Archive
FDA approves Plan B One-Step emergency contraceptive without a prescription for women 15 years of age and older
Source: U.S. Food and Drug Administration
The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women’s Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years of age and older.
After the FDA did not approve Teva’s application to make Plan B One-Step available over-the-counter for all females of reproductive age in December 2011, the company submitted an amended application to make the product available for women 15 years of age and older without a prescription.
The product will now be labeled “not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified.” Plan B One-Step will be packaged with a product code prompting a cashier to request and verify the customer’s age. A customer who cannot provide age verification will not be able to purchase the product. In addition, Teva has arranged to have a security tag placed on all product cartons to prevent theft.
In addition, Teva will make the product available in retail outlets with an onsite pharmacy, where it generally, will be available in the family planning or female health aisles. The product will be available for sale during the retailer’s normal operating hours whether the pharmacy is open or not.
Plan B One-Step is an emergency contraceptive intended to reduce the possibility of pregnancy following unprotected sexual intercourse – if another form of birth control (e.g., condom) was not used or failed. Plan B One-Step is a single-dose pill (1.5 mg tablet) that is most effective in decreasing the possibility of unwanted pregnancy if taken immediately or within 3 days after unprotected sexual intercourse.
Plan B One-Step will not stop a pregnancy when a woman is already pregnant, and there is no medical evidence that the product will harm a developing fetus.
Judge Says FDA Must Make Morning-After Pill Available Over the Counter for All Ages
Memorandum and Order – 12-cv-763, Tummino et al v. Hamburg et al. (PDF)
Source: U.S. District Court, Eastern District of New York
The decisions of the Secretary with respect to Plan B One-Step and that of the FDA with respect to the Citizen Petition, which it had no choice but to deny, were arbitrary, capricious, and unreasonable. I decline to direct a remedy comparable to that which I directed in my 2009 opinion, such as directing that emergency contraception be made available without a prescription but with the current point-of-sale restrictions to women whom studies have demonstrated are capable of understanding the label and using the product appropriately. As I have previously observed, the obstructions in the path of those adolescents in obtaining levonorgestrel-based emergency contraceptives under the current behind-the-counter regime have the practical effect of making the contraceptives unavailable without a doctor’s prescription. Consequently, the decision of the FDA denying the Citizen Petition is reversed, and the case is remanded to the FDA with the instruction to grant the Citizen Petition and make levonorgestrel-based emergency contraceptives available without a prescription and without point-of-sale or age restrictions within thirty days. On remand, the FDA may determine whether any new labeling is reasonably necessary. Moreover, if the FDA actually believes there is any significant difference between the one- and two-pill products, it may limit its over-the-counter approval to the one-pill product.
FDA Gives Tips to Prevent Salmonella Infection from Handling Feeder Rodents and Pet Reptiles and Amphibians
FDA Gives Tips to Prevent Salmonella Infection from Handling Feeder Rodents and Pet Reptiles and Amphibians
Source: U.S. Food and Drug Administration
The Food and Drug Administration is giving consumers, especially reptile owners, tips on how to prevent Salmonella infection from handling feeder rodents and reptiles. Feeder rodents are mice and rats—both frozen and live—used to feed some reptiles, such as certain snakes and lizards, as well as some amphibians. Feeder rodents, reptiles, and amphibians can be sources of Salmonella infection for people.
Salmonellosis is an infection with bacteria called Salmonella. People get salmonellosis by ingesting Salmonella germs. Persons infected with Salmonella develop diarrhea, fever, and abdominal cramps 12-72 hours after infection. The illness usually lasts 4-7 days, and most persons recover without treatment. However, the illness can be serious, even fatal, in some people. Children under 5 years of age, the elderly, and people with weakened immune systems are at higher risk for salmonellosis and may develop more severe illness.
Rodents and reptiles can naturally carry Salmonella in their intestines but show no signs of illness. The animals shed the bacteria in their feces and droppings. These, in turn, contaminate the environment with Salmonella, including the outside of the animals’ bodies and their habitats. Freezing does not kill Salmonella, so both frozen and live feeder rodents can be contaminated with these germs. Over 500 human cases of salmonellosis in three countries, including the U.S., were linked to frozen rodent exposure between 2008 and 2010.
People may become infected with Salmonella after handling feeder rodents, reptiles, or amphibians, surfaces that have been in contact with these animals, or the environment in which the animal lives.
