Site Archives FDA

7,000 Trips Annually to Emergency Rooms for Children Taking Cough and Cold Meds


If there is any question about cough and cold medicines being completely safe for chil­dren, well consider this. Annually, about 7,000 children ages 11 and younger require a hospital emergency room visit because of an adverse reaction to one of these substances.
This figure comes from the U.S. Centers for Disease Control and Prevention (CDC). To [...]

The Potential of Sudden Hearing Loss Prompts FDA Mandated Label Changes


Sudden hearing loss among people taking two separate classifications of drugs has prompted the Food and Drug Administration to require new label warnings. One class of drugs involves those taken for erectile dysfunction and the other is taken by people to treat a severe high blood pressure situation.
An FDA investigation into hearing loss followed on [...]

FDA Study Raises Concerns About Anesthesia Risk for Children


“More research is needed to assess the safety of anesthetics on newborn and young children”, says a recent study published by Food and Drug Administration (FDA) scientists in the journal Anesthesia & Analgesia.
“There is no scientific evidence that anesthetics commonly administered for decades cause brain damage in children”, the report said. No studies have been [...]

FDA Approves Cancer-Causing Drug for Over-the-Counter Use


The Food and Drug Administration (FDA) has approved a potentially carcinogenic drug as an over-the-counter (OTC) weight loss aid for overweight adults. Orlistat was initially approved in 1999 as a prescription drug to treat obesity, and it remains a prescription drug for obesity at a higher dose than the OTC version.
Dr. Sidney M. Wolfe, Director [...]

“Singulair®” Placed Under Ingvestigation for Possible Link to Suicide


Yet another drug is being placed under investigation by the U.S. Federal Drug Administration. This time it is the pharmaceutical drug Singulair manufactured by Merck & Co. Inc.
The FDA has received reports that the drug is responsible for causing behavior/mood changes, suicidality (suicide thinking and behavior) and suicide. The agency has issued a warning to [...]

FDA Approves the First Ever Fibromyalgia Drug


The FDA approved the release of a new drug to treat fibromyalgia. This drug may have side effects that are far worse than the actual condition.
This new drug called Lyrica® (pregabalin), marketed by Pfizer, claims to reduce pain and improve function in patients with fibromyalgia. Some of the side effects include dizziness, sleepiness, blurry vision, [...]

FTC and FDA Act Against Internet Vendors of “Fraudulent” Diabetes Cures and Treatments


The Federal Trade Commission (FTC) and the Food and Drug Administration (FDA), working with government agencies in Mexico and Canada, have launched a drive to stop “deceptive Internet advertisements and sales of products misrepresented as cures or treatments for diabetes.”
The ongoing campaign has so far included approximately 180 warning letters and other advisories sent to [...]

Selective Reporting of Drug Trials Exaggerates Effectiveness of Antidepressants


What many people have been suspecting all along with regards to the accurate reporting of drug testing was brought to light in the January issue of the New England Journal of Medicine. Drug companies have been engaging in selective reporting of antidepressant drug trials and, by doing so, have been exaggerating the effectiveness of these [...]