Heartburn Drugs Can Thwart Popular Blood Thinner Nov 19, 2009
D., deputy director for safety, Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Associated Press. HealthDay. (MEDLINEplus)
FDA Warning: Sex Pill May Carry Health Dangers Nov 7, 2009
"Because this product is labeled as an all natural dietary supplement, consumers may assume it is harmless and poses no health risk," said Deborah M. Autor, director of FDA s Center for Drug Evaluation and Research Office of Compliance, in a news release. "In fact, this product is illegally marketed and can cause serious complications. The FDA advises consumers who have experienced adverse effects from sexual enhancement products to consult a health care professional. Consumers and health care... (Fox News)
Consumer Warning: Sexual Enhancement Products Nov 6, 2009
"Because this product is labeled as an 'all natural dietary supplement,' consumers may assume it is harmless and poses no health risk," said Deborah M. Autor, director of FDA's Center for Drug Evaluation and Research Office of Compliance. "In fact, this productis illegally marketed and can cause serious complications.". (W-USA News, DC)
FDA Issues Warning for Diabetes Drug Nov 5, 2009
"Health-care professionals and patients taking Byetta should pay close attention to any signs or symptoms of kidney problems," Dr. Amy Egan, of the Division of Metabolism and Endocrinology Products at the FDA's Center for Drug Evaluation and Research, said in an FDA news release. "Patients also should be aware that problems with kidney function could lead to changes in urine color, frequency of urination or the amount of urine, unexplained swelling of the hands or feet, fatigue, changes in... (MEDLINEplus)
Compound interest In this age of "have it your way" burgers, made-to-fit jeans and personalized ring tones, its no surprise that prescription ... Nov 3, 2009
"There may be unknown risks when using a compound (medication) since they dont go through the same approval process as FDA-approved drugs and there is no data available," says Kathleen Anderson, deputy director of the FDAs Center for Drug Evaluation and Research in Maryland. Pharmacies, including compounding pharmacies, are regulated by state boards, not the FDA, which regulates drug manufacturing. (San Diego Union-Tribune)
Obama administration calls for chemical-law reform Sep 30, 2009
"We have a difficult time figuring out exactly what products are on the market," said Michael Levy, director of new drug and labeling compliance at the Food and Drug Administration's Center for Drug Evaluation and Research. "Once those products are on the market, it's not easy to figure out exactly what's in those products. The only way to truly do that is to test them in a lab, which is a cost- and resource-intensive type of activity.". (Fresno Bee -- Business)
Care-Tech Laboratories Agrees to Stop Making, Selling and Distributing Unapproved Antimicrobial Products Sep 9, 2009
"The FDA is concerned about Care-Tech's products because they lack FDA approval, do not conform to any applicable over-the-counter drug monograph, and are not appropriately manufactured," said Deborah Autor, director of the FDA's Office of Compliance, Center for Drug Evaluation and Research. "Companies have an obligation to consumers to ensure that their products are safe, effective, and high quality, and the FDA recommends that Care-Tech's customers seek alternative products.". (PR Newswire)
FDA Investigating Weight-Loss Drug Over Reports of Liver Damage Aug 26, 2009
The Drug Safety Oversight Board, part of FDA's Center for Drug Evaluation and Research, first looked into the issue in April. The agency stressed that there is no established association or evidence of a cause-and-effect relationship at this time. (Atlanta Journal-Constitution -- Health)
FEATURE - Europe's Saharan power plan: miracle or mirage? Aug 24, 2009
CSP installations placed in the Sahara generate around 30 percent more power per area than in southern Spain, according to Morocco's renewable energy agency CDER.. "Desertec can help reduce emissions in Europe and foster economic and social development in northern Africa, so everyone loves this project," said Santiago Siage, head of Desertec consortium member Abengoa Solar. (The Star Online, Malaysia)
Suicide Risk with Antidepressants Falls with Age Aug 13, 2009
Information on the suicide risk linked to antidepressant use was posted on the FDA Web site some time ago, but "we thought it needed to be in a peer-reviewed publication, which would make it more useful to professionals," said Dr. Marc Stone, a senior medical reviewer in the agency's Center for Drug Evaluation and Research and lead author of the BMJ report ... SOURCES: Marc Stone, M.D., senior medical reviewer, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Bethesda,... (MEDLINEplus)
