Results tagged “safety” from Drugs & Medicaments

More evidence supporting the idea that rosiglitazone (Avandia, GlaxoSmithKline) does increase the risk of cardiovascular events has come from a new population-based study [1].

The retrospective case-control study, published in the December 12, 2007 issue of the Journal of the American Medical Association, was conducted in older patients with diabetes and showed that thiazolidinedione (TZD) treatment, primarily with rosiglitazone, was associated with an increased risk of congestive heart failure (CHF), myocardial infarction (MI), and mortality when compared with other combination oral hypoglycemic agent treatments.

The study has reignited the arguments surrounding the safety of rosiglitazone, with Dr Steven Nissen (Cleveland Clinic) issuing new calls for more forceful action on the drug from the Food and Drug Administration (FDA), while GlaxoSmithKline highlights limitations of the new study and continues to defend the cardiovascular profile of its product.

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).

by David Gutierrez

(NewsTarget) A diabetes expert has claimed that pharmaceutical company GlaxoSmithKline threatened him with legal action after he raised concerns about the safety of the company's anti-diabetes drug rosiglitazone, marketed as Avandia.

In a written testimony to a congressional subcommittee, John Buse of the University of North Carolina said that he received phone calls from company executives in 1999, just after Avandia's release, warning him that his comments about the drug "were scurrilous enough to attempt to hold me liable for a loss in market capitalization." Buse later signed a statement, drafted by GlaxoSmithKline, attempting to alleviate the concerns that his comments had raised with stockholders.

by Mike Adams, NewsTarget.com

The U.S. Senate Health, Education, Labor and Pensions Committee voted 15-5 to approve a bill that aims to strengthen FDA oversight of drug company advertising and post-approval follow-up studies. The bill was sponsored by Wyoming Republican Sen. Mike Enzi and Massachusetts Democrat Sen. Edward Kennedy. The primary motive for the bill is to give the FDA more power to stop a future Vioxx disaster from being repeated.

The Bush Administration is against the bill and offered sharp objections to the bill's provisions, saying it would slow down drug approvals. Republicans also argued that the banning of drug advertisements on television was "unconstitutional."

Genentech and FDA notified healthcare professionals of important new safety information regarding tracheoesophageal (TE) fistula formation in a recent clinical study in patients with limited-stage small cell lung cancer (SCLC).

This multicenter, non-randomized, single-arm phase II clinical trial study combined chemotherapy and radiation plus Avastin.

There have been two confirmed serious adverse events of TE fistula (one fatal) reported in the first 29 patients enrolled in this study. A third, fatal event (upper aerodigestive tract hemorrhage and de ath of unknown cause), was also reported, in which TE fistula was suspected but not confirmed. All three events occurred during the Avastin maintenance phase of the study in the context of persistent esophagitis. Additionally, six other cases of TE fistula have also been reported in other lung and esophageal cancer studies using Avastin and chemotherapy alone or with concurrent radiation treatment.

BOSTON, MA -- March 6, 2007 -- For years, pharmaceutical companies have sought to restrict public access to drug safety data collected in clinical trials on the basis that it is proprietary information, arguing that competitors could use that information in the development of their own products. However, a number of recent cases of drugs found to have dangerous side effects after coming to market, such as the anti-inflammatory drug rofecoxib (Vioxx), have raised concerns about safety data being treated as confidential.

A new analysis by researchers at the Harvard School of Public Health and Brigham and Women's Hospital of laws and regulations governing public disclosure of clinical trial data submitted to the FDA suggests changes should be made to the way the FDA implements its policy regarding the confidentiality of those data. Allowing greater access to safety data would enable researchers to independently evaluate risks, resulting in more timely risk detection. The review and commentary appears in the current issue of Health Affairs.

"Although the current pharmacovigilance system is good and safe, there are now more countries in the EU, and therefore there is a need for an improved system," Ton Van Lierop, a Commission spokesperson told In-PharmaTechnologist.com.

The move comes hot on the heels of a consultation conducted by the Commission last year which found that that the current system is "contradictory, confusing, unclear and complex."

The feedback from the consultation suggested that there are complex reporting rules implemented differently by different EU member States, a lack of robust safety studies and complex decision-making at EU-level.

Worries are emerging about the safety of new diabetes medicines Januvia and Galvus, drugs expected to be big sellers for makers Merck and Novartis. But it is unclear if the concerns are justified or just the result of a hair-trigger tendency concerning drug safety on the part of doctors and regulators.

On Monday, Novartis said the U.S. Food and Drug Administration wants it to run a new safety study of Galvus. Analysts say that could take another year; the pill has already been delayed for three months.

That follows a Feb. 1 article in The New England Journal of Medicine that questioned the safety data available for these drugs. David M. Nathan, a Harvard Medical School endocrinologist, wrote that it is "surprising" that the FDA decided to clear Januvia at all, given the "paucity of published data from long-term clinical trials on its safety and efficacy." Nathan, who is a consultant for Novartis and other drug makers but not Merck , did not return requests for comment.

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.

During the past several years, there has been a perceived drug safety crisis in the United States. The Institute of Medicine (IOM), recently released its final recommendations for reforming the U.S. drug safety system, but an editorial published in Health Economics by Tomas Philipson and colleagues at the University of Chicago finds little evidence of a drug safety crisis and no scientific evidence to back up the IOM's recommendations.

The current drug controversy is largely due to the withdrawal of Vioxx from the market, but the decrease in drug approval times thanks to the Prescription Drug User Fee Acts (PDUFA), and undue influence from the pharmaceutical industry that these acts may have invited have also played a role. Yet the scientific basis that too many unsafe drugs enter the market is lacking.

