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Dangers of Synthetic Cannabis

Synthetic cannabis, often called spice, has become increasingly popular in high schools and on college campuses.  New research has demonstrated that the drug is capable of triggering schizophrenia/psychosis in a certain percentage of people using the drug, at virtually any dose. These episodes of schizophrenia pass when the effects of the drug has worn off, but the long-term effects of this drug remain to be seen. The public must be educated about the use of synthetic cannabis and the risk of developing serious mental illness.  The following newsbrief from Medscape summarizing a presentation from the American Academy of Addiction Psychiatry annual meeting summarizes these findings:

Read more: Dangers of Synthetic Cannabis

Sofosbuvir for Hepatitis C has been approved by the FDA

Hepatitis C is a chronic, ultimately terminal liver condition.  Liver transplants are often necessary to prolong life.  The medical treatment for this condition is anti-viral drugs.  Recently, the FDA approved an entire new class of drugs to treat Hepatitis C, and it stands to dramatically improve patient outcome.  The following is a news report on this new class of drugs, and the specific drug, Sofosbuvir, the FDA has just approved.

Read more: Sofosbuvir for Hepatitis C has been approved by the FDA

Zohydro ER is dangerous

Prescription narcotic abuse is a major public health problem.  Physicians prescribe too much oral narcotic medication.  The most popular short-acting narcotics are indicated for the relief of acute pain, but are not a good option for long-term chronic pain management.  The long-term use of these medications result in opioid tolerance, dependency, and addiction.  The over-prescribing and inappropriate use of oral narcotic medication is an important substance abuse issue that is now being vigorously dealt with by state and federal governments as well as independent medical associations.  

The following is a Medscape news brief about the latest drug, Zohydro ER which will for sure exacerbate the problem:

The attorneys general of 29 states and territories have sent a letter to the US Food and Drug Administration (FDA) asking that the agency consider reversal of its recent approval of a single-entity extended-release hydrocodone product (Zohydro ER, Zogenix Inc).

The letter is addressed to Margaret Hamburg, MD, FDA Commissioner of Food and Drugs.

"We believe your approval of Zohydro ER has the potential to exacerbate our nation's prescription drug abuse epidemic because this drug will be the first hydrocodone-only opioid narcotic that is reportedly 5 to 10 times more potent than traditional hydrocodone products, and it has no abuse-deterrent properties," the attorneys general write.

"We hope that the FDA either reconsiders its approval of Zohydro ER, or sets a rigorous timeline for Zohydro ER to be reformulated to be abuse-deterrent while working with other federal agencies on how Zohydro ER can be marketed and prescribed," they conclude. "Law enforcement officers, public health workers, and substance abuse treatment providers are just now beginning to stem the tide of prescription drug addiction. We do not want to see their dedicated work undone."

Asked for comment, the FDA press office told Medscape Medical News that the agency is reviewing the letter and plans to respond directly to the attorneys general.

On November 1, Zogenix announced a new collaboration with Altus Formulation Inc to develop an abuse-deterrent formulation of Zohydro ER.

A "Vicious Cycle"

Zohydro ER was approved in October "for the management of pain severe enough to require daily around-the-clock long-term treatment and for which alternative options are inadequate," the FDA said in a statement at that time.

"Zohydro ER will offer prescribers an additional therapeutic option to treat pain, which is important because individual patients may respond differently to different opioids," the FDA statement said. "Due to the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with ER/LA [extended-release/long-acting] opioid formulations, Zohydro ER should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain."

The decision to approve the product had many puzzled, both because the FDA's decision went against the recommendation of the agency's advisory panel and because of its proximity to another decision, to reschedule all other combination hydrocodone formulations, including the hydrocodone-acetaminophen combo Vicodin, from Schedule III to Schedule II, increasing security measures associated with its use in an effort to reduce misuse.

"By early December, FDA plans to submit our formal recommendation package to HHS [US Department of Health and Human Services] to reclassify hydrocodone combination products into Schedule II," Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said in a statementposted on the FDA Web site October 24.