Contaminated surfaces may include countertops, microwave ovens, refrigerators and freezers, kitchen utensils, and glasses and bowls used to store, thaw, and prepare frozen feeder rodents. Reptile and rodent habitats, including their cages or enclosures, bedding, basking rocks, food and water dishes, and other objects in their cages or enclosures may also be contaminated with Salmonella. Germs picked up from touching the animal or habitat can be spread to other people or surfaces. Therefore, people should wash their hands thoroughly with soap and water right after touching these animals, their food, or anything in the area where they live and roam. Running water and soap are best, but hand sanitizers may be used if running water and soap are not available.
FDA Report Regarding Jerky Pet Treats and Illnesses
FDA Report Regarding Jerky Pet Treats and Illnesses
Source: U.S. Food and Drug Administration
As FDA investigates consumer complaints and other reported adverse event data from the public concerning jerky pet treats, it is important to remember that these data must be carefully interpreted. In most cases, information from these reports cannot be further confirmed or verified. This information is not data obtained from a controlled clinical trial or as part of an observational epidemiologic study, but rather are a series of reports of events believed by the reporting party to be associated with the consumption of jerky-type products.
There are several limitations to interpreting passively reported adverse event data, and it is important to note that adverse event data consist of reports or complaints of illness or death and the subjective link with product exposure. The Center is carefully evaluating these reports to try and determine if they should be considered evidence of a causal relationship. The numbers in this report should not be used to calculate incidence rates or estimates of risk, because there is no accurate way to determine overall how many animals were exposed to a product, which is needed as the denominator in calculations of relative risk. It is also inappropriate to make use of adverse event data to compare the relative safety of different products, which may have different usage patterns and/or reporting rates.
It is possible that other food or drug exposures caused the signs and symptoms reported in these reports; thus, there is no certainty that the reported jerky treat caused the adverse event. There may be one or more concomitant diseases, conditions, medications or other foods that can better explain the clinical signs seen. Sometimes a significant amount of time elapses between the date the problem occurred and the date the problem is reported and the reporter does not remember specific details (which can include the brand name or the names of other brands fed at the same time or prior to the report), so the report may contain erroneous information. Reporting bias also may exist in passive reporting systems. For example, increased media attention to specific products may cause increased reporting for those products for some period of time, causing an apparent sudden increase in the number of reports received. CVM Updates were publicly released September 26, 2007, December 19, 2008 and November 18, 2011, and all were followed by increased reporting activity after the update was issued.
However, even with these limitations, CVM strongly believes that the reports, especially the numerous reports documenting Fanconi syndrome, warrant FDA’s continued in-depth investigation of the potential causes of the reported illnesses.
FDA requiring lower recommended dose for certain sleep drugs containing zolpidem
FDA requiring lower recommended dose for certain sleep drugs containing zolpidem
Source: U.S. Food and Drug Administration
The U.S. Food and Drug Administration today announced it is requiring the manufacturers of Ambien, Ambien CR, Edluar and Zolpimist, widely used sleep drugs that contain the active ingredient zolpidem, to lower current recommended doses. Ambien and Ambien CR are also available as generics. New data show that zolpidem blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving.
Using lower doses of zolpidem means less of the drug will remain in the blood in the morning hours. Since women eliminate zolpidem from their bodies more slowly than men, the FDA has notified the manufacturers that the recommended dose should be lowered for women and that the labeling should recommend that health care professionals consider a lower dose for men. Data show the risk for next-morning impairment is highest for patients taking the extended-release forms of these drugs. The FDA urges health care professionals to caution all patients (men and women) who use these products about the risks of next-morning impairment for activities that require complete mental alertness, including driving.
The FDA has informed the manufacturers that the recommended dosage of zolpidem for women should be lowered from 10 milligrams (mg) to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR). For men, the FDA has informed the manufacturers that the labeling should recommend that health care professionals consider prescribing these lower doses (5 mg for immediate-release products and 6.25 mg for extended-release products). These products are currently available on the market in both the higher and lower dosages.
CFSAN Adverse Event Reporting System: Voluntary and Mandatory Reports on 5-Hour Energy, Monster Energy, and Rockstar Energy Drink (January 1, 2004 through October 23, 2012 )
Source: U.S. Food and Drug Administration
FDA’s Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System (CAERS) collects reports about adverse health events and product complaints related to CFSAN-regulated products, including conventional foods, dietary supplements, and cosmetics. Based on a search of CAERS, this document summarizes the adverse events reported to FDA in connection with products under the labels 5-Hour Energy, Monster, and Rockstar between January 1, 2004 and October 23, 2012. These products are currently marketed as dietary supplements.
