FDA issues boxed warning for antipsychotics
WASHINGTON The Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 to require manufacturers of “conventional” antipsychotic drugs to make safety changes to prescribing labeling to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia. Antipsychotic drugs commonly are categorized into two classes, the older “conventional” antipsychotics and the newer “atypical” antipsychotics.
In 2005, the FDA announced similar labeling changes for “atypical” antipsychotic drugs. At that time, boxed warnings were added. The boxed warning will now be added the older class of drugs known as “conventional” antipsychotics. The warning for both classes of drugs will say that clinical studies indicate that antipsychotic drugs of both types are associated with an increased risk of death when used in elderly patients treated for dementia-related psychosis.
“It is important that health care professionals and consumers have the most up-to-date drug safety information,” said Thomas Laughren, director of the FDA’s Division of Psychiatry Products in the Center for Drug Evaluation and Research. “The prescribing information for all antipsychotic drugs will be updated to describe the risk of death in elderly patients being treated for symptoms associated with dementia.”
The FDA today issued letters to the manufacturers of both types of antipsychotic drugs, notifying the manufacturers that they should make changes to drug labeling. Manufacturers of both classes of drugs are being asked to change labeling so that all of the drugs carry uniform warning language. Manufacturers of these drugs are required to submit new language to the FDA within 30 days, or to provide a reason why they do not believe such labeling changes are necessary.
The medications involved in this action are:
Conventional Antispychotic Drugs
- GlaxoSmithKline’s Compazine
- Ortho-McNeil’s Haldol
- Watson’s Loxitane
- Novartis’ Mellaril
- Endo’s Moban
- Pfizer’s Navane
- Gate’s Orap
- Bristol-Myers Squibb’s Prolixin
- GSK’s Stelazine
- GSK’s Thorazine
- Schering’s Trilafon
- BMS and Otsuka’s Abilify
- Novartis’ Clozaril
- Avanir’s FazaClo
- Pfizer’s Geodon
- Janssen’s Invega
- Janssen’s Risperdal
- AstraZeneca’s Seroquel
- Eli Lilly’s Zyprexa
- Eli Lilly’s Symbyax
Mass. approves $1 billion for state life sciences industry
BOSTON The Massachusetts Senate has approved a $1 billion dollar bill designed to help development in the state’s life sciences industry, according to the Boston Globe.
The House passed the bill on Wednesday, which was followed by the Senate’s 31 to 7 vote in favor of approving the bill, a central piece of Governor Deval Patrick’s agenda.
The governor expects to sign the bill Monday, said his spokeswoman, Becky Deusser. Lawmakers are hoping to trumpet the legislation at an international biotechnology conference next week in San Diego.
Proponents of the bill said in Senate debate that the bill would boost the state’s economy while developing life-saving treatments. “This isn’t just for one industry. This will have an enormous impact over a longer run,” said Senator Harriette Chandler, a Worcester Democrat. She said the bill would also have an “absolutely revolutionary” impact on healthcare.
Senate minority leader Richard Tisei told members that the bill was an example of “pork barrel spending. …I just remind you that it’s the taxpayers that are paying. … It’s taxpayers’ money, it doesn’t grow on trees.”
nFinanSe raises $10.7 million in securities sale
TAMPA, Fla. The prepaid and gift card company nFinanSe has raised $10.7 million through the issuance of almost 1.5 million share of its common stock, about 4 million shares of its Series C Convertible Preferred stock and warrants to purchase over 2.6 million shares of its common stock.
Each share of the Series C Convertible Preferred Stock is convertible into one share of the company’s common stock. Both the Series C Convertible Preferred Stock and the common stock were sold at the purchase price of $2.00 per share. The warrants entitle holders to purchase shares of common stock at an exercise price of $2.30 per share.
In addition, the nFinanSe has closed on its previously announced $15.5 million accounts receivable line of credit with certain institutional investors and shareholders of the company, including Ballyshannon Partners, an affiliate of one of its directors. This line of credit will be used solely to support the company’s reloadable prepaid and gift cards at retail store locations.
Jerry Welch, chairman and chief executive officer, said, “The prepaid card industry is a rapidly growing and very dynamic sector of the U.S. economy. This financing, which will provide the company with over $26 million of capital, enhances our financial condition, strengthens our balance sheet and helps position us to aggressively pursue market share in the prepaid card marketplace.”