Warning Issued to Doctors In Regard to SynchroMed Infusion Pumps
Medtronic and the Food and Drug Administration are warning of potential complications that could result when an administrator fails to use the proper drugs in conjunction with the SynchroMed EL and the SynchroMed II Implantable Drug Infusion Pump. These systems, which distribute drugs to a specified portion of a patient’s body, are only to be… read more
Aborted Pradaxa Clinical Trial Prompts New Usage Warning From the FDA
The safety of Pradaxa has been called into question again, this time in situations where the drug is given to people who have a mechanical heart valve. The Food and Drug Administration issued the warning following the results of an aborted clinical trial taking place in Europe. That trial was brought to a halt once… read more
LASIK Providers Warned By FDA to Correct Marketing Violations
Before a medical procedure is performed, patients have to be warned of the risks that might be associated with that operation. The Food and Drug Administration carefully monitors advertisements and various promotional materials of both medical devices and medical procedures to ensure that patients know what they’re getting into before agreeing to treatment. Any failure… read more
FDA Warns Consumers About Possible Chantix Cardiovascular Risks
The Food and Drug Administration is warning consumers about the results of a study which suggests that users of Chantix might be at risk of suffering some sort of adverse cardiovascular event. Chantix, which is provided to individuals who seek to cut their smoking habit, was compared to placebo intake during a series of clinical… read more
Skin Biology Cosmetics The Target of FDA Scrutiny
The Food and Drug Administration has accused cosmetics company Skin Biology of violating regulations in the process of marketing their products. The organization alleges that BioHeal Cream, CP Serum, Copper Sun Tanning & Firming Body Lotion, and Squalane were promoted on the company’s website via claims that such items could be used to treat medical… read more
FDA Steers Consumers Clear of Zi Xiu Tang Bee Pollen Capsules
The presence of Sibumatrine has prompted the Food and Drug Administration to steer consumers clear of Zi Xiu Tang Bee Pollen Capsules, otherwise known as Zi Xui Tang Beauty, Face, and Figure Capsules. Sibumatrine, a controlled substance that can lead to heightened pulse rates and blood pressure, was removed from the market two years ago. … read more
FDA Provides Safety Tips to Neti Pot Users
We’ve probably all used them at some point in our lives, or at least had someone swear by their curative properties. I’m talking about sinus cleansers known as neti pots. These long-spouted tea pots, when placed directly into an individual’s nostril, send a saline solution through the sinus cavities as a means to ease allergies,… read more
Consumers Warned of Tattoo Ink Danger In Wake of Infections and Recall
The Food and Drug Administration wants consumers to know the danger that exists with contaminated tattoo inks. Some recalled tattoo inks have been linked to an outbreak of nontuberculous Mycobacteria that has led to reports of serious infections in four separate states. Once the organization was alerted to potential infection stemming from a New York… read more
FDA Warns of Danger to Children Posed by Post-Surgery Codeine Use
The Food and Drug Administration is warning healthcare professionals and patients of a potential danger associated with providing codeine to children in the wake of a tonsillectomy or adenoid removal. Some kids might have livers that can turn codeine into morphine in doses that are larger than what would be considered safe. Three fatalities have… read more
FDA Gives Advice on Dental Cone-Beam CT Safety
A new webpage has been released by the Food and Drug Administration that advises proper usage of Dental Cone-beam Computed Tomography. The page was necessitated because of the low levels of radiation emitted by such devices. Kids are at greater risk from radiation, and although the levels are lower than those of CT exams, they… read more
FDA Warns Forest Labs to Correct Alleged Product Promotion Violations
Forest Labs was recently the recipient of a warning letter from the Food and Drug Administration alleging that the company’s sales reps had violated laws regarding promotional practices. This and another letter issued in April of last year came on the heels of a September 2010 settlement with the Department of Justice over similar allegations. … read more
FDA Warns MS Patients of Seizure Side Effect Associated with Ampyra
Both the public and people in the healthcare industry are being alerted to a potential side effect associated with a drug used to help people with Multiple Sclerosis. The drug is known as Ampyra, and the Food and Drug Administration is warning that seizures could be had by patients just starting to use this drug. … read more
