tagged w/ FDA & Pharmaceuticals
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Regeneron Pharmaceuticals Inc said on Monday that U.S. regulators placed the companys experimental pain drug for osteoarthritis on clinical hold after a patient in another companys trial developed a serious bone disorder...
http://www.indiareport.com/India-usa-uk-news/reuters/Health/71427Regeneron Pharmaceuticals Inc said on Monday that U.S. regulators placed the companys... more
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February 20, 2010 — Twenty-seven drugs and drug categories have landed on the watch list of the US Food and Drug Administration (FDA) based on potential signs of serious risks or new safety information identified in the agency's Adverse Event Reporting System (AERS) last year.
The key word here is potential. The FDA states that the appearance of a drug on the AERS list does not mean that the agency has determined that the drug actually poses the listed risk. While the FDA evaluates whether there is a casual relationship between a listed drug and a possible risk, it is not suggesting that physicians stop prescribing these drugs, or that patients stop taking them.
Drugs coming under surveillance include oseltamivir (Tamiflu), used to treat influenza, and cisplatin (Platinol), a staple in cancer chemotherapy. Oseltamivir made the list due to reports of hypothermia, while cisplatin is there based on reports of leukoencephalopathy.
Yet another chemotherapy agent on the watch list is imatinib mesylate (Gleevec). The FDA will evaluate whether hearing disorders and hearing loss are possible adverse effects.
In the case of dexlansoprazole (Kapidex), prescribed for gastroesophageal reflux disease and erosive esophagitis, the possible problem is alphabetical in nature. FDA is wondering if physicians and patients are confusing the brand name Kapidex with Casodex, the brand name for the prostate cancer drug bicalutamide.
Some Safety Issues Have Already Been Addressed
The 27 drugs and drug categories appear on quarterly reports generated by AERS for the second and third quarters of 2009; the reports were made public on Wednesday. AERS is a database for adverse drug events and medication errors reported by clinicians, patients, drug manufacturers, and others.
Because the reports cover the second and third quarters of 2009, the FDA and drug manufacturers have had time since then to address some of the possible safety issues. For example, the antihypertensive agent aliskiren (Tekturna and Tekturna HCT) surfaced in AERS because of reports of angioedema so severe that it required intubation. In November, the warnings and precautions section of aliskiren's labeling was revised to include angioedema as a possible adverse effect.
if you cant open the article, google it:
FDA Studying 27 Drugs, Drug Classes for Potential Safety Issues
Feb 20, 2010 ... Lamotrigine (Lamictal), Central nervous system infection, aseptic meningitis, Under FDA study. Neuromuscular blocking agents, Anaphylactic ...
www.medscape.com/viewarticle/717321 - 7 hours agoFebruary 20, 2010 — Twenty-seven drugs and drug categories have landed on the... more
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Rolaids and 27 different formulations and packaging types of Tylenol are under voluntary recall right now.
The FDA slammed its manufacturer Friday for being to slow to take steps to recall it. The contaminated products were detected by consumers to have a musty, moldy smell and made them ill.
It has been discovered that many lots of the medication were manufactured with chemicals contaminated with by-products of chemicals used to kill molds and fungus. The result is taking the medication can give people a variety of acute flu-like stomach problems.
[Surprisingly, the vast majority of people presumed by health authorities to have H1N1 did not have it, only 1% did, CBS News investigators discovered last year. Right after the Tylenol recall finally started and CBS released its report, the number of cases health authorities measured in the US plummeted. Two other related events: Taking Tylenol was found to reduce the effectiveness of vaccines receive before taking Tylenol, and a maker of the H1N1 vaccine said its product loses its effectiveness quickly - and so it was taking back its supply of the drug. No news articles I know of have linked the coincidences that Tylenol causes flu-like symptoms, and that it reduces the effectiveness to some vaccines - to the high H1N1 infection numbers quoted across the US until mid-Fall 2009 when they mysteriously sharply dropped all of a sudden.]Rolaids and 27 different formulations and packaging types of Tylenol are under... more
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Pfizer and Lilly lead a parade of U.S. companies that have paid $7 billion in penalties after promoting drugs for uses not approved by the FDA. This unlawful behavior may not end until prosecutors force a drugmaker into bankruptcy.
http://www.bloomberg.com/apps/news?pid=20601109&sid=a4yV1nYxCGoA&pos=10Pfizer and Lilly lead a parade of U.S. companies that have paid $7 billion in... more
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In June, the federal Food and Drug Administration issued a statement linking drugs used to treat Attention Deficit Hyperactivity Disorder (ADHD) and sudden, fatal heart problems in children taking the medications.