ZURICH (Reuters) -- U.S. regulators have asked for more data on Novartis AG's diabetes drug Galvus, potentially delaying any approval of the possible blockbuster by a year and sending shares tumbling.

The Food and Drug Administration has requested a further clinical study to show Galvus's safety and efficacy in patients with kidney impairment, Novartis (Charts) said Monday, but the drugmaker remains confident of getting approval for the medication.

"There are no details on the study requirements, but we would expect this study to take a minimum of 12 months to complete, taking likely U.S. approval beyond August '08," JPMorgan analyst Craig Maxwell said in a note.

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.

Read the package and label of all over-the-counter medicines carefully. Look for the section called "Drug Interaction Precaution."

Make sure your doctor and pharmacist have a list of all the prescription and over-the-counter medicines, vitamins and herbal products you use every day or every so often. Keep a personal medication record and take it with you to doctor's appointments and pharmacy visits.

Consider using one pharmacy for all of your prescription and over-the-counter medicines.

The Food and Drug Administration yesterday warned consumers who ordered pills for depression, anxiety and insomnia over the Internet that they may have received an antipsychotic drug instead.

Haloperidol, a medicine for schizophrenia, was substituted for Sanofi-Aventis SA's Ambien, Pfizer Inc.'s Xanax, Forest Laboratories Inc.'s Lexapro, and Wyeth's Ativan, the FDA said.

Ambien is a sleeping pill. Xanax and Ativan are anti- anxiety treatments. Lexapro is used to treat depression.

By Jerry Avorn

A FEW BLOCKS from the high-rise casinos of Atlantic City, Merck & Co. Inc. is in the middle of a multi billion-dollar bet. A jury is about to decide whether the pharmaceutical giant knew that its blockbuster Vioxx could cause heart attacks, but then minimized that risk in the information it gave to doctors and patients. The decision could have implications for the prevention of future drug disasters more profound than all the tepid plans being discussed by Congress and the FDA.

Faced with thousands of patients assigned to her jurisdiction suing the drugmaker for Vioxx-related heart damage, Superior Court Judge Carol Higbee decided to first resolve a few over-arching issues, before getting to the details of each individual case. She'll instruct the jury first to determine whether the pain reliever could ever increase the risk of heart attack. Most experts agree that it does, and Merck took the drug off the market in 2004 when its own clinical trial proved it, but the company still does not fully acknowledge this fact. Next, she'll ask the jury a kind of pharmacological Watergate question: What did the company know, and when did it know it? And finally, did Merck misrepresent this risk in its promotional materials?

With a lot of fanfare, the Food and Drug Administration last week announced a first — its approval of a diet pill that can be bought without a prescription.

A lower-dosage version of the prescription drug Xenical, the over-the-counter medication will be marketed by GlaxoSmithKline and goes on sale this summer. Since nearly 130 million Americans are considered overweight, the drug is expected to be popular. Conservative estimates are that 5 million-6 million Americans will use the drug in its first year.

Since obesity has been identified as a worsening problem in the United States, this news could be greeted with optimism, except for the many "ifs" and "buts."

NEW YORK - February 13 - A U.S. District Court judge today refused Eli Lilly's request to ban a number of websites from publishing leaked documents relating to Zyprexa, Eli Lilly's top-selling drug. Although the judge rejected the First Amendment arguments made by a variety of individuals eager to publish the documents, the court concluded that "it is unlikely that the court can now effectively enforce an injunction against the Internet in its various manifestations, and it would constitute a dubious manifestation of public policy were it to attempt to do so."

The order is a victory for the Electronic Frontier Foundation (EFF), which represents an anonymous individual who was previously barred by the court's earlier orders from posting links to the Zyprexa documents on the zyprexa.pbwiki.com wiki.

by Jerry Avorn, MD

It has become fashionable to argue that if we just let the marketplace do its thing in healthcare, quality will rise, costs will plummet, and our patients -- I mean our customers -- will prosper. But this is a bad way to organize medical care delivery, and it's an even worse way to generate information about the medications we use.

The Food and Drug Administration does not test drugs itself, instead relying on manufacturers to design and conduct the clinical trials that determine whether their products are approved or not. The companies even pay the salaries of the FDA employees who make those approval decisions. The FDA has hardly any resources to conduct its own postmarketing safety studies of drugs. Instead, it asks the manufacturers to do them -- and most of the studies it requests are not done.^[1,2]

Scientists who have worked at the U.S. Food and Drug Administration and criticized agency decisions are now helping Congress fashion legislation to tighten product- safety rules.

The scientists include David Ross, who said in an interview that FDA supervisors forced him to retract a recommendation that the antibiotic Ketek, made by Sanofi-Aventis SA, was probably too dangerous to be used for treating two common respiratory infections. The drug was approved in 2004 and had $148 million in sales in 2005.

Ross is one of four current or former employees of the FDA who are working with Congress on bills intended to create more stringent drug safety rules. One change being proposed would create a new office to monitor the safety record of drugs after they're on the market. Next week, several of the critics will state their concerns at a congressional hearing into the FDA.

CHICAGO - A drug widely used to prevent excessive bleeding during heart surgery appears to raise the risk of dying in the five years afterward by nearly 50 percent, an international study found.

The researchers said replacing the drug -- aprotinin, sold by Bayer AG under the brand name Trasylol -- with other, cheaper medications for a year would prevent 10,000 deaths worldwide over the next five years.

The findings were more bad news for Trasylol: The same scientists found the drug raised the risk of kidney failure, heart attacks and strokes in a study published last year. Most of the deaths in the new study were related to those problems.