Hospira Inc said it has issued a nationwide recall of four of its injectable cancer drugs because of particles embedded in the glass at the neck of the vial.
The drugs recalled are carboplatin, cytarabine, paclitaxel, methotrexate and were distributed nationwide to wholesalers and direct customers.
The U.S. Food and Drug Administration said there may be potential for the drugs to come into contact with the embedded particles and the particles may become dislodged into the solutions.
Injury could result if the solution were injected into a patient, the FDA said. Signs and symptoms might include bleeding, bruising, inflammation, itching, rash, chest pain and respiratory symptoms.
Hospira attributed the root cause to a supplier glass defect and said it was arranging for return and replacement of all recalled products, according to the FDA notice.
Formal recall letters have been distributed within the U.S. along with notification to safety organizations. (Reporting By Debra Sherman; Editing by Gerald E. McCormick)
http://www.huffingtonpost.com/2012/07/16/cancer-drug-recall-glass-particles-hospira_n_1676389.html
ChanneledKnowledgeTV
Showing posts with label drugs. Show all posts
Showing posts with label drugs. Show all posts
Friday, July 20, 2012
Friday, June 29, 2012
New Mexico Tightens Rx Drug System
Seeking to combat a growing epidemic of prescription drug abuse in New Mexico, the state Board of Pharmacy voted Thursday to strengthen an existing monitoring program that tracks drug prescriptions, who dispenses them and under what circumstances.
Other rule changes adopted by the board, which will go into effect later this year, will require additional training for pharmacists on how to use that monitoring system, limit the supply of drugs prescribed in certain situations and tighten language regarding penalties for anyone lawfully allowed to dispense prescription drugs who withholds or falsifies information going into the tracking system.
"We're accomplishing great things by educating pharmacists," Danny Cross, a board member and pharmacist, said during a well-attended, two-hour hearing Thursday at the board's Albuquerque headquarters. "This is not punishing pharmacists. This is to educate pharmacists, practitioners and patients ... to help control this drug abuse problem."
Over the past decade, New Mexico has experienced a spike both in the number of pills being prescribed and the number of drug overdose deaths reported. From 2001 to 2010, the sales of opioid pain relievers rose by 131 percent in the state, from 489,809 grams to 1.13 million grams, according to the state Department of Health. Meanwhile, over roughly the same period, the state's drug overdose death rate increased by 79 percent -- from the 261 people who died in 2001 to the 468 who lost their lives in 2010.
The epidemic, of course, is not confined to New Mexico. Nationwide, the National Survey on Drug Use and Health estimated that in 2010, 7 million people used prescription drugs nonmedically.
But New Mexico's rate of drug overdose deaths is the highest in the nation.
Even some of the state's pharmacists don't understand the size of the problem, Dale Tinker told board members Thursday.
"It's a lot bigger issue than I think they thought," Tinker, a lobbyist for the New Mexico Pharmacists Association, said.
Tackling the prescription drug abuse problem is complex because it involves multiple challenges. Emergency rooms might see addicts looking for their next fix or dealers trying to corral a new supply, but they also come into contact with patients who want to get off the drugs and don't know where else to turn.
One of the challenges is to ensure that those who are handed a white bag with a bottle of pills inside are the people who truly need it. Another is ensuring that those who hand the prescribed drugs to individuals have access to up-to-date information that the prescription is appropriate.
The rules adopted Thursday represent an attempt to address those problems, mostly by ensuring pharmacists and pharmacist interns are better armed with information on how to prevent abuse and stop addiction before it starts, officials said.
One of the changes would give New Mexico's pharmacists the ability to request from the state's prescription monitoring system a report detailing the past year of a patient's history if he or she exhibits signs of potential abuse or misuse of opiate drugs or if the prescription order is from a dispenser with whom the pharmacist is unfamiliar.
Also under the new rules, practitioners including doctors, dentists, veterinarians, pharmacists and certified nurse practitioners would have to register and train for the state's monitoring program when they complete their controlled-substance registration.
