09/30/16

Chantix Tug-of-War

© AndreyPopov | stockfresh.com

© AndreyPopov | stockfresh.com

On May 18, 2008, George MacDonald was at Fort Benning Georgia. George and his identical twin brother James had successfully completed Infantry Training and the Airborne Course at Fort Benning. They had also been selected for the U.S. Military Academy Preparatory School. George was a one-time Eagle Scout. He got up from his bunk to do some laundry and slipped a knife into his pocket. He approached the bunk where Rick Bulmer, who he did not know, was sleeping. Then he stabbed and slashed Rick more than 50 times. A month before, MacDonald had been prescribed Chantix by an Army doctor to help him stop smoking.

Nine hours after the killing, Macdonald wrote: “I snapped and didn’t like it … I was stretched and it made me crazy.” The military judge refused to allow an involuntary intoxication defense and quashed a subpoena issued to Pfizer by MacDonald’s lawyer. Within a month of the judge’s decision, the FDA imposed a black box warning on Chantix. “Within weeks of the military trial judge’s decision in 2009 to quash the subpoena, Pfizer began getting hit with civil lawsuits claiming Chantix had caused suicides, suicide attempts or other neuropsychiatric problems.” MacDonald was convicted of premeditated murder in 2009 and sentenced to life without parole.

The U.S. Court of appeals for the Armed Forces overturned MacDonald’s conviction saying the trial judge had erred in not allowing the involuntary intoxication defense. MacDonald agreed to plead guilty to the unpremeditated murder of Rick Bulmer and his sentence was reduced to 45 years. Bulmer’s family was outraged, according to Tom Jackman writing for The Washington Post. “’It’s a mindblower, and we don’t understand it,’ said Bulmer’s mother, Wendy Smith. ‘He cold-bloodedly killed my son. He knew what he was doing and … he should take his punishment.’”

In a 2010 clemency request for his brother, James wrote that he remarked to his brother that life had started to feel like a video game, where he was disconnected from his body. James had also been prescribed Chantix. George agreed he felt the same way. James said, “I remember the two of us waking up at night having really weird dreams, scary dreams.” In 2013, James killed himself by jumping off of a 19-story building. His sister said he never got over his grief over his brother’s ordeal. You can read more about the MacDonald case here, here  and here on McClatchyDC.

George MacDonald is not alone is claiming that his use of Chantix led to violent acts. In the beginning of August 2016, a Maryland man was found not criminally responsible for shooting his wife in the neck because he was “involuntarily intoxicated” from Chantix. A woman who was taking medication for other reasons used Chantix briefly in 2007. She got her daughter off to school and the next thing she remembered was standing in her kitchen in a puddle of blood. Six hours has passed during which she had used a kitchen knife to cut her left arm. Federal prosecutors dropped charges against a man who “who extremely psychotic and disorganized” aboard a United Airlines flight because of a “Chantix-induced psychotic disorder.”

Al Jazeera reported that Chantix has been linked to 544 suicides and 1,869 attempted suicides.  As a result of a report issued by the Institute for Safe Medication Practices that said the organization had “immediate safety concerns” about individuals operating aircraft, trains buses and other vehicles who were using Chantix, the FAA and Defense Department banned Chantix use among pilots and air traffic controllers.

Eventually some 2,700 former Chantix users sued Pfizer in 2011. Pfizer began to settle with the lawyers representing the mass of civil lawsuits at a cost of $299 million through the first quarter of 2013. Pfizer said the settlement would allow the company to focus on the benefits of the drug. This strategy has been the typical way pharmaceutical companies try to settle lawsuits they aren’t sure they can win. It keeps subpoenaed records out of the hands of the public and other individuals who may want to sue them as well. And it prevents the articulation of a coherent argument about the association between a specific drug and an adverse event from being made in the public square. It enables the pharmaceutical continue to assert as Pfizer did in a statement to McClatchy: “There is no reliable scientific evidence that Chantix causes serious neuropsychiatric events.”

Chantix is approved for use in more than 100 countries and has been prescribed to over 20 million patients worldwide, including more than 10 million in the United States.

