Content about Analgesics

May 19, 2011

Two Food and Drug Administration advisory committees on Wednesday unanimously voted in favor of mandating weight-based dosing for children between the ages of 2 and 12 years who are being administered acetaminophen.

SILVER SPRING, Md. — Two Food and Drug Administration advisory committees on Wednesday unanimously voted in favor of mandating weight-based dosing for children between the ages of 2 and 12 years who are being administered acetaminophen.

May 17, 2011

The National Association of Chain Drug Stores delivered on Tuesday testimony on the safe usage of pediatric acetaminophen products before a joint meeting of the Food and Drug Administration Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee.

ALEXANDRIA, Va. — The National Association of Chain Drug Stores delivered on Tuesday testimony on the safe usage of pediatric acetaminophen products before a joint meeting of the Food and Drug Administration Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee.

May 16, 2011

The Food and Drug Administration is convening its Nonprescription Drugs Advisory Committee Tuesday and Wednesday to debate mandating weight-based dosing for pediatric medicines containing acetaminophen on the Drug Facts label, as well as the potential expansion of dosing instructions to incorporate children under the age of 2 years old, according to material posted online by the FDA on Friday.

WASHINGTON — The Food and Drug Administration is convening its Nonprescription Drugs Advisory Committee Tuesday and Wednesday to debate mandating weight-based dosing for pediatric medicines containing acetaminophen on the Drug Facts label, as well as the potential expansion of dosing instructions to incorporate children under the age of 2 years old, according to material posted online by the FDA on Friday.

May 5, 2011

The Consumer Healthcare Products Association on Wednesday announced plans to convert liquid pediatric acetaminophen products to just one concentration.

WASHINGTON — The Consumer Healthcare Products Association on Wednesday announced plans to convert liquid pediatric acetaminophen products to just one concentration.

This voluntary change means the current children’s strength of liquid acetaminophen (160 mg/5 mL) will become the only liquid concentration available for all children younger than 12 years, and the current concentrated infant drops no longer will be sold.

April 28, 2011

The American Pain Foundation on Wednesday launched new information and resources on pain medication safety for acetaminophen and nonsteroidal anti-inflammatory drugs as part of its PainSafe educational initiative.

BALTIMORE — The American Pain Foundation on Wednesday launched new information and resources on pain medication safety for acetaminophen and nonsteroidal anti-inflammatory drugs as part of its PainSafe educational initiative.

The new information will be launched with a national public service announcement emphasizing the safe use of pain treatment options, particularly medications containing NSAIDs (aspirin, ibuprofen and naproxen) and acetaminophen (Tylenol and APAP).

April 20, 2011

The Obama administration is looking to curb the growing national epidemic of prescription painkiller abuse, according to a plan unveiled Tuesday.

WASHINGTON — The Obama administration is looking to curb the growing national epidemic of prescription painkiller abuse, according to a plan unveiled Tuesday.

Elements of the plan include expansion of state-based prescription drug monitoring programs, recommendation of convenient and environmentally responsible drug-disposal methods, education and reduction of doctor shopping.

April 11, 2011

Another generic drug maker is seeking to market its version of a popular opioid painkiller.

HAYWARD, Calif. — Another generic drug maker is seeking to market its version of a popular opioid painkiller.

Impax said it had filed applications with the Food and Drug Administration seeking approval for a generic version of Purdue Pharma’s Oxycontin (oxycodone) controlled-release tablets in the 10-, 15-, 20-, 30-, 40-, 60- and 80-mg strengths.

Purdue filed suit against Impax on April 8 in the U.S. District Courts for the Southern District of New York, seeking to prevent Impax from marketing its version before the expiration of Purdue's patents.

April 4, 2011

A drug used to treat pain in cancer patients now is available in the United States.

BEDMINSTER, N.J. — A drug used to treat pain in cancer patients now is available in the United States.

ProStrakan Group announced Monday the launch of Abstral (fentanyl) sublingual tablets. The tablets, which disintegrate rapidly and are placed under the tongue, treat breakthrough pain, common in one-half to two-thirds of people with cancer-related pain.

The drug, an opioid and controlled substance, only is available through a Food and Drug Administration-mandated REMS program. The FDA approved the drug in January.

March 30, 2011

Many patients with heart failure skip pills due to medication costs, according to research by the Mayo Clinic.

ROCHESTER, Minn. — Many patients with heart failure skip pills due to medication costs, according to research by the Mayo Clinic.