The FDA stated that because the study is limited in scope, it doesn't justify a change in the agency's safety recommendations for doctors prescribing the stimulants to kids.
The study was of two groups of 564 children; one group was of otherwise healthy kids who died of sudden cardiac failure and the other was a group of children killed in motor vehicle accidents. Researchers examining the data gathered between 1985 and 1996 found that 10 children who died of sudden cardiac disturbances were taking stimulant medications prior to their deaths, whereas only two in the car accidents were taking the medications.
The FDA currently urges physicians to consider a child's personal and family history of cardiovascular disease before prescribing medications such as Ritalin, Concerta, Metadate, Methylin, Dexedrine, Dextrostat and Adderall. The doctors are urged to conduct a physical examination with a focus on the cardiovascular system and consider further tests, including a screening electrocardiogram and echocardiogram.
Over three million American children use ADHD drugs. Some estimates place usage of ADHD medications as high as 10 percent among 10-year-old American boys. Many critics believe the drugs are overprescribed; often for children for whom the associated risks outweigh the benefits.
The FDA is co-sponsoring a large study of the potential for danger in ADHD medications in partnership with the Agency for Healthcare Research and Quality. It will evaluate the potential increased risk of heart attacks, strokes and other cardiovascular disturbances associated with the use of stimulants in children.
Findings from this study are expected later this year.In June, the federal Food and Drug Administration issued a statement linking drugs... more
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If you reside in the U.S., you may use our online screener to find out if you or someone you know may be eligible to participate in the SPRAY clinical study. You will also be able to find the study sites nearest to you. We can also be reached by calling
1-877-388-3315.
http://www.spraytrial.com/If you reside in the U.S., you may use our online screener to find out if you or... more
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Upon approval in the United States, Sativex® will be marketed by Otsuka.
The SPRAY study (Sativex® for Pain Research in Advanced malignancY) is a medical research study looking at whether an investigational medication, Sativex®, is effective in managing persistent cancer pain in approximately 336 patients worldwide.
Investigational means it has not been approved by all the necessary regulatory agencies where this study is taking place. Sativex® has been approved in Canada as an add-on treatment for pain in patients with advanced cancer.
In this study, Sativex® comes in the form of a metered dose oro-mucosal spray (like a breath freshener), taken by spraying it inside the cheeks of your mouth. More details on how to take this study medication will be provided to you upon study entry.
http://www.spraytrial.com/Upon approval in the United States, Sativex® will be marketed by Otsuka.
The... more
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Patients, hospitals face shortages of some medications.
Periodic shortages of pain relief medications have caused problems in recent months for some area hospitals and the patients who rely on them.
On its Web site, the Food and Drug Administration reported the shortage of oxycodone immediate release tablets in 5, 15 and 30mg.
Erica Abbett, a spokeswoman for drugmaker Covidien, explained the shortage this way: "Currently there is an industrywide supply issue with oxycodone-related products. The situation is due to multiple factors, including two competitors' products being removed from the market because of recalls.
"Covidien has significantly increased our product output as a result of the supply issue, however we alone cannot meet the total demand for these products. We are working diligently to ensure that interruption of patient access to vital pain management products, like oxycodone, is minimized," Abbett said.
The medicines affected are grouped mostly among the narcotics, said Andrew Lowe, Director of Pharmacy at Arrowhead Regional Medical Center. Among those he cited are morphine-related Oxycontin, Percocet and Vicodin, all derivatives of oxycodone.
"There is nothing specific (to cause the shortages) that they have told us about," Lowe said. "It's usually a manufacturing problem.
"There has been no action by the FDA" that could have caused it, he said.
Oxycontin is oxycodone in a time-released formula, and its generic cousin oxycodone releases the drug without
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delay. Percocet is a combination of oxycodone and Tylenol, Lowe said.
