drug heparin. The tainted drug was linked to 81 deaths and exposed tens of thousands of people to danger. The F.D.A. never inspected the plants making the crucial ingredients, a larger problem that only now, more than three years later, may be fixed.

The agreement will not affect the making of over-the-counter medicines or vitamins, whose global supply chains are even more vulnerable to tampering since government inspectors almost never visit their makers. Aspirin and vitamin C supplements, among others, are now made almost entirely in uninspected plants in China.

Nor will the agreement change the F.D.A.’s oversight of name-brand prescription medicines. Although branded drugs usually have more secure supply chains than those of generics, major pharmaceutical companies have moved aggressively into China in recent years and often rely on rarely inspected suppliers.

Federal officials for years have expressed concerns about the nation’s growing reliance on sometimes mysterious foreign drug suppliers, but they had largely despaired of fixing the problem. Congress has never given the F.D.A. the money needed to inspect these plants, and for nearly two decades the generic drug industry resisted proposals to pay inspection fees.

According to Dow Jones Newswire the change affects Extra Strength Tylenol sold in the US for which package labels starting this fall, will list the maximum daily dose as six pills (3,000 mg) down from eight daily pills (4,000 mg). Early next year, McNeil will reduce the maximum daily dose on labeling for Regular Strength Tylenol and other acetaminophen-containing products.

CNN in its “The Chart” blog, reported that the J&J unit said acetaminophen is in “more than 600 over-the-counter and prescription medications including common pain relievers and fever reducers,” such as NyQuil and Sudafed. Some people “accidentally exceed the recommended dose when taking multiple products at the same time, often…by not reading and following the dosing instructions,” said McNeil VP Dr. Edwin Kuffner.

Bloomberg News adds that McNeil said it is “working closely with fellow manufacturers to ‘ensure consistency in dosing instructions’ for acetaminophen.” Notably, the FDA in January, announced limits on the agents “use in prescription pills,” such as Percocet (acetaminophen and oxycodone) and Vicodin (acetaminophen and hydrocodone).

ABC News on its website noted that when the FDA “ordered drugmakers to reduce the amount of the painkiller in prescription medications by 50 percent, critics warned that prescription medications covered only 20 percent of the acetaminophen used in the US.”

From the American Association for Justice news release.