FDA says Vytorin link to cancer risk is unlikely.
According to reports from the US Food and Drug Administration, it is not likely that two cholesterol medications, Vytorin (ezetimibe and simvastatin) and Zetia (ezetimibe), increase an individual's cancer risk. However, the agency said that it cannot completely rule out an association between the drugs and an increased risk of cancer.
Further it states that it has examined all of the data from the" Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial, which "first raised the alarm about a possible risk and showed that significantly more subjects treated with Vytorin developed and died from all types of cancer when compared with those taking placebo."
The FDA report supposedly further states that it is not advising doctors or consumers to stop using any of the...medications, but will continue to evaluate the clinical benefits and potential risks of Vytorin and Zetia compared to other cholesterol-lowering drugs it has approved."
Chemotherapy drugs may cross blood-brain barrier, disrupt brain cell regeneration.
According to research published in the journal Cancer Investigation, four chemotherapy drugs "caused a significant breakdown in brain cell regeneration" in rodents. In fact, researchers found "a 15.4 percent reduction in new brain cells after use of fluorouracil, a 30.5% reduction following cyclophosphamide, a 22.4% reduction following doxorubicin, and a 36% reduction following paclitaxel." The researchers suggested that "all...chemo drugs cross into the brain after all, or that they act via peripheral mechanisms, such as inflammation, that could open up the blood-brain barrier."
Some doctors, researchers concerned generics may not work as well as brand-name drugs.
A column in the NewYork Times, Lesley Alderman wrote that "there is a gnawing concern among some doctors and researchers that certain prescription generic drugs may not work as well as their brand-name counterparts." Cardiologists and neurologists in particular are concerned about variations in generic formulations that "could have a serious effect on a patient's health." But, insurers cite research that shows "no difference in hospitalizations or emergency-room visits for people on brand-name epilepsy drugs compared with those taking generics." For its part, the FDA "says it stands behind generic medications and its methods of approving them." Gary J. Buehler, director of the FDA's office of generic drugs, said the agency has "not seen any scientific studies that show generics do not hold up as well as brand name drugs."
Cold capsules recalled.
According to a report published in the American Press, consumer-product maker "Procter & Gamble Co. is recalling 700,000 packs of Vicks DayQuil [acetaminophen, dextromethorphan, doxylamine, pseudoephrine] capsules because they are not childproof," in spite of "labeling claims on the box" that they are. Specifically, P&G is recalling DayQuil Cold & Flu 24-Count LiquiCaps Bonus Pack. According to a P&G spokeswoman, "the product was distributed nationally between September 2008 and February 2009, and more recently between September and December this year."
Small infection risk with antibiotic-free intravitreal drug injections.
According to report published in the Dec. issue of the Archives of Ophthalmology, "intravitreal drug injections led to an infection rate of less than one in 1,000 with a protocol that avoided antibiotics and sterile gloves and drape." After analyzing data on "a total of 3,838 intravitreal injections" of ranibizumab or triamcinolone "administered to 733 eyes by 124 physicians," researchers found that "only three cases of culture-positive endophthalmitis occurred following intravitreal injection." Notably, "in about a third of cases, patients received antibiotics before and after injection, but in the remaining two-thirds, patients received antibiotics before or after the procedure or not at all."
Also at http://www.pharm-education.com/2009/12/quality-and-safety-updates.html
According to reports from the US Food and Drug Administration, it is not likely that two cholesterol medications, Vytorin (ezetimibe and simvastatin) and Zetia (ezetimibe), increase an individual's cancer risk. However, the agency said that it cannot completely rule out an association between the drugs and an increased risk of cancer.
Further it states that it has examined all of the data from the" Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial, which "first raised the alarm about a possible risk and showed that significantly more subjects treated with Vytorin developed and died from all types of cancer when compared with those taking placebo."
The FDA report supposedly further states that it is not advising doctors or consumers to stop using any of the...medications, but will continue to evaluate the clinical benefits and potential risks of Vytorin and Zetia compared to other cholesterol-lowering drugs it has approved."
Chemotherapy drugs may cross blood-brain barrier, disrupt brain cell regeneration.
According to research published in the journal Cancer Investigation, four chemotherapy drugs "caused a significant breakdown in brain cell regeneration" in rodents. In fact, researchers found "a 15.4 percent reduction in new brain cells after use of fluorouracil, a 30.5% reduction following cyclophosphamide, a 22.4% reduction following doxorubicin, and a 36% reduction following paclitaxel." The researchers suggested that "all...chemo drugs cross into the brain after all, or that they act via peripheral mechanisms, such as inflammation, that could open up the blood-brain barrier."
Some doctors, researchers concerned generics may not work as well as brand-name drugs.
A column in the NewYork Times, Lesley Alderman wrote that "there is a gnawing concern among some doctors and researchers that certain prescription generic drugs may not work as well as their brand-name counterparts." Cardiologists and neurologists in particular are concerned about variations in generic formulations that "could have a serious effect on a patient's health." But, insurers cite research that shows "no difference in hospitalizations or emergency-room visits for people on brand-name epilepsy drugs compared with those taking generics." For its part, the FDA "says it stands behind generic medications and its methods of approving them." Gary J. Buehler, director of the FDA's office of generic drugs, said the agency has "not seen any scientific studies that show generics do not hold up as well as brand name drugs."
Cold capsules recalled.
According to a report published in the American Press, consumer-product maker "Procter & Gamble Co. is recalling 700,000 packs of Vicks DayQuil [acetaminophen, dextromethorphan, doxylamine, pseudoephrine] capsules because they are not childproof," in spite of "labeling claims on the box" that they are. Specifically, P&G is recalling DayQuil Cold & Flu 24-Count LiquiCaps Bonus Pack. According to a P&G spokeswoman, "the product was distributed nationally between September 2008 and February 2009, and more recently between September and December this year."
Small infection risk with antibiotic-free intravitreal drug injections.
According to report published in the Dec. issue of the Archives of Ophthalmology, "intravitreal drug injections led to an infection rate of less than one in 1,000 with a protocol that avoided antibiotics and sterile gloves and drape." After analyzing data on "a total of 3,838 intravitreal injections" of ranibizumab or triamcinolone "administered to 733 eyes by 124 physicians," researchers found that "only three cases of culture-positive endophthalmitis occurred following intravitreal injection." Notably, "in about a third of cases, patients received antibiotics before and after injection, but in the remaining two-thirds, patients received antibiotics before or after the procedure or not at all."
Also at http://www.pharm-education.com/2009/12/quality-and-safety-updates.html
