FDA

FDA Approves New DVT Treatment

The FDA has approved the use of the anti-clotting drug apixaban (Eliquis) to treat deep vein thrombosis (DVT) and pulmonary embolism (PE).

Apixaban is also now approved to lower the risk of DVT and PE returning in people who’ve already had one.

The FDA posted a copy of an Aug. 19 letter to drugmaker Bristol-Myers, announcing its decision. Apixaban was already approved for use in lowering the risks of stroke and blood clots in people with atrial fibrillation not caused by a heart valve problem and to prevent DVT and PE in people who’ve had hip- or knee-replacement surgery.

FDA Approves New DVT Treatment

Last month the European Commission granted a similar extension of apixaban in countries where drug policies are covered by the European Medicines Agency.

Other blood thinners, including rivaroxaban (Xarelto)and dabigatran (Pradaxa), are also FDA-approved for the treatment of DVT and PE and the prevention of DVT or PE’s return.

Source: web md

Unease grows among U.S. doctors over Indian drug quality

Some U.S. doctors are becoming concerned about the quality of generic drugs supplied by Indian manufacturers following a flurry of recalls and import bans by the Food and Drug Administration.

India supplies about 40 percent of generic and over-the-counter drugs used in the United States, making it the second-biggest supplier after Canada.

In recent months, the FDA, citing quality control problems ranging from data manipulation to sanitation, has banned the importation of products from Ranbaxy Laboratories Ltd, Wockhardt Ltd and, most recently, Sun Pharmaceutical Industries Ltd.

“I’m just beginning to realize the gravity of the problem,” said Dr. Steven Nissen, head of cardiology at the Cleveland Clinic. “It’s terrible and it is starting to get a lot of traction among physicians.”

Indian drugmakers are by no means the only companies to recall products or be warned by the FDA about manufacturing problems. For instance, quality control failures at Johnson & Johnson forced the company to recall dozens of products over the past five years, ranging from artificial hips to children’s Tylenol.

And last year, Germany’s Boehringer Ingelheim said it would shut down its U.S. contract manufacturing unit, Ben Venue Laboratories, after it was cited for repeated manufacturing violations that led to shortages of the cancer drug Doxil.

India’s drugmakers, a $14 billion industry, reject any criticism that their products are inferior to drugs made in other countries.

“We have heard doctors making generalized statements, without being specific on any product or company,” said D.G. Shah, Secretary General of the Indian Pharmaceutical Alliance, a trade group representing large Indian drugmakers. “This is a deliberate and serious campaign to malign the Indian generic industry.”

If U.S. doctors come across a medicine that does not meet quality standards, they should report it to regulators, he said. “Doctors are not in a position to judge whether manufacturing processes are correct or not. That is the U.S. FDA’s job.”

Generic drugs account for nearly 85 percent of medicines prescribed in the United States and the government is relying on them to help rein in healthcare costs.

“We are losing control over what people are swallowing,” said Dr. Harry Lever, a cardiologist at the Cleveland Clinic who is trying raise awareness of the matter among U.S. lawmakers. “Now, when a patient comes in who is not doing well, the first thing I do is look at their drugs and find out who makes it.”

Increasingly, Lever said, he is recommending patients seek out generic drugs from specific manufacturers outside India.

“I’m tending to stay away from India,” he said. “There’s something wrong. Too many things are happening.”

INDIA DOCTORS HIT BACK

Indian physicians do not share the concerns.

“Our drugs are being sold in many countries and being accepted, so we have no issues,” said Narendra Saini, Secretary General of the Indian Medical Association, a voluntary body of 215,000 doctors. “How do I know that Western drugs are better than our drugs?”

A 2012 report by India’s parliament alleged collusion between pharmaceutical firms and officials at the Central Drugs Standard Control Organization (CDSCO), the country’s drugs regulator, and described an agency that was both understaffed and underqualified.

Saini said physicians trust that the CDSCO is taking care of the quality and the standard of the drugs made in India.

“We very much trust those medicines,” he added.

Representatives of Ranbaxy, Sun and Wockhardt were not immediately available to comment.

