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Autism Tied to Valproate in Pregnancy

From MedPage Today:

Women who take valproate (Depacon) during pregnancy may increase the risk of childhood autism and its spectrum disorders in their children, a population-based study showed.

In utero exposure to the drug was associated with a five-fold elevated risk of autism and three-fold elevated risk for autism spectrum disorder, Jakob Christensen, PhD, of Denmark's Aarhus University Hospital, and colleagues found.

The American Academy of Neurology recommends avoiding valproate in pregnancy whenever possible due to cognitive and physical birth defect problems for children exposed in utero.

Posted: 4/24/2013 12:59:00 PM

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Abuse-resistant OxyContin will be only version available: FDA

From the Los Angeles Times:

Three years after it approved a version of the opioid analgesic OxyContin designed to discourage the painkiller's abuse, the Food and Drug Administration has effectively barred the original form of the drug from ever reaching the legal U.S. market. The agency says it will approve no new applications from generic drug manufacturers to produce cheaper versions of OxyContin in its original form.

OxyContin has been one of the nation's most abused prescription painkillers, in part because as those addicted to the potent drug built up tolerance for it, they could easily ground it up or dissolve it in water, making the potent extended-release drug easy to snort or inject for a faster, more intense high.

But in April of 2010, the FDA approved a reformulated version of the drug that was resistant to crushing, breaking, chewing or dissolving in water. The newer version is virtually unbreakable, and when dissolved in water, turns into a jelly-like mass.

Posted: 4/17/2013 10:55:00 AM

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No Substitute: When a Generic Drug Isn’t What it Seems

From ProPublica:

Andrew Richards remembers that he had just sat down in front of the TV when the lightning bolt struck. "It was almost like it went through my ear because I could hear it. It was kind of like, 'fwomp,' right through my head," he says.

Stunned and disoriented, Richards tried to get up, he says, but spasms rumbled through his torso and his back; his muscles kept clenching and relaxing. He doesn't recall falling. "It was almost like a little piece of time was missing, almost like a record skipped ahead a little bit," he says, "like I was sitting on my couch and time had moved forward and I was on the floor."

The next thing Richards remembers was calling out to his wife, who scooped him up and drove him to the emergency room. He would soon discover that the lightning bolt that struck him down was an electrical storm taking place entirely in his brain: a seizure. Less than a year later he was in court, contending that his seizure -- and the spasms that he says still plague him -- were caused by a faulty generic medication.

The drug Richards took is Teva Pharmaceutical USA's 300 milligram version of extended-release buproprion -- an antidepressant better known by its brand name, Wellbutrin XL. Shortly after Teva's generic Wellbutrin was approved by the FDA in 2006, patients began to complain that the drug wasn't working as well as the name-brand version. Some contended that it was causing more severe side effects.

Richards says he suffered his seizure in March 2008 after his pharmacy switched him to the Teva generic. Within a few days of starting the new pills, he says, he started to experience jolts and jerks.

Despite having stopped taking Teva's drug, Richards says he continues to have spasms several times a day. Richards, who was a lead plaintiff in a lawsuit against Teva, contends that it was a direct result of his taking Teva's generic Wellbutrin. The suit ended in a settlement in which Teva did not admit fault.

Posted: 4/17/2013 10:49:00 AM

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MS drug proves to help stroke patients walk again, study finds

From Fox News:

A phase II study proved a drug that helps multiple sclerosis patients walk can also help stroke patients walk, Medical News Today reported.

Acorda Therapeutics, which makes Ampyra (dalfampridine), said patients with post-stroke deficits – such as impaired walking, motor and/or sensory function and manual dexterity – showed significant improvement after taking the extended release tablets.

“There were clear efficacy signals in the dalfampridine-ER post-stroke deficits trial, and we therefore plan to proceed with a clinical development program for this indication,” said Dr. Ron Cohen, president and CEO of Acorda. “A top-line analysis of the data found dalfampridine-ER improved walking for people with mobility impairment resulting from ischemic stroke. Dalfampridine-ER treatment was also associated with a positive change versus placebo on a scale of functional independence in this study.”

Cohen said after the company analyzes more data, it will be in touch with the Food and Drug Administration so a much larger study can be conducted.

Posted: 4/16/2013 1:58:00 PM

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Dole, Del Monte, Gerber in court over lead warnings for baby food

From the Los Angeles Times:

Major baby-food makers such as Dole Food Co., Del Monte Foods Co. and Nestle’s Gerber business are going to court Monday to determine whether they need to warn consumers of certain lead levels in their products.

In a 2011 lawsuit, the Environmental Law Foundation alleged that some of the companies' foods and juices -- which included ingredients such as carrots, peaches, pears and sweet potatoes -- contained enough lead to warrant a consumer caution label under California's Proposition 65 toxins warning law.