The study, published in the journal Mayo Clinic Proceedings, tracked the pharmacy records of 209 patients ages 60 to 86 years in Olmsted County, Minn., who were asked how often they missed doses or didn’t take their drugs at all and why.

March 30, 2011

McNeil Consumer Healthcare on Tuesday recalled one product lot of the analgesic Tylenol 8 Hour extended-release caplets 150-count bottles distributed in the United States, and three brands at the wholesale level.

FORT WASHINGTON, Pa. — McNeil Consumer Healthcare on Tuesday recalled one product lot of the analgesic Tylenol 8 Hour extended-release caplets 150-count bottles distributed in the United States, and three brands at the wholesale level.

“McNeil is taking this action as part of our ongoing surveillance and monitoring efforts that identified a small number of complaints of a musty or moldy odor,” the company stated, specifically referencing only the Tylenol 8 Hour recall. The lot number found on the label on the side of the bottle is ADM074; UPC Code 300450297181.

March 25, 2011

A generic painkiller made by Watson Pharmaceuticals infringes a patent covering the branded version, a U.S. District Court ruled.

MORRISTOWN, N.J. — A generic painkiller made by Watson Pharmaceuticals infringes a patent covering the branded version, a U.S. District Court ruled.

Watson said Friday that the U.S. District Court for the District of Delaware decided that Watson’s generic version of Cephalon’s Fentora (fentanyl) buccal tablets infringes U.S. Patent No. 6,264,981, though the Food and Drug Administration had approved Watson’s version of the drug.

March 25, 2011

A pill developed by AstraZeneca and Pozen that combines a nonsteroidal anti-inflammatory drug with a proton-pump inhibitor was well-tolerated in patients with osteoarthritis, according to a new study.

NATIONAL HARBOR, Md. — A pill developed by AstraZeneca and Pozen that combines a nonsteroidal anti-inflammatory drug with a proton-pump inhibitor was well-tolerated in patients with osteoarthritis, according to a new study.

AstraZeneca announced results of PN400-304, a 12-month study of Vimovo (naproxen and esomeprazole magnesium) delayed-release tablets in patients with osteoarthritis who need daily treatment with NSAIDs but are at risk of NSAID-related gastric ulcers. Vimovo is designed to reduce pain while reducing gastric ulcer risk.

March 15, 2011

A generic painkiller made by Watson Pharmaceuticals does not infringe on the patent covering the branded version, a U.S. District Court has ruled.

MORRISTOWN, N.J. — A generic painkiller made by Watson Pharmaceuticals does not infringe on the patent covering the branded version, a U.S. District Court has ruled.

Watson said the U.S. District Court for the District of Delaware ruled that Watson’s generic version of Cephalon’s Fentora (fentanyl buccal tablets) does not infringe on two patents that were set to expire in March 2019, according to Food and Drug Administration records.

March 9, 2011

Drug maker Purdue Pharma is giving a $1 million grant to the state of Florida to help fund the state’s prescription drug monitoring program, the company said Wednesday.

STAMFORD, Conn. — Drug maker Purdue Pharma is giving a $1 million grant to the state of Florida to help fund the state’s prescription drug monitoring program, the company said Wednesday.

Purdue said the program was designed to combat illegal diversion and abuse of prescription drugs. Purdue is the maker of OxyContin (oxycodone), an extended-release opioid painkiller that often is a target of abuse.

March 7, 2011

Actavis last week named Lisa Buono to lead its over-the-counter drug division as part of the company’s strategic expansion of the division.

MORRISTOWN, N.J. — Actavis last week named Lisa Buono to lead its over-the-counter drug division as part of the company’s strategic expansion of the division.

As director of OTC, Buono will oversee the division’s day-to-day operations and will focus on identifying and capitalizing on new product opportunities. Actavis manufactures and distributes numerous nonprescription liquids, creams and ointments sold under the Actavis label and its customers’ own brands, as well as FeverAll brand acetaminophen suppositories.

March 7, 2011

The OTC Pain Relief Ingredient Guide breaks down the indication, active ingredients, purpose and dosage of OTC internal and external analgesics.

The spring 2011 Pain Relief Ingredient Guide breaks down the indication, active ingredients, purpose and dosage of such OTC internal and external analgesics as Aleve, Excedrin, Bayer, Tylenol, Advil, ThermiPaq, Arnicare, Max-Freeze and Stopain.