Then in April of 2016 the results of a study on more than 8,100 people were published in Lancet. The study had been ordered by the FDA because of the ongoing reports of neuropsychiatric adverse events with Pfizer’s Chantix and GlaxoSmithKline’s Zyban. “The study did not show a significant increase in neuropsychiatric adverse events attributable to varenicline or bupropion relative to nicotine patch or placebo.” However, the funding for the study was from Pfizer and GlaxoSmithKline.

Writing for STAT News, Ed Silverman quoted the study authors as saying: “The findings show that it is highly unlikely that (the medicines) contribute to neuropsychiatric adverse events.” The results of the EAGLES study, which the Lancet article was reporting, were processed by Clinical Trials.gov on September 1, 2016, and are available here: Clinical Trials.gov Identifier: NCT01456936.

The results may be a boon for Pfizer, which has struggled for a decade to transform Chantix into a blockbuster product, but instead has encountered negative publicity, expensive litigation, and stalled sales.

Pfizer plans to ask the FDA to remove the black box warning from Chantix. A company spokesperson said: “Available scientific evidence concerning neuropsychiatric events in patients attempting to quit smoking does not support a boxed warning in the Chantix label.” The FDA will review the findings along with additional scientific evidence as they continue to evaluate the issue.

Thomas Moore, a senior scientist with the Institute for Safe Medical Practices, said it would be a mistake to claim the study proves that severe psychiatric side effects don’t occur with Chantix. Because it was a manufacturer-sponsored study done in 140 different centers in 16 countries, Moore suggested it be independently reviewed. Early onset cases of psychosis, aggression and suicidal behaviors have been observed with Chantix by regulators in many countries, “far outnumbering those reported for other smoking treatments.”

With eight different treatment arms, the number of patients in each may not be enough to capture the severe psychiatric side effects for which the drug is known.  The study’s severity assessments were subjective judgments, and the combined endpoint included many psychiatric side effects that Chantix is not suspected of causing.

The criticism by Moore has some legitimacy. Here is a study that found Chantix (varenicline) was no better than NRT (nicotine patch) and C-NRT (nicotine patch and lozenge) with regard to abstinence. “However it is notable that there were significant adverse events of varenicline compared to NRT (e.g. nausea, insomnia, sleepiness) and C-NRT compared to NRT (indigestion, nausea, mouth problems and hiccups).” The website RxISK described several examples of “Chantix and Violence” that were originally reported in the FDA database for adverse drug events.

MacDonald’s case was one of the ones reported on RxISK. There it was reported that George and his twin brother (James) enlisted in the Army were selected for an appointment to the United States Military Academy Preparatory School.  The reported adverse effects experienced by MacDonald included: nightmares, psychosis, homicidal ideation, senseless act, and homicide. The Case report said:

Appellant had been experiencing “new and strange thoughts” including a “person [was] telling me . . . dangerous things that arent [sic] me.” These included violent thoughts of killing someone. On May 18, 2008, one month after the Army doctor prescribed Chantix, Appellant fatally attacked Private (PVT) Bulmer while he was sleeping, stabbing him to death. Prior to this attack, Appellant did not know nor had he ever interacted with PVT Bulmer.

The other cases reported suicidal and homicidal ideation, a suicide attempt, uncontrolled aggression/anger, and senseless violence. What follows are two more of the case reports on RxISK. Thomas Moore sent this information to RxISK.

By the third day of taking Chantix I was completely out of control. I woke my boyfriend up in the middle of the night and started physically beating him. I contemplated suicide about 5 times a day and contemplated homicide about 3 times a day. On Saturday while at home she got into a verbal argument with her mom over a minor issue and reports now that she was ‘totally out of hand’ and she was unable to control her impulses and was yelling and screaming and crying. She acutely became suicidal and also became homicidal threatening her mother with a shotgun. Her mother fled the house and called police. She locked herself in the bathroom and eventually calmed down.

In October of 2014, five nonprofit consumer organizations (Consumer Reports, Institute for Safe Medication Practices, National Center for Health Research, National Physicians Alliance, and Public Citizen) petitioned the FDA to require that the Chantix have boxed warnings clearly describing adverse psychiatric adverse events: suicidal behaviors, aggression/violence, psychosis, and depression. Additional risks with Chantix the petition noted were: sudden blackouts, seizures and impaired vision. I hope and expect they will again protest when Pfizer formally requests that the FDA drop its black box warning for Chantix.

