Sunday, November 7, 2010
July 8, 2010 - FDA Cautions Against Using Quinine For Leg Cramps.
The Los Angeles Times (7/8, Maugh) reported, "The Food and Drug Administration on Thursday cautioned consumers against using quinine [Qualaquin] for" nocturnal "leg cramps, warning that the drug could cause severe side effects, including death." Indeed, "studies have shown that it can reduce the incidence of cramps by one-third to one-half." However, "as many as one in every 25 users can suffer serious side effects." The FDA issued the warning due to adverse-event reporting system, according to the Wall Street Journal (7/8, Dooren). Over three and a half years, 38 reports had been submitted. In those reports, "24 instances of serious life-threatening reactions" were noted according to MedPage Today (7/8, Petrochko). "These adverse events resulted in permanent kidney impairment and hospitalization in some people, and death in two." This warning reiterates a prior warning from 2006. Nevertheless according to the FDA, most of the quinine used in the United States continues to be for the prevention or treatment of leg cramps.
July 7, 2010 - Training Can Help Patients Better Control High Blood Pressure At Home.
HealthDay (7/7, Reinberg) reported, "With proper training, people with high blood pressure may be able to control it more effectively on their own at home than through conventional methods." In fact, "through telemonitoring of their blood pressure and adjusting their medications according to guidelines agreed upon in advance, patients assigned to self-managed care saw greater reductions in blood pressure after six and 12 months than patients receiving standard care through health professionals," according to a paper in The Lancet.
July 7, 2010 - Rheumatologists Claim Intimidation From Maker Over Criticism Of Colcrys.
The Wall Street Journal (7/7, Rockoff) reports that last year after the FDA approved URL Pharma, Inc.'s gout treatment, Colcrys (colchicine), several physicians criticized both the drugmaker and the FDA online, and some urged fellow rheumatologists to instead use the generic version which costs pennies a pill, as opposed to Colcrys, which costs $5. URL responded by sending letters to the physicians, warning them that their posts could lead to lawsuits. Several of the physicians, who are members of a discussion group sponsored by the American College of Rheumatology, say that URL is attempting to intimidate them.
July 7,2010 - FDA Approves AD/HD Patch For Adolescent Use.
Businessweek (7/7) reports, "Shire PLC said Tuesday that US regulators approved its attention deficit hyperactivity disorder patch Daytrana [methylphenidate transdermal] for use in adolescents age 13 to 17." The FDA previously "approved Daytrana in April 2006 for use in children age six to 12." The patch "is sold in strengths of 10 milligrams, 15 milligrams, 20 milligrams, and 30 milligrams, and is designed to be worn for nine hours." The Philadelphia Inquirer (7/7, Rudolph) also reported on this story.
July 7, 2010 - FDA Warns Cornerstone Over Zyflo CR Promotional Materials.
Businessweek (7/7) reports, "The Food and Drug Administration said Tuesday it sent a warning letter to Cornerstone Therapeutics Inc. alleging that Cornerstone's promotional materials withheld information about the risks of its asthma drug Zyflo CR [zileuton]." The FDA "said the materials violated the Food, Drug, and Cosmetic Act" by using "outdated labeling" and suggesting "Zyflo CR is more effective than competing drugs like Singulair [montelukast]." In addition, the agency "said a Cornerstone visual aid did not include warnings about the most serious side effects or the most common ones."
July 6, 2010 - Testosterone Gel Trial Halted Due To High Number Of Heart Attacks.
The New York Times (7/6, D7, Rabin) reports, "A federally financed study to see if testosterone gel helps frail elderly men build muscle and strength was abruptly halted late last year after participants taking it suffered a disproportionate number of heart attacks and other serious cardiac problems, and one died of what was apparently a heart attack." The Times says that "researchers were taken aback by the high rate of adverse heart problems." The FDA "has approved it for use only in men with hypogonadism, whose sex glands produce extremely low amounts of testosterone or none at all because of an underlying disorder," yet, "off-label use has increased in recent years."
July 6, 2010 - STD Rates Higher Among Men Taking ED Drugs.
