Results tagged “risks” from Drugs & Medicaments

Desmopressin acetate intranasal formulations are no longer indicated for the treatment of primary nocturnal enuresis (PNE) because of the risk for severe hyponatremia that can lead to seizures and death, the US Food and Drug Administration (FDA) warned healthcare professionals yesterday.

These formulations are currently marketed as DDAVP (sanofi-aventis US, LLC), Minirin (Ferring Pharmaceuticals, Inc), and Stimate (CSL Behring, LLC).

China will tighten the inspection of pharmaceutical products to prevent drug safety accidents, the country's drug watchdog said Tuesday, disclosing that the licenses of 353 medicines have been revoked since August 2006.

Wu Zhen, deputy director of the State Food and Drug Administration (SFDA), said about 3,049 applications for producing new drugs were turned down since last August to fend off shoddy manufacture of medicines.

Attending an online interview hosted by the central government's website, Wu said the administration has required its officials to leave offices to check whether the production conditions meet the description of the applications filed to the SFDA.

The U.S. Food and Drug Administration (FDA) is facing renewed criticism over the process by which it approves drugs for market. Recent reports indicate many drugs are approved before they are proven safe, and problems with the agency's structure and processes prevent it from fulfilling its mission. Subsequently, Congress has started using its oversight powers to scrutinize the agency, and the clamor for FDA reform is growing louder.

The Federal Food Drug and Cosmetic Act requires FDA to ensure the safety of new drugs before the agency approves the drugs for market. However, operating within a provision of the law, FDA often approves drugs before safety is established. The agency then requires drug manufacturers to further study drugs while they are on the market. These "post-marketing commitments" serve to streamline the drug approval process.

GeneEd, Inc., a leading provider of Continuing Medical Education (CME) accredited online learning for the life-science and healthcare professions, announced today the release of a Drug Safety: Adverse Event Reporting course.

The course discusses the reasons and mechanisms for adverse event collection during and following clinical studies. Key concepts and roles are defined and current and legacy terminologies used to report adverse events (AEs) in clinical trials are discussed. In addition, the reporting responsibilities of the sponsor and investigator are explored on both a national and global scale.

People taking two drugs to treat symptoms of Parkinson's disease may be at risk of heart valve damage, a potentially life-threatening side-effect, two studies on European patients suggest.

The drugs are pergolide, sold as Permax, and cabergoline, sold as Dostinex. The medications are not the main treatment for the disease, which affects about six million people worldwide.

In Thursday's New England Journal of Medicine, Italian researchers said about one-quarter of 155 patients taking pergolide or cabergoline had moderate to severe heart valve problems compared with a control group.

Jan. 2 (Bloomberg) -- A consumer group said U.S. food regulators have backed away from plans to limit a cancer-causing byproduct that forms during the baking or frying of foods, including products from PepsiCo Inc., the largest U.S. maker of salty snacks.

The group, the Center for Science in the Public Interest, based in Washington, sent a letter to U.S. Food and Drug Administration Commissioner Andrew C. von Eschenbach on Dec. 1, urging him to follow through on agency promises to limit acrylamide. Swedish scientists discovered in 2002 that the substance develops in carbohydrate-rich foods, such as potatoes and breakfast cereals.

After initially reporting variations in acrylamide levels in branded products within the same food categories, the FDA has stopped publishing the information, and food makers refuse to provide it to the public, said Michael F. Jacobson, executive director of the Center. He said the FDA isn't reporting test results or setting limits.

by Paul Howard, The Examiner

WASHINGTON - William Osler, one of the founding faculty members at Johns Hopkins Medical School, once remarked: “If it were not for the great variability among individuals, medicine might as well be a science and not an art.” A century later, medicine is, despite its technical prowess, in many ways still an art — albeit an expensive one.

Pfizer learned that lesson the hard way in early December, when they halted development of their much anticipated “good cholesterol” boosting drug, torcetrapib. A late-stage clinical trial revealed excess deaths and cardiovascular problems in patients taking the drug together with Lipitor, compared to Lipitor alone.

In the 15,000-patient trial, there were 82 deaths for the torcetrapib combo vs. 51 for Lipitor. The failure cost Pfizer $800 million in research costs, $20 billion in market capitalization and 15 years of research.

A powerful painkiller is raising red flags in western Wisconsin after an increase in the number of overdoses. There have been a string of deaths from Fentanyl overdoses. Some have been intentional, some were not.

