Posts Tagged ‘FDA’

On June 29, the Food and Drug Administration (FDA) confirmed that samples of cookie dough taken from the Nestle factory in Danville, Virginia tested positive for E. coli O157:H7. Nestle recalled its refrigerated cookie dough products on June 19 when the FDA announced that it believed people were getting sick from eating raw dough contaminated with E. coli. The outbreak is surprising because cookie dough is not normally associated with E. coli contamination, although salmonella is sometimes a concern because raw dough contains uncooked eggs. Only Nestle refrigerated cookie and brownie dough has been recalled; other Nestle products appear to be unaffected.

E. coli is a bacterium that can cause infections in people when consumed in contaminated food products. So far 69 cases in 29 states have been reported to the Center for Disease Control. Of these, 34 required hospitalization and nine have developed Hemolytic Uremic Syndrome, which can cause kidney failure, but there have been no deaths linked to the outbreak.

Nestle cookie and brownie dough has been pulled from store shelves and the FDA is advising people who had previously purchased these products to throw them away. The agency also advises against baking the dough because it might contaminate kitchen utensils. Individuals who experience E. coli symptoms after consuming Nestle refrigerated cookie or brownie dough should see a doctor immediately. Read more about dangerous products.

On June 17, 2009, the FDA reported the conclusions of its studies on Maxipime, an antibiotic generically known as cefepime.  Maxipime is a Bristol Meyers Squibb drug used to treat infections caused by abdominal surgery and other conditions. A recent published study suggested that patients given the drug might be more likely to suffer deadly complications compared to patients treated with other drugs.  The FDA determined that Maxipime did not increase the rate of death in its users.  The FDA reviewed the study’s data and conducted additional analyses based on additional data, including data provided by Bristol Meyers Squibb.

In a letter it sent to healthcare professionals, the FDA stated that it still approved Maxipime as an appropriate treatment for its approved indications, at least for now.  However, the FDA will continue to investigate into the safety of Maxipime.  As part of its ongoing investigation, both the FDA and Bristol Meyers Squibb are conducting separate studies on Maxipime’s potential link to increased death rates in its users.  The results of these studies will be reported in approximately a year.

Currently, the FDA has not indicated that Maxipime is a dangerous drug, but perhaps as it continues to do further investigations into the drug, it will find contrary information.  If you or loved one has been harmed by a dangerous drug, contact a dangerous drug lawyer today.

The Food and Drug Administration took steps to protect consumers from predatory and misleading advertising by manufacturers when it issued its new proposed advertising guidelines for drugs and medical devices. While the guidelines are not binding, they provide information to companies about how to avoid breaking FDA regulations.

According to the FDA, the document was issued in part because of a request from the drug industry for advice on how to comply with the agency’s rules for the marketing of medical products. Of particular concern is the omission or minimization of information about possible risks associated with a product, which compromise the most common violations of FDA regulations.

The guidelines recommend that advertisements be as specific as possible, and describe how small details like font and the amount of white space in printed material can best present information about risks and side effects. The FDA guidelines also discourage companies from sending conflicting messages in advertisements, such as using cheerful music in commercials while the risk information for a drug or device is being listed. Hopefully, if companies follow these guidelines, they will increase awareness in patients and health-care providers about the possible side effects of their drugs and medical devices. Read more about FDA product warnings.

Medication adherence, which is really the extent to which patients take medication as prescribed by their doctors, is important to the medication’s effectiveness to cure and treat the particular illness.  Poor medication adherence can have a particularly negative impact on the medication’s ability to treat many diseases, causing more severe complications from the illness and decreased quality of life for patients.   Many factors cause poor adherence; the most common ones being the inability to pay for medications, lack of belief that the treatment is necessary or helping, busy schedules, forgetfulness, and confusion about how and when to take the medication.

The Food Drug Administration recently published an article on its website, which discusses the importance of medication adherence and provides tips on how to take different types of medication correctly.  For example, when taking antibiotics, the FDA warns strict medication adherence is vital.  If antibiotics are not taken as prescribed by the doctor, a small number of bacteria is likely to survive and continue to replicate and become resistant to the antibiotics.  The same reasoning goes for the HIV virus.  When patients with AIDS skip or stop taking their prescribed medication, they might develop strains of HIV that are more resistant to the prescribed medication and even some medications that patients aren’t currently on.

The FDA advises people to communicate with their doctors or pharmacists if they are experiencing side effects of their prescribed medication and understand how long they need to take the medication.  Setting a daily routine to take medication, keeping medications in noticeable places, using daily dosing containers, and keeping written or computerized schedules are all good ways to help people remember to take their medication.

Ultimately, if there is ever an issue of negligence, consumers want to make sure it is medical negligence outside of their control and not negligence of their own.  Making sure you properly take medications, at least according to the FDA, is an important consumer health issue.

On June 10, 2009, a Food and Drug Administration (FDA) panel supported the use of Seroquel, a mood-stabilizing medicine manufactured by AstraZeneca, in children and adolescent, stating that the drug was “acceptably safe” and useful to treat schizophrenia and bipolar disorder.  At this time, FDA has not officially approved Seroquel for use in children and adolescents.

Seroquel is an oral medication used to control the symptoms associated with schizophrenia.  Seroquel is AstraZeneca’s second-best-selling drug with $4.45 billion in sales in 2008.  AstraZeneca is asking FDA to approve to market Seroquel in patients aged 13 to 17 with schizophrenia, and in patients aged 10 to 17 with bipolar disorder.

Schizophrenia afflicts about 1% or around 2.4 million Americans, specifically those in their late teens and early 20’s. Bipolar disorder is significantly more severe when found in children than adults and is characterized by frequent mood shifts and energy levels. It affects anywhere from 1-3 percent or around 5.7 million Americans.

In 1997, the FDA approved Seroquel for the treatment of schizophrenia.  However, the FDA has also reported that Seroquel has serious side effects when used by adult or elderly patients, including:

• An increased chance of death in elderly person
• Neuroleptic malignant syndrome (NMS), a life-threatening nervous system problem that can cause high fever, muscle stiffness, sweating, a fast or irregular heartbeat, a change in blood pressure and confusion
• An uncontrollable muscle movement condition known as tardive dyskinesia
• High blood sugar and diabetes

Seroquel lawsuits allege that AstraZeneca knew of Seroquel’s side effects, but did not take adequate steps to warn doctors and patients of them.  In addition, the lawsuits also allege that AstraZeneca aggressively marketed and promoted Seroquel for “off label” use, despite not getting FDA approval during that time.

The FDA panel also supports use of another drug Zyprexa, manufactured by Eli Lilly & Co., for use as a second-line treatment, or a second option after other drugs have failed in adolescents, because of concerns about significant weight gain in many adolescent patients.  In schizophrenia studies of Lilly’s Zyprexa, more than 30 percent of adolescents gained weight, compared with just 6 percent of adults. On average, adolescents gained nearly 10 pounds, compared with 6 pounds for adults.  Zyprexa is Lilly’s top-selling drug with $4.7 billion in sales in 2008.  Lilly is seeking FDA’s approval for Zyprexa in patients aged 13 to 17 with schizophrenia, and in patients aged 10 to 17 with bipolar disorder.