That electronic database gives doctors and pharmacists access to a patient's prescription-drug history. Providers update the information at least every seven days -- an improvement over the monthly updates that were previously all that was required.
"It's a message from the board," said Bill Harvey, the Board of Pharmacy's director. "It's about professional expectations."
The board also voted to require that any controlled-substance prescriptions that go directly to a patient could not be refilled before 75 percent of the days have passed since the prescription was filled, unless a doctor approves the refill. Similarly, prescriptions that go to a patient indirectly, such as through a mail-order service, couldn't be refilled until 66 percent of the days in a 90-day supply have gone by, or half of the days in a 30-day supply, unless a doctor authorizes the refill.
Another change would limit new over-the-phone prescriptions for some controlled substances to a 10-day supply that cannot be refilled. Currently, a phone prescription for those drugs can be refilled up to five times in six months.
Board members seemed intent on adopting the changes Thursday despite potential obstacles.
"We're trying to get things in place sooner rather than later," board member Buffy Saavedra said at one point when someone in the audience asked a question that appeared not to be answered in the proposed rules.
At another point, the board learned that a proposed change would bar the state from qualifying for future U.S. Drug Enforcement Administration funding for the state's prescription monitoring program.
The change under consideration would allow individual pharmacists to access and use the state's prescription monitoring program instead of circumscribing access only to pharmacies, which the DEA requires for a state to qualify for certain types of funding. Many pharmacies employ more than one pharmacist, officials pointed out Thursday. And by having individual pharmacists register to use the system, New Mexico officials believe the state can better track potential abuse.
"This is a big enough problem" that the board should go ahead with the change despite the potential loss of future federal funding, pharmacy board chairman Richard Mazzoni said.
http://www.hispanicbusiness.com/2012/6/22/new_mexico_tightens_prescription_drug_system.htm
Other rule changes adopted by the board, which will go into effect later this year, will require additional training for pharmacists on how to use that monitoring system, limit the supply of drugs prescribed in certain situations and tighten language regarding penalties for anyone lawfully allowed to dispense prescription drugs who withholds or falsifies information going into the tracking system.
"We're accomplishing great things by educating pharmacists," Danny Cross, a board member and pharmacist, said during a well-attended, two-hour hearing Thursday at the board's Albuquerque headquarters. "This is not punishing pharmacists. This is to educate pharmacists, practitioners and patients ... to help control this drug abuse problem."
Over the past decade, New Mexico has experienced a spike both in the number of pills being prescribed and the number of drug overdose deaths reported. From 2001 to 2010, the sales of opioid pain relievers rose by 131 percent in the state, from 489,809 grams to 1.13 million grams, according to the state Department of Health. Meanwhile, over roughly the same period, the state's drug overdose death rate increased by 79 percent -- from the 261 people who died in 2001 to the 468 who lost their lives in 2010.
The epidemic, of course, is not confined to New Mexico. Nationwide, the National Survey on Drug Use and Health estimated that in 2010, 7 million people used prescription drugs nonmedically.
But New Mexico's rate of drug overdose deaths is the highest in the nation.
Even some of the state's pharmacists don't understand the size of the problem, Dale Tinker told board members Thursday.
"It's a lot bigger issue than I think they thought," Tinker, a lobbyist for the New Mexico Pharmacists Association, said.
Tackling the prescription drug abuse problem is complex because it involves multiple challenges. Emergency rooms might see addicts looking for their next fix or dealers trying to corral a new supply, but they also come into contact with patients who want to get off the drugs and don't know where else to turn.
One of the challenges is to ensure that those who are handed a white bag with a bottle of pills inside are the people who truly need it. Another is ensuring that those who hand the prescribed drugs to individuals have access to up-to-date information that the prescription is appropriate.
The rules adopted Thursday represent an attempt to address those problems, mostly by ensuring pharmacists and pharmacist interns are better armed with information on how to prevent abuse and stop addiction before it starts, officials said.