In September, Dr. Susan Momont was found dead in her Eau Claire home. Her husband has now been charged with providing the Fentanyl that caused her death.

The St. Croix County medical examiner says three people have died in his county since this spring. Last week, the Chippewa County district attorney said a man there died from an overdose, which may have been a suicide.

Eli Lilly encouraged primary care physicians to use Zyprexa, a powerful drug for schizophrenia and bipolar disorder, in patients who did not have either condition, according to internal Lilly marketing materials.

The marketing documents, given to The New York Times by a lawyer representing mentally ill patients, detail a multiyear promotional campaign that Lilly began in Orlando, Fla., in late 2000. In the campaign, called Viva Zyprexa, Lilly told its sales representatives to suggest that doctors prescribe Zyprexa to older patients with symptoms of dementia.

A Lilly executive said that she could not comment on specific documents but that the company had never promoted Zyprexa for off-label uses and that it always showed the marketing materials used by its sales representatives to the Food and Drug Administration, as required by law.

The mother of a woman who died in June 2003 after using Johnson & Johnson subsidiary Ortho-McNeil's birth control patch Ortho Evra recently filed a wrongful-death lawsuit in San Francisco Superior Court alleging that the company knowingly misinformed the public about the drug's risk of severe side effects, the AP/San Jose Mercury News reports.

Celena Devault, a 26-year-old woman from Tennessee, began using Ortho Evra in April 2003 and died of a pulmonary embolism in June 2003. Her mother, Mary Devault, filed the lawsuit alleging Ortho McNeil misled the public about the drug's risk of side effects, including pulmonary embolism, stroke, deep vein thrombosis and blood clots (AP/San Jose Mercury News, 12/12).

By Robert Goldberg, The Washington Times

Recently the Food and Drug Administration updated its warning on the use of oral sodium phosphate products (OSPs) as a cause of kidney failure. What are OSPs? If you had a colonoscopy as I did, you drank an OSP to clear the way for your inspection. In 1998, the FDA limited the OSP bottle size to no more than 90 ml. People were going into toxic shock and dying because they were told to use a bottle of the preparation and used a 240 ml jug instead of the 45 ml or 90 ml container. The FDA just updated warning labels about exceeding recommended doses since OSP-related kidney failure is still a problem.

The president of Alliance for Human Research Protection’s explains the importance of informing the public.

Just as Vera Sharav sits down to talk about the lack of government oversight of the drug industry, the phone rings. She jumps up to answer it, and after listening patiently for a few minutes, she starts talking about Prozac, warning the caller that U.S. consumers don’t always get the same detailed health warnings about pharmaceuticals as residents of some other countries. After hanging up, Sharav, president of the advocacy group Alliance for Human Research Protection, gets right to the point.

“We’ve got a major crisis in America now,” Sharav says. “There is carnage going on. There are thousands of preventable deaths every year.” Approval of a drug by the U.S. Food and Drug Administration implies that a drug is safe to market to consumers, but Sharav asserts that the FDA’s assurances are not based on good science.

The FDA said Wednesday it planned to expand warnings on up to a dozen antidepressant medications following studies suggesting the drugs raise the risk of suicidal behavior in a wider range of patients than previously thought.

In 2004, the agency ordered "black box" warnings to be added to antidepressant packaging alerting doctors of evidence that the drugs increase the risk of suicidal thoughts and attempts in children and teens under the age of 18. Officials said Wednesday they would now move to expand the warning to include young adults up to age 25.

The warnings apply to selective serotonin reuptake inhibitors (SSRIs) such as Prozac and Paxil, in addition to related drugs including Effexor and Wellbutrin. Officials said the warnings would also likely be included in medication guides distributed to patients

by Dr. Peter Breggin

On December 13, 2006 the FDA's Psychopharmaceutical Drugs Advisory Committee (PDAC) is meeting in Silver Spring, Maryland to discuss antidepressant-induced suicidal behavior in adults. In 2004 the FDA held similar hearings on children and concluded that antidepressants do in fact cause suicide in humans under age eighteen. A warning has been placed in all antidepressant labels or package inserts.

Now the agency has given advanced notice of its new findings--antidepressants, all of them according to the FDA, cause increased suicidality in young adults. Suicide occurs more than twice as much on antidepressants than on sugar pills in individuals under age 25.

Dec. 6, 2006 -- When first introduced in 2001, Gleevec was hailed as a miracle drug poised to usher in a new age in cancer treatment. Now, five years later, it appears that promise is being fulfilled.