The shortages at Arrowhead have occurred in oxycodone and Percocet. Last month, Vicodin was in short supply. Supplies of morphine, a well-known and widely used generic, have not been affected, Lowe said. Supplies of Norco, a combination of acetaminophen and hydrocodone, have been unaffected. Lowe described Norco as the most widely used legal narcotic in the Inland Empire.
Brian Kawahara, chief of pharmacy at Jerry L. Pettis Veterans Administration Medical Center in Loma Linda, said the supply there has been in flux. "It varies from day to day. It has a kind of domino effect.
"It is taking a while for the supply lines to get back to normal" from an earlier shortage, Kawahara said.
The shortage has been "mainly narcotics," he said. "That's why I am being cautious.
"I don't want to say what I have and what I don't," the pharmacy chief said, "because those are drugs that are highly abuseable.
"We are getting supplies," he confirmed.
When asked if his caution was from fear of theft, Kawahara said, "You could say that."
Do you know when supplies will be normal again, he was asked.
"If I could predict like that," Kawahara said, "I'd be sitting on a yacht."
Lowe at Arrowhead didn't seem particularly worried about the situation. "Shortages occur periodically," he said. "We just find an alternative."Patients, hospitals face shortages of some medications.
Periodic shortages of pain... more
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Medical marijuana already exists. It's called Marinol.
The FDA has not approved smoking marijuana for medicinal purposes, but has approved the active ingredient-THC-in the form of scientifically regulated Marinol.
A pharmaceutical product, Marinol, is widely available through prescription. It comes in the form of a pill and is also being studied by researchers for suitability via other delivery methods, such as an inhaler or patch. The active ingredient of Marinol is synthetic THC, which has been found to relieve the nausea and vomiting associated with chemotherapy for cancer patients and to assist with loss of appetite with AIDS patients.
Unlike smoked marijuana--which contains more than 400 different chemicals, including most of the hazardous chemicals found in tobacco smoke-Marinol has been studied and approved by the medical community and the Food and Drug Administration (FDA), the nation's watchdog over unsafe and harmful food and drug products. Since the passage of the 1906 Pure Food and Drug Act, any drug that is marketed in the United States must undergo rigorous scientific testing. The approval process mandated by this act ensures that claims of safety and therapeutic value are supported by clinical evidence and keeps unsafe, ineffective and dangerous drugs off the market.
There are no FDA-approved medications that are smoked. For one thing, smoking is generally a poor way to deliver medicine. It is difficult to administer safe, regulated dosages of medicines in smoked form. Secondly, the harmful chemicals and carcinogens that are byproducts of smoking create entirely new health problems. There are four times the level of tar in a marijuana cigarette, for example, than in a tobacco cigarette
The DEA recognizes the importance of listening to science. That's why the DEA has registered seven research initiatives to continue researching the effects of smoked marijuana as medicine. For example, under one program established by the State of California, researchers are studying the potential use of marijuana and its ingredients on conditions such as multiple sclerosis and pain. At this time, however, neither the medical community nor the scientific community has found sufficient data to conclude that smoked marijuana is the best approach to dealing with these important medical issues.
The most comprehensive, scientifically rigorous review of studies of smoked marijuana was conducted by the Institute of Medicine, an organization chartered by the National Academy of Sciences. In a report released in 1999, the Institute did not recommend the use of smoked marijuana, but did conclude that active ingredients in marijuana could be isolated and developed into a variety of pharmaceuticals, such as Marinol.
In the meantime, the DEA is working with pain management groups, such as Last Acts, to make sure that those who need access to safe, effective pain medication can get the best medication available. Medical marijuana already exists. It's called Marinol.
The FDA has not... more
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Takes a look at why patented drugs are so readily prescribed by doctors, the role insurance companies and HMO's play in promoting compliance, and the problem of rising health care costs. An in-depth investigation into the symbiotic relationships between the pharmaceutical industry, the FDA, lobbyists, lawmakers, medical schools, and researchers, and the impact this has on consumers and their health care.
One and a half hour show...grab your iced tea and sit back : )
Takes a look at why patented drugs are so readily prescribed by doctors, the role... more
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