CAERS includes voluntary reports for cosmetics and conventional foods, and both voluntary and mandatory reports for dietary supplements. Mandatory reports are those required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. Specifically, dietary supplement manufacturers, packers, and distributors must notify FDA if they receive reports about serious adverse events in connection with the use of their products. This law defines a serious adverse event as an adverse health-related event that is associated with the use of a dietary supplement and that results in death, a lifethreatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect, or that requires, based on reasonable medical judgment, a medical or surgical intervention to prevent one of those outcomes. The requirement to report serious adverse events to FDA applies only to dietary supplements and not to beverages, other conventional foods, or cosmetics.
Medical officers with the agency’s Dietary Supplement Program staff review all serious adverse events reported to FDA about dietary supplements as part of the normal process of assessment and categorization. In addition to these mandatory reports, the CAERS system also contains adverse events (both serious and non-serious) that are voluntarily reported to FDA by consumers and health care providers.
…
Individual adverse event reports about a particular product and the total number of adverse event reports for that product in CAERS only reflect information AS REPORTED and do not represent any conclusion by FDA about whether the product actually caused the adverse events. Because CAERS is constantly updated with new information, the number of reports for a given product and the content of individual reports may change over time.
Even with mandatory reporting of serious adverse events for dietary supplements, generally only a small fraction of adverse events associated with any product is reported. On the other hand, there may be duplicate reports in CAERS for the same adverse event because multiple people (such as an injured consumer and a health care provider who treated him or her) may have submitted reports.
FDA reports conditions observed at New England Compounding Center facility
FDA reports conditions observed at New England Compounding Center facility
Source: U.S. Food and Drug Administration
Today, the U.S. Food and Drug Administration released a copy of the FDA Form 483 issued to the New England Compounding Center (NECC). The FDA observed and has since confirmed contaminated products and listed a number of observations regarding conditions in the clean room at NECC’s Framingham, Mass. facility.
The investigators also observed problems with NECC’s ability to maintain its clean room, which is the enclosed space that is designed and maintained to have a controlled environment with low levels of airborne particles and surface contamination. Production of sterile drug products in a properly functioning and maintained clean room reduces the risk of the introduction of microbial contamination into the drug during processing, including filling into its final container.
The FDA issues a 483 at the end of an inspection when the investigators believe that they observed conditions or practices that, in their judgment, may indicate violations of the Federal Food, Drug, and Cosmetic Act, or related regulations.
The 483 does not constitute a final FDA determination that any observation listed on the 483 is a violation of the Federal Food, Drug, and Cosmetic Act or any related regulations.
The FDA considers the 483 along with an Establishment Inspection Report (EIR), prepared by FDA investigators, and any other relevant information, including any responses received by the company. The agency then considers whether further action, if any, is appropriate. The inspection report for NECC has not been completed and is not being shared at this time.
The FDA continues to work closely with the U.S. Centers for Disease Control and Prevention and state partners, including the Massachusetts Board of Registration in Pharmacy, to investigate the outbreak of fungal meningitis among patients who received NECC’s compounded preservative-free methylprednisolone acetate (80mg/ml), an injectable steroid.
FDA Announces Draft Compliance Policy Guide on Labeling and Marketing of Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, Treat or Prevent Disease in Dogs and Cats
Source: U.S. Food and Drug Administration
Today, FDA is announcing the availability of a draft compliance policy guide (CPG) entitled, “Labeling and Marketing of Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, Treat or Prevent Disease in Dogs and Cats.” The CPG provides guidance to FDA staff and industry on how FDA intends to use its enforcement discretion with regard to the labeling and marketing of these therapeutic diets.
These nutritional products or therapeutic diets are pet foods that are specially formulated to address specific disease conditions (for example urinary tract disease in cats). The products were originally sold through and used under the direction of licensed veterinarians.
Recently, FDA has observed an increase in marketing directly to pet owners over the internet and in supermarkets or pet stores. This shift in marketing directly to pet owners without veterinary direction, concerns FDA because these products are formulated for specific needs and may not be tolerated by all animals.
The draft CPG sets out the factors FDA will consider when determining whether or not to initiate enforcement action if the products are sold or marketed inappropriately.
Is Rinsing Your Sinuses Safe?