For a previous article about the tug-of-war over problems with Chantix, see “Smoke and Mirrors.”

03/18/16

Smoke and Mirrors

© Ivan Mikhaylov | 123rf.com

© Ivan Mikhaylov | 123rf.com

In this commercial, a guy named Herb said he stopped smoking with the help of Chantix: “The urges weren’t like they used to be and that helped me quit.” In the advertisement, which lasted 81 seconds, there were about twenty seconds worth of dialogue on asking your doctor if Chantix is right for you, telling you that Herb quit smoking with the help of Chantix and support and Herb’s 4 to 6 second testimony quoted above. The remainder of the commercial was a review of the potential side effects, which included: behavior changes, hostility, agitation, depressed mood and suicidal thoughts while taking or after stopping Chantix. Now watch this Saturday Night Live skit that essentially reworks all the same warnings about Chantix.

Soon after its approval in 2006, patients and their doctors began reporting adverse events such as suicidal thinking, aggression, depression and agitation. The drug was given a black box warning by the FDA in 2009 and then updated it in 2011. Refer to the medication guide for Chantix for more information on the possible side effects. But that wasn’t the end of concerns with the drug. In December of 2012, Chantix was linked by the FDA to the risk of a higher rate of heart attacks. A month later, the CEO of Pfizer was kept from testifying in court about the safety profile of Chantix because a plaintiff agreed to a settlement with Pfizer. Then in March of 2013, Pfizer agreed to a $273 million settlement for about 80% of the pending Chantix lawsuits.  In July of 2013, Pfizer said: “The resolution of these cases reflects a desire by the company to focus on the needs of patients and prescribers, and return the conversation to how Chantix can help smokers quit.” For more details on this description of the FDA and Chantix, see the various Chantix articles on FiercePharma from which this information was gleaned.

Pfizer began to win a few battles about Chantix. In September of 2014, a judge would not allow sealed court records of thousands of Pfizer documents related to the settled lawsuits to be opened. Out of court settlements with plaintiffs in cases against drug companies is standard operating procedure if it seems the case could be lost in court because then the related documents could be released into the public record. A standard condition of these kinds of settlements seems to require that all the documents that would have become evidence in a trial sealed.

That same month, the FDA approved changes to the medication guide for Chantix, suggesting that the drug might not be at greater risk of psychiatric problems. Pfizer wanted the black box warning removed. Steve Romano of Pfizer said: “Based on all this new information, a boxed warning is not supported. . . . The bottom line is that the label needs to reflect the most current understanding of the product’s benefits and risks.” Their target was a looming October 2014 FDA advisory panel meeting, where the committee would look at Pfizer’s data from observational studies and a meta-analysis of controlled trials conducted after the original side effects were reported.

FDA reviewers of the Pfizer data pointed out limitations with Pfizer’s meta-analyses and concluded that the observational studies “provided evidence of insufficient quality” to rule out an increased risk of suicide, suicide attempt or psychiatric hospitalization. Recent adverse event reports to the FDA were also said to be consistent with the findings that led to the black boxed warning. They noted how “neuropsychiatric side effects disappeared when patients stopped using Chantix, and/or recurred when therapy resumed.” It suggested that removing a black boxed warning had “limited precedent,” and should await the results from a controlled trial to be released in 2015.

The FDA finally announced its ruling in March of 2015. Not only did it keep the black box warning, it added new cautionary advice about Chantix’s interactions with alcohol. Some patients have reported increased drunkenness, blackouts and unusual or aggressive behavior while drinking. Others have had seizures. In September of 2015 Pfizer released the results of its latest study, in yet another attempt to convince the FDA to revoke the black-box warning. This large-scale by Kotz et al. followed 150,000 smokers over 6 months and found that individuals who took Chantix (known as Champix in Europe) were no more likely to have a heart attack then study participants using nicotine replacement therapy or another drug (Zyban) to facilitate smoking cessation. The study also found they were not at a higher risk of depression or self-harm. Three of the study’s authors reported financial ties to Pfizer independent of the study here.