Dr. Joel Zonszein, director of the Clinical Diabetes Center at Montefiore Medical Center in New York, said he is concerned about the quality of generic drugs in general, not just those from India. He cited, as an example, his experience with the diabetes drug metformin.

“When patients open the bottle of medication it smells like dead fish,” he said. Zonszein did not know which company made the foul-smelling drug.

Physicians do not have a say in which generic drug a patient receives, as that depends on which products are stocked by individual pharmacies. If a patient wants to avoid a certain manufacturer, he or she may have to change pharmacies.

Doctors may specify that the branded version of a drug be dispensed, but insurance companies frequently refuse to pay for them.

Dr. Richard Kovacs, who heads a number of American College of Cardiology committees and sits on its board of trustees, said doctors may need to play a greater role monitoring the medications prescribed by their practices.

“The average U.S. cardiologist has been able to assume that the drugs were safe and effective. It now appears we need to be more vigilant as a profession, and assist the FDA by reporting cases where we are concerned about irregularities in the drugs supplied to our patients,” he said.

Source: Reuters

U.S. FDA approves first device to prevent migraine headaches

The U.S. Food and Drug Administration (FDA) said Tuesday it has approved the marketing of a medical device as a preventative treatment for migraine headaches.

The FDA said in a statement that this is the first transcutaneous electrical nerve stimulation (TENS) device specifically authorized for use prior to the onset of pain.

The device, to be marketed under the name Cefaly, is manufactured by STX-Med in Herstal, Liege, Belgium.

“Cefaly provides an alternative to medication for migraine prevention,” said Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “This may help patients who cannot tolerate current migraine medications for preventing migraines or treating attacks. ”

Cefaly is a small, portable, battery-powered, prescription device that resembles a plastic headband worn across the forehead and atop the ears, the FDA said. The user positions the device in the center of the forehead, just above the eyes, using a self- adhesive electrode.

The device applies an electric current to the skin and underlying body tissues to stimulate branches of the trigeminal nerve, which has been associated with migraine headaches. The user may feel a tingling or massaging sensation where the electrode is applied, the agency said.

According to the FDA, Cefaly is indicated for patients 18 years of age and older and should only be used once per day for 20 minutes.

The FDA said the approval was based on data from a clinical trial in Belgium involving 67 individuals who experienced more than two migraine headache attacks a month and who had not taken any medications to prevent migraines for three months prior to using Cefaly.

The study found that those who used Cefaly experienced ” significantly fewer days” with migraines per month and used less migraine attack medication than those who used a placebo device, the agency said.

The approval was also based on a patient satisfaction study of more than 2,300 Cefaly users in Belgium and France, which showed that about 53 percent of patients were satisfied with Cefaly treatment and willing to buy the device for continued use, it said, noting that no serious adverse events occurred during either study.

Source; News

New F.D.A. Nutrition Labels Would Make ‘Serving Sizes’ Reflect Actual Servings

The Food and Drug Administration for the first time in two decades will propose major changes to nutrition labels on food packages, putting calorie counts in large type and adjusting portion sizes to reflect how much Americans actually eat.

It would be the first significant redrawing of the nutrition information on food labels since the federal government started requiring them in the early 1990s. Those labels were based on eating habits and nutrition data from the 1970s and ’80s, before portion sizes expanded significantly, and federal health officials argued that the changes were needed to bring labels into step with the reality of the modern American diet.

“It’s an amazing transformation,” said Dr. Margaret A. Hamburg, commissioner of the F.D.A. “Things like the size of a muffin have changed so dramatically. It is important that the information on the nutrition fact labels reflect the realities in the world today.”

The proposed changes include what experts say will be a particularly controversial item: a separate line for sugars that are manufactured and added to food, substances that many public health experts say have contributed substantially to the obesity problem in this country. The food industry has argued against similar suggestions in the past.

“The changes put added sugars clearly in the cross hairs,” said Dr. David A. Kessler, who was commissioner during the original push for labels in the 1990s. “America has the sweetest diet in the world. You can’t get to be as big as we’ve gotten without added sweeteners.” Millions of Americans pay attention to food labels, and the changes are meant to make them easier to understand — a critical step in an era when more than one-third of adults are obese, public health experts say. The epidemic has caused rates of diabetes to soar, and has increased risks for cancer, heart disease and stroke.