Bloomberg News (7/6, Ostrow) reports, users of medicines for erectile dysfunction (ED) “showed almost triple the rate of sexually transmitted diseases compared with those not taking the medications." In fact, the "higher rate of infections was seen in the year before and after the men started taking the prescription medicines," Harvard researchers explained. Investigators "looked at health insurance claims from 44 large US employers from 1997, one year before Viagra [sildenafil] was introduced, through 2006." The "most frequently reported STD was HIV/AIDS, followed by chlamydia," HealthDay (7/5, Behen) noted. The findings "suggest a need for greater responsibility in prescribing ED medications." The Boston Globe (7/5, Cooney) "White Coat Notes" blog also covered the study.
July 5, 2010 - Study Finds Drug Prices In Europe Comparable To Those In US.
The Financial Times (7/5, Jack) reported on a study from the London School of Economics to be published in Health Economics, Policy and Law. The study shows that despite claims by US pharmaceutical manufacturers, the prices for patented medicines in the US are comparable to those in other OECD nations. The Times considered the report particularly damaging to arguments made by PhRMA, which has long claimed that European policies, such as regulation and price controls, make the continent less appealing to researchers. The new data suggest that drug maker profits, and prices, in the US are only marginally higher than in Europe.
July 2, 2010 - FDA Approves Prograf Generic
Watson Pharmaceuticals Inc. announced it received approval to sell a generic version of the drug Prograf [tacrolimus], which is used to prevent rejection of transplanted organs." The FDA approved the drug "in 5-milligram capsules," and Watson "said it will start shipping the drug immediately."
Saturday, July 3, 2010
June 2010 - Week 5 News
June 28, 2010 - Two Studies Suggest Diabetes Drug Avandia Increases Risk Of Heart Problems.
ABC World News (6/28, story 7, 2:20, Sawyer), CBS Evening News (6/28, story 10, 0:30, Smith), and NBC Nightly News (6/28, story 8, 0:20, Williams) reported on two studies providing additional evidence of cardiovascular disease associated with Avandia [rosiglitazone] use in advance of a scheduled FDA committee meeting to review safety data. The Washington Post (6/29, Stein) reported that one study, "involving more than 35,500 people, found that Avandia significantly raises the chances of a heart attack." A separate study "of more than 227,500 Medicare patients -- the largest such study to date -- found that the drug boosts the risk for strokes, heart failure, and death." The Los Angeles Times (6/29, Roan) reports that the first study "found Avandia raised the risk of heart attacks by 28% to 39% as compared with other diabetes medications. The study was published online in the Archives of Internal Medicine." USA Today (6/29, Marcus) reports that in the second study, published in the Journal of the American Medical Association, "scientists from the Center for Drug Evaluation and Research at the Food and Drug Administration evaluated data from 227,571 Medicare beneficiaries taking either Avandia or Actos [pioglitazone hydrochloride]." The investigators found "no differences in the risk for heart attack between the two drugs, but the study found that compared with Actos, Avandia was associated with a 25% increased risk of heart failure, a 27% increased risk of stroke and a 14% increased risk of death."
The Boston Globe (6/29, Rowland) quotes one of the study authors Dr. David Graham, the FDA's associate director for science and medicine, as saying, "Look at our study, and then ask yourself, 'Why would you want to take Avandia?'" The New York Times (6/29, Harris) reports that "the studies were made public Monday in hopes of influencing an expert panel that will convene on July 13 and 14 to offer advice to the Food and Drug Administration about whether Avandia should be removed from the market." According to Dr. Joshua M. Sharfstein, the FDA's principal deputy commissioner, the studies "will be part of the discussion that FDA has as we consider the important question of Avandia's safety." Bloomberg News (6/29, Cortez), the NPR (6/28, Hensley) "Shots" blog, the Wall Street Journal (6/29, Mundy, Dooren), the Washington Times (6/28, Duke), Reuters (6/29, Fox), AFP (6/29), HealthDay (6/28, Gardner), MedPage Today (6/28, Phend), and WebMD (6/28, DeNoon) also covered the story. The Hill (6/28, Pecquet) "Healthwatch" blog, and Bloomberg News (6/29, Peterson, Cortez) reported on Congressional reactions.