The longest follow-up yet of chronic myeloid leukemia (CML) patients treated with Gleevec shows a survival rate of 95% after five years. (The survival rate does not count people who died from causes unrelated to CML or stem-cell transplantation). Before the drug’s introduction, about half of patients died within five years of diagnosis.

And there is more good news. Relapse rates seem to be trending down the longer patients stay on the drug. After three years of treatment, 15% of patients in the study experienced relapses. Two years later, that figure had risen by just 2%.

Gleevec was the first treatment to specifically target cancer cells, leaving healthy cells unharmed. It is marketed by Swiss drug maker Novartis. 

WASHINGTON--(BUSINESS WIRE)--Dr. Stephen Galson, Director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration, led a slate of keynote speakers and panelists from industry, regulatory agencies and academia at Windhover’s 2nd Annual FDA/CMS Summit today. Across the presentations was a common resonating theme of imminent drug safety reform. However, rather than being seen as an obstacle to business, industry executives and regulators suggest the coming discussion presents an opportunity to define a new model of drug development and evaluation for the 21st century.

Executives from MedImmune, Merck and Roche posited that developments in personalized medicine and a focus on value-based healthcare offer a business opportunity on which companies may capitalize. To understand the implications of potential changes to drug safety evaluation, as well as other hot topics, the audience of more than 200 heard from:

SEIU, the nation's largest health care union, issued a report today entitled "Failure to Care: A National Report on Universal Health Services' Behavioral Health Operations." The report alleges poor case management and understaffing at behavioral health facilities owned by the corporate health care giant, Universal Health Services (UHS).

The report documents cases of understaffed facilities and poor case management leading to sexual abuse, runaway patients, physical assaults on patients, violations of patients' rights, and patient dumping in several states. The report documents incidents from 13 different facilities in six states, including Massachusetts, Connecticut, Delaware, Georgia, Texas, and Nevada.

November 29, 2006 — The US Food and Drug Administration (FDA) has approved safety labeling revisions to advise that use of central nervous system stimulants may increase the risk for cardiovascular events and exacerbate psychotic symptoms in certain patients and that chronic use may cause temporary suppression of growth rate in children. Also, interferon-alfa-2a [recombinant] subcutaneous injection may be linked to potential risks for severe infection and pancreatitis.

CNS Drugs May Potentiate Risk for Sudden Death

The FDA approved safety labeling revisions in August for dexmethylphenidate HCl tablets and extended-release capsules (Focalin and Focalin XR, made by Novartis Pharmaceuticals Corp), methylphenidate HCl extended-release capsules (Metadate CD, made by UCB Pharma, Inc), methylphenidate chewable tablets/oral solution (Methylin, made by Mallinckrodt), and methylphenidate tablets, sustained-release tablets, and extended-release capsules (Ritalin, Ritalin SR, and Ritalin LA, made by Novartis Pharmaceuticals Corp).

HealthDay News -- A group representing America's obstetricians is recommending that women avoid the antidepressant Paxil if they are pregnant or planning on becoming pregnant, due to a potential heightened risk for birth defects.

The American College of Obstetricians and Gynecologists (ACOG) also cautioned that treatment with other antidepressants should be considered on a case-by-case basis.

ACOG's Committee on Obstetric Practice "recommends that treatment with all SSRIs [selective serotonin reuptake inhibitors] or selective norepinephrine reuptake inhibitors or both during pregnancy be individualized and paroxetine [Paxil] use among pregnant women or women planning to become pregnant be avoided, if possible," read the statement, which is in the December issue of Obstetrics & Gynecology.

WASHINGTON -- Despite Celebrex's well-documented link to higher heart risks, Pfizer Inc. wants permission to sell its painkiller to treat children as young as 2 who have arthritis.

Even as critics call for the drug to be removed from the market, Food and Drug Administration advisers will meet Wednesday to consider the company's request to expand Celebrex use.

Celebrex was the first of a class of new-style painkillers, called cox-2 inhibitors , approved in December 1998, and it is the last one to remain on the market. The drugs were designed to relieve pain without causing the stomach distress associated with other treatments, but they have been plagued by safety concerns. Merck & Co. pulled Vioxx from the market in 2004 after its studies showed the painkiller doubled the risk of heart attacks and strokes. Merck now faces more than 20,000 Vioxx lawsuits. Pfizer, under pressure from the FDA, last year halted sales of another cox-2 inhibitor, Bextra , because of heart risks and potentially fatal skin reactions.