The approval of Zohydro ER was "more shocking to me than this announcement," Edward Michna, MD, member of the American Pain Society, told Medscape Medical News at that time. That these 2 events happened back-to-back is "kind of odd," added Dr. Michna, who is director of the Pain Trials Center at Brigham and Women's Hospital and assistant professor at Harvard Medical School, both in Boston, Massachusetts.

"Zohydro is another drug that doesn't have abuse-deterrent technology; so you have another opioid in high dose that is going to be released [in the midst] of pressure on drug companies to develop abuse-deterrent drugs," Dr. Michna noted.

Signing the letter addressed to the FDA are attorneys general from Alaska, Arizona, Arkansas, Connecticut, Delaware, Florida, Georgia, Guam, Hawaii, Illinois, Indiana, Iowa, Kentucky, Maine, Maryland, Massachusetts, Michigan, Mississippi, Nevada, New Hampshire, North Carolina, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Utah, Vermont, and Washington.

What they don't want, they write, is "a repeat of the recent past, when potent prescription painkilling drugs entered the market without abuse-deterrent qualities and without clear guidance on how they were to be prescribed. This created an environment whereby our nation witnessed a vicious cycle of overzealous pharmaceutical sales, doctors over-prescribing the narcotics, and patients tampering with these drugs, ultimately resulting in a nationwide prescription drug epidemic claiming thousands of lives."

FDA Adds 8 Drugs to Watch List

The US Food and Drug Administration (FDA) has added 8 drugs to its list of products to monitor because of possible signs of serious risks or new safety information. The drugs treat conditions that include cancer, epilepsy, hypertension, and malaria.

The agency spotted yellow flags for the 8 drugs in the FDA Adverse Event Reporting System (FAERS) database during April, May, and June 2012.

Making the FDA's watch list does not mean that the agency has concluded that the drug actually poses the health risk reported through FAERS, formerly known as AERS. Rather, the agency will study the drug to determine whether there is truly a causal link. If it establishes a link, the FDA then would consider a regulatory response such as gathering more data to better characterize the risk, revising the drug's label, or requiring a risk-evaluation and mitigation strategy.

The FDA also is not suggesting that clinicians should stop prescribing watch-list drugs, or that patients should stop taking them, according to an agency press release.

Potential Signals of Serious Risks/New Safety Information Identified by FAERS, April to June 2012

Product Name: Active Ingredient (Trade) or Product Class

Potential Signal of a Serious Risk/New Safety Information

Additional Information (as of August 1, 2012)*

Cetirizine HCl (Zyrtec, McNeil)

Oculogyric crisis

 

Codeine sulfate

Respiratory depression or arrest resulting in death in children taking codeine who are CYP2D6 ultra-rapid metabolizers

FDA Drug Safety Communication

Docetaxel (Taxotere, sanofi-aventis)

Drug interaction with dronedarone HCl resulting in death

FDA decided that no action is necessary at this time based on available information.

Fluoroquinolone products

Retinal detachment

 

Levetiracetam (Keppra, UCB)

Potential for drug abuse, misuse, or dependence

 

Mefloquine HCl (Lariam, Roche)

Vestibular disorder

 

Olmesartan medoxomil (Benicar, Daiichi Sankyo)

Malabsorption resulting in severe diarrhea and weight loss

FDA is continuing to evaluate this issue to determine if the current labeling, which contains information about diarrhea, is adequate.

Proton pump inhibitors

Pneumonia

 

* Unless otherwise noted, the FDA is continuing to evaluate these issues to determine the need for any regulatory action.

More information on FAERS and its quarterly watch list is available on the FDA Web site.

Acetaminophen Causes Asthma in Children

The following is a report from the NY Times based on research implicating Acetaminophen (Tylenol) in the development of childhood asthma.  This has wide reaching toxicologic and pharmacologic implications because of the increase in childhood asthma over the past few decades.

Read the entire article by clicking here

Sublingual Fentanyl for Chronic Pain

Sublingual Fentanyl has just been released and is a new addition to other preparations including patch and lollypop.  It is a big developement for chronic pain control, particularly in cancer patient.