June 28, 2010 - Severe Headache, Migraine Patients Treated More, But Not By Guidelines.
Medscape (6/28, Gandey) reported, "A new study assessing trends in prescribing has found that, although more patients are being treated for severe headaches and migraine than ever before, they are" often receiving "more opioids, nonsteroidal anti-inflammatory drugs, benzodiazepines, muscle relaxants, and barbiturates." Opioids, benzodiazepines, muscle relaxants and barbiturates may lead to dependence and have poor evidence of effectiveness in treating headaches. They are not supported as appropriate treatment in guidelines for treating migraine. The study of "4,280 people from the National Health and Nutrition Examination Survey" also "found that although nonspecific medication use continued to increase, daily use of over-the-counter and prescription nonsteroidal anti-inflammatory drug use decreased."
June 29, 2010 - Half Of Breast Cancer Patients Stop Taking Key Medications Ahead Of Schedule.
USA Today (6/29, Szabo) reports that, according to research published online Monday in the Journal of Clinical Oncology, "half of breast cancer patients stop taking key medications ahead of schedule, a decision that can increase their risk of relapse and death." In the study of 8,769 women, researchers found that "only 49% of women took hormonal therapy pills for at least 4½ years." The study authors theorized that the length of time the prescriptions must be taken, or side effects may contribute to poor adherence or early discontinuation. The Los Angeles Times (6/28, Schiewe) "Booster Shots" blog also covered the story.
June 29, 2010 - Statins May Not Lower Death Rates Among Patients Without Heart Disease.
The Los Angeles Times (6/29, Healy) reported on the ongoing debate of the long-term benefits of cholesterol-lowering medications “that rake in some $26 billion a year for their makers.” A meta-analysis "published in the Archives of Internal Medicine found that statins do not lower death rates among patients with risk factors but no evidence of established cardiovascular disease who take them as a preventive measure." AFP (6/29) reports that the meta-analysis "involving 65,229 people questioned the wider use of statins...in patients who do not have but could develop heart disease." Researchers found that altogether, nearly 2,800 participants "died, including 1,447 in the placebo group and 1,346 in the statin group. It is not a statistically meaningful enough difference to recommend preventative treatment with statins, the authors concluded." HealthDay (6/28, Reinberg) reported that "even though the statins were doing their job and the levels of LDL...cholesterol were higher among people taking the placebo than those taking statins, there was no association between risk of dying and LDL level," the researchers found.
Meanwhile, "a study released Monday characterized as 'flawed' a widely hailed 2008 study that appeared to establish the benefit of the statin rosuvastatin (commercially marketed as Crestor) in the prevention of heart attack and stroke." Bloomberg News (6/29, Kelley) reports that the authors of the second article indicate that "nine of the 14 researchers who conducted the study, dubbed Jupiter, had financial ties to London-based AstraZeneca that may have influenced the way they did their job." Bloomberg points out that "AstraZeneca in March 2008 stopped the study early because of 'unequivocal' evidence that the pill cut deaths better than a placebo in people who had no evidence of existing heart disease." Reuters (6/29, Kelland), and MedPage Today (6/28, Bankhead) also covered the story.
June 29, 2010 - Effient Linked To Higher Cancer Risk Compared To Plavix.
Bloomberg News (6/29, Gibson) reports, "Eli Lilly's blood-thinner Effient [prasugrel] was linked to higher rates of cancer than Bristol-Myers Squibb Co.'s rival product Plavix [clopidogrel]," according to research published June 28 in the Archives of Internal Medicine. Patients "taking Effient had a 43 percent higher rate of solid tumors, excluding some skin cancers and brain tumors, than those who received Plavix." MedPage Today (6/28, Gever) reported that "potential cancer risks associated with the antiplatelet drug prasugrel (Effient) should raise clinical concerns -- and may even warrant a boxed warning." Never-published "data from the pivotal TRITON-TIMI 38 trial that tested the drug against its chief competitor, clopidogrel (Plavix), suggested that the risk of new or worsened solid-tumor cancers was increased more than 60% with prasugrel (relative risk 1.62, P=0.001)." These "findings...pointed to a greater risk than was apparent from the published results from TRITON-TIMI 38 or the FDA's own analysis, presented at a February 2009 advisory committee meeting." Although the relative risks were found to be elevated, the absolute risks of a solid tumor diagnosis was small. Of 13,600 patients only 102 were diagnosed with new cancers, and fewer only 54 trial participants died due to a pre-existing or new tumor.