New rules may help dying patients access drugs Aug 13, 2009
The goal is to encourage more companies to provide the medicines to appropriate patients, said Dr. Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research. Patients can try experimental drugs through clinical trials, but enrollment in the studies is limited, creating a push for other options. (MSNBC -- Health)
US Marshals seize sanitizer for bacteria problems Aug 5, 2009
FDA's Center for Drug Evaluation and Research. FDA. (Yahoo News)
Harmful skin sanitizers seized in U.S. Aug 2, 2009
"The FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our current good manufacturing practice requirements," said Deborah M. Autor, director of the FDA's Center for Drug Evaluation and Research Office of Compliance. Editor: Lin Zhi. (Xinhuanet, China)
FDA approves new drug treatment for type 2 diabetes Aug 1, 2009
"Keeping blood sugar levels in adequate control is essential to the good health of the 24 million people in the United States with Type 2 diabetes," said Mary Parks, director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research. "High blood sugar levels can cause blurry vision and excessive urination and eventually result in such serious conditions as kidney and eye disease.". (Xinhuanet, China)
E-cigarettes pose a health hazard, FDA warns Jul 28, 2009
and Florida-based Smoking Everywhere, according to Benjamin Westenberger, deputy director of the pharmaceutical analysis division at the Center for Drug Evaluation and Research, part of the FDA. ... So far, 50 shipments have been seized, according to Michael Levy, division director of the Office of Compliance at the Center for Drug Evaluation and Research ... SOURCES: July 22, 2009, teleconference with: Joshua Sharfstein, M.D., principal deputy commissioner, U.S. Food and Drug Administration;... (KLAS-TV)
FDA wants consumers warned about pain meds Jul 9, 2009
"Physicians need to be aware of the risk of overdose when prescribing these drugs," said Dr. Janet Woodcock, director of the food and drug agency's Center for Drug Evaluation and Research. "They should carefully review patient histories and make appropriate treatment decisions based on the warnings and directions stated within the drug's label. "Prescribers and patients should be aware of propoxyphene's potential risks when used at doses higher than those recommended. (CNN -- Health)
If 2 Painkillers Are Banned, What Next? Jul 4, 2009
Dr. Sandra L. Kweder, deputy director of the FDA's Office of New Drugs at the Center for Drug Evaluation and Research, gave a strong hint Tuesday of what the agency might do with the advisory panel's recommendations. "I think the top recommendation of this committee was that the agency needs to do something to address and decrease the usual dose of acetaminophen, both for over-the-counter products and also prescription combination products," Kweder said during a press conference. (MEDLINEplus)
Anti-smoking drugs to carry mental-health warnings Jul 3, 2009
"The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. " is the leading cause of preventable disease, disability and death in the United States, and we know these products are effective aids in helping people quit.". (CNN -- Health)
Want Tylenol? You May Need Rx Jul 1, 2009
Specifically, the panel at the Center for Drug Evaluation and Research Joint Meeting of the Drug Safety and Risk Management Advisory Committee, the FDA's Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee has already voted to urge the FDA to switch to prescription status the strongest of the over-the-counter acetaminophen products, which contain a 1,000 mg dose. The decision affects a variety of popular over the counter products, including the... (ABC News)
FDA Eyes Acetaminophen's Liver Risk Jun 30, 2009
These concerns and more will be the subject of discussion today and Tuesday at the Center for Drug Evaluation and Research Joint Meeting of the Drug Safety and Risk Management Advisory Committee, the FDA's Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee. No matter the outcome of the meeting, however, consumers will still be able to get acetaminophen. (ABC News)
Novo Nordisk Insulin Analogs Have Proven Safety Profiles Jun 29, 2009
(5) Center for Drug Evaluation and Research, FDA. Application number 21-536: Pharmacology review of insulin detemir. (6) Shukla A, Grisouard J, Ehemann V, Hermani A, Ensmann H, Mayer D (2009) Analysis of signalling pathways related to cell proliferation stimulated by insulin analogs in human mammary epithelial cell lines. (PR Newswire)
FDA: More data needed on Glaxo nausea drug Jun 24, 2009
