Posts Tagged ‘methadone’

Heart Warning Added to Label on Popular Antipsychotic Drug Seroquel

Tuesday, July 19th, 2011

Today the New York Times has reported, “AstraZeneca is adding a new heart warning to the labels of Seroquel, its blockbuster antipsychotic drug, at the request of the Food and Drug Administration, company and agency officials said on Monday.”   And that  “Seroquel is one of the top-selling drugs in the world, at $5.3 billion last year, including $3.7 billion in the United States. Introduced in 1997, it has been approved for schizophrenia, bipolar disorder and severe depression. Seroquel has caused legal problems for AstraZeneca, including a $520 million payment in 2009 to settle government charges of illegal marketing. Thousands of lawsuits are pending over side effects like diabetes.” (read the full article here http://www.nytimes.com/2011/07/19/health/19drug.html )

While this is seemingly good news, look a little deeper—today’s article from Paul Thacker, an investigator for Project on Government Oversight:

Paging Dr. Woodcock…Dr. Janet Woodcock….Do You Have Any Clue What’s Happening Inside the FDA?

There is confusion and then there is confused confusion–a level of incomprehensibility that defies sound, sober attempt at explanation. After confused confusion comes…the FDA.

Case in point: the FDA’s dithering over changes to the label of an antipsychotic drug now widely prescribed to veterans with post-traumatic stress disorder. Last October, POGO sent a letter to FDA Commissioner Margaret Hamburg asking her to look into a potentially dangerous interaction of the drugs Seroquel (quetiapine) and methadone that may be putting veterans at risk.

Prescriptions of Seroquel and methadone are at an all-time high for veterans who are suffering extremely high rates of PTSD after combat. An investigation by the Military Times found that military spending on Seroquel almost quadrupled between 2001 and 2009. Many of these veterans are also taking methadone for pain relief and to control anxiety caused by PTSD. The Military Times found that methadone overdose has caused at least 60 deaths in the military—more than any other drug, legal or illegal.

A separate investigation by the Associated Press noted that military expenditures on Seroquel have jumped sevenfold since the beginning of the war in Afghanistan. The military spent $8.6 million on Seroquel in 2009. Physicians said that they are prescribing it to provide relief from nightmares and anxiety caused by PTSD.

The Associated Press also discovered that Seroquel has become the Department of Veterans Affairs’ (VA) second biggest drug expenditure since 2007. In 2009, the VA spent $125 million on Seroquel compared to $14.4 million in 2001.

Alerting the FDA to this problem, we also sent a study published in 2007 in the Journal of Clinical Psychopharmacology. This study found that Seroquel significantly increases blood plasma levels of methadone.

How did FDA respond? In April, we received a letter signed by Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at the FDA. According to Dr. Woodcock, there was nothing to worry about:

After assessment of our evaluations, we believe that a potentially dangerous interaction involving quetiapine and methadone is unlikely, and, therefore, no further Agency action is indicated regarding either a revision in labeling that would include new warnings or cautions, or targeted public and professional communications efforts.

To make sure we got the point, she added:

At this point, there is agreement within CDER that an interaction between quetiapine and methadone that confers unreasonable risks to patients is exceedingly unlikely and, therefore, no further action is indicated regarding the labeling for these products or for related communication initiatives.

Less than two months later, in June, the FDA approved changes to the label for Seroquel to note that the drug “should be avoided in combination with other drugs” such as methadone.

What the hell? This is exactly what we asked them to do. Exactly what Dr. Woodcock said didn’t need to be done.

Can somebody please explain this to me? Please!

Anyways, we are now sending a second letter to the FDA asking them, as we did in October, to please issue an action alert to inform patients and prescribers. There is a potential for people to die if they are on Seroquel and methadone, and it seems highly improbable that a military doctor treating veterans with PTSD has the time to read the entire 73 pages of the Seroquel label.

That’s right. It’s 73 fricking pages!!!

That’s not a label, that’s a novella.

We hope the FDA agrees to send out an action alert. But maybe we’ll get a letter from Dr. Woodcock saying that everything is okay, and no further action is indicated…and there’s no need to alarm people by sending out an action alert….

And then they’ll send it anyways.