June 29, 2010 - FDA Approves Arimidex Generic.
Teva Pharmaceutical Industries Ltd. announced "U.S. Food and Drug Administration (FDA) approval and commercial launch of Anastrozole Tablets 1 mg, the Company's generic version of AstraZeneca's ARIMIDEX®. The product is indicated for treatment of certain forms of breast cancer in postmenopausal women." Market exclusivity periods on several of AstraZeneca's biggest-selling drugs are set to expire in the next few years.
June 29, 2010 - Heart Group Issues Statement Regarding Avandia Following New Data On Drug's Heart Risks.
The Los Angeles Times (6/29, Roan) "Booster Shots" blog reported that, following new research linking Avandia (rosiglitazone) to increased heart risks, "the American Heart Assn. weighed in Tuesday with some advice for people taking" the drug. In a statement, the group lists its "recommendations, including that the drug metformin should generally be considered the first choice for glucose-lowering drugs.” According to a Consumer Reports Insights article in the Washington Post (6/29), "For people who need a diabetes drug, Consumer Reports' free Best Buy Drugs report recommends metformin, either alone or with glipizide or glimepiride, as the first option. It has a well-established safety profile and is available as an inexpensive generic." MedPage Today (6/29, Phend) , and NPR (6/30, Knox) also reported on the story.
June 29, 2010 – Pioglitazone, Rosiglitazone May Increase Fracture Risk In Men.
Medscape (6/29, Lowry) reported that, according to research presented at the American Diabetes Association meeting, "thiazolidinediones increase fracture risk, not just in women, as is commonly believed, but in men." After analyzing "data on 212,977 people 40 years and older with type 2 diabetes to determine the number of patients who had had a fracture between 2000...and 2008," Scottish researchers found that "male thiazolidinedione users had a two-fold risk for hip fracture, with an age-adjusted incidence rate ratio of 2.23, compared with male nonusers." The study's lead author pointed out that the risk was seen "more in middle-aged men between 55 and 65 years."
June 29, 2010 - Teva's Generic Effexor XR Approved By FDA.
Teva Pharmaceutical Industries Ltd. announced "U.S. Food and Drug Administration (FDA) approval of Venlafaxine HCl ER Capsules, the Company's generic version of Wyeth's antidepressant Effexor XR®." The company said "shipment is expected to commence on July 1, 2010, as per the terms of the 2006 agreement with Wyeth." This produce, like the brand name will carry a safety warnings regarding the increased risk for suicidal thinking and behavior in children, adolescents, and young adults receiving antidepressants. HealthDay (6/29) and Reuters (6/29, Scheer) also covered the story.
June 30, 2010 - FDA Warns Shire On Overstating Benefits Of Intuniv, ADHD Medication.
Bloomberg News (6/30, Peterson) reported that, according to a June 22 letter (pdf) posted to its website, the Food and Drug Administration says that "Shire Plc overstates" in its promotional materials "the benefits of Intuniv" (guanfacine hydrochloride), its medication for attention-deficit/hyperactivity disorder in children. The letter charged that "brochures in a patient starter kit for the drug make 'unsubstantiated effectiveness claims' and 'omit and minimize important risk information.'" The FDA said that "clinical studies don't support the company's claims that the drug improves 'individual behavioral problems,' such as 'bedtime blowups,' 'homework hassles,' and 'mall meltdowns.'"
June 30, 2010 – New Emergency Contraception Option May Also Treat Uterine Fibroids.