The FDA's Center for Drug Evaluation and Research issues complete response letters when staff have finished reviewing all the experimental and other data in a new drug application and there are outstanding questions or issues that bar approval of the product. GlaxoSmithKline said in a statement that the company is reviewing the FDA's letter and will work with the agency to decide the next appropriate steps. (NJ.com -- News)
Certain Zinc-based Cold Remedies Linked To Loss Of Sense Of Smell, FDA Says Jun 21, 2009
Loss of sense of smell is a serious risk for people who use these products for relief from cold symptoms, said Janet Woodcock, M.D., director of the FDA s Center for Drug Evaluation and Research (CDER). We are concerned that consumers may unknowingly use a product that could cause serious harm, and therefore we are advising them not to use these products for any reason. (Science Daily)
Zicam Spray May Hurt Sense of Smell Jun 17, 2009
The FDA has received more than 130 reports of anosmia from patients who used zinc-containing nasal products, said Dr. Charles Lee, medical officer at the FDA's Center for Drug Evaluation and Research ... "People without the sense of smell may not be able to detect dangers, such as gas leaks or something burning in the house and may not be able to tell before eating," said Deborah Autor, director of the office of compliance at the Center for Drug Evaluation and Research. (ABC News)
Higher death rates for kids on ADHD drugs Jun 16, 2009
Robert Temple, director of the Office of Drug Evaluation at the Center for Drug Evaluation and Research at the FDA, said that the study had been well conducted, but that he was concerned that all parents may not accurately recall whether children who died were taking stimulant drugs. When a child dies suddenly, he said, it is natural for a parent to pay close attention to all the medications the child was taking at the time and to report that to researchers. (AZCentral -- News)
FDA: Keep Kids On Attention Deficit Drugs Despite Sudden Death Risk Jun 16, 2009
The FDA continues to review drug safety information for stimulant medications used to treat ADHD so that we can give health care professionals and families the most up-to-date drug safety information available, said Janet Woodcock, M.D., director of the FDAs Center for Drug Evaluation and Research. More Stories. (KWTX.com, TX)
FDA Report Urges Tougher Acetaminophen Warning May 30, 2009
D., deputy director, Division of Nonprescription Regulation Development, Office of Nonprescription Products, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration. HealthDay. (MEDLINEplus)
NORD Sponsors Rare Disease Summit May 15, 2009
The blockbuster model is no longer viable, said Janet Woodcock, MD, director of the Center for Drug Evaluation and Research at FDA. As a result, she said, companies are more willing to consider new options, including more products for rare diseases. Former National Human Genome Research Institute Director Francis Collins, MD, PhD, agreed, adding that it's time to de-risk orphan drug development, making it a more viable business model for companies. (PR Newswire)
FDA Orders Label Warning for Testosterone Gels May 9, 2009
"In the cases we reviewed, the average duration of exposure was around six months to a year" before the children received medical attention, noted Dr. Mary Roberts, a medical officer in the division of metabolism and endocrinology within the FDA's Office of New Drugs, Center for Drug Evaluation and Research (CDER). "We can't tell you if it lasted for five minutes or five hours, but we do know the exposure did occur over a period of time.". (MEDLINEplus)
New warning labels ordered for some painkillers Apr 29, 2009
"Acetaminophen and NSAIDs are commonly used drugs for both children and adults because they are effective in reducing fevers and relieving minor , such as headaches and muscle aches," said Dr. Charles Ganley, director of nonprescription drugs in the Center for Drug Evaluation and Research. "However, the risks associated with their use need to be clearly identified on the label so that consumers taking these drugs are fully aware of the potential harm they can cause. It is important that they... (CNN -- Health)
Unapproved Liquid Morphine Can Still Be Sold in U.S. Apr 11, 2009
On Thursday, the FDA sent new letters to the makers or distributors of the liquid morphine telling them sales could continue for now, according to Douglas Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research. Sales of unapproved versions will have to stop after an acceptable liquid morphine wins approval or when the FDA determines that appropriate alternatives are available, Throckmorton told reporters. (MEDLINEplus)
FDA reconsiders painkiller for dying Apr 11, 2009
