WASHINGTON - The FDA said it received 526,527 reports of drug-related adverse events in 2008, the highest number the agency has on record in a single year.
That figure is up from 482,154 in 2007, according to the FDA's annual report of its adverse event reporting system (AERS), a database that supports the agency's postmarketing safety surveillance program.
Drugmakers are required to submit adverse event reports to AERS. The agency also obtains reports from physicians and other health care providers and consumers voluntarily through the FDA's MedWatch program.
Not all of the drug-related adverse event reports the FDA receives are entered into the AERS database, regulators said, noting that there were 441,367 reports entered into AERS for 2008. There were 364,449 entered into the database in 2007.
Of those the agency received last year, 275,421 were from so-called 15-day reports, which are submitted by manufacturers and contain at least one event that is not currently described in the product labeling and is considered a serious outcome for the patient.
Manufacturers last year also submitted 218,207 "periodic reports" - those that did not meet the criteria of a 15-day report for adverse events.
Drugmakers are required to submit periodic reports to the FDA quarterly for new drugs and annually for older products.
The FDA also received 32,899 reports of adverse events directly from patients, physicians or others, the agency said.
AERS contains more than 4 million reports of adverse events and reflects data going back as far as 1969.
FDA Warns 14 Firms about Drug Ad Violations
Drug regulators last week warned 14 drugmakers, including Biogen Idec Inc., Cephalon Inc. and Genentech Inc., that their online marketing communications for certain products made misleading statements about efficacy and failed to provide any risk information.
In addition, the companies also failed to properly identify the drugs they were advertising by the brand names and some of the ads did not disclose the medicines' indications.
Many of the products involved in the warning letters carry black-box warnings - the agency's strongest alert - about serious cardiovascular and other lethal risks. However, that information was not disclosed in the online advertisements, the FDA said.
By omitting the most serious and frequently occurring risks associated with the drugs, the manufacturers were misleadingly suggesting that their products were safer than they actually are, regulators said.
Most of the products involved in the warnings are used to treat serious conditions, such as cancer, multiple sclerosis, diabetes, depression and severe pain.
The firms were told to immediately remove the promotional materials from the Internet and to check all of their commercials for violations.
"It is your responsibility to ensure that your promotional materials" comply with the Food, Drug and Cosmetic Act and FDA regulations, the agency told drugmakers in the letters.
More HHS ARRA Funds Released
The Obama administration is making $2.3 billion from the economic stimulus package available for child care and vaccine programs, Vice President Job Biden revealed last week.
In addition, the Department of Health and Human Services announced that $1 billion from the American Recovery and Reinvestment Act (ARRA) of 2009 will be allotted to states for community service organizations that provide nutrition programs, housing assistance, job training and credit counseling. The $2 billion in ARRA funds for child care will be used by states to provide vouchers to families for care services and to improve child care programs, the vice president said.
A majority of the $300 million set aside for vaccine programs will be used to buy the products, which will be distributed through the Centers for Disease Control and Prevention, Biden said. The remainder of the funding will be used to support national public awareness campaigns about the importance of immunizing children and to provide grants to states that demonstrate innovative new ways to ensure more Americans receive the vaccines, the vice president said.
The $1 billion devoted to community programs will help more Americans get back on their feet by reducing poverty, revitalizing low-income communities and helping needy families become self-sufficient, said HHS spokeswoman Jenny Backus.