WebMD (6/30, Mann) reported that EllaOne, a "drug used in Europe as emergency contraception, may also treat painful uterine fibroids," researchers said at the annual meeting of the European Society of Human Reproduction and Embryology. In a study "of 57 women aged 25 to 50 whose fibroids were causing symptoms, a large percentage of women who took the drug once a day for three menstrual cycles showed reductions in the size of their fibroids, compared with women who took a" placebo. In addition, during "the third month of treatment, 80% of women who took the 10 milligram dose of the new drug and 95% who took the higher 20 milligram dose experienced no menstrual bleeding."
June 30, 2010 - Metformin Use May Reduce Type 2 Diabetes Mortality.
MedPage Today (6/30, Fiore) reported that "metformin use may reduce mortality among patients with type 2 diabetes who are at risk for cardiovascular events," according to research presented at the American Diabetes Association (ADA) meeting. Investigators reported that "a large, multicenter trial found a 24% reduced risk of all-cause mortality among patients on the drug, compared with those not taking it." HeartWire (6/30, Lowry) reported that "even patients thought to have contraindications to metformin, such as those with moderate renal failure, congestive heart failure, or advanced age up to 80 years, showed benefit."
July 1, 2010 - Endo Pharmaceuticals Provides New Information On Fortesta To FDA For Extended Review.
Endo Pharmaceuticals Holdings Inc. announced that it has provided a complete response to the Food and Drug Administration regarding "its intention to offer FORTESTA as a treatment option in the United States for men diagnosed with low testosterone (Low T), also known as hypogonadism." According to the company, this response was a a new analysis of testosterone levels in one of the studies of Fortesta which the FDA had previously questioned. The company expects the agency to complete its review in about six months.
July 2, 2010 - House Passes Proposal Restricting "Pay To Delay" Arragements.
Bloomberg News (7/2, Bliss) reports, "The US House approved a measure restricting the ability of drugmakers to enter agreements that the Federal Trade Commission has said keep generic medicines off the market." The proposal, included in a war-funding bill, would fine companies "if the FTC and courts find they are involved in settlements that preserve a brand-name pharmaceutical firm's patent by delaying a generic- drug maker's introduction of a lower-priced product." Drug companies "are lobbying against the provision, and passage in the Senate isn't assured. At a June 9 hearing, Senators Orrin Hatch, a Utah Republican, and Arlen Specter, a Pennsylvania Democrat, said they were concerned the FTC campaign against the deals may discourage agreements that benefit consumers." Dow Jones Newswire (7/2, Boyles) says that the measure would raise $2.5 billion over 10 years, according to a senior House Democratic aide. The funds would be used to offset the cost of other domestic policy items.
July 2, 2010 - Report Says Oxycodone Was The Cause Of 1,185 Deaths In Florida Last Year.
St. Petersburg Times (7/2, Martin, Farlow) reports that data "from the Florida Department of Law Enforcement released Thursday" indicate "that oxycodone was the cause of 1,185 state deaths in 2009, a 26 percent increase from the year before and a whopping 249 percent increase from 2005." Altogether, "prescription drug deaths monitored by the state Medical Examiner's Office continued to climb to 2,488 last year." Meanwhile, "deaths caused by some illegal drugs declined."
ABC World News (6/28, story 7, 2:20, Sawyer), CBS Evening News (6/28, story 10, 0:30, Smith), and NBC Nightly News (6/28, story 8, 0:20, Williams) reported on two studies providing additional evidence of cardiovascular disease associated with Avandia [rosiglitazone] use in advance of a scheduled FDA committee meeting to review safety data. The Washington Post (6/29, Stein) reported that one study, "involving more than 35,500 people, found that Avandia significantly raises the chances of a heart attack." A separate study "of more than 227,500 Medicare patients -- the largest such study to date -- found that the drug boosts the risk for strokes, heart failure, and death." The Los Angeles Times (6/29, Roan) reports that the first study "found Avandia raised the risk of heart attacks by 28% to 39% as compared with other diabetes medications. The study was published online in the Archives of Internal Medicine." USA Today (6/29, Marcus) reports that in the second study, published in the Journal of the American Medical Association, "scientists from the Center for Drug Evaluation and Research at the Food and Drug Administration evaluated data from 227,571 Medicare beneficiaries taking either Avandia or Actos [pioglitazone hydrochloride]." The investigators found "no differences in the risk for heart attack between the two drugs, but the study found that compared with Actos, Avandia was associated with a 25% increased risk of heart failure, a 27% increased risk of stroke and a 14% increased risk of death."