Paul Thacker is a POGO Investigator.

http://pogoblog.typepad.com/pogo/2011/07/paging-dr-woodcockdr-janet-woodcockdo-you-have-any-clue-whats-happening-inside-the-fda.html

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Dangerous doctors slipping through the cracks

Friday, February 25th, 2011

It took the discovery of guns and grenades to suspend the license of a psychiatrist who some say should have come under scrutiny years earlier

Chicago Tribune
By Megan Twohey
February 24, 2011

One night a Crestwood police sergeant doing a routine building check noticed an open door to the office of psychiatrist Joel Carroll. Stepping inside the cluttered office, he discovered roaming cats, a Colt AR-15 assault rifle and other guns, ammunition, military-grade smoke grenades, sex toys, and pornography.

“Well, for the lack of better terminology, we considered it a pigsty,” Sgt. Thomas Kaniewski testified about his April 2009 discovery. “It looked in complete disarray. We couldn’t believe that someone could actually conduct business in an office like that because of the conditions it was in.”

When state regulators determined that Carroll had engaged in sexual misconduct and committed other violations of the state Medical Practice Act, they suspended his license, proclaiming him “a danger to his patients,” according to state records.

But the psychiatrist’s practice could have been shut down years earlier, after the Illinois Department of Corrections in 2007 found that Carroll — as a state contractor — committed inappropriate conduct with a female inmate and barred him from working in a prison, a Tribune investigation showed.

Critics say the case raises questions about a crucial part of the medical disciplinary system.

State agencies, county prosecutors, insurance companies, and health care employers and associations are mandatory reporters — they’re required to report potentially dangerous and unprofessional doctors to medical regulators, who can bar the doctors from practicing and keep patients out of harm’s way.

But the mandatory reporters sound few alarms, and when they do, regulators rarely take action, the Tribune found. There were 348 mandatory reports filed with the state in 2009. That’s out of nearly 46,000 physicians statewide. In only one case did the Illinois Department of Financial and Professional Regulation respond by suspending the physician’s license, records show.

Sue Hofer, a department spokeswoman, said it can take longer than a year to discipline a doctor following a mandatory report. She said regulators frequently learn of a dangerous doctor from members of the public before being told about the doctor from a mandatory reporter. If they are already investigating, she said, the regulators don’t make a separate record of the notification.

But in the case of Carroll, the corrections department provided no notification that the psychiatrist had breached security during a visit to the inmate and allegedly made a sexual advance toward her, even though state agencies must report any potential violation of the Medical Practice Act. Carroll’s actions might have amounted to “dishonorable, unethical or unprofessional conduct” — a violation under the act that can lead to suspension — but regulators were robbed of the opportunity to seek disciplinary action, said John Goldberg, a former medical prosecutor.

“The Department of Corrections should have reported, but these agencies hardly ever do,” Goldberg said. “If they had, the regulators could have opened an investigation that at the very least asked: What’s the explanation for your actions against this inmate? What else is this doctor doing?”

Regulators also were not contacted at the time by Wexford Health Sources, the contracting agency that fired him after his administrative lockout from the prison system. Health care employers must report terminating or restricting a doctor’s privileges based on actions that may directly threaten patient care. Elaine Gedman, a spokeswoman for the Pittsburgh-based company, said that in 2007 the “Department of Corrections did not necessarily disclose their rationale for revoking an employee’s clearance.”

“When we look at this, we realize there are places where dangerous doctors get caught, where they’re identified, but no one reports it, or the state doesn’t take action,” said Gary Schoener, a Minneapolis psychologist who has consulted on thousands of medical misconduct cases across the country.

Sharyn Elman, a corrections spokeswoman, said prison officials believe they did not have to report Carroll to regulators because they could confirm only that he breached security during a visit to the female inmate, not that he engaged in sexual misconduct as alleged.

But after police stumbled on the office, regulators received documentation from the Department of Corrections indicating “the doctor had told that inmate that he would take her to Mexico, and hugged her and kissed her,” a medical investigator said during a 2009 disciplinary hearing.

Carroll, who could not be reached for comment, said in the hearing that the inmate made a pass at him, not vice versa.

The psychiatrist maintained his practice while he worked in the prison system from September 2006 to February 2007 and during several months in 2009 while he worked at medical centers for veterans in Danville and Marion.

His personal appearance was concerning to patients and other observers, as was his office, according to testimony.

One former patient said the psychiatrist went shoeless with holes in his socks. A pharmacist questioned whether he was really a doctor.