Source: U.S. Food and Drug Administration
Little teapots with long spouts have become a fixture in many homes for reasons that have nothing to do with tea.
Called neti pots, they are used to rinse the nasal passages with a saline (salt-based) solution, and have become popular as a treatment for congested sinuses, colds and allergies, and for moistening nasal passages exposed to dry indoor air.
However, the Food and Drug Administration (FDA) has concerns about the risk of infection tied to the improper use of neti pots and other nasal rinsing devices. The agency is informing consumers, manufacturers and health care professionals about safe practices for using all nasal rinsing devices, which include bulb syringes, squeeze bottles, and battery-operated pulsed water devices.
These devices are generally safe and useful products, says Steven Osborne, M.D., a medical officer in FDA’s Center for Devices and Radiological Health (CDRH). But they must be used and cleaned properly.
Most important is the source of water that is used with nasal rinsing devices. Tap water that is not filtered, treated, or processed in specific ways is not safe for use as a nasal rinse.
Food safety guides for groups most vulnerable to foodborne illness now available
Food safety guides for groups most vulnerable to foodborne illness now available
Source: U.S. Food and Drug Administration
The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) and the Department of Health and Human Services’ Food and Drug Administration (FDA) have partnered to create six booklets with food safety advice for populations that are most susceptible to foodborne illness. The booklets in this “at-risk series” are tailored to help older adults, transplant recipients, pregnant women, and people with cancer, diabetes or HIV/AIDS reduce their risk for foodborne illness.
“These booklets are a much needed resource for consumers who are at increased risk of getting sick from food,” said USDA Under Secretary for Food Safety Dr. Elisabeth Hagen. “The clear, understandable information in these booklets will help at-risk individuals feel confident about the safety of foods they prepare and eat. The booklets are also helpful to physicians and other health care providers for educating their at-risk patients about foodborne illnesses.”
Each of the booklets contains 24 pages of practical guidance on how to prevent foodborne illness. The information is presented in easy-to-read charts, illustrated how-tos, and straightforward descriptions of why each group is at higher risk for foodborne illness and symptoms that may mean trouble. The booklets contain three tear-out cards with quick-reference tips for grocery shopping, cooking to the right temperature, and eating at restaurants for times when taking along the entire booklet would be impractical.
“Everyone from farmers to food manufacturers to food preparers in the home has a role in food safety,” said FDA Deputy Commissioner for Foods Michael Taylor. “It is important that consumers, particularly those who are at higher risk of foodborne illness, have information they can use to do their part in preventing illness by properly selecting and preparing foods.”
While booklets on five of these topics were previously produced in 2006, the two agencies this year created a sixth booklet for pregnant women, who are at particular risk for the illness listeriosis. The six new booklets list food safety resources, such as http://www.foodsafety.gov, that have been made available since the earlier copies were printed. They also include revised safe cooking temperatures for meat and poultry: 145 °F for whole cuts of meat, followed by a three-minute rest time; 160 °F for ground meats; and 165 °F for all poultry and leftovers.
CRS — How FDA Approves Drugs and Regulates Their Safety and Effectiveness
How FDA Approves Drugs and Regulates Their Safety and Effectiveness (PDF)
Source: Congressional Research Service (via Federation of American Scientists)
The Food and Drug Administration (FDA) is a regulatory agency within the Department of Health and Human Services. A key responsibility is to regulate the safety and effectiveness of drugs sold in the United States. FDA divides that responsibility into two phases: preapproval (premarket) and postapproval (postmarket). FDA reviews manufacturers’ applications to market drugs in the United States; a drug may not be sold unless it has FDA approval. The agency continues its oversight of drug safety and effectiveness as long as the drug is on the market. Beginning with the Food and Drugs Act of 1906, Congress has incrementally refined and expanded FDA’s responsibilities regarding drug approval and regulation.
The progression to drug approval begins before FDA involvement. First, basic scientists work in the laboratory and with animals; second, a drug or biotechnology company develops a prototype drug. That company must seek and receive FDA approval, by way of an investigational new drug (IND) application, to test the product with human subjects. Those tests, called clinical trials, are carried out sequentially in Phase I, II, and III studies, which involve increasing numbers of subjects. The manufacturer then compiles the resulting data and analysis in a new drug application (NDA). FDA reviews the NDA with three major concerns: (1) safety and effectiveness in the drug’s proposed use; (2) appropriateness of the proposed labeling; and (3) adequacy of manufacturing methods to assure the drug’s identify, strength, quality, and identity. The Federal Food, Drug, and Cosmetic Act (FFDCA) and associated regulations detail the requirements at each step. FDA uses a few special mechanisms to expedite drug development and the review process when a drug might address an unmet need or a serious disease or condition. Those mechanisms include accelerated approval, animal efficacy approval, fast track applications, and priority review.