One of the study’s authors, Aziz Sheikh, said that it was “highly unlikely that (Chantix) has any significant adverse effects on cardiac and mental health.” He though the drug’s black box safety warning “may be unnecessarily limiting access to this effective smoking aid.” Emily Wasserman commented this was exactly the kind of assessment Pfizer was looking for with Chantix. In 2014, Chantix grossed $647 million in worldwide sales; $377 million of which was in the U.S.

What was tellingly silent in this study was no further information on the association of Chantix (varenicline) with violence and aggression. A 2010 study, “Prescription Drugs Associated with Reports of Violence Towards Others” found that acts of violence towards other are associated with a relatively small group of drugs. Varenicline (Chantix or Champix) and antidepressants “were the most strongly and consistently implicated drugs.” Dr. Glenmullen, one of the study’s authors, was also one of the experts who unsuccessfully attempted to have thousands of Pfizer documents related to litigation over Chantix’s potential to trigger depression, suicide and violence made public.  Makes me wonder what was in those documents.

On the RxISK website, you can review an article on Chantix and Violence with a sampling of six selected cases taken from the FDA database on adverse events.  One case involved a 24 year old woman who said she was completely out of control by the third day of taking Chantix. She work her boyfriend up in the middle of the night and started physically beating him. She had suicidal ideation, homicidal ideation and an attempted suicide. Another woman, 28 years old, had a fit of uncontrollable rage after consuming alcohol one evening. She had been taking Chantix for about two weeks. It resulted “in me beating my boyfriend, followed by an attempt to take my own life. An overnight stay in the ER followed.”

Looking like the misdirection practiced by an illusionist, the attention on why Chantix should have its black box warning removed focused on two of the more serious adverse effects—depression and heart attack, but ignored a third—violence and aggression. The potential for violence was also been buried within catch-all categories such as “neuropsychiatric events” or adverse effects on mental health. Indeed, the recent Kotz et al. study admitted that it did not measure neuropsychiatric symptoms that involved aggression. So when the authors said they found no evidence of increased risk of “neuropsychiatric adverse events in smokers using varenicline” we need to recognize that symptoms involving aggression were not measured. They wouldn’t find any evidence for something if they didn’t look for it.

Finally, Paul Christiansen reviewed a recent study published in JAMA that compared the effectiveness of Chantix (varenicline) to the nicotine patch and combination nicotine replacement therapy (C-NRT, a nicotine patch and lozenge). The researchers concluded there were no significant differences in rates of smoking abstinence. “The results raise questions about the relative effectiveness of intense smoking pharmacotherapies.” Christiansen wrote that while the trial suggested there was evidence that varenicline and C-NRT may help lessen craving and withdrawal, there were significant adverse events with varenicline and C-NRT when they were compared to NRT—treatment with a nicotine patch only.

11/4/15

Abilify in Denial

© elenarts | stockfresh.com

© elenarts | stockfresh.com

Modern Healthcare reported that Proteus Digital Health, a California company, is partnering with Otusuka Pharmaceuticals to approve an Abilify “smart pill.” When a medication embedded with a sensor reaches the stomach, it sends a signal to a wearable sensor patch. The patch records and time-stamps the information and other information such as rest and activity patterns. Then the information can be relayed to patients on their phones or other Bluetooth-enabled devices; or it can be forwarded to physicians or caregivers.

It was just in July of 2015 that Proteus announced that the FDA had expanded the Indications for Use statement for its Ingestible Sensor technology to be used as an aid in measuring medication adherence. At this point in time, it seems to be the only device with an FDA-sanctioned claim for measuring medication compliance. Proteus and Modern Healthcare pointed to findings from a 2014 article in Risk Management and Healthcare Policy that estimated avoidable healthcare costs from poor medication adherence as between $100 to $300 billion annually in the U.S. That represents 3% to 10% of total U.S. healthcare costs.