One of the changes would give New Mexico's pharmacists the ability to request from the state's prescription monitoring system a report detailing the past year of a patient's history if he or she exhibits signs of potential abuse or misuse of opiate drugs or if the prescription order is from a dispenser with whom the pharmacist is unfamiliar.
Also under the new rules, practitioners including doctors, dentists, veterinarians, pharmacists and certified nurse practitioners would have to register and train for the state's monitoring program when they complete their controlled-substance registration.
That electronic database gives doctors and pharmacists access to a patient's prescription-drug history. Providers update the information at least every seven days -- an improvement over the monthly updates that were previously all that was required.
"It's a message from the board," said Bill Harvey, the Board of Pharmacy's director. "It's about professional expectations."
The board also voted to require that any controlled-substance prescriptions that go directly to a patient could not be refilled before 75 percent of the days have passed since the prescription was filled, unless a doctor approves the refill. Similarly, prescriptions that go to a patient indirectly, such as through a mail-order service, couldn't be refilled until 66 percent of the days in a 90-day supply have gone by, or half of the days in a 30-day supply, unless a doctor authorizes the refill.
Another change would limit new over-the-phone prescriptions for some controlled substances to a 10-day supply that cannot be refilled. Currently, a phone prescription for those drugs can be refilled up to five times in six months.
Board members seemed intent on adopting the changes Thursday despite potential obstacles.
"We're trying to get things in place sooner rather than later," board member Buffy Saavedra said at one point when someone in the audience asked a question that appeared not to be answered in the proposed rules.
At another point, the board learned that a proposed change would bar the state from qualifying for future U.S. Drug Enforcement Administration funding for the state's prescription monitoring program.
The change under consideration would allow individual pharmacists to access and use the state's prescription monitoring program instead of circumscribing access only to pharmacies, which the DEA requires for a state to qualify for certain types of funding. Many pharmacies employ more than one pharmacist, officials pointed out Thursday. And by having individual pharmacists register to use the system, New Mexico officials believe the state can better track potential abuse.
"This is a big enough problem" that the board should go ahead with the change despite the potential loss of future federal funding, pharmacy board chairman Richard Mazzoni said.
http://www.hispanicbusiness.com/2012/6/22/new_mexico_tightens_prescription_drug_system.htm
Friday, March 23, 2012
Direct link between GABA activation and dopamine suppression
What characterizes many people with depression, schizophrenia and some other mental illnesses is anhedonia: an inability to gain pleasure from normally pleasurable experiences.
Exactly why this happens is unclear. But new research led by neuroscientists at the University of North Carolina at Chapel Hill School of Medicine may have literally shined a light on the answer, one that could lead to the discovery of new mental health therapies. A report of the study appears on-line March 20 in the journal Neuron.
The study used a combination of genetic engineering and laser technology to manipulate the wiring of a specific population of brain cells deep in a portion of a midbrain area that's known to promote behavioral responses to reward.
"For many years it's been known that dopamine neurons in the ventral midbrain, the ventral tegmental area, or VTA, are involved in reward processing and motivation. For example, they're activated during exposure to drugs of abuse and to naturally rewarding experiences," said study lead author Garret D. Stuber, PhD, assistant professor in the departments of Psychiatry and Cell and Molecular Physiology, and the UNC Neuroscience Center.
"The major focus in our lab is to determine what other sorts of neural circuits or genetically defined neural populations might be modulating the activity of those neurons, whether it's increasing or decreasing their activity," Stuber said. "In our study we found that activation of the nearby VTA GABAergic neurons directly inhibit the function of dopamine neurons, which is something that's never been shown before."
In the past, researchers have tried to get a glimpse into the inner workings of the brain using electrical stimulation or drugs, but those techniques couldn't quickly and specifically change only one type of cell or one type of connection. But optogenetics, a technique that emerged about six years ago, can.