Once a drug is on the U.S. market (following FDA approval of the NDA), FDA continues to address drug production, distribution, and use. Its activities, based on ensuring drug safety and effectiveness, address product integrity, labeling, reporting of research and adverse events, surveillance, drug studies, risk management, information dissemination, off-label use, and directto-consumer advertising, all topics in which Congress has traditionally been interested.
FDA seeks to ensure product integrity through product and facility registration; inspections; chain-of-custody documentation; and technologies to protect against counterfeit, diverted, subpotent, adulterated, misbranded, and expired drugs. FDA’s approval of an NDA includes the drug’s labeling; the agency may require changes once a drug is on the market based on new information. It also prohibits manufacturer promotion of uses that are not specified in the labeling. The FFDCA requires that manufacturers report to FDA adverse events related to its drugs; clinicians and other members of the public may report adverse events to FDA. The agency’s surveillance of drug-related problems, which had primarily focused on analyses of various adverse-event databases, is now expanding to more active uses of evolving computer technology and linking to other public and private information sources.
The FFDCA allows FDA to require a manufacturer to conduct postapproval studies of drugs. The law specifies when FDA must attach the requirement to the NDA approval and when FDA may issue the requirement after a drug is on the market. To manage exception risks of drugs, FDA may require patient or clinician guides and restrictions on distribution. The agency publicly disseminates information about drug safety and effectiveness; and regulates the industry promotion of products to clinicians and the public.
See also: FDA’s Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective (PDF)
See also: FDA Regulation of Medical Devices (PDF)
See also: The FDA Medical Device User Fee Program (PDF)
Medicines to Help You: Depression
Lists the brands and generic names of various anti-depressants. Learn the side effects, who should not take them, and warning signs regarding harmful drug and food interactions.
Bad Bug Book 2nd Edition — Foodborne Pathogenic Microorganisms and Natural Toxins Handbook
Bad Bug Book 2nd Edition — Foodborne Pathogenic Microorganisms and Natural Toxins Handbook
Source: U.S. Food and Drug Administration
The second edition of the Bad Bug Book, published by the Center for Food Safety and Applied Nutrition, of the Food and Drug Administration (FDA), U.S. Department of Health and Human Services, provides current information about the major known agents that cause foodborne illness. The information provided in this handbook is abbreviated and general in nature, and is intended for practical use. It is not intended to be a comprehensive scientific or clinical reference. Each chapter in this book is about a pathogen – a bacterium, virus, or parasite – or a natural toxin that can contaminate food and cause illness. The book contains scientific and technical information about the major pathogens that cause these kinds of illnesses. A separate “consumer box” in each chapter provides non-technical information, in everyday language. The boxes describe plainly what can make you sick and, more important, how to prevent it.
+ Full Document (PDF)
Hat tip: PW
Publication Bias in Antipsychotic Trials: An Analysis of Efficacy Comparing the Published Literature to the US Food and Drug Administration Database
BackgroundPublication bias compromises the validity of evidence-based medicine, yet a growing body of research shows that this problem is widespread. Efficacy data from drug regulatory agencies, e.g., the US Food and Drug Administration (FDA), can serve as a benchmark or control against which data in journal articles can be checked. Thus one may determine whether publication bias is present and quantify the extent to which it inflates apparent drug efficacy.Methods and FindingsFDA Drug Approval Packages for eight second-generation antipsychotics—aripiprazole, iloperidone, olanzapine, paliperidone, quetiapine, risperidone, risperidone long-acting injection (risperidone LAI), and ziprasidone—were used to identify a cohort of 24 FDA-registered premarketing trials. The results of these trials according to the FDA were compared with the results conveyed in corresponding journal articles. The relationship between study outcome and publication status was examined, and effect sizes derived from the two data sources were compared. Among the 24 FDA-registered trials, four (17%) were unpublished. Of these, three failed to show that the study drug had a statistical advantage over placebo, and one showed the study drug was statistically inferior to the active comparator. Among the 20 published trials, the five that were not positive, according to the FDA, showed some evidence of outcome reporting bias. However, the association between trial outcome and publication status did not reach statistical significance. Further, the apparent increase in the effect size point estimate due to publication bias was modest (8%) and not statistically significant. On the other hand, the effect size for unpublished trials (0.23, 95% confidence interval 0.07 to 0.39) was less than half that for the published trials (0.47, 95% confidence interval 0.40 to 0.54), a difference that was significant.ConclusionsThe magnitude of publication bias found for antipsychotics was less than that found previously for antidepressants, possibly because antipsychotics demonstrate superiority to placebo more consistently. Without increased access to regulatory agency data, publication bias will continue to blur distinctions between effective and ineffective drugs.
