FDA to Force Medical Device Manufacturer Pay for Violating Law
March 29, 2008
The U.S. Food and Drug Administration (FDA) today announced it is seeking a $2.2 million penalty against a California hearing aid manufacturer for violations of federal law, including manufacturing standards violations and the failure to notify the FDA of a change in an outside supplier or vendor, which may have exposed recipients of the devices to unnecessary health risks.
The hearing aids pose a public health risk due to excessive moisture, exposing patients to the risk of device failure, possible surgery, and the potential for additional hearing loss.
The agency’s complaint, originally filed this past November and amended on March 17, seeks penalties against California medical device manufacturer Advanced Bionics, LLC and its president and co-CEO, Jeffrey H. Greiner.
The complaint alleges that Advanced Bionics shipped hearing aids to customers in the United States prior to filing appropriate supplemental information with the Agency, including a notice of changes made to the devices that affected their safety and effectiveness.
On July 7, 2003, Advanced Bionics received FDA approval to market the HiRes90k Implantable Cochlear Stimulator, a cochlear implant hearing aid surgically implanted under the skin behind the ear to treat profound hearing loss in adults and children. The hearing aid is considered a Class III device by the FDA—the most stringent regulatory category for devices.
The complaint alleges that the company failed to comply with the FDA’s current Good Manufacturing Practice (GMP) requirements for devices. GMP requires that companies manufacturing medical devices for sale in the United States establish and follow quality systems procedures to assure the safety and quality of their products.
Advanced Bionic’s alleged GMP violations include the failure to sufficiently evaluate and select a new vendor as the supplier of a critical device component and the failure to adequately validate the continued safety and effectiveness of the hearing aid by testing lots under actual or simulated use when the unapproved vendor’s component was used.
The complaint also states that Advanced Bionics shipped hearing aids in violation of the law between January 2005 and July 2006. Two hearing aids shipped and implanted after a March 2006 recall contained the component from the unapproved vendor.
FDA’s complaint states that the company’s failure to file the required supplement occurred after a 2001 inspection. At that time, the company was cited for similar failures and made commitments to correct the problems.
Popularity: 72% [?]
Dietary Supplement Associated with Severe Adverse Reactions
March 28, 2008
The FDA notified consumers of a recall of, and advised them not to purchase or consume, the liquid dietary supplement products Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. The Florida Department of Health recently provided reports to the FDA on 23 individuals who experienced serious reactions to these products seven to 10 days after ingestion. In all cases, the reactions included significant hair loss, muscle cramps, diarrhea, joint pain and fatigue. FDA laboratories are analyzing samples of the products to identify the cause of the reactions.
Popularity: 64% [?]
Increased Cancer Risk Associated with Treatment for Diabetic Leg and Foot Ulcers
March 28, 2008
The FDA is conducting a safety review based on study data suggesting there may be an increased risk of death from cancer in diabetic patients using Regranex (becaplermin) Gel, a skin product used to heal leg and foot ulcers. While the review is ongoing, the FDA recommends health care professionals discuss the potential risks and benefits of using Regranex with their patients.
Popularity: 69% [?]
Cantaloupe from Honduran Grower Tainted with Salmonella
March 24, 2008
The Food and Drug Administration (FDA) is advising consumers who have recently bought cantaloupes to check with the place of purchase to determine if the fruit came from Agropecuaria Montelibano, a growing and packing company in Honduras. If so, consumers should throw away the cantaloupes.
Based on current information, fruit from this company appears to be associated with a Salmonella Litchfield outbreak in the United States and Canada.
To date, FDA has received reports of 50 illnesses in 16 states and nine illnesses in Canada linked to eating cantaloupes. The states are Arizona, California, Colorado, Georgia, Illinois, Missouri, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Tennessee, Utah, Washington, and Wisconsin. No deaths have been reported; however, 14 people have been hospitalized.
Symptoms of Foodborne Salmonella Infection
Symptoms include nausea, vomiting, fever, diarrhea, and stomach cramps. In individuals with poor health or weakened immune systems, Salmonella can invade the bloodstream and cause life-threatening infections. Individuals who have recently eaten cantaloupe and experienced any of these symptoms should contact their health care professional.
Tips for Consumers
To reduce the risk of getting Salmonella or other foodborne illnesses from cantaloupes:
Buy cantaloupes that are not bruised or damaged. If buying fresh-cut cantaloupe, be sure it is refrigerated or surrounded by ice.
After purchase, refrigerate cantaloupes promptly.
Wash hands with hot, soapy water before and after handling fresh cantaloupes.
Scrub whole cantaloupes by using a clean produce brush and cool tap water immediately before eating. Don’t use soap or detergents.
Use clean cutting surfaces and utensils when cutting cantaloupes. Wash cutting boards, countertops, dishes, and utensils with hot water and soap between the preparation of raw meat, poultry, or seafood and the preparation of cantaloupe.
If there is a bruised or damaged area on a cantaloupe, cut away that area before eating.