In this study, the scientists used a transgenic animal with a foreign gene that has been inserted into its genome to express a bacterial enzyme that can cause DNA recombination only in GABA neurons and not dopamine cells. Using a gene transfer method developed at UNC and with the animal anesthetized, the Stuber team transferred light-sensitive proteins called "opsins" - derived from algae or bacteria that need light to grow - into the VTA, targeting GABA cells. The presence of these foreign opsins in GABA neurons allows researchers to excite or inhibit them by pumping light from a laser into brain tissue.
The animals were then tested in different reward situations, simple tasks in which they were trained to associate a cue with a sugar water reward from a bottle or were given the opportunity to drink the reward by "free licking," where they could drink as much as they want.
http://www.news-medical.net/news/20120322/Direct-link-between-GABA-activation-and-dopamine-suppression.aspx
Exactly why this happens is unclear. But new research led by neuroscientists at the University of North Carolina at Chapel Hill School of Medicine may have literally shined a light on the answer, one that could lead to the discovery of new mental health therapies. A report of the study appears on-line March 20 in the journal Neuron.
The study used a combination of genetic engineering and laser technology to manipulate the wiring of a specific population of brain cells deep in a portion of a midbrain area that's known to promote behavioral responses to reward.
"For many years it's been known that dopamine neurons in the ventral midbrain, the ventral tegmental area, or VTA, are involved in reward processing and motivation. For example, they're activated during exposure to drugs of abuse and to naturally rewarding experiences," said study lead author Garret D. Stuber, PhD, assistant professor in the departments of Psychiatry and Cell and Molecular Physiology, and the UNC Neuroscience Center.
"The major focus in our lab is to determine what other sorts of neural circuits or genetically defined neural populations might be modulating the activity of those neurons, whether it's increasing or decreasing their activity," Stuber said. "In our study we found that activation of the nearby VTA GABAergic neurons directly inhibit the function of dopamine neurons, which is something that's never been shown before."
In the past, researchers have tried to get a glimpse into the inner workings of the brain using electrical stimulation or drugs, but those techniques couldn't quickly and specifically change only one type of cell or one type of connection. But optogenetics, a technique that emerged about six years ago, can.
In this study, the scientists used a transgenic animal with a foreign gene that has been inserted into its genome to express a bacterial enzyme that can cause DNA recombination only in GABA neurons and not dopamine cells. Using a gene transfer method developed at UNC and with the animal anesthetized, the Stuber team transferred light-sensitive proteins called "opsins" - derived from algae or bacteria that need light to grow - into the VTA, targeting GABA cells. The presence of these foreign opsins in GABA neurons allows researchers to excite or inhibit them by pumping light from a laser into brain tissue.
The animals were then tested in different reward situations, simple tasks in which they were trained to associate a cue with a sugar water reward from a bottle or were given the opportunity to drink the reward by "free licking," where they could drink as much as they want.
http://www.news-medical.net/news/20120322/Direct-link-between-GABA-activation-and-dopamine-suppression.aspx
Monday, January 16, 2012
Drugs Being Tested on Children in India
BHOPAL: Indian activists have reacted in anger after 12 doctors were fined just 5,000 rupees ($94) each for conducting secret drug trials on children and patients with learning disabilities.The Madhya Pradesh state government said the tests had not been cleared by health authorities, and it added that the doctors refused to disclose further details citing patient confidentiality laws.
Anand Rai, a doctor who acted as a whistle-blower over the case, told AFP on Tuesday he was angered and frustrated that the scale of the punishment would not deter future illegal trials.
“The Madhya Pradesh government has now slapped a nominal 5,000-rupee penalty on the 12 government doctors who were involved in the bizarre case,” he said. “The penalty was for their failure to inform about the trials.”
“All drug trials were performed on patients who had gone to these government hospitals for routine treatment. It’s a criminal offence to put them under drug trials without their consent.”
Ajay Singh, the leader of opposition in the Madhya Pradesh assembly, described the fine as “ridiculous”.