“He looked messy, unkempt,” the pharmacist testified in a disciplinary hearing. “I was surprised at his appearance. He did not look, to me, like any physician I had ever met before. … He was wearing a T-shirt. It did not appear to be clean. It was very wrinkled. He was unshaven.”

Carroll’s former secretary said the presence of pornography and guns in the office was disturbing.

“The point is, putting myself aside, why does a doctor — a psychiatrist — have guns in the office with psychiatric patients?” she said during a hearing. “That’s the problem.”

When asked about the weapons in his office, Carroll said he collected them for fun and protection. He told authorities he had close to 100 guns stored in the walls of a Skokie home, state records show. Carroll had a firearms license.

The police never arrested Carroll. During the disciplinary hearing, Kaniewski said he did not know whether Carroll’s assault rifle was a type that is illegal for him to own, only that he thought it was cause for concern. (Crestwood police Chief Theresa Neubauer did not respond to written questions or calls seeking comment.)

While law enforcement did not pursue charges against Carroll, state regulators determined that having these weapons at his office amounted to dishonorable, unethical or unprofessional conduct.

The former secretary, who first had been a patient of Carroll’s, said she was surprised when he visited her behind bars and then offered her a job immediately after she finished serving time for a drug conviction.

Carroll gave her presigned prescriptions to use when he was out of the office, she said. The woman, a recovering drug addict who had no medical training and suffered from bipolar disease, would pen prescriptions for patients — a violation of drug laws, a Drug Enforcement Administration official testified.

“The medications would range from antidepressants all the way up to controlled substances such as Methadone,” the woman explained during the hearing.

Carroll took the woman to New Mexico when he attended a conference and they shared a hotel room, according to the secretary’s testimony. Carroll denied it, but she testified he walked around in his underwear and made an unwelcome sexual advance toward her.

When the secretary quit after the state launched its investigation, Carroll showed up at her home more than once, prompting her to call Chicago Ridge police, records show.

“Because after the investigation started, he went and he bought more guns and he just … I don’t trust him today,” she said in a hearing.

Carroll admitted he spent numerous nights at the home of a patient who suffered from anxiety and panic disorder, state records show. Regulators alleged he took nude pictures of her while she was asleep, threatened to have her committed, masturbated in front of her and attempted to climb through her bedroom window while she was in bed with her boyfriend — all of which he denied.

Another former patient who had turned to Carroll for treatment of severe anxiety said she was confused when he showed up unannounced at her family’s Crestwood home. He allegedly tried to kiss her as he was leaving, which prompted her to cry to her mother.

The psychiatrist allegedly returned to the house more than 20 times, records show. The woman and her mother testified he would lay his body against the doorbell and throw rocks at her window.

“It upset me. I was crying. … I did call his telephone and asked him to please don’t come to my house,” the former patient said in a medical disciplinary hearing.

Carroll said he only threw rocks at the woman’s window once. He denied he tried to kiss her.

When she realized the Department of Corrections and Wexford Health Services had taken action against Carroll in 2007 but had not informed regulators, she was outraged.

“This guy should have been out years ago,” the woman said. “This should never have happened to any of us.”

Withdrawal from the drugs wasn’t the only hard part, she said. Her anxiety, already debilitating, worsened.

She is afraid to leave her home, she said, for fear that Carroll will be outside.

Read the article here:  http://www.chicagotribune.com/news/local/ct-met-doctor-guns-smoke-grenades-20110224,0,5943165,full.story

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Prescription Drug Epidemic Spreads to Babies

Friday, July 16th, 2010

St. Petersburg Times
By Richard Martin
July 16, 2010

Dr. Mary Newport sees the symptoms more and more in the babies she treats: oddly stiff limbs, severe tremors, vomiting, diarrhea, insomnia, crying that never stops.

The common denominator: Their mothers were taking prescription drugs, mostly painkillers like OxyContin and Vicodin, and antianxiety drugs like Xanax during pregnancy.

Some of the moms had no idea these medications would hurt their developing babies — after all, it’s not like it’s heroin or cocaine, many think.

“They are seriously misinformed,” said Newport, medical director of Spring Hill Regional Hospital’s neonatal intensive care unit.

The prescription drug epidemic, well documented among teens and adults, now is claiming victims before they are even born. Tampa Bay area doctors and addiction specialists are reporting a dramatic increase in the number of pregnant addicts and infants needing treatment for withdrawal from prescription drugs.