The proposal will be open to public comment for 90 days, and it will take months before any change is made final. In a special concession to industry, the agency is allowing companies two years to put the changes into effect.

Source: New York Times

FDA: Aleve may be safer on heart than other drugs

Federal health officials say the pain reliever in Aleve may be safer on the heart than other popular anti-inflammatory drugs taken by millions of Americans.

A Food and Drug Administration review posted online Tuesday said naproxen — the key ingredient in Aleve and dozens of other generic pain pills — may have a lower risk of heart attack and stroke than rival medications like ibuprofen, sold as Advil and Motrin. FDA staffers recommend relabeling naproxen to emphasize its safety.

The safety review was prompted by a huge analysis published last year that looked at 350,000 patients taking various pain relievers. The findings suggest naproxen does not carry the same heart risks as other medications in the class known as nonsteroidal anti-inflammatory drugs, or NSAIDs.

The agency released its memo ahead of a public meeting next month where outside experts will discuss the new data and whether naproxen should be relabeled. The agency is not required to follow the group’s advice, though it often does.

If ultimately implemented, the labeling changes could reshape the multibillion-dollar market for drugs used to treat headaches, muscle pain and arthritis.

The change could make Aleve and other naproxen drugs the first choice for patients with a higher risk for heart problems, according to Ira Loss, a pharmaceutical analyst with Washington Analysis. But he added that all NSAIDs will continue to carry warnings about internal bleeding and ulceration, a serious side effect that is blamed for more than 200,000 hospital visits every year.

Source: nbc news

FDA approves Mental Disability Blood Test for Infants

The Food and Drug Administration on Friday cleared a first-of-a-kind blood test that can help diagnose mental disabilities in babies by analyzing their genetic code.

The laboratory test from Affymetrix detects variations in patients’ chromosomes that are linked to Down syndrome, DiGeorge syndrome and other developmental disorders. About 2 to 3 percent of U.S. children have some sort of intellectual disability, according to the National Institutes of Health.

The test, known as the CytoScan Dx Assay, is designed to help doctors diagnose children’s disabilities earlier and get them appropriate care and support. It is not intended for prenatal screening or for predicting other genetically acquired diseases and conditions, such as cancer.

While there are already genetic tests used to detect conditions like Down’s syndrome, doctors usually have to order them individually and they can take several days to develop. Pediatricians said Friday that Affymetrix’s test should offer a faster, more comprehensive screening approach. Dr. Annemarie Stroustrup stressed that such tests are generally only used after children exhibit certain physical or behavioral signs that suggest a disorder.

“When there’s something about the child that strikes us as unusual or pointing to a potential genetic disease, that’s when we would use this testing,” said Stroustrup, an assistant professor of pediatrics at Mount Sinai Hospital in New York. “This is not a screening test to be done on all newborns to predict how they are going to do in school when they are 5.”

The technology behind Affymetrix’s test has already been used for several years to screen fetuses for potentially debilitating diseases. Known as microarray analysis, the technique involves a high-powered computer scanning a gene chip of the patient’s DNA for slight chromosome imbalances. Older techniques involve scientists looking at chromosomes under a microscope for major irregularities.

The FDA said it approved the new test based on studies showing it accurately analyzes a patient’s entire genome and can accurately spot variations associated with intellectual disabilities.

Currently hospitals in all 50 states are required to screen newborns for at least 29 disorders that can be detected though laboratory testing, including sickle cell anemia and cystic fibrosis. Generally those tests pickup irregularities in metabolism, not genetic variations. The mandatory screening program, begun a half-century ago, is considered one of the nation’s most successful public health programs.

Affymetrix Inc. is based in Santa Clara, Calif. Shares of the company declined 22 cents to close at $9.26 in trading.