Throw away any leftover cut cantaloupe if it’s left at room temperature for more than two hours.
Use a cooler with ice or use ice gel packs when transporting or storing cantaloupes outdoors.
Popularity: 58% [?]
Biovail Settles with SEC. Three Executives Still under Investigation.
March 24, 2008
The U.S. Securities and Exchange Commission said on Monday that
Popularity: 51% [?]
Dietary Supplements with Dangerous Ingredients
March 21, 2008
Palo Alto Labs and FDA notified consumers and healthcare professionals of a voluntary nationwide recall of two dietary supplements, Aspire36 and Aspire Lite. The products were recalled because they were found to contain Aildenafil in trace amounts and Dimethyl sildenafil thione, an analog of Sildenafil, a drug used to treat erectile dysfunction. The presence of these ingredients in the dietary supplements may pose a threat to consumers because the analogue may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers who have Aspire36 and Aspire Lite in their possession should stop using the products and return any unused product to the place of purchase.
Popularity: 79% [?]
Bush’s Legacy
March 21, 2008
Stephanie Mencimer, Mother Jones
When it comes to notorious Bush political appointees, Daniel Troy’s name doesn’t usually make the top-10 list, overshadowed as he is by more high profile cronies such as FEMA’s Michael Brown. But for three years in the president’s first term, Troy served as the chief counsel to the Food and Drug Administration (FDA), where he quietly advanced a legal revolution that is playing out in earnest in the U.S. Supreme Court this year. This revolution has the potential to affect the health and safety of the nation’s citizens for years to come, all while making Troy a rich man. In fact, his career is an illustration of how the Bush administration’s revolving door has allowed industry lawyers to radically reshape regulatory agencies to benefit the big businesses they once represented and then profit from those changes when they return to the private sector.
Popularity: 55% [?]
Graft use Associated with Increase Risk of Death
March 20, 2008
FDA issued a Public Health Notification to inform healthcare professionals of an update to earlier FDA safety information on this product. The notification re-emphasizes the need for continued surveillance of patients treated with endovascular grafts, and provides updated information on the mortality risks associated with the use of the AneuRx Stent Graft System to prevent abdominal aortic aneurysm rupture.
Popularity: 63% [?]
Tamiflu associated with Changes in Behavior
March 20, 2008
Roche and FDA informed healthcare professionals of neuropsychiatric events associated with the use of Tamiflu, in patients with influenza.The label has been revised as follows: Influenza can be associated with a variety of neurologic and behavioral symptoms which can include events such as hallucinations, delirium, and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease. There have been postmarketing reports (mostly from Japan) of delirium and abnormal behavior leading to injury, and in some cases resulting in fatal outcomes, in patients with influenza who were receiving Tamiflu. Because these events were reported voluntarily during clinical practice, estimates of frequency cannot be made but they appear to be uncommon based on Tamiflu usage data. These events were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution. The contribution of Tamiflu to these events has not been established. Patients with influenza should be closely monitored for signs of abnormal behavior. If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated for each patient.
Popularity: 56% [?]
Spiriva HandiHaler Associated with Possible Increase in Stroke
March 20, 2008
Boehringer Ingelheim and FDA notified healthcare professionals that ongoing safety monitoring has identified a possible increased risk of stroke in patients who take Spiriva. This product contains tiotropium bromide and is used to treat bronchospasm associated with chronic obstructive pulmonary disease. Boehringer Ingelheim reported to the FDA that it has conducted an analysis of the safety data from 29 placebo controlled clinical studies (“pooled analysis”). Based on data from these studies, the preliminary estimates of the risk of stroke are 8 patients per 1000 patients treated for one year with Spiriva, and 6 patients per 1000 patients treated for one year with placebo. This means that the estimated excess risk of any type of stroke due to Spiriva is 2 patients for each 1000 patients using Spiriva over a one year period.
It is important to interpret these preliminary results with caution. FDA is working with Boehringer Ingelheim to further evaluate the potential association between Spiriva and stroke. FDA has not confirmed these analyses and while pooled analyses can provide early information about potential safety issues, these analyses have inherent limitations and uncertainty that require further investigation using other data sources. Patients should not stop taking Spiriva HandiHaler before talking to their doctor, if they have questions about this new information.
Popularity: 64% [?]
Prescription Drug Sales Growth Slows To Lowest Rate Since 1961
March 15, 2008
Sales growth in the U.S. prescription drug market slowed to the lowest rate in 46 years in 2007 as more brand-name drugs lost their exclusivity to generics and new product approvals declined, according to a report issued Wednesday.Sales came to $286.5 billion in 2007, up 3.8 percent, IMS Health said in its annual U.S. Pharmaceutical Market Performance Review. The rate of growth was the lowest since 1961, when sales increased by 3.3 percent.
In contrast, prescription drug sales grew by 8 percent in 2006.
Growth moderated beginning in 2001, but picked up in 2006 with the start of the federally subsidized prescription drug program for seniors, Norwalk-based IMS Health said. However, growth slowed again last year.
The