Read more: Sublingual Fentanyl for Chronic Pain

Blood Lead Level Limits to be Lowered

For the first time in 20 years the EPA and CDC are primed to lower acceptable blood lead levels from 10 mcg/L down to 5 mcg/L based on ongoing research establishing that blood lead levels between 5 and 10 mcg/L are deleterious to the developing brains of children.

You can see the news by clicking here

Anti-Arrythmic Causes Unexpected Deaths

FDA Puts New Warnings on Dronedarone

Reed Miller

Posted: 12/19/2011

December 19, 2011 (Silver Spring, Maryland) — The FDA is requiring new safety warnings to be included on the labeling for the antiarrythmic drug dronedarone (Multaq, Sanofi-Aventis) in light of clinical data showing the drug increases the risk of serious cardiovascular events, including death, in patients with permanent atrial fibrillation (AF) [1].

The agency is adding the following revisions and recommendations to the drug's label: Healthcare professionals should prescribe the drug only to patients who can be converted into normal sinus rhythm, and the drug should be discontinued in patients in AF. Healthcare professionals should monitor the heart rhythm of patients taking dronedarone by ECG at least once every three months.

Dronedarone is indicated to reduce hospitalization for AF in patients in sinus rhythm with a history of paroxysmal or persistent AF. Patients on dronedarone should also be on appropriate antithrombotic therapy, the FDA insists.

The FDA issued the new labeling after reviewing data from the Permanent Atrial Fibrillation Outcome Study Using Dronedarone on Top of Standard Therapy (PALLAS) study. As reported by heartwire , PALLAS was a randomized trial of dronedarone in high-cardiovascular-risk patients with permanent atrial fibrillation that was stopped early when an interim analysis showed a significant increase in CV events in patients on the drug. The FDA also reviewed data from the pivotal ATHENA trial, which showed a 24% reduction in the primary end point of death or cardiovascular hospitalization over 21 months in lower-risk patients with recent paroxysmal or intermittent AF.

The FDA says it is still reviewing the risk evaluation and mitigation strategy for dronedarone and will determine what changes may be necessary to ensure that the benefits of the drug outweigh the risks.

As reported by heartwire , the European Medicines Agency (EMA) recently recommended that dronedarone "should only be prescribed after alternative treatment options have been considered."

References

  1. Food and Drug Administration. FDA drug safety communication: Review update of Multaq (dronedarone) and increased risk of death and serious cardiovascular adverse events [press release]. December 19, 2011. Available here.

 

Sublingual Ambien for Mid-Night Awakening

Insomnia, characterized by difficulty falling asleep or staying asleep, is a highly prevalent condition. On the basis of duration and frequency, insomnia can be classified ranging from mild to severe. Adverse consequences of insomnia may include excessive daytime sleepiness; lack of energy; anxiety; depression; irritability; and difficulty focusing on tasks, paying attention, learning, and remembering.

Zolpidem tartrate was first approved in the United States in 1992 as the drug Ambien. The newly approved formulation (Intermezzo) is a lower dose than Ambien, but it is still a federally controlled substance because of its potential for abuse or dependence.   The drug is first approved drug for people who wake in the middle of the night and can't fall back asleep.  The FDA advises that the individual should have at least 4 hours of sleep time remaining before they have to get up.

This new drug preparation is discussed in a recent Medscape issue for physicians.

Read more: Sublingual Ambien for Mid-Night Awakening

Bath Salts Banned by the DEA

In the wake of a growing number of overdose visits to emergency departments, the US Drug Enforcement Administration (DEA) has moved to make psychoactive "bath salts" (PABS) a controlled substance.

In a statement released today, the DEA announced it is using its emergency scheduling authority to temporarily control methylenedioxypyrovalerone and 2 other synthetic stimulants: mephedrone and methylone.

As of September 7, 2011, possessing and selling these chemicals or the products that contain them are both illegal in the United States for at least 1 year while the DEA and the US Department of Health and Human Services mull over whether the substances should be permanently controlled.

To get the full story from Medscape:  Click here

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