Click here for the complete guide.

March 3, 2011

Long-term use of a class of drugs used to control pain could increase the risk of erectile dysfunction in men, according to a new study.

PASADENA, Calif. — Long-term use of a class of drugs used to control pain could increase the risk of erectile dysfunction in men, according to a new study.

The study, sponsored by Kaiser Permanente and published online in the Journal of Urology, found that men who took nonsteroidal anti-inflammatory drugs, or NSAIDs, three times a day for more than three months were 2.4 times as likely to have erectile dysfunction as men who didn’t take the drugs regularly. The study used data from 80,966 men ages 45 to 69 years in California.

February 18, 2011

MOUNT KISCO, N.Y. — Prestige Brands became one of the first cough-cold marketers to develop a branded smart-phone app to help moms hone in on the most appropriate 
PediaCare remedy for their sick children. It’s not a bad play; a recent Millennial Media report indicated that in 2010, 32% of moms owned a smart phone, versus 20% in 2009.


February 18, 2011

NEW BRUNSWICK, N.J. — McNeil Consumer’s absence from cough-cold and analgesic aisles, including several pediatric formulations, will extend into the fourth quarter, Johnson and Johnson executives told analysts in January. 


February 18, 2011



McNeil Consumer Healthcare recently parlayed its Tylenol brand franchise into external analgesics to quite a bit of success. For the four weeks ended Dec. 26, 2010, Precise “from the makers of Tylenol” became the No. 3 best-selling heat patch, with $1.9 million in sales across food, drug and mass (excluding Walmart), according to Symphony­IRI Group. And its pain-relieving cream similarly broke in among the top-selling brands — No. 9 with $1.3 million in sales for the four-week period.

February 14, 2011

The Food and Drug Administration has accepted for review an application for a pain medication designed to thwart drug abusers.

PALATINE, Ill. — The Food and Drug Administration has accepted for review an application for a pain medication designed to thwart drug abusers.

Acura Pharmaceuticals announced Monday the acceptance of King Pharmaceuticals’ application for Acurox (oxycodone hydrochloride). King developed the drug using Acura’s Aversion technology, which is designed to limit or impede the ability to abuse the drug by dissolving or crushing the pills and then injecting them.

February 11, 2011

The Food and Drug Administration has approved a painkiller delivered through a skin patch made by Mallinckrodt, the generic drug maker said Friday.

ST. LOUIS — The Food and Drug Administration has approved a painkiller delivered through a skin patch made by Mallinckrodt, the generic drug maker said Friday.

Mallinckrodt, part of Covidien, said the FDA approved its fentanyl transdermal system patch.

The patch is a generic version of Johnson & Johnson’s Duragesic. The drug, an opioid and Class II controlled substance, is used for managing persistent, moderate-to-severe pain that requires continuous opioid administration.

February 2, 2011

GlaxoSmithKline on Wednesday announced its support for the Wounded Warrior Project and Victory Junction, a camp for children with special needs, through its analgesic powder brands, BC and Goody’s.

MEMPHIS — GlaxoSmithKline on Wednesday announced its support for the Wounded Warrior Project and Victory Junction, a camp for children with special needs, through its analgesic powder brands, BC and Goody’s.

January 27, 2011

Johnson & Johnson on Tuesday postponed its plans to begin folding many of its recalled products, including several pediatric formulations, back onto retail shelves until later this fall.

NEW BRUNSWICK, N.J. — Johnson & Johnson on Tuesday postponed its plans to begin folding many of its recalled products, including several pediatric formulations, back onto retail shelves until later this fall.

However, when those products are ready to occupy the brand blocks McNeil has carved out for Tylenol and others, J&J will be placing a significant emphasis on reacquainting those products with quality in the consumer’s mind.

January 20, 2011

British drug maker ProStrakan Group will partner with two U.S. companies to administer its risk evaluation and mitigation strategy for a cancer pain drug.

ATLANTA — British drug maker ProStrakan Group will partner with two U.S. companies to administer its risk evaluation and mitigation strategy for a cancer pain drug.

ProStrakan said it would use RelayHealth Pharmacy Solutions’ and McKesson Specialty Care Solutions’ services to administer the REMS for Abstral (fentanyl citrate), a drug that patients can place under the tongue to treat breakthrough pain associated with cancer when they already have received and become tolerant of opioid painkillers.