The doctors, two of whom denied any wrong-doing to AFP, are alleged to have been paid by companies to conduct trials in the central city of Indore on drugs to treat sexual dysfunction and other problems.
http://tribune.com.pk/story/315943/anger-over-secret-drug-trials-on-indian-children/
http://tribune.com.pk/story/315943/anger-over-secret-drug-trials-on-indian-children/
Nodding Disease runs rampant in Uganda
Uganda: Pader Runs Out of Drugs for Controlling Nodding
Jacky Adure17 January 2012
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Pader — Parents in Pader District have to dig deeper into their pockets to get medicine for controlling nodding disease among their children.
The district two weeks ago ran out of epilepsy drugs (Phenobarbitoin and Carbamaxpine) which are used to control the nodding disease. The areas where the disease is most severe are Atanga, Lapul, Angagura, Awere and Puranga sub-counties.
Ms Ventorino Aol of Lacekocot, whose two grandchildren are battling the disease, had to seek medication at Gulu Hospital, about 45 kilometers away. Transport from Pader to Gulu is about Shs15,000. The district has been largely dependant on the Transcultural Psychosocial Organisation, an NGO, that has been providing treatment for managing the disease since its outbreak three years ago.
In Angagura Health Centre III, medical workers say they are stuck with over 200 children who were receiving treatment from the centre but now have nothing to control the ailment, whose cause and mode of spread is still unknown.
Dr Jacinto Amandua, commissioner for clinical services, asked the health workers to be patient as the Ministry of Health sends more drugs. He, however, cautioned that the drugs be administered to those with severe signs to avoid disastrous side-effects.
Dr Amandua said although the disease is overwhelming Kitgum and Pader districts, the ministry with its partners are working closely to ensure that all efforts are directed at its control as they await the results of sample tests from Atlanta, USA.
The District Health Officer, Ms Janet Oola, however, said following the drug shortage, the district procured more drugs a few days ago. "When we ran short of drugs, we ordered for an emergency supply from the National Medical Stores," she said. However, when Daily Monitor visited some of the health facilities last week, they had not yet received the medicine.
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The district chairman, Mr Alfred Akena, in an interview with Daily Monitor on Sunday, said they are overwhelmed by the disease because parents can no longer concentrate on income generating activities as they have to attend to their sick children. "We have fears that the coming months would not be good for the people because almost every family here is affected by the disease," Mr Akena said.
Mr Akena said the district has raised about Shs3b to support families that have been affected by the disease. Nodding disease is a fatal, mentally and physically disabling disease that stunts the growth of its victims. Bouts of nodding and seizure usually begin when food is served.
http://allafrica.com/stories/201201170100.html
Jacky Adure17 January 2012
Email|Print|Comment
Share:
Pader — Parents in Pader District have to dig deeper into their pockets to get medicine for controlling nodding disease among their children.
The district two weeks ago ran out of epilepsy drugs (Phenobarbitoin and Carbamaxpine) which are used to control the nodding disease. The areas where the disease is most severe are Atanga, Lapul, Angagura, Awere and Puranga sub-counties.
Ms Ventorino Aol of Lacekocot, whose two grandchildren are battling the disease, had to seek medication at Gulu Hospital, about 45 kilometers away. Transport from Pader to Gulu is about Shs15,000. The district has been largely dependant on the Transcultural Psychosocial Organisation, an NGO, that has been providing treatment for managing the disease since its outbreak three years ago.
In Angagura Health Centre III, medical workers say they are stuck with over 200 children who were receiving treatment from the centre but now have nothing to control the ailment, whose cause and mode of spread is still unknown.
Dr Jacinto Amandua, commissioner for clinical services, asked the health workers to be patient as the Ministry of Health sends more drugs. He, however, cautioned that the drugs be administered to those with severe signs to avoid disastrous side-effects.
Dr Amandua said although the disease is overwhelming Kitgum and Pader districts, the ministry with its partners are working closely to ensure that all efforts are directed at its control as they await the results of sample tests from Atlanta, USA.
The District Health Officer, Ms Janet Oola, however, said following the drug shortage, the district procured more drugs a few days ago. "When we ran short of drugs, we ordered for an emergency supply from the National Medical Stores," she said. However, when Daily Monitor visited some of the health facilities last week, they had not yet received the medicine.