FDA announces safety changes in labeling for some cholesterol-lowering drugs
FDA announces safety changes in labeling for some cholesterol-lowering drugs
Source: U.S. Food and Drug Administration
Important safety changes to the labeling for some widely used cholesterol-lowering drugs known as statins are being announced today by the U.S. Food and Drug Administration.
These products, when used with diet and exercise, help to lower a person’s “bad” cholesterol (low-density lipoprotein cholesterol). The products include: Lipitor (atorvastatin), Lescol (fluvastatin), Mevacor (lovastatin), Altoprev (lovastatin extended-release), Livalo (pitavastatin), Pravachol (pravastatin), Crestor (rosuvastatin), and Zocor (simvastatin). Combination products include: Advicor (lovastatin/niacin extended-release), Simcor (simvastatin/niacin extended-release), and Vytorin (simvastatin/ezetimibe).
“We want health care professionals and patients to have the most current information on the risks of statins, but also to assure them that these medications continue to provide an important health benefit of lowering cholesterol,” said Mary Parks, M.D., director for the Division of Metabolism and Endocrinology Products in the Office of Drug Evaluation II in FDA’s Center for Drug Evaluation and Research.
The changes to the statin labels are:
- The drug labels have been revised to remove the need for routine periodic monitoring of liver enzymes in patients taking statins. FDA now recommends that liver enzyme tests should be performed before starting statin therapy, and as clinically indicated thereafter. FDA has concluded that serious liver injury with statins is rare and unpredictable in individual patients, and that routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing this rare side effect. Patients should notify their health care professional immediately if they have the following symptoms of liver problems: unusual fatigue or weakness; loss of appetite; upper belly pain; dark-colored urine; yellowing of the skin or the whites of the eyes.
- Certain cognitive (brain-related) effects have been reported with statin use. Statin labels will now include information about some patients experiencing memory loss and confusion. These reports generally have not been serious and the patients’ symptoms were reversed by stopping the statin. However, patients should still alert their health care professional if these symptoms occur.
- Increases in blood sugar levels (hyperglycemia) have been reported with statin use. The FDA is also aware of studies showing that patients being treated with statins may have a small increased risk of increased blood sugar levels and of being diagnosed with type 2 diabetes mellitus. The labels will now warn healthcare professionals and patients of this potential risk.
- Health care professionals should take note of the new recommendations in the lovastatin label. Some medicines may interact with lovastatin, increasing the risk for muscle injury (myopathy/rhabdomyolysis). For example, certain medicines should never be taken (are contraindicated) with Mevacor (lovastatin) including drugs used to treat HIV (protease inhibitors) and drugs used to treat certain bacterial and fungal infections.
FDA proposes draft guidelines intended to improve the representation of women in medical device clinical studies
Draft guidance aimed to address the historic underrepresentation of women in clinical studies was issued by the U.S. Food and Drug Administration today. Intended for medical device developers and manufacturers, the guidance outlines agency recommendations for designing and conducting device clinical studies that may enhance the enrollment of women in such studies, if appropriate.
“The FDA recommends that investigators and manufacturers strive to enroll representative proportions of both women and men in their device studies,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “Our draft guidance outlines what we recommend for obtaining and improving the quality and consistency of sex-specific data on devices.”
Certain medical products may elicit different responses in women than in men. This may be due in part to basic differences in men and women, including genetics, hormones, body size, diet, and sociocultural issues. In addition, certain variables associated with women, such as size or certain illnesses, may be responsible for certain differences between men and women in the safety and effectiveness of medical devices.