The Boston Globe (6/29, Rowland) quotes one of the study authors Dr. David Graham, the FDA's associate director for science and medicine, as saying, "Look at our study, and then ask yourself, 'Why would you want to take Avandia?'" The New York Times (6/29, Harris) reports that "the studies were made public Monday in hopes of influencing an expert panel that will convene on July 13 and 14 to offer advice to the Food and Drug Administration about whether Avandia should be removed from the market." According to Dr. Joshua M. Sharfstein, the FDA's principal deputy commissioner, the studies "will be part of the discussion that FDA has as we consider the important question of Avandia's safety." Bloomberg News (6/29, Cortez), the NPR (6/28, Hensley) "Shots" blog, the Wall Street Journal (6/29, Mundy, Dooren), the Washington Times (6/28, Duke), Reuters (6/29, Fox), AFP (6/29), HealthDay (6/28, Gardner), MedPage Today (6/28, Phend), and WebMD (6/28, DeNoon) also covered the story. The Hill (6/28, Pecquet) "Healthwatch" blog, and Bloomberg News (6/29, Peterson, Cortez) reported on Congressional reactions.
June 28, 2010 - Severe Headache, Migraine Patients Treated More, But Not By Guidelines.
Medscape (6/28, Gandey) reported, "A new study assessing trends in prescribing has found that, although more patients are being treated for severe headaches and migraine than ever before, they are" often receiving "more opioids, nonsteroidal anti-inflammatory drugs, benzodiazepines, muscle relaxants, and barbiturates." Opioids, benzodiazepines, muscle relaxants and barbiturates may lead to dependence and have poor evidence of effectiveness in treating headaches. They are not supported as appropriate treatment in guidelines for treating migraine. The study of "4,280 people from the National Health and Nutrition Examination Survey" also "found that although nonspecific medication use continued to increase, daily use of over-the-counter and prescription nonsteroidal anti-inflammatory drug use decreased."
June 29, 2010 - Half Of Breast Cancer Patients Stop Taking Key Medications Ahead Of Schedule.
USA Today (6/29, Szabo) reports that, according to research published online Monday in the Journal of Clinical Oncology, "half of breast cancer patients stop taking key medications ahead of schedule, a decision that can increase their risk of relapse and death." In the study of 8,769 women, researchers found that "only 49% of women took hormonal therapy pills for at least 4½ years." The study authors theorized that the length of time the prescriptions must be taken, or side effects may contribute to poor adherence or early discontinuation. The Los Angeles Times (6/28, Schiewe) "Booster Shots" blog also covered the story.
June 29, 2010 - Statins May Not Lower Death Rates Among Patients Without Heart Disease.
The Los Angeles Times (6/29, Healy) reported on the ongoing debate of the long-term benefits of cholesterol-lowering medications “that rake in some $26 billion a year for their makers.” A meta-analysis "published in the Archives of Internal Medicine found that statins do not lower death rates among patients with risk factors but no evidence of established cardiovascular disease who take them as a preventive measure." AFP (6/29) reports that the meta-analysis "involving 65,229 people questioned the wider use of statins...in patients who do not have but could develop heart disease." Researchers found that altogether, nearly 2,800 participants "died, including 1,447 in the placebo group and 1,346 in the statin group. It is not a statistically meaningful enough difference to recommend preventative treatment with statins, the authors concluded." HealthDay (6/28, Reinberg) reported that "even though the statins were doing their job and the levels of LDL...cholesterol were higher among people taking the placebo than those taking statins, there was no association between risk of dying and LDL level," the researchers found.