Relevant Links
East Africa
Uganda
Health
Children
The district chairman, Mr Alfred Akena, in an interview with Daily Monitor on Sunday, said they are overwhelmed by the disease because parents can no longer concentrate on income generating activities as they have to attend to their sick children. "We have fears that the coming months would not be good for the people because almost every family here is affected by the disease," Mr Akena said.
Mr Akena said the district has raised about Shs3b to support families that have been affected by the disease. Nodding disease is a fatal, mentally and physically disabling disease that stunts the growth of its victims. Bouts of nodding and seizure usually begin when food is served.
http://allafrica.com/stories/201201170100.html
Monday, January 9, 2012
US Patent #5676977 said to cure AIDS
Method of curing AIDS with tetrasilver tetroxide molecular crystal devices
Abstract The diamagnetic semiconducting molecular crystal tetrasilver tetroxide (Ag.sub.4 O.sub.4) is utilized for destroying the AIDS virus, destroying AIDS synergistic pathogens and immunity suppressing moieties (ISM) in humans. A single intravenous injection of the devices is all that is required for efficacy at levels of about 40 PPM of human blood. The device molecular crystal contains two mono and two trivalent silver ions capable of "firing" electrons capable of electrocuting the AIDS virus, pathogens and ISM. When administered into the bloodstream, the device electrons will be triggered by pathogens, a proliferating virus and ISM, and when fired will simultaneously trigger a redox chelation mechanism resulting in divalent silver moieties which chelate and bind active sites of the entities destroying them. The devices are completely non-toxic. However, they put stress on the liver causing hepatomegaly, but there is no loss of liver function.
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=5676977.PN.&OS=PN/5676977&RS=PN/5676977
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=5676977.PN.&OS=PN/5676977&RS=PN/5676977
FDA says Walnuts are Drugs After seller says they reduce Heart Disease
Walnuts are DRUGS! FDA makes bizarre claim after seller says they 'reduce risk of heart disease and cancer'
By PAUL BENTLEY
Last updated at 6:53 AM on 26th July 2011
Hard drugs? The FDA allegedly classed walnuts as a drug because of claims they are good for your health
They may just be the hardest drugs on the market, if the FDA are to be believed.
A company which sells walnuts has been told they are dealing in drugs because their packaging suggests health benefits which the Food and Drug Administration has not approved, it has been reported.
A fiercely-worded letter from the agency allegedly insisted Diamond Foods, from Stockton, California, remove the health claims or send off for a new drug application if it did not wish to be closed down.
The nut company has been selling its products with packaging which states the omega-3 fatty acids in walnuts have been shown to reduce the risk of heart disease and some types of cancer.
But while the claims are backed up by research, including 35 published medical papers supporting assertions that eating walnuts improves vascular health and may reduce risk of heart attacks, the FDA is said to have insisted the company is 'misbranding' its foods because the 'product bears health claims that are not authorised by the FDA'.
The letter from the FDA reportedly stated: 'We have determined that your walnut products are promoted for conditions that cause them to be drugs because these products are intended for use in the prevention, mitigation, and treatment of disease.'
It went on to emphasise that the nuts are 'misbranded' because they 'are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners.
'Therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes.'
Critics have slammed the FDA for the supposedly 'tyrannical' manner in which they have accused the walnut sellers of dealing in drugs.
William Faloon, from Life Extension Magazine, said: 'The FDA’s language resembles that of an out-of-control police state where tyranny [reigns] over rationality.
'This kind of bureaucratic tyranny sends a strong signal to the food industry not to innovate in a way that informs the public about foods that protect against disease.
'While consumers increasingly reach for healthier dietary choices, the federal government wants to deny food companies the ability to convey findings from scientific studies about their products.'
Read more: http://www.dailymail.co.uk/news/article-2018807/Walnuts-DRUGS-FDA-makes-bizarre-claim-seller-says-reduce-risk-heart-disease-cancer.html#ixzz1iwo5wM1Z
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