Source: ABC news

FDA approves post-natal test to help diagnose developmental delays

The US Food and Drug Administration has authorized for marketing the Affymetrix CytoScan Dx Assay, which can detect chromosomal variations that may be responsible for a child’s developmental delay or intellectual disability. Based on a blood sample, the test can analyse the entire genome at one time and detect large and small chromosomal changes.

According to the National Institutes of Health and the American Academy of Paediatrics, two to three per cent of children in the United States have some form of intellectual disability. Many intellectual and developmental disabilities, such as Down syndrome and DiGeorge syndrome, are associated with chromosomal variations.

“This new tool may help in the identification of possible causes of a child’s developmental delay or intellectual disability, allowing healthcare providers and parents to intervene with appropriate care and support for the child,” said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Centre for Devices and Radiological Health. “The FDA’s review of the test provides clinical laboratories with information about the expected performance of the device and the quality of the results.”

The FDA reviewed the Affymetrix CytoScan Dx Assay through its de novo classification process, a regulatory pathway for some novel low-moderate-risk medical devices.

For the de novo petition, the FDA’s review of the CytoScan Dx Assay included an analytical evaluation of the test’s ability to accurately detect numerous chromosomal variations of different types, sizes, and genome locations when compared to several analytically validated test methods. The FDA found that the CytoScan Dx Assay could analyse a patient’s entire genome and adequately detect chromosome variations in regions of the genome associated with intellectual and developmental disabilities.

Additionally, the agency’s review included a study that compared the performance of the CytoScan Dx Assay to tests that are commonly used for detecting chromosomal variations associated with a developmental delay or intellectual disability. A comparison of test results from 960 blood specimens showed the CytoScan Dx had improved ability over commonly used tests, including karyotyping and FISH chromosomal tests, to detect certain chromosomal abnormalities.

This device should not be used for stand-alone diagnostic purposes, pre-implantation or prenatal testing or screening, population screening, or for the detection of, or screening for acquired or genetic aberrations occurring after birth, such as cancer. The test results should only be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including confirmation by alternative methods, evaluation of parental samples, clinical genetic evaluation, and counselling as appropriate, according to a statement issued by the FDA.

Interpretation of test results is intended to be performed only by healthcare professionals who are board certified in clinical cytogenetics or molecular genetics, the statement said.

Affymetrix CytoScan Dx Assay is manufactured by Affymetrix, Inc, located in Santa Clara, California.

Source: India Medical Times

FDA Approves New Magnet Device to Treat Migraines

The U.S. Food and Drug Administration has approved the first device aimed at easing the pain of migraines preceded by aura — sensory disturbances that occur just before an attack.

The Cerena Transcranial Magnetic Stimulator would be obtained through prescription, the FDA said in a statement released Friday. Patients use both hands to hold the device against the back of their head and press a button so that the device can release a pulse of magnetic energy. This pulse stimulates the brain’s occipital cortex, which may stop or ease migraine pain.

“Millions of people suffer from migraines, and this new device represents a new treatment option for some patients,” Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in the statement.

The agency’s approval is based on a trial involving 201 patients who had suffered moderate-to-strong migraine with aura. One hundred and thirteen of the patients tried treating their migraines while an attack was in progress, and it was the testimony of this group that led to the approval of the new device, the FDA said.

More than a third (38 percent) of people using the stimulator said they were pain-free two hours later, compared to 17 percent of patients who did not use the device. A full day after the onset of migraine, nearly 34 percent of device users said they were pain-free, compared to 10 percent of people who hadn’t used the device.

Two experts welcomed the news of the approval.

“The Cerena TMS is another tool in the battle to relieve migraines,” said Dr. Mark Green, director of Headache and Pain Management at the Mount Sinai Medical Center in New York City. “Experience with TMS over the past few years have shown that these agents have the potential to reduce the pain of an attack without the use of medications, or in addition to medical treatment.”

Dr. Noah Rosen is director of the Headache Center at North Shore-LIJ’s Cushing Neuroscience Institute, in Manhasset NY. He said that, “although only 20 percent of migraneurs suffer from an aura associated with their headaches, they suffer significantly. Although this device is unwieldy, it may be a preferred choice by those who don’t want [drug] treatment.”