The order has not changed for the other painkillers, at least for now, said Throckmorton, deputy director of the agency s Center for Drug Evaluation and Research. In interviews, experts said they didn t have firm numbers on how many patients use the concentrated liquid. (Atlanta Journal-Constitution)
FDA reversal keeps painkiller on market Apr 10, 2009
The order has not changed for the other painkillers, at least for now, said Throckmorton, deputy director of the agency's Center for Drug Evaluation and Research. The agency said last week that the unapproved drugs might be unsafe, ineffective or poor quality. (MSNBC -- Health)
FDA: 'Unapproved' morphine to stay on market Apr 10, 2009
"While the FDA remains committed to ultimately ensuring that all prescription drugs on the market are FDA approved, we have to balance that goal with flexibility and compassion for patients who have a few alternatives for the alleviation of their pain," Dr. Douglas Throckmorton, deputy director of the FDA's Center for drug Evaluation and Research, said Thursday. "In light of the concerns raised by these patients and their health-care providers, we have adjusted our actions with regard to these... (CNN -- US)
FDA orders Mallinckrodt to halt drug production Apr 2, 2009
The FDA threatens legal actions, including a seizure and injunction, if Mallinckrodt does not cease marketing its morphine sulfate concentrate oral solution, according to a letter Deborah Autor, compliance director for the FDA s Center for Drug Evaluation and Research, sent to Richard Meelia, chairman, president and chief executive officer of St. Louis-based Mallinckrodt. The drug brought in under $10 million in annual sales for Mallinckrodt, a subsidiary of Bermuda-based , which reported sales... (St. Louis Business Journal, MO)
FDA warns makers of unapproved narcotics Apr 2, 2009
"We estimate there are several hundred unapproved drugs out there," said Deborah Autor, director of the office of compliance within the FDA's Center for Drug Evaluation and Research ... "Consumers have a right to expect that their drugs meet the FDA's safety and effectiveness standards," said Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research. (CNN -- Health)
Skin Patches Can Cause Burns During MRIs Mar 7, 2009
"Adhesive patches are commonly used to slowly deliver a variety of medications -- there are some to treat pain, some deliver hormonal medications, or nicotine," Dr. Sandra Kweder, deputy director of the Office of New Drugs at FDA's Center for Drug Evaluation and Research, said during a teleconference on Thursday. "Some, but not all, of these patches contain a little bit of aluminum or other metal -- just enough that they can overheat during an MRI," Kweder said. (MEDLINEplus)
FDA review: Ranbaxy set to lose $150m US revenue Feb 27, 2009
"Companies must provide truthful and accurate information in their marketing applications. The American public expects and deserves no less," said Janet Woodcock, director of the USFDA's Center for Drug Evaluation and Research (CDER). Meanwhile, the company said on Thursday that it has received a FDA letter, and will ``analyze the letter and other information fully and respond appropriately in a timely manner". Daiichi Sankyo's stock crashed 9.5% to 1,680 yen at the close Daiichi Sankyo's stock... (India Times, India -- Intl Business)
Bad food pyramid: Fast food, candy bars, cookies and potato chips all taste good, but all are also the cause of weight gain. (Thelma Grimes/photo.) Feb 25, 2009
"These tainted weight- loss products pose a great risk to public health, because they contain undeclared ingredients and, in some cases, contain prescription drugs in the amounts that greatly exceed their maximum recommended dosages," said Janet Woodcock, the FDA director of the Center for Drug Evaluation and Research. "Consumers have no way of knowing that these products contain powerful drugs that could cause serious health consequences.". (Benson San Pedro Valley News Sun, AZ)
Drug Regulators Admit Mistake Tossing Lilly Critic From Panel Feb 24, 2009
The decided to eject panel member after Lilly contacted the agency, said , director of the FDAs Center for Drug Evaluation and Research ... It is unclear how the conclusions Dr. Kaul came to regarding the efficacy and safety of prasugrel suggest any bias, as opposed to well-reasoned scientific inquiry, said , director of Washington-based Public Citizens health- research group, in a letter to the FDAs Center for Drug Evaluation and Research on Feb. 19. (Bloomberg)
Pharmacies' pamphlet on drugs often incomplete Feb 22, 2009