+ Draft Guidance: Evaluation of Sex Differences in Medical Device Clinical Studies
FDA approves first cord blood product
FDA approves first cord blood product
Source: U.S. Food and Drug Administration
The U.S. Food and Drug Administration today approved HEMACORD, the first licensed hematopoietic progenitor cells-cord (HPC-C) cell therapy.
HEMACORD is indicated for use in hematopoietic stem cell transplantation procedures in patients with disorders affecting the hematopoietic (blood forming) system. For example, cord blood transplants have been used to treat patients with certain blood cancers and some inherited metabolic and immune system disorders.
“The use of cord blood hematopoietic progenitor cell therapy offers potentially life-saving treatment options for patients with these types of disorders,” said Karen Midthun, M.D., director, FDA’s Center for Biologics Evaluation and Research.
HEMACORD contains hematopoietic progenitor cells (HPCs) from human cord blood. Cord blood is one of three sources of HPCs used in transplants; the other two are bone marrow and peripheral blood. Once these HPCs are infused into patients, the cells migrate to the bone marrow where they divide and mature. When the mature cells move into the bloodstream they can partially or fully restore the number and function of many blood cells, including immune function.
+ Guidance document (PDF)
+ Approved Products
FDA: 35 innovative new drugs approved in fiscal year 2011
FDA: 35 innovative new drugs approved in fiscal year 2011
Source: U.S. Food and Drug Administration
Over the past 12 months, the U.S. Food and Drug Administration approved 35 new medicines. This is among the highest number of approvals in the past decade, surpassed only by 2009 (37). Many of the drugs are important advances for patients, including: two new treatments for hepatitis C; a drug for late-stage prostate cancer; the first new drug for Hodgkin’s lymphoma in 30 years; and the first new drug for lupus in 50 years.
In a report released today, FY 2011 Innovative Drug Approvals, the FDA provided details of how it used expedited approval authorities, flexibility in clinical trial requirements and resources collected under the Prescription Drug User Fee Act (PDUFA) to boost the number of innovative drug approvals to 35 for the fiscal year (FY) ending Sept. 30, 2011. The approvals come while drug safety standards have been maintained.
The report shows faster approval times in the United States when compared to the FDA’s counterparts around the globe. Twenty-four of the 35 approvals occurred in the United States before any other country in the world and also before the European Union, continuing a trend of the United States leading the world in first approval of new medicines.
Why We Can’t Wait: Taking Action to Reduce Prescription Drug Shortages
Why We Can’t Wait: Taking Action to Reduce Prescription Drug Shortages
Source: White House
Sometimes the most important component of a patient’s treatment is the type of medication they receive and the consistency at which they receive it. For some Americans, a change in their treatment regimen or a substitution of a medication can seriously threaten their ability to get better.
Between 2005 and 2010, the number of prescription drug shortages nearly tripled. While the FDA successfully prevented 137 drug shortages between January 1, 2010 and September 26, 2011, prescription drug shortages continue to threaten the health and safety of the American people. Today, too many people are waiting for their prescription to become available. Some are forced to switch from the medication they prefer, while others go without their medicine altogether. In some cases, drug shortages can even force people to stop a course of treatment before it finishes.
We cannot control the factors that cause these drug shortages. But we are committed to doing our part to counteract them. Which is why President Obama signed an Executive Order today that will lead to earlier FDA notification of any impending shortages for certain prescription drugs. Early notification can help prevent a shortage from becoming a crisis by allowing hospitals, doctors and manufacturers to take action to ensure medications remain available.
In addition, the President’s Executive Order will call on FDA to work with the Justice Department to examine whether “gray market” profiteers are responding to potential drug shortages either by hoarding medications or charging exorbitant prices. In recent months, we’ve heard reports of enormous markups such as a blood pressure medicine usually priced at $26 being sold for $1,200. And under this Executive Order, the Justice Department will watch the market closely to make sure companies are not exploiting drug shortages to raise their profits at the expense of patients.
+ Executive Order — Reducing Prescription Drug Shortages
+ Economic Analysis of the Causes of Drug Shortages (Assistant Secretary for Planning and Evaluation)
+ A Review of FDA’s Approach to Medical Product Shortages (U.S. Food and Drug Administration)
New From the GAO
New GAO Report (PDFs)
Source: Government Accountability office
1. Food Safety: FDA Needs to Reassess Its Approach to Reducing an Illness Caused by Eating Raw Oysters. GAO-11-607, September 8.
http://www.gao.gov/products/GAO-11-607
Highlights - http://www.gao.gov/highlights/d11607high.pdf
