Tagged Articles

drug safety 16 articles

FDA, EMA still investigating pancreatic problems with diabetes drugs Byetta, Januvia

U.S. and European drug regulators have yet to reach a final conclusion about whether a widely prescribed class of type 2 diabetes drugs increases the risk of pancreatic problems. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) launched separate investigations a year ago into the safety of so-called incretin mimetics drugs such as Januvia and Byetta after studies linked the medications to acute pancreatitis and pancreatic cancer. Incretin mimetics, which include GLP-1 receptor agonists and DDP-4 inhibitors, work by increasing the release of insulin after meals and by slowing the absorption of food in the gastrointestinal ... Read More

FDA wants more safety data before it will approve new type 2 diabetes drugs

Takeda Pharmaceutical Co. will have to produce more evidence on the safety of two new type 2 diabetes medications, delaying even more what has been a long road to Food and Drug Administration (FDA) approval. Takeda is seeking United States marketing rights for alogliptin and alogliptin/pioglitazone for the treatment of type 2 diabetes. “Our partner Takeda has extensive Phase III data, including interim findings from a cardiovascular outcomes trial and we remain confident in the future potential of alogliptin and alogliptin/pioglitazone for the treatment of type 2 diabetes,” said June Almenoff, the company’s chief medical officer. Takeda sought approval for ... Read More

FDA panel considers risks, benefits of experimental hepatitis C drug

A Food and Drug Administration (FDA) advisory committee this week will vote whether recommend the approval for Merck & Co.’s new hepatitis C drug boceprevir. Clinical trials with the drug have shown promising results, but potential side effects have left the committee questioning the drug’s safety. The biggest concern the FDA’s Antiviral Drugs Advisory Committee has about boceprevir is the increased risk and severity of anemia and other blood disorders in patients who use the drug. Anemia is a decrease in the number of blood cells. Red blood cells carry oxygen from the lungs to the tissues. Depending on the ... Read More

FDA approved fewer new drugs in 2010 compared to previous two years

Fewer drugs were approved by the Food and Drug Administration (FDA) in 2010 compared with the two previous years, suggesting that drug safety concerns are driving a tougher regulatory process. According to drug-approval reports provided by the FDA, 21 new drugs were approved in 2010, compared to 25 in 2009 and 24 in 2008. Last year’s total was higher than 2007, during which only 18 drugs were approved for use. A spokesperson with the federal agency that oversees the approval of new drugs says the FDA has not strengthened its process. The agency bases its decisions on the same criteria, ... Read More

Anti-seizure, bipolar drug Lamictal can cause meningitis

Lamictal (lamotrigine), a medication commonly used for seizures in children 2 years old and older, and bipolar disorder in adults, can cause aseptic meningitis, according to a Drug Safety Communication issued by the Food and Drug Administration (FDA). The warning will be added to the drug’s Warnings and Precautions section of the drug safety label as well as the patient Medication Guide. Meningitis is an inflammation of the protective membranes that cover the brain and spinal cord. Aseptic meningitis is generally diagnosed when test of a patient with signs and symptoms of meningitis do not detect bacteria. Causes of aseptic ... Read More

China says tainted drug blame should fall on foreign suppliers

A Chinese senior health official says China has been unfairly labeled as a center for fake drug production and that blame should be placed instead on foreign companies who do business with unregistered firms against Chinese regulations. Bian Zhenijia, director of the drug safety supervision department of the State Food and Drug Administration (SFDA), urged companies to be more responsible when dealing with foreign suppliers. “The problem lies in the fact that some overseas companies have an implicit deal with underground factories or illegal manufacturers in China, so the product involved has problems,” Bian said at a press conference. China’s ... Read More

Texas woman sues Digitek manufacturer for husband’s death

A woman from Texas claims that her husband died in January 2007 as a result of his Digitek medication containing twice the active ingredient. On Jan. 23, 2008, Vickie Butts, representing the estate of her deceased husband, Donnie Butts, filed a product liability lawsuit against Actavis, the drug manufacturer, and Mylan, the distributor. The Southeast Texas Record states, “According to the original complaint, just a year after acquiring the business of manufacturing Digitek, the defendants received a warning from the U.S. Food and Drug Administration that they had failed to provide periodic safety reports from its solid oral dose manufacturing ... Read More

Torti named interim commissioner of FDA

FDA chief scientist and principal deputy commissioner Dr. Frank Torti will serve as the agency’s acting commissioner when Dr. Anderew Von Eschenbach leaves office this week, a position he will hold until the Obama administration appoints a new leader and the Senate approves the choice, according to Scrip World Pharmaceutical News. Dr. Torti joined the FDA in May, just as the tainted heparin scandal was still brewing at the agency. Dr. Von Eschenbach recruited Dr. Torti to “help bolster the agency’s scientific infrastructure,” according to the news story. Last year more than 80 Americans died and hundreds more became ill ... Read More

Actavis N.J. plant agrees with FDA

Actavis Inc. has made an agreement with the FDA not to issue any drugs from its Totowa facilities in Morristown, N.J., where Digitek is produced. According to the Philadelphia Inquirer, the agreement says Actavis cannot resume its practices until it conforms to “the agency’s good manufacturing practice.” Actavis must improve its labs, facilities, and equipment. Actavis has faced numerous lawsuits over the recalled drug Digitek. One such lawsuit includes the death of a patient and claims that Digitek is an unsafe and flawed drug. Actavis would not comment if the FDA agreement had influenced the Digitek lawsuits or not. ... Read More

Digitek believed responsible for 667 deaths

According to reports filed to the FDA and consumers, the Center for Public Integrity has found that Digitek is responsible for 667 consumers’ deaths from April through June 2008. Pharma Live says health experts believe the FDA should have made more “aggressive warnings” to the public. The number of deaths associated with Digitek consumers have increased since the last reporting period.Because all Digitek consumers already have heart disease, the issue is whether or not Digitek has caused an increase in death from heart problems. In April of this year, Digitek pills were recalled due to a suspicion of Digitek pills ... Read More