Drug News
Doctors Criticize Sleeping-Pill Ads
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An advertising campaign by Sepracor Inc. is drawing fire from psychiatrists who say the Marlborough company misrepresents its new sleeping pill.
The complaints from several high-profile psychiatrists hinge on language in advertisements for the prescription drug, Lunesta, and illustrate how drug makers and the Food and Drug Administration can expect stiff scrutiny of product claims as the debate over direct-to-consumer advertising heats up.
FDA lowers patient age for hepatitis A vaccine
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Merck & Co. on Monday said US regulators have approved its already marketed Hepatitis A Vaccine Inactivated for use in children as young as 12 months old; the minimum age had been least two years old.
Cannabis-based drugs might relieve bowel disease
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Derivatives of the active compound in cannabis—cannabinoids—may have the potential for treating inflammatory bowel diseases like Crohn’s Disease and Ulcerative colitis, UK researchers report.
“The system that responds to cannabis in the brain is present and functioning in the lining of the gut,” said lead researcher Dr. Karen Wright, of the University of Bath. “There is an increased presence of one component of this system during inflammatory bowel diseases,” she explained.
U.S. drug makers to review advertising complaints
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Drug makers will set up an office to review complaints about the marketing of prescription drugs, industry officials said on Tuesday as they moved to quiet rising criticism of glitzy commercials and magazine ads.
That pledge, and voluntary guidelines urging balanced and informative ads, failed to appease critics who say drug promotions exaggerate the benefits of some drugs and prompt unnecessary prescribing to patients who may not need them.
Perrigo recalls oral drops for children in U.S.
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Perrigo Co. voluntarily recalled four types of liquid pain, cough and cold drops packaged with syringes that could make it difficult to measure proper doses for young children, the company and regulators said on Monday.
Perrigo said the recall would cost the company about $2 million.
The recalled products are Cherry Flavor Infant Pain Reliever 160 mg Acetaminophen (0.5 oz. and 1.0 oz.), Grape Flavor Infant Pain Reliever 160 mg Acetaminophen (0.5 oz. and 1.0 oz.), Cherry Flavor Cough and Cold Infant Drops (0.5 oz.) and Cherry Flavor Decongestant and Cough Infant Drops (0.5 oz.).
FDA bans Bayer antibiotic for poultry use
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The Food and Drug Administration on Thursday banned the use of Baytril, a poultry antibiotic made by Bayer, an unprecedented action aimed at preventing the rise of drug-resistant germs that infect people.
The FDA, which first proposed the ban five years ago, said the use of Baytril in chickens has made it difficult for doctors to treat human patients who have food poisoning. The drug was sometimes used by farmers to treat entire poultry flocks when a few birds showed signs of respiratory disease.
BioSante says hot flash gel study is positive
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Drug maker BioSante Pharmaceuticals Inc. on Wednesday said its experimental drug relieved hot flashes better than a placebo, and that it will soon file with U.S. regulators for approval.
Shares rose about 6 percent on the American Stock Exchange in opening trade.
Among 484 patients followed for 12 weeks on three doses of the investigational compound, patients experienced a drop in the frequency and severity of hot flashes by week 5, and as early as week 4 with higher doses.
House panel bill to crack down on steroids
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Legislation to combat illegal use of steroids and other performance-enhancing drugs in professional sports leagues won the approval on Wednesday of a U.S. congressional committee.
On a 38-2 vote, the U.S. House of Representatives Energy and Commerce Committee approved the measure, which would create minimum standards for drug testing and provide for a lifetime suspension for a third offense.
Docs want to dispense drugs if pharmacists won’t
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The American Medical Association wants legislation that will allow physicians to dispense drugs when pharmacists say their consciences will not allow them to fill prescriptions for contraceptives, painkillers and mood stabilizers.
The AMA says conscientious objection by pharmacists is a major public health problem in many areas of the country.
To solve the problem, the AMA’s policy-making House of Delegates voted Monday to ask for changes in state laws so that physicians can dispense medications when there is no “willing pharmacist within 30 miles.”
Drug testing company sues PETA over videos
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Covance Inc., a pharmaceutical testing firm, said on Monday it filed suit against animal rights group PETA, charging it with fraud and conspiracy for illegally videotaping animals at a Covance plant.
Covance said an agent for People for the Ethical Treatment of Animals misrepresented herself to get hired by Covance and then violated her employee contract when she videotaped the firm’s Vienna, Virginia facility.
Europe follows U.S. lead on child medicine testing
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Europe is following the U.S. lead with proposals requiring medicine testing on children, in a move welcomed by many doctors, patients and research-based companies but criticised by makers of cheap generic drugs.
More than half of medicines currently used to treat children in the European Union have not been specifically tested in youngsters.
As a result, clinicians lack clear guidelines on the best drug to use and often have to guess at the correct dose, since many products are not formulated properly for younger patients.
West Nile vaccine making progress
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People inoculated with a vaccine being developed to protect against West Nile virus infection suffer no ill effects, and nearly all of them develop antibodies that neutralize the virus, researchers report.
“These are the first complete phase I results from a clinical trial of a West Nile virus vaccine,” Dr. Thomas Monath, Chief Scientific Officer for vaccine maker Acambis, told Reuters Health.
Results with the vaccine, called ChimeriVax-West Nile, were presented Wednesday at the National Foundation for Infectious Disease’s 8th annual vaccine meeting in Baltimore.
Drug makers working on U.S. advertising guidelines
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Drug makers are developing voluntary guidelines aimed at improving television and other advertisements as part an effort to rebuild public trust, the industry’s top lobbyist said on Monday.
Companies have been criticized for creating television commercials and magazine ads that glorify a drug’s benefits while minimizing the risks of side effects.
“We obviously have room for improvement,” said Billy Tauzin, president of the Pharmaceutical Research and Manufacturers of America, known as PhRMA. The industry “needs to recapture the trust of the American people,” he told reporters.
Mexico drug use soars as U.S. meth labs shift south
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Crouched down a few yards south of a border fence dividing Mexico and the United States, vagrant drug addict Marco Aurelio takes a battered syringe and searches among the running sores on his skin for a vein to inject.
Pushing the charger in to the hilt, he slips into a $5 burst of euphoria that the Mexican says “neutralizes” life on the streets of Tijuana, one of the roughest cities along the border.
Cheaper than cocaine or heroin and with a longer-lasting high, methamphetamine has been widely snorted, smoked and injected by blue-collar drug users in towns and cities over the border in California for decades.