Side effects from the device were rare, the FDA said, but included “single reports of sinusitis, aphasia (inability to speak or understand language) and vertigo.”

The new device is approved only for use by those aged 18 or older, and should not be used by people with suspected or diagnosed epilepsy or a family history of seizures. It should also not be used by anyone with any metal device implanted in the head, neck or upper body, or by people with “an active implanted medical device such as a pacemaker or deep brain stimulator,” the FDA said.

The stimulator, manufactured by eNeura Therapeutics of Sunnyvale, Calif., is not meant to be used more than once every 24 hours, the FDA added. It has also not been tested to see if it is effective against other symptoms of migraine such as nausea or sensitivities to light or sound.

Green called that last point “disappointing,” and added that “the other concern is whether insurance carriers will make the product available [to patients].”

Source: Web md

FDA examining antibacterial soaps, body washes

Manufacturers of antibacterial hand soap and body wash will be required to prove their products are more effective than plain soap and water in preventing illness and the spread of infection, under a proposed rule announced Monday by the Food and Drug Administration.

Those manufacturers also will be required to prove their products are safe for long-term use, the agency said.
“Millions of Americans use antibacterial hand soap and body wash products,” the agency said in a statement. “Although consumers generally view these products as effective tools to help prevent the spread of germs, there is currently no evidence that they are any more effective at preventing illness than washing with plain soap and water.

“Further, some data suggest that long-term exposure to certain active ingredients used in antibacterial products — for example, triclosan (liquid soaps) and triclocarban (bar soaps) — could pose health risks, such as bacterial resistance or hormonal effects.”
About 2,000 individual products contain these products, health officials said.

“Our goal is, if a company is making a claim that something is antibacterial and in this case promoting the concept that consumers who use these products can prevent the spread of germs, then there ought to be data behind that,” said Dr. Sandra Kweder, deputy director of the Office of New Drugs in FDA’s Center for Drug Evaluation and Research.

“We think that companies ought to have data before they make these claims.” Studies in rats have shown a decrease in thyroid hormones with long-term exposure, she said. Collecting data from humans is “very difficult” because the studies look at a long time period.

Get dangerous germs out of your home

Before the proposed rule is finalized, companies will need to provide data to support their claims, or — if they do not — the products will need to be reformulated or relabeled to remain on the market.

“This is a good first step toward getting unsafe triclosan off the market,” said Mae Wu, an attorney for the Natural Resources Defense Council. “FDA is finally taking concerns about triclosan seriously. Washing your hands with soap containing triclosan doesn’t make them cleaner than using regular soap and water and can carry potential health risks.

The FDA first proposed removing triclosan from certain products in 1978, the council said, “but because the agency took no final action, triclosan has been found in more and more soaps.”

In 2010, the council said it sued FDA to force it to issue a final rule. The new proposed rule stems from a settlement in that suit, according to the NRDC.

The rule is available for public comment for 180 days, with a concurrent one-year period for companies to submit new data and information, followed by a 60-day period for rebuttal comments, according to the FDA.

The target deadline is June 2014 for the public comment period, then companies will have until December 2014 to submit data and studies. The FDA wants to finalize the rule and determine whether these products are “generally recognized as safe and effective” by September 2016.

“Antibacterial soaps and body washes are used widely and frequently by consumers in everyday home, work, school and public settings, where the risk of infection is relatively low,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.

“Due to consumers’ extensive exposure to the ingredients in antibacterial soaps, we believe there should be a clearly demonstrated benefit from using antibacterial soap to balance any potential risk.”

The action is part of FDA’s ongoing review of antibacterial active ingredients, the agency said. Hand sanitizers, wipes and antibacterial products used in health care settings are not affected.

Most hand sanitizers have 60% alcohol or ethanol and are generally recognized as safe when water isn’t available, Kweder said. However, health officials still believe washing hands with soap and water is the best method.

Source: CNN

FDA approves new treatment for hepatitis C virus

New drug is part of a revolution in treatment for a virus widespread among Baby Boomers, experts say.A new medication for chronic hepatitis C that can be paired with other drugs to make treatment of the liver-damaging disease faster, easier and more effective got approval from the Food and Drug Administration Friday.

