Tagged Articles

over-the-counter 52 articles

Federal officials crack down on Phillips’ Colon Health for making unsupported claims

Bayer’s dietary supplement Phillips’ Colon Health is making unsupported claims that it can prevent diarrhea, constipation, gas and bloating but the company does not have reliable scientific evidence to support those claims, according to the Department of Justice. Federal officials took aim at Bayer in a motion filed last week, referencing the company’s multimillion dollar marketing campaigns using both print and television advertisements featuring “the Colon Lady,” who asks people about their colon health. As a result, consumers have spent hundreds of millions of dollars on Phillips’ Colon Health, the motion claims. The government’s crackdown on Bayer stems from a ... Read More

Acetaminophen as effective as placebo in treating lower back pain

The commonly used painkiller acetaminophen, the same drug in over-the-counter Tylenol, doesn’t relieve lower-back pain any better than a placebo, according to a new study published in the journal The Lancet. Medical guidelines recommend acetaminophen as a first-line treatment for acute lower back pain, however few studies have been conducted to show whether the treatment actually works. Researchers with the University of Sydney in Australia set out to put the painkiller to the test. For the study, researchers randomly assigned more than 1,600 people with sudden, or acute, lower-back pain into three groups. One group took acetaminophen tablets regularly three ... Read More

FDA sends strong warning against using lidocaine anesthetic for teething pain in infants, children

Prescription oral viscous lidocaine 2% anesthetic solution should not be used to treat teething pain in infants or children because it can cause serious injuries, including death, the Food and Drug Administration (FDA) warned. The agency is ordering a new black box warning be added to the safety label of lidocaine products to alert health care professionals, providers and caregivers of this risk. Topical pain relieves and medications that are rubbed on the gums to relieve pain are not necessary or even useful because they wash off the baby’s mouth within minutes, the agency warned. When too much viscous lidocaine is ... Read More

FDA warns of serious, life-threatening allergic reactions with OTC acne products

Rare but serious and potentially life threatening allergic reactions or severe irritation have been reported by consumers who used certain over-the-counter (OTC) topical acne products, the Food and Drug Administration (FDA) warned. People are advised to stop using the acne products and seek emergency medical attention immediately if they experience any symptoms of hypersensitivity, which include throat tightness; difficulty breathing; feeling faint; or swelling of the eyes, face, lips or tongue. People should also stop using the products if they develop hives or itching. These hypersensitivity reactions can occur within minutes to a day or more after using these products. ... Read More

Drug companies plan to market OTC version of ED drug Cialis

Drug companies are devising a plan to market a nonprescription version of the erectile dysfunction drug Cialis (tadalafil) in major markets, however they will have an uphill battle with regulators to get the impotence drugs on store shelves. Drug makers Eli Lilly & Co. and Sanofi SA have struck a licensing deal to sell the blockbuster prescription drug as an over-the-counter product. Cialis generated as much as $2.2 billion in sales last year, overtaking its rival Viagra, which drummed up $1.9 billion in revenue last year. The drug makers are targeting the United States, Canada and Australia for exclusive rights ... Read More

FDA panel votes against approval of Singulair Allergy for OTC use

A Food and Drug Administration (FDA) advisory panel is recommending that the agency not approve Merck’s Singulair Allergy drug for over-the-counter treatment for allergic rhinitis because of safety concerns. Singulair, which contains the active ingredient montelukast, was approved in 1998 for the treatment of asthma in both children and adults. In 2002 and 2005, the indication was expanded to include the treatment for seasonal allergic rhinitis and perennial allergic rhinitis, respectively. In 2007, it was approved for exercise-induced bronchoconstriction. Merck was seeking OTC approval of Singulair Allergy for the treatment of allergy symptoms only in adults 18 years and older, ... Read More

Ranbaxy recalls 30,000 packages of generic OTC Claritin allergy pills

Ranbaxy is recalling 30,000 packs of its over-the-counter allergy medication due to problems with the packaging causing defects in the blister packs. The recall involves generic versions of Claritin’s slow-release pills with an added decongestant. Packages of the affected medicines are labeled with, “Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant, Pseudoephedrine Sulfate, USP 240 mg, Loratadine, USP, 10 mg,” and include 5-, 10-, and 15-count blister packs with an expiration date of September 2015. Affected drugs were sold at or under the labels of CVS, Discount Drug Mart, Kroger, Sunmark, Good Neighbor Pharmacy, H-E-B, and Rite Aid in ... Read More

Alli weight loss pills recalled due to potential tampering

GlaxoSmithKline (GSK) is recalling all of its Alli weight loss products in the United States and Puerto Rico after numerous reports across several states that packages may have been tampered with and may contain counterfeit pills. GSK received reports from customers in seven states that bottles of Alli tablets and capsules were not Alli. The counterfeit pills inside the bottles were in various shapes and colors. Some of the bottles inside the outer carton were missing labels and had tamper-evident seals that were not authentic. All of the tampered with products were purchased in retail stores. Alli is an over-the-counter ... Read More

FDA wants to overhaul process for reviewing nonprescription medicines and products

The Food and Drug Administration (FDA) wants to overhaul its process for regulating over-the-counter medicines, saying the decades-old system is flawed and grossly outdated. A two-day meeting among drug regulators is planned next month to discuss a modern-day alternative. The current monograph was established in 1972 as a way to set dosing, labeling and other standards for nonprescription drug ingredients, from aspirin to anti-bacterial soaps. But the process is slow and laborious, requiring scientific reviews, public hearings and comments before a final monograph is published, resulting in a review backlog of many common pain relievers. It also stalls the addition ... Read More

FDA panel split on heart risks with non-steroidal anti-inflammatory drugs

Two Food and Drug Administration (FDA) advisory committees were split on whether data from an analysis of multiple clinical trials showed an increased risk of cardiovascular events in people using common painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs). The FDA’s Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee met jointly to review data and determine whether naproxen was less dangerous to the heart than other NSAIDs such as ibuprofen and Celebrex, as the journal The Lancet suggested. Naproxen is sold as a prescription drug under the name Naprosyn and over-the-counter under the brand name Aleve. Ibuprofen is ... Read More