Dr. George Savage, the co-founder and chief medical officer of Proteus, said the company hopes to give patients feedback on their adherence so they can improve their health and avoid adverse medication events. Dr. William Carson, the president and CEO of Otsuka Pharmaceuticals said: “We believe this new digital medicine could revolutionize the way adherence is measured and fulfill a serious unmet medical need in this population.” They expect a response from the FDA by April of 2016.

There is reportedly a widespread problem of with non-adherence to taking medications as prescribed, especially with individuals with mental illness. So the FDA suggested to Proteus that the need for an ingestible sensor was most needed by mental health patients. It seems to have been rushed through the approval process, with about nine months from the FDA approved expansion of the Indications for Use statement for Proteus’s Ingestible Sensor to the expected response by the FDA approving the Abiliy “smart pill.” So there are two questions to ask about this. Why the rush? Why is the greatest need for a smart pill with antipsychotics like Abilify?

Abilify went off of patent in October of 2014 and was made available as a generic in April of 2015. The Abilify smart pill would probably be a new molecular entity (NME) and thus eligible for a new patent. While aripiprazole (Abilify) will be available as a generic, only Otsuka and Proteus will be able to sell the smart pill version. Otsuka and its former distribution partner, Bristol-Myers Squibb, grossed $5.5 billion in Abilify sales for 2014.

The pressing need for a smart pill with psychiatric medications to help counter non-adherence issues is because there are serious, and sometimes debilitating side effects from taking them. Here is a link to an advertisement for Abilify as an add-on medication with antidepressants to treat depression. Most of the audio in the 90-second commercial is describing the potential side effects.

The side effects from antipsychotics can include: weight gain, diabetes, pancreatitis, gynecomastia (abnormal breast tissue growth), hypotension, akathesia (a feeling of inner restlessness), cardiac arrhythmias, seizures, sexual dysfuntion, tardive dyskinesia, anticholinergic effects (constipation, dry mouth, blurred vision, urinary retention and at times cognitive impairment). Read more about these and other side effects at: “Side Effect of Atypical Antipsychotics: A Brief Overview”;  “Antipsychotic Drugs, Their Adverse Effects”; “Adverse Effects of Antipsychotic Medications”; and “An Overview of Side Effects Caused by Typical Antipsychotics.”

The website RxISK described some of the reports and first-hand accounts about individuals who had used Abilify in: “Abilify From the Inside Out.” Out of 34 who had used Abilify, only five had taken it for a “psychotic” diagnosis. Fourteen were taking it for depression. Six used it for bipolar disorder; three for other diagnoses; two for “stress”; and three for unknown reasons. Fifteen individuals were taking Abilify in conjunction with antidepressants.

Most patients were on more than one medication, so they could not be sure that if Abilify alone caused these adverse effects. Nevertheless, there were three confirmed suicides and several episodes of severe emotional stress or physical misery. Eight people reported akathisia and six reported unusual anger or aggression. Two of the aggression episodes were violent physical attacks on family members. One woman assaulted her husband when she had “bizarre and frightening thoughts.”

At the other extreme, 14 people reported over-sedation and cognitive slowing, with memory, concentration and word-finding problems.  About half felt a profound emotional numbing, an inability to feel pleasure or care about anything. One man regretted this state, but felt it was better than his prior severe depression.  For the rest, however, it brought new or worse depression.  Three felt trapped at home by “total lack of interest in life” along with anxious depression; loss of the ability to pursue, or even care about, formerly cherished goals was painful for others.  Most reported suicidal thoughts of varying intensity.

Three people had tremors, but of these cases cleared up when they stopped the drug. Four others had tardive dyskinesia. Their symptoms started after using Abilify for at least a year; and they continued despite stopping the drug. “They found their condition painful, debilitating, disfiguring and socially isolating.” Four men reported sexual dysfunction. One man had a gambling problem that began two months after starting Abilify. “Eight people had their worst problems on stopping Abilify.”

Johanna Ryan, who wrote the article on RxISK, said that most antidepressants are metabolized in the liver by the same enzymes that process Abilify. So the resulting “traffic jam” will effectively raise the level of Abilify in your blood. Some SSRIs have also a stronger effect than others on this issue. “Your actual Abilify levels might be 150% to 300% of your official dose.” Side effects such as agitation, anxiety, insomnia and nervousness commonly occur with antidepressants and can increase your chances of akathisia with Abilify.