The federal agency said that "even low levels of lead in the blood have been shown to affect IQ, ability to pay attention and academic achievement."

Posted: 4/8/2013 3:23:00 PM

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Common Heart Drug Associated With Increased Cancer Risk

From Medical News Today:

A drug known as amiodarone, used to treat heartbeat irregularities, could raise a person's cancer risk, according to new research published in the journal Cancer.

The study reveals that the risk, which the investigators described as "borderline significantly increased", is more prevalent in men and people who take greater doses of amiodarone.

Amiodarone was approved for use in 1985 for the treatment of arrhythmias, or irregular heartbeats. The medication is fat-soluble and breaks down slowly, leaving large amounts to build up in soft tissues after a long-term treatment period.

Earlier studies have indicated that amiodarone may elevate the risk of certain cancers, however, no large-scale study has investigated this issue.

The cancers shown to be associated with amiodarone were:
  • lung
  • ovaries
  • prostate
  • liver
  • digestive system
  • colon
Posted: 4/8/2013 3:16:00 PM

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Orioles RHP McCutchen suspended for positive test

From The Wall Street Journal:

Baltimore Orioles pitcher Daniel McCutchen has been suspended for 50 games under baseball's minor league drug program following a positive test for Methenolone and a metabolite of Trenbolone.

The suspension, announced Saturday, raised the total this year under the minor league program to 12.

Posted: 4/8/2013 12:33:00 PM

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Duloxetine May Ease Pain from Chemo

From MedPage Today:

The depression and anxiety drug duloxetine effectively treated painful chemotherapy-induced peripheral neuropathy, results of a phase III trial showed.

Over 5 weeks of treatment, patients receiving duloxetine experienced significantly larger mean decreases in pain as measured by the Brief Pain Inventory Short Form (BPI-SF) than did patients on placebo (1.06 versus 0.34, P=0.003), with a mean difference between the two groups of 0.73 (95% CI 0.26 to 1.20), according to Ellen Lavoie Smith, PhD, of the University of Michigan School of Nursing in Ann Arbor, and colleagues.

Additionally, more patients initially treated with duloxetine than with placebo reported pain decreases of any amount (59% versus 38%), they wrote online in the Journal of the American Medical Association.

Painful chemotherapy-induced peripheral neuropathy occurs in roughly 20% to 40% of patients treated with neurotoxic chemotherapy agents such as taxanes, platinums, and vinca alkaloids, Lavoie Smith and co-authors noted, adding that the condition can persist for years following completion of treatment and can induce functional and quality of life impairments.

Prior research has shown that serotonin and norepinephrine dual reuptake inhibitors such as duloxetine may be effective at treating pain associated with the condition, and duloxetine has been shown in other phase III trials to be effective in treating painful diabetic neuropathy.

More than half a million young children have lead poisoning under revised standard

From The Washington Post:

More than half a million U.S. children are now believed to have lead poisoning, roughly twice the previous high estimate, health officials reported Thursday.

The increase is the result of the government last year lowering the threshold for lead poisoning, so now more children are considered at risk.

Too much lead can harm developing brains and can mean a lower IQ. Lead poisoning used to be a much larger concern in the United States, but has declined significantly as lead was removed from paint and gasoline and other sources.

The new number translates to about 1 in 38 young children. That estimate suggests a need for more testing and preventive measures, some experts said, but budget cuts last year eliminated federal grant funding for such programs.

Posted: 4/8/2013 12:24:00 PM

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New definition of DUI adds tool for law enforcement

From the Trib Total Media:

In 2004, Pennsylvania changed its DUI laws to include the word “drug,” DUID, not just “controlled substances,” which traditionally covered only illegal drugs such as marijuana and cocaine.

And the number of DUID arrests has increased ever since.

In Pennsylvania in 2012, there were 50,000 DUI arrests. About 15,000, or 30 percent, of those were DUIDs, according to the Office of Pennsylvania Courts.

“The new law opened the floodgates to successfully prosecute any person impaired on any drug ranging from gasoline, bug and tar remover to designers drugs, prescription drugs,” said George Geisler, director of law enforcement services with the Pennsylvania DUI Association, eastern office in Harrisburg.

“Now, the new war is DUID,” said Cathy Tress, law enforcement liaison with the association.

A drug recognition expert and a police officer, Geisler trains police officers across the commonwealth to recognize the classic signs and symptoms of drug-impaired drivers.

“We examine drivers' eyes, their perception of time and distance, and then blood, pulse, body pressure and other indicators,” he said.

Geisler said, “We are looking at a tremendous switch to prescription drug abuse, over-the-counter drug abuse and of course, the designer drugs.”

Pennsylvania adopted the drug recognition expert program in 2004, the 39th state in the nation to do so, Geisler said.

Posted: 4/2/2013 2:57:00 PM

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