Dr. Gustin's Blog

Synthetic Cannabis Linked to Schizophrenia

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: Synthetic Cannabis Linked to Schizophrenia

FDA approves "game-changer" Hepatitis C drug

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: FDA approves "game-changer" Hepatitis C drug

Raw Milk is Hazardous to Health

In your local health food store or chain market you might come across "raw milk" products.  Recent research has demonstrated that these products might be hazardous to human health.  The following article is a synopsis of a study published in December 2013 issue of Emerging Infectious Disease Journal.

Read more: Raw Milk is Hazardous to Health

New Dangerous Narcotic Medication

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."

The FDA Revises Ambien Dosing Guidelines

Ambien is the most common sleeping medication at the present time.  Unfortunately, although Ambien is usually quite effective at facilitating sleep, it also has been found to have several disturbing side effects, including tolerance, addiction, and somambulism.  Recently the FDA has revised its dosing guidelines on how the medication should be used.  The news brief follows:

Read more: The FDA Revises Ambien Dosing Guidelines

Ambien and Toxicology

Ambien (zolpidem) is currently the most commonly used sleeping medication on the market. Most physicians believe, unknowingly, that it can be prescribed with impunity.  This is not the case.  Ambien has many side effects that have resulted in a big increase in visits to emergency departments.

Read more: Ambien and Toxicology

Amitiza for Opioid-Induced Constipation

The FDA finally approved a new drug which ameliorates the severe constipation that accompanies the use of Opiates.  Constipation is one of the main side effects that causes individuals to stop Opiate medication prematurely without any other option for their pain.  This addition to treatment with opiates is a notable advancement.

Read more: Amitiza for Opioid-Induced Constipation

"Spices" and Synthetic Cannabinoids

The following article is printed in its entirety from the Journal of Emergency Medicine, February, 2013.  Those of us who attend high volume emergency rooms have seen a recent spike in drug-related overdoses connected to the ingestion of "spices" laced with synthetic cannabinoids.  The article that follows will provide a basic understanding of this new toxic exposure in our communities.

Read more: "Spices" and Synthetic Cannabinoids

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