In other words, the “little baby dose” was an illusion.  Even 2 mg was bigger than it seemed – and doses over 5 mg could put you on a par with patients taking Abilify for psychosis.  (Those patients may be taking excessive doses as well: Two patients with psychotic symptoms in the RxISK group found they did better on half the dose their doctor initially prescribed.)

In “Dodging Abilify” on RxISK, Johanna Ryan related how a psychiatrist had tried to convince her once to try Abilify for her depression.  He told her “these drugs” (referring to Abilify) weren’t really antipsychotics since they were used to treat several kinds of things. “’Oh, come on,’ he coaxed.  ‘We’re talking about little baby doses here, just a fraction what they give people for schizophrenia.’”  Like other antipsychotics, it blocks certain dopamine receptors. Unlike them, it is a “partial agonist,” meaning it activates others.

Now let’s go back to the cute Abilify commercials. This one includes a woman and her umbrella. Listen to see if Abilify is ever referred to as an antipsychotic or neuroleptic. As a matter of fact, it wasn’t. The same is true for the link to the commercial above. Admittedly, these commercials were pushing Abilify as an add-on to antidepressants. But now download the FDA Medication Guide for Abilify, and search through it. You won’t find the word “antipsychotic.” The word “neuroleptic” appears once within the listing of a side effect: neuroleptic malignant syndrome. Abilify is described and presented as an “antidepressant medicine” throughout the medication guide. There were other antipsychotics that seemed to also minimize using these two words (neuroleptic and antipsychotic) in referring to their drug, but not to the same extent as noted for Abilify. My thought is Otusuka decided that referring to Abilify as an antipsychotic or neuroleptic was bad for business.

So Abilify is a neuroleptic that apparently wants to be known as an antidepressant and absolutely HATES to be referred to as an antipsychotic. Yet it has the same kinds of adverse side effects as other neuroleptics. (If it walks like a duck and talks like a duck …) And of all the current antipsychotics on the market, Proteus partnered with Otsuka first to create an Abilify smart pill to facilitate medication compliance with its drug. To borrow a phrase from addiction recovery, it sounds like Abilify is in denial about being an antipsychotic.

02/18/15

Hellish Withdrawal 101

© : Todd Arena 123RF.com

© : Todd Arena 123RF.com

Melissa Bond described herself as never having any physiological or psychological dependencies on anything “… besides perhaps rock climbing, yoga and writing large volumes of poetry.”  She developed pregnancy-related insomnia and went to an MD who specialized in hormonal imbalances, where she confirmed her insomnia involved an endocrine problem. She didn’t know at the time that her doctor had a “strong proclivity for prescribing benzodiaepines.”  You can read about her experience in the article she did for Mad In America: Killer Brain Candy.

After 2 years of Ativan for pregnancy-related insomnia, and the knowledge that the drug was slowly disassembling her brain and body, Melissa Bond went through a hellish withdrawal. She writes about it on her website and in her forthcoming book “Dear Little Fish.”

Melissa followed medical advice; and was told by a doctor who she trusted and respected that he knew a man who had used benzos for nineteen years and didn’t have a problem. “This drug, he told me, is phenomenal. You’ll sleep. And when you don’t need them anymore it may or may not be slightly difficult to get off but you’ll be fine.” That wasn’t what happened.

The advice I give to the drug addicts and alcoholics applies here as well. Whenever a medical person recommends that you take a potentially addictive drug for any reason, ALWAYS ALWAYS get a second opinion from someone with knowledge about addiction. Do research on people who have used the medication being prescribed to you. Mad in America, RxISK and Psychiatric Drug Facts with Dr. Peter Breggin are good places to start. And as you will see on these sites, hellish withdrawal problems aren’t confined to just the drugs classified as “addictive.”

What follows is just some basic information on how drugs are classified as controlled substances by the U.S. government. Remember that Melissa’s experiences were with a benzodiazepine, which are considered a Schedule IV controlled substance—the next to the lowest of the schedules.

