A new study suggests that at least 1 in every 20 outpatients-those who receive care without being admitted to a hospital-experience a misdiagnosis. The study, which was published in the journal BMJ Quality & Safety, found that the rate of misdiagnosis in outpatients was about 5 percent. This translates to 1 in 20 adults, 12 million people when applied to the entire US population. Continue reading
Following an inspection by federal regulators, pharmaceutical firm, Endo International PLC, was sent a warning letter by the U.S. Food and Drug Administration (FDA) over issues discovered at a vaginal mesh facility.
The inspection was conducted at an Endo subsidiary’s Minnesota facility, Endo wrote this week in a regulatory filing with the U.S. Securities and Exchange Commission (SEC), according to Law360. Endo wrote that the April 10 warning letter came after issues were identified by the FDA following an inspection of a Minnetonka, Minnesota facility operated by its subsidiary, American Medical Systems Inc. (AMS). Continue reading
A new study reports that boys with autism were three times more likely to have been exposed to SSRI antidepressants (selective serotonin reuptake inhibitors) in the womb than typically developing children.
Boys whose mothers took SSRIs – including Celexa (citalopram), Lexapro (escitalopram), Paxil (paroxetine), Prozac (fluoxetine), and Zoloft (certaline) – during pregnancy were also more likely to have developmental delays, HealthDay News reports. The study was published online this week in Pediatrics and will appear in May in the print issue. Continue reading
Reports of injuries and other harm from e-cigarettes – burns, nicotine toxicity, respiratory and cardiovascular problems – have risen in the past year as the devices become more popular, recent data show.
More than 50 e-cigarette complaints were filed with the U.S. Food and Drug Administration (FDA) between March 2013 and March 2014, Reuters reports. This about equals combined numbers for the previous five years. Continue reading
Some patients who have been implanted with spinal-cord stimulators have ended up with paralysis, Wall Street Journal reports. These devices are manufactured by a number of companies, the biggest of which include Medtronic, St. Jude Medical and Boston Scientific. The devices use stimulation therapy to help manage chronic pain; a small external remote is used to send low currents of electricity to the implanted generator and the electrical current from the leads creates a tingling sensation that it supposed to mask pain signals being sent to the brain, WSJ says. According to a Wall Street Journal analysis of the U.S. Food and Drug Administration’s (FDA) adverse-event reports and a review of medical malpractice lawsuits, more than 100 patients have experienced partial or permanent paralysis after having a spinal-cord stimulator inserted into their backs. Continue reading
A federal class action alleges that General Motors Corp. fraudulently concealed a defect in the ignition switches of 2.6 million Chevrolet, Pontiac and Saturn vehicles, and that the defect is linked to at least 13 deaths.
The complaint, Ruff v. General Motors, was filed Monday in Trenton, New Jersey, and it claims company engineers first learned in 2001 that ignition switches in these vehicles can accidentally move from the “run” to the “accessory” or “off” position, shutting off the engine and disabling such systems as power steering, antilock brakes, and air bags, the New Jersey Law Journal (Law.com) reports. Plaintiffs claim the number of deaths may be far higher than the 13 GM has acknowledged. They cite 303, from a study of airbag deployment failures in crashes of Chevrolet Cobalt and Saturn Ion cars. Continue reading
The Consumer Product Safety Commission (CPSC) has announced the recall of the STX Shield Throat Protector because the product can crack or break when struck by a lacrosse ball, posing an injury risk to the user.
The STX Shield throat protector is black and has the letters STX engraved on the outer surface of the protector. The shield attaches to the goalie’s helmet below the chin guard with straps on each side and the bottom. The shield sold for $20 to $25 at specialty sporting goods stores such as Athlete’s Connection, Commonwealth Lacrosse, Lacrosse Unlimited, Play It Again Sports, Sport Stop USA and Universal Lacrosse and online at www.LAX.com from September 2013 through February 2014.
STX has received one report of the throat protector breaking, which reportedly resulted in bruising and lacerations to the user’s neck, according to the CPSC.
The CPSC said consumers should stop using the Shield and return the product to STX for a full refund. Consumers can contact STX toll-free at 888.789.7894, 8:30 a.m. to 5 p.m. ET Monday through Friday or online at www.stx.com. Click on RECALL–Shield Throat Protector for more information. Continue reading
Matt Cahill, who runs Driven Sports, has received a warning letter from the U.S. Food and Drug Administration (FDA) over concerns about the ingredients in Craze, a controversial workout supplement that is reported to have a methamphetamine-like compound. According to the letter, the agency questions whether several ingredients that are claimed to be from dendrobium orchids actually come from the plant. The FDA says that the proprietary blend of ingredients listed as “Dendrobex” made the product adulterated under federal law, since the agency was not aware of evidence that the ingredient was present in food supply. Additionally, the company never submitted any paperwork to have it permitted as a new dietary ingredient. Continue reading
No state is exempt from abuse reports. According to a study by the Special Investigations Division of the House Government Reform Committee, 5,283 facilities in the U.S. were involved in almost 9,000 instances of abuse over a two-year period from January 1999 to January 2001, Carbonated.tv.com reports. The National Center on Elder Abuse (NCEA) of the Department of Health and Human Services estimates that only 1 in 14 cases of elder abuse ever comes to the attention of authorities.
The European Medicines Agency (EMA) is reviewing the cardiovascular risks of testosterone drugs, MedPage Today reports. Like the U.S. Food and Drug Administration (FDA) the agency is basing its investigation on two recent studies showing that the drugs are associated with a higher risk of heart attack and cardiovascular death. The review was prompted by the Estonian State Agency of Medicines and will be conducted by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). Continue reading