Meanwhile, "a study released Monday characterized as 'flawed' a widely hailed 2008 study that appeared to establish the benefit of the statin rosuvastatin (commercially marketed as Crestor) in the prevention of heart attack and stroke." Bloomberg News (6/29, Kelley) reports that the authors of the second article indicate that "nine of the 14 researchers who conducted the study, dubbed Jupiter, had financial ties to London-based AstraZeneca that may have influenced the way they did their job." Bloomberg points out that "AstraZeneca in March 2008 stopped the study early because of 'unequivocal' evidence that the pill cut deaths better than a placebo in people who had no evidence of existing heart disease." Reuters (6/29, Kelland), and MedPage Today (6/28, Bankhead) also covered the story.
June 29, 2010 - Effient Linked To Higher Cancer Risk Compared To Plavix.
Bloomberg News (6/29, Gibson) reports, "Eli Lilly's blood-thinner Effient [prasugrel] was linked to higher rates of cancer than Bristol-Myers Squibb Co.'s rival product Plavix [clopidogrel]," according to research published June 28 in the Archives of Internal Medicine. Patients "taking Effient had a 43 percent higher rate of solid tumors, excluding some skin cancers and brain tumors, than those who received Plavix." MedPage Today (6/28, Gever) reported that "potential cancer risks associated with the antiplatelet drug prasugrel (Effient) should raise clinical concerns -- and may even warrant a boxed warning." Never-published "data from the pivotal TRITON-TIMI 38 trial that tested the drug against its chief competitor, clopidogrel (Plavix), suggested that the risk of new or worsened solid-tumor cancers was increased more than 60% with prasugrel (relative risk 1.62, P=0.001)." These "findings...pointed to a greater risk than was apparent from the published results from TRITON-TIMI 38 or the FDA's own analysis, presented at a February 2009 advisory committee meeting." Although the relative risks were found to be elevated, the absolute risks of a solid tumor diagnosis was small. Of 13,600 patients only 102 were diagnosed with new cancers, and fewer only 54 trial participants died due to a pre-existing or new tumor.
June 29, 2010 - FDA Approves Arimidex Generic.
Teva Pharmaceutical Industries Ltd. announced "U.S. Food and Drug Administration (FDA) approval and commercial launch of Anastrozole Tablets 1 mg, the Company's generic version of AstraZeneca's ARIMIDEX®. The product is indicated for treatment of certain forms of breast cancer in postmenopausal women." Market exclusivity periods on several of AstraZeneca's biggest-selling drugs are set to expire in the next few years.
June 29, 2010 - Heart Group Issues Statement Regarding Avandia Following New Data On Drug's Heart Risks.
The Los Angeles Times (6/29, Roan) "Booster Shots" blog reported that, following new research linking Avandia (rosiglitazone) to increased heart risks, "the American Heart Assn. weighed in Tuesday with some advice for people taking" the drug. In a statement, the group lists its "recommendations, including that the drug metformin should generally be considered the first choice for glucose-lowering drugs.” According to a Consumer Reports Insights article in the Washington Post (6/29), "For people who need a diabetes drug, Consumer Reports' free Best Buy Drugs report recommends metformin, either alone or with glipizide or glimepiride, as the first option. It has a well-established safety profile and is available as an inexpensive generic." MedPage Today (6/29, Phend) , and NPR (6/30, Knox) also reported on the story.
June 29, 2010 – Pioglitazone, Rosiglitazone May Increase Fracture Risk In Men.
Medscape (6/29, Lowry) reported that, according to research presented at the American Diabetes Association meeting, "thiazolidinediones increase fracture risk, not just in women, as is commonly believed, but in men." After analyzing "data on 212,977 people 40 years and older with type 2 diabetes to determine the number of patients who had had a fracture between 2000...and 2008," Scottish researchers found that "male thiazolidinedione users had a two-fold risk for hip fracture, with an age-adjusted incidence rate ratio of 2.23, compared with male nonusers." The study's lead author pointed out that the risk was seen "more in middle-aged men between 55 and 65 years."
June 29, 2010 - Teva's Generic Effexor XR Approved By FDA.
Teva Pharmaceutical Industries Ltd. announced "U.S. Food and Drug Administration (FDA) approval of Venlafaxine HCl ER Capsules, the Company's generic version of Wyeth's antidepressant Effexor XR®." The company said "shipment is expected to commence on July 1, 2010, as per the terms of the 2006 agreement with Wyeth." This produce, like the brand name will carry a safety warnings regarding the increased risk for suicidal thinking and behavior in children, adolescents, and young adults receiving antidepressants. HealthDay (6/29) and Reuters (6/29, Scheer) also covered the story.