The new medication, called sofosbuvir and made by Gilead Sciences Inc., is part of a “revolution in treatment,” says Douglas Dieterich, a specialist in liver disease at Mt. Sinai Hospital, New York. Dieterich is a consultant to Gilead and other drug companies.

“The upshot is that over the next year to the next 18 months there will be a series of medications approved that will vastly simplify the treatment of hepatitis C for nearly everyone and increase the cure rate beyond 90%,” says David Thomas, a liver specialist at Johns Hopkins Medical Institutions, Baltimore. Thomas says he has no current financial ties to drug makers.

More than 3 million people in the USA are infected with the hepatitis C virus, the nation’s leading cause of liver cancer and liver transplants. Most have no symptoms until their livers start to fail, causing jaundice, fatigue and other problems. Up until now, standard three-drug treatments have taken 24 to 48 weeks and required self-injections of interferon, an immune therapy that can cause difficult-to-tolerate flu-like symptoms and mood swings.

Sofosbuvir, which has the brand name Sovaldi, will be the first treatment that some patients will be able to take for just 12 weeks with just one additional drug and no interferon. The FDA approved the no-interferon combination for patients with two strains of the virus, known as genotypes 2 and 3. For most patients with a more common strain, genotype 1, sofosbuvir is approved to be taken with interferon and an older drug called ribavirin. Some patients still will have to be treated for 24 weeks.

None of the regimens are 100% effective. But in one study, 89% of genotype 1 patients who took the three-drug version were cured in 12 weeks, compared with 75% cured in longer-lasting available regimens, says Ira Jacobson, a liver specialist at Weill Cornell Medical College, New York, who has led drug studies for Gilead.

Sofosbuvir does not add any obvious side effects to those already associated with the drugs it is paired with, he says. So patients taking it with ribavirin may experience fatigue and insomnia and those who also take interferon will have additional side effects, but for a shorter time than in the past, he says

The wholesale cost for a one-month supply of Solvadi will be $28,000, Gilead said in a press release.

Therapies will continue to evolve. For example, some doctors may decide, based on recent studies, to treat some type 1 patients with an interferon-free cocktail of sofosbuvir and another antiviral medication called simeprevir, Dieterich says. FDA approved simeprevir, made by Janssen Therapeutics, in late November, but has not approved the two drugs in combination. Such “off-label” use is legal, but it’s not clear insurers will pay for it, Thomas says.

Doctors also may put off treating some patients with milder illnesses until additional combinations, including one-pill versions, are approved. That’s the “holy grail” of treatment, Jacobson says.

Two medical groups, the American Association for the Study of Liver Disease and the Infectious Diseases Society of America, will publish new online treatment guidelines in January to help doctors make decisions in the rapidly evolving field, Thomas says. He is co-chairing the guideline committee.

Hepatitis C is one of several viruses that can cause liver damage. Vaccines can prevent hepatitis A and B but not C. The virus infects about 16,000 people a year and 75% to 80% develop chronic infections, according to federal Centers for Disease Control and Prevention. Most then develop chronic liver disease and up to 5% die of cancer or cirrhosis.

The virus spreads through blood, most often through shared drug needles, accidental needle sticks and birth. But transmission through sex and through unsanitary tattooing and piercing is possible, CDC says. Because the infection is most common in Baby Boomers, CDC recommends that everyone born between 1945 and 1965 be tested for it

The availability of safe, effective treatment makes it more urgent for people to get tested, Thomas says. Many picked up the virus through youthful drug use, medical mishaps or sex many decades ago and half of those who are infected don’t know it, he says. “We want to find the people who have it so we can give them the treatments and help them.”

More are likely to choose and stick with quicker, easier therapies, Dieterich says. “One of my patients told me that taking interferon was like 48 weeks of having PMS with a cold,” he says. Dieterich says he once had hepatitis C, caused by a needle-stick, and suffered through many months of interferon treatment for it in the late 1990s. It worked, he says, but “it was bad.”

Source: USA today