There was a time when there was no federal laws regulating the use or distribution of drugs. Cocaine was in wine, cola and toothache drops; opiates were in everything from cough suppressants to teething medication. As a direct result of the Hague Convention in 1912, which was an international attempt to regulate opium, the U.S. passed the Harrison Tax Act in 1914. But it only regulated and taxed the production, importation and distribution of opiates and coca (cocaine) products. Doctors could prescribe these “narcotics” in the course of medical treatment. However they could not be used as a way to treat addiction.

While the Controlled Substances Act (CSA) of 1970 essentially replaced the Harrison Tax Act, there have been several lasting effects from this 100 year-old legislation. It began using the term ‘narcotics’ to refer to any illegally used substance. It also initiated the social construct of the “criminal” drug addict and the black market for drugs. But there still wasn’t any federal oversight and regulation of drug development. It wasn’t until the 1962 Kefauver-Harris Amendments that the Food and Drug Administration (FDA) was created, which was to approve the safety and effectiveness of a drug being developed for human consumption.

The CSA is the federal drug policy regulating the manufacture, importation, possession, use and distribution of certain substances. It created five Schedules or classifications for drugs; with varied qualifications for a substance to be included in each of the schedules. Two federal agencies, the Drug Enforcement Administration (DEA) and the FDA typically determine which substances are added to or removed from the various schedules. There have been several amendments to the CSA since 1970, including the Psychotropic Substances Act of 1978 and The Electronic Prescriptions for Controlled Substances Act of 2010.

The placement of a drug into a specific Schedule or the reclassification of a drug from one Schedule to another is based upon a series of laws under Title 21, which governs food and drugs in the United States. Each Schedule requires that the “potential for abuse” for a substance has to be determined before in can be placed within its respective Schedule. According to the DEA,  “The abuse rate is a determinate factor in the scheduling of the drug.”

The hierarchy begins with Schedule V drugs at the lowest level and ends with Schedule I drugs at the highest level. The designated abuse potential of drugs increases as you move up the hierarchy from Schedule V to Schedule I. Schedule I drugs are defined as having no current accepted medical use and a high potential for abuse. They are the most dangerous drugs, “with potentially severe psychological or physical dependence.”  Schedule V drugs are defined as having the lowest potential for abuse and are generally antidiarrheal, antitussive [cough suppressant] and analgesic medications. See the DEA link for a description of each of the five drug Schedules.

Sometimes the Schedule within which a drug is placed is controversial, and doesn’t seem to follow what would to be a common knowledge of a drug’s abuse potential. One example of this is marijuana. While it has a significantly lower dependency liability and harm potential than heroin (See “The Most Addictive and Harmful Drugs”), it is placed within Schedule I with heroin. This means that research into its potential medicinal use is highly regulated and difficult to do. There are other times where drugs are rescheduled, as was the case with Vicodin, when it became a Schedule II controlled substance instead of a Schedule III controlled substance in October of 2014 because it had become the most widely abused prescription opioid.

The following chart places some of the more common drugs within their current Schedules. You can review a pdf of all Controlled Substances in alphabetical order if there is one you don’t see here and want to check.

Schedules

Drugs

Schedule I

Heroin, marijuana, LSD, peyote, mescaline, ecstasy, MMDA, ibogaine, Quaalude, psilocybin,

Schedule II

Cocaine, morphine, methadone, methamphetamine, hydromorphone, oxycodone, hydrocodone, fentanyl, Adderall, Ritalin, Concerta, Vicodin, codeine, Demerol, Nembutal, PCP,

Schedule III

ketamine, anabolic steroids, testosterone, Suboxone (buprenorphine),

Schedule IV

Xanax, Klonopin, Valium, Ativan, Soma, Provigil, Serax, Serenel, Talwin, Tramadol/Ultram, Halcion, Ambien, Lunesta, Sonata,

Schedule V

Robbitussin AC, Lacosamide, Pyrovalerone, Lomotil

07/30/14

Getting Off the Antidepressant Merry-Go-Round

I told Allison to concentrate on my voice and imitate how I was breathing. My coworker held her head in her lap. Together we kept Allison focused until the paramedics came. Determined to stop all drug use after she came into outpatient drug and alcohol treatment, she decided to stop taking her Paxil … cold turkey. The result was a severe panic attack and ER visit.

