Disability Happens ™

FDA Warnings

1. FDA seeks court order against Michigan dairy - The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against Scenic View Dairy of Hamilton, Mich., its president, and three of its managers alleging that they sold dairy cows for human consumption that contained illegal drug residues in edible tissues.
2. FDA launches new organizational performance management system - The U.S. Food and Drug Administration today launched an innovative performance management system designed to advance the President’s commitment to transparency, public participation, and collaboration in the work of government.
3. FDA Warns Consumers to Avoid TimeOut Capsules - The U.S. Food and Drug Administration is warning consumers not to take TimeOut Capsules because it contains an active drug ingredient that can dangerously lower blood pressure. The product is marketed as a dietary supplement for sexual enhancement.
4. FDA releases guidance on federal menu labeling requirements - The U.S. Food and Drug Administration today released two documents that outline steps to help chain restaurants comply with new federal nutrition labeling requirements.
5. FDA Warns of Possible Dangers from Portable Foot-Tanning Device - The U.S. Food and Drug Administration is warning consumers about the risk of ultraviolet radiation overdose with the Tootsie Tanner portable foot tanning device.
6. Study: Presence of murine leukemia virus found in CFS Patients, others - Researchers have found murine leukemia viruses (MLV) in blood samples collected from patients diagnosed with chronic fatigue syndrome (CFS) and some healthy blood donors, according to a study published online today by the scientific journal Proceedings of the National Academy of Sciences (PNAS).
7. Urgent Nationwide Egg Recall - The current recall of eggs in their shells, or “shell eggs,” is part of an ongoing and intensive investigation by local, state, and federal officials into the cause of recent cases of Salmonella Enteritidis.
8. Urgent Nationwide Frozen Mamey Fruit Products Recall - An investigation by the CDC and state partners showed an epidemiologic link between an ongoing outbreak of Salmonella Typhi and frozen mamey fruit products sold under the La Nuestra brand by Montalvan Sales Inc. Ontario, Calif, and under the Goya brand by Goya Foods Inc. Secaucus, New Jersey.
9. U.S. Marshals seize food from rodent-infested Ga. warehouse - U.S. Marshals, acting under a court order sought by the U.S. Food and Drug Administration, today seized packaged food products from a rodent-infested warehouse in Athens, Ga. A variety of products, including crackers, cookies and potato chips, were intended for sale to jails and prisons throughout the southeastern United States.
10. FDA Proposes Withdrawal of Low Blood Pressure Drug - The U.S. Food and Drug Administration today proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the drug have not been done.

FDA Recalls

1. Recalls and Safety Alerts: Warning on Proton Pump Inhibitors and Fracture Risk - FDA is cautioning healthcare professionals and patients that proton pump inhibitors (PPIs) may increase the risk of fractures of the hip, wrist and spine. The drugs' labeling will be revised to reflect these concerns. PPIs are used to reduce gastric...
2. Recalls and Safety Alerts: Lifeline and ReviveR AED Battery Packs Recalled - Defibtech is recalling certain battery packs used in Lifeline and ReviveR automatic external defibrillators (AED). These battery packs may cause the AED to inappropriately cancel the charge and be unable to deliver therapy. The company has received...
3. Recalls and Safety Alerts: Update on Counterfeit Polypropylene Mesh - FDA now has more information on the counterfeiting of Bard flat polypropylene surgical mesh, commonly known as Marlex mesh. This was first reported earlier this year. The counterfeit products, which were distributed between October 21, 2008 and Octo...
4. Recalls and Safety Alerts: Thrombosis with Off-Label Promacta Use - GlaxoSmithKline is warning healthcare professionals about the risk of thrombosis if patients with chronic liver disease are treated with Promacta (eltrombopag). Promacta is approved to treat thrombocytopenia in certain adult patients with chronic id...
5. Recalls and Safety Alerts: Severe Liver Injury with Orlistat (Xenical, Alli) - The labeling for the weight loss drug orlistat will include new safety information about rare cases of severe liver injury in patients taking this drug. Orlistat is sold by prescription as Xenical in 120 mg strength and over the counter as Alli in 6...
6. Preventing Medical Errors: Dosing Errors with Certain Oral Syringes - The Institute for Safe Medication Practices (ISMP) recently pointed out that measuring doses with certain oral syringes can be confusing for healthcare practitioners and patients, and that this can lead to overdoses. This type of syringe is pack...
7. Preventing Medical Errors: Reporting Adverse Events to MedWatch - An important FDA program called "MedWatch" allows health care professionals and consumers to report serious problems that they believe may be associated with the medical products they prescribe, dispense, or use. These reports, along with follow-up i...
8. New from FDA: Help FDA Stop ?Bad Ads? - FDA monitors the way drug companies advertise and promote prescription drugs to help assure that the information is accurate and balanced. But it is difficult for the agency to check on these activities when they take place in doctors' offices, or i...

FDA Consumer Updates

1. Consumer Update Analytics (Aug. 16 - Aug. 31, 2010) - Consumer Update Analytics (Aug. 16 - Aug. 31, 2010)
2. Registries Help Moms Measure Medication Risks - Pregnancy registries help cut the risk of birth defects by identifying drugs that are dangerous to women and babies.
3. Consumers Check for Recalled Eggs - A nationwide recall has consumers checking the source of their eggs.
4. FDA's MedWatch Safety Alerts: July 2010 - FDA warns about a number of products, including a “Miracle Mineral Supplement” that acts like an industrial-strength bleach—causing severe side effects—when consumed as directed.
5. Consumer Update Analytics (August 1 - August 13, 2010) - Consumer Update Analytics (August 1 - August 13)
6. Keep Kids, Pets Away From Skin Sprayed With Evamist - FDA advises that children and pets be kept from making contact with skin where Evamist has been applied.
7. Combating Misuse and Abuse of Prescription Drugs: Q&A with Michael Klein, Ph.D. - The director of the Food and Drug Administration (FDA) Controlled Substance Staff talks about the causes and prevalence of misuse and abuse of prescription drugs, and what government agencies such as FDA are doing to prevent it.
8. FDA Cautions Against Using Unapproved IUDs - FDA says U.S. women who unknowingly had unapproved IUDs inserted could end up with an unplanned pregnancy.
9. Stolen Inhalers Pose Risk - As seasonal allergies have some asthma sufferers reaching for inhalers, FDA issues warning on stolen medicine.
10. Using Malaria Medication for Leg Cramps is Risky - Life-threatening side effects have been reported with the use of a malaria drug to treat leg cramps.