The trend is reminiscent of the “crack baby” epidemic of the 1980s, when mothers used crack cocaine during their pregnancies.

But area neonatologists say that in some ways, the current trend is worse. Some women don’t understand that prescription drugs can be dangerous during pregnancy. Others decide to stop the drugs as soon as they learn they are pregnant, causing sudden withdrawal that can lead to miscarriage.

And doctors say that treating a baby with drugs like oxycodone, methadone or Xanax in the system takes longer, and involves more medication, than treatment for heroin or cocaine.

“Babies are suffering more,” said Dr. Terri Ashmeade, medical director of Tampa General Hospital’s neonatal intensive care unit. “Withdrawal patterns seem to be worse (with prescription drugs) than what we were seeing with heroin.”

Note from CCHR Int: To see for yourself what psychiatric drug reactions for infants and babies have been reported to the U.S. FDA’s medwatch system (by doctors, pharmacists, consumers etc),  go to our decrypted Medwatch reports: Under the drop down menu for DRUG NAME/DRUG CLASS, scroll all the way down to the bottom until you see CLASS OF DRUGS such as ATYPICAL ANTIPSYCHOTICS or ANTIDEPRESSANTS or STIMULANTS and select one of those.   In the AGE RANGE drop down menu select 0-1 year old then click GENERATE REPORT.   You can do this for each class of psychiatric drug.  And consider this,   by the FDA’s own admission, only 1-10% of side effects are ever reported, so the actual side effects occurring in the general population are much higher.

Click here for Decrypted Medwatch Reports http://www.cchrint.org/psychdrugdangers/medwatch_psych_drug_adverse_reactions.php

Click her to read the rest of the article:  http://www.tampabay.com/news/health/article1109348.ece

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Its Not Just Celebrities Overdosing on Prescription Drugs—Its Happening Nationwide

Tuesday, April 6th, 2010

Reuters
By Megan Brooks
April 6, 2010

More and more Americans are landing in the hospital due to poisoning by powerful prescription painkillers, sedatives and tranquilizers, according to a report released today. City-living middle-aged women seem particularly vulnerable.

“People have seen the headlines related to Heath Ledger, Michael Jackson, Anna Nicole Smith and they think that’s tragic but maybe contained to Hollywood,” Dr. Jeffrey H. Coben of West Virginia University School of Medicine in Morgantown told Reuters Health.

“But the fact of the matter is we are seeing, across the country, very significant increases in serious overdoses associated with these prescription drugs,” Coben warned.

Between 1999 and 2006, US hospital admissions due to poisoning by prescription opioids, sedatives and tranquilizers rose from approximately 43,000 to about 71,000.

That increase of 65 percent is about double the increase observed in hospitalizations for poisoning by other drugs and medicines, Coben and colleagues found.

Opioids — examples include morphine, methadone, OxyContin and the active ingredient in Percocet — are powerful narcotic painkillers that can be habit-forming. Some examples of sedatives or tranquilizers include Valium, Xanax, and Ativan.

Read entire article:  http://www.reuters.com/article/idUSTRE6350MR20100406

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Anna Nicole Smith’s psychiatrist prescribed “pharmaceutical suicide” according to court records

Tuesday, September 22nd, 2009

Vicki Hyman
The Star Ledger
September 22, 2009

Anna Nicole Smith’s psychiatrist Khristine Eroshevich prescribed the equivalent of “pharmaceutical suicide” in the days after the death of her son, according to court records obtained by the Los Angeles Times.

On at least three occasions, pharmacists refused to fill drug orders prescribed by Eroshevich and Smith’s internist Sandeep Kapoor, who are each facing several counts of illegally prescribing controlled substances to the late model and obtaining opiate prescriptions by fraud.

Five days after the death of Smith’s son, Daniel, (and eight days after Smith gave birth to her daughter Dannielynn, Eroshevich tried to prescribe two sedatives, 300 tablets of methadone, a muscle relaxer, an anti-inflammatory drug and 4 bottles of a painkiller called “hospital heroin.”

“They are going to kill her with this,” one of the pharmacists told himself at the time.

Read entire article: http://www.nj.com/entertainment/celebrities/index.ssf/2009/09/khristine_eroshevich_prescribe.html

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