The Center for Disease Control and Prevention (CDC) estimated that eleven percent of Americans 12 and over use antidepressants. More than 60% of those taking an antidepressant medication have taken it for 2 years or longer; 14% have taken the medication for 10 years or more. Like Allison, women between the ages of 40 and 59 are those most likely to be taking an antidepressant (22.8%). Antidepressants were the most commonly used medication by persons aged 18-44; they were the third most commonly used prescription drug by all Americans in 2005-2008.

Okay, you’re thinking you want to try to withdraw from antidepressants; but you don’t want to duplicate Allison’s experience. What should you do?

First, do some research on the growing evidence of problems with antidepressants.

Look at some of the material available on the websites “ToxicPsychiatry” by Peter Breggin and PsychRights by Jim Gottstein. Here are a few recommendations.

Start with Patient Online Report of Selective Serotonin Reuptake Inhibitor-Induced Persistent Postwithdrawal Anxiety and Mood Disorders, by Carlotta Belaise,  Alessia Gatti, Virginie-Anne Chouinard, and Guy Chouinard,on Psychrights. It is a short, easy to read study of online self-reports of withdrawal symptoms and postwithdrawal symptoms that they attributed to the discontinuation of SSRI antidepressants.

Then read “Do Antidepressants Cure or Create Abnormal Brain States?” by Joanna Moncrieff, found on ToxicPsychiatry. If you want further information, try her book, The Myth of the Chemical Cure. Dr. Moncrieff effectively challenges the received wisdom of the chemical imbalance theories underlying the use medications for depression, psychosis and bipolar disorder.

If you have used antidepressants for a number of years, also read: “Now Antidepressant-induced Chronic Depression Has a Name: Tardive Dysphoria,” by Robert Whitaker. Try out his website as well, Mad in America.

You can also read two articles that I’ve written and made available here on Faith Seeking Understanding: “Antidepressant Withdrawal or Discontinuation Syndrome?” and “Antidepressants Their Ineffectiveness and Risks.

Second, become familiar with the potential postwithdrawal side effects of antidepressant withdrawal.

There is a website of free resources at RxISK. You can research reported side effects by drug name; and you can report a drug’s side effects. But be sure to look at the “Symptoms-on-Stopping Zone.” Read about the concept of medication spellbinding coined by Peter Breggin on his ToxicPsychiatry site. Try his article, “Intoxication Anosognosia: The Spellbinding Effect of Psychiatric Drugs” or his book, Medication Madness for a more detailed discussion.

Mario Fava has developed a scale to assess withdrawal/discontinuation symptoms during an antidepressant taper. You can see a copy of his DESS Scale here; and read about antidepressant discontinuation here. You can download the original Fava article here after registering with psychiatrist.com.

Finally, don’t try this at home alone.

Read this blog post on Mad in America by Monica Cassani. Locate psychiatric support groups and websites like Beyond Meds by Monica Cassani. RxISK has published a detailed “Guide to Stopping Antidepressants.” Also read Your Drug May Be Your Problem: How and Why to Stop Taking Psychiatric Medications or Psychiatric Drug Withdrawal, both by Peter Breggin.

Make sure you have medical support and monitoring from a doctor or psychiatrist who is supportive of your attempt to taper. Someone who is president of the local chapter of NAMI and believes in the chemical imbalance theory of depression is not a good choice to supervise your drug taper. Postwithdrawal symptoms will be seen as the re-emergence of your underlying psychiatric disorder and proof you need to be on medications for life.

Tell family and friends of your decision and enlist them (those who are receptive to your decision to taper) as members of an accountability or support group. Have them read this material.

In closing, remember this warning by Dr. Peter Breggin on his website:

Most psychiatric drugs can cause withdrawal reactions, sometimes including life-threatening emotional and physical withdrawal problems. In short, it is not only dangerous to start taking psychiatric drugs, it can also be dangerous to stop them. Withdrawal from psychiatric drugs should be done carefully under experienced clinical supervision.