The current voluntary system has failed to provide consumers with the quality information they need in order to use medicines effectively and safely, Dr. Janet Woodcock, director of the FDA s Center for Drug Evaluation and Research, said recently. Walgreens, CVS and other pharmacy industry officials contacted by the AJC said the pamphlets are appropriate and strive to provide accurate and concise information written at a sixth- to eighth-grade comprehension level. (Atlanta Journal-Constitution -- Health)
Newly Discovered Gene Could Be A Prime Target In The Most Lethal Brain Cancer Feb 20, 2009
The remaining authors came from the Ludwig Center for Cancer Genetics and Therapeutics and the Howard Hughes Medical Institute at Johns Hopkins Kimmel Cancer Center, the Johns Hopkins Department of Neurosurgery, the Department of Pediatrics at Baylor College of Medicine, and the Center for Drug Evaluation and Research of the U.S. Food and Drug Administration. Funding came from the Pediatric Brain Tumor Foundation Institute, a Damon Runyon Foundation Scholar Award, a grant from the Southeastern... (Science Daily)
Could Genetics Improve Warfarin Dosing? New Research Says Yes -- Now For The Clinical Trial Feb 20, 2009
The article is accompanied by an editorial by Janet Woodcock and Lawrence Lesko of the Center for Drug Evaluation and Research at the Food and Drug Administration. In an important step toward putting these findings into clinical practice, NIH is launching the largest prospective, multi-center, randomized clinical trial in the United States to test whether a gene-based strategy for prescribing the initial warfarin dose will improve patient outcomes. (Science Daily)
Pharmacogenetics — Tailoring Treatment for the Outliers Feb 19, 2009
From the Center for Drug Evaluation and Research, Food and Drug Administration, White Oak, MD.. . (New England Journal of Medicine)
IDH1 and IDH2 Mutations in Gliomas Feb 19, 2009
From the Departments of Pathology (H.Y., G.J., R.M., B.A.R., D.D.B.), Radiation Oncology (I.K., I.B.-H.), Neuro-Oncology (H.F.), and Surgery (A.F., D.R.), the Pediatric Brain Tumor Foundation Institute and the Preston Robert Tisch Brain Tumor Center; and the Cancer Statistical Center (J.H.) all at Duke University Medical Center, Durham, NC; the Ludwig Center for Cancer Genetics and Therapeutics and the Howard Hughes Medical Institute at Johns Hopkins Kimmel Cancer Center (D.W.P., S.J., K.W.K.,... (New England Journal of Medicine)
FDA Seeks Better Regulation of Painkillers Feb 10, 2009
Speaking at a Monday teleconference, Dr. John Jenkins, director of the FDA's Office of New Drugs, part of the Center for Drug Evaluation and Research, said that approximately 21 million prescriptions for 3. 7 million patients were issued in 2007 for the targeted medications. (U.S. News & World Report)
FDA Adds Suicide Warning to Epilepsy Drugs Feb 7, 2009
"Patients being treated with antiepileptic drugs for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior," Dr. Russell Katz, director of the division of neurology products in the FDA's Center for Drug Evaluation and Research, said in an agency news release ... "We have concluded this was a real signal, and the signal applied to all drugs we studied," Dr. Russell Katz, director of the division... (MEDLINEplus)
FDA Warns About Weight Loss Products Feb 7, 2009
"These tainted weight loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed their maximum recommended dosages," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a news release. "Consumers have no way of knowing that these products contain powerful drugs that could cause serious health consequences. Therefore, FDA is taking this action to... (MEDLINEplus)
FDA Puts Black-Box Warning on Bowel-Cleansing Drugs Feb 7, 2009
"The FDA has received reports of 20 unique cases of kidney injury associated with the use of OsmoPrep," Dr. Joyce Korvick, deputy director of FDA's Division of Gastroenterology Products at the Center for Drug Evaluation and Research, said during an afternoon teleconference. "Of the reported cases, three were biopsy-proven cases of acute phosphate nephropathy. The onset of kidney injury in these cases varied, occurring in some within several hours of use of these products and in other cases up to... (MEDLINEplus)
USP announces new standards to protect patients from counterfeit and adulterated medicines Feb 7, 2009
D., director, Office of New Drug Quality Assessment (ONDQA), CDER, FDA. "This provides a considerable safeguard for citizens of the United States and the world by helping to prevent fraudulent suppliers from adding components that in the past have eluded existing identity tests due to similar properties. The new standards represent a significant improvement to the safety nets that keep substandard drugs from reaching the marketplace. FDA is pleased to have worked together with USP on this... (EurekAlert! -- Business News)