June 30, 2010 - FDA Warns Shire On Overstating Benefits Of Intuniv, ADHD Medication.
Bloomberg News (6/30, Peterson) reported that, according to a June 22 letter (pdf) posted to its website, the Food and Drug Administration says that "Shire Plc overstates" in its promotional materials "the benefits of Intuniv" (guanfacine hydrochloride), its medication for attention-deficit/hyperactivity disorder in children. The letter charged that "brochures in a patient starter kit for the drug make 'unsubstantiated effectiveness claims' and 'omit and minimize important risk information.'" The FDA said that "clinical studies don't support the company's claims that the drug improves 'individual behavioral problems,' such as 'bedtime blowups,' 'homework hassles,' and 'mall meltdowns.'"
June 30, 2010 – New Emergency Contraception Option May Also Treat Uterine Fibroids.
WebMD (6/30, Mann) reported that EllaOne, a "drug used in Europe as emergency contraception, may also treat painful uterine fibroids," researchers said at the annual meeting of the European Society of Human Reproduction and Embryology. In a study "of 57 women aged 25 to 50 whose fibroids were causing symptoms, a large percentage of women who took the drug once a day for three menstrual cycles showed reductions in the size of their fibroids, compared with women who took a" placebo. In addition, during "the third month of treatment, 80% of women who took the 10 milligram dose of the new drug and 95% who took the higher 20 milligram dose experienced no menstrual bleeding."
June 30, 2010 - Metformin Use May Reduce Type 2 Diabetes Mortality.
MedPage Today (6/30, Fiore) reported that "metformin use may reduce mortality among patients with type 2 diabetes who are at risk for cardiovascular events," according to research presented at the American Diabetes Association (ADA) meeting. Investigators reported that "a large, multicenter trial found a 24% reduced risk of all-cause mortality among patients on the drug, compared with those not taking it." HeartWire (6/30, Lowry) reported that "even patients thought to have contraindications to metformin, such as those with moderate renal failure, congestive heart failure, or advanced age up to 80 years, showed benefit."
July 1, 2010 - Endo Pharmaceuticals Provides New Information On Fortesta To FDA For Extended Review.
Endo Pharmaceuticals Holdings Inc. announced that it has provided a complete response to the Food and Drug Administration regarding "its intention to offer FORTESTA as a treatment option in the United States for men diagnosed with low testosterone (Low T), also known as hypogonadism." According to the company, this response was a a new analysis of testosterone levels in one of the studies of Fortesta which the FDA had previously questioned. The company expects the agency to complete its review in about six months.
July 2, 2010 - House Passes Proposal Restricting "Pay To Delay" Arragements.
Bloomberg News (7/2, Bliss) reports, "The US House approved a measure restricting the ability of drugmakers to enter agreements that the Federal Trade Commission has said keep generic medicines off the market." The proposal, included in a war-funding bill, would fine companies "if the FTC and courts find they are involved in settlements that preserve a brand-name pharmaceutical firm's patent by delaying a generic- drug maker's introduction of a lower-priced product." Drug companies "are lobbying against the provision, and passage in the Senate isn't assured. At a June 9 hearing, Senators Orrin Hatch, a Utah Republican, and Arlen Specter, a Pennsylvania Democrat, said they were concerned the FTC campaign against the deals may discourage agreements that benefit consumers." Dow Jones Newswire (7/2, Boyles) says that the measure would raise $2.5 billion over 10 years, according to a senior House Democratic aide. The funds would be used to offset the cost of other domestic policy items.
July 2, 2010 - Report Says Oxycodone Was The Cause Of 1,185 Deaths In Florida Last Year.
St. Petersburg Times (7/2, Martin, Farlow) reports that data "from the Florida Department of Law Enforcement released Thursday" indicate "that oxycodone was the cause of 1,185 state deaths in 2009, a 26 percent increase from the year before and a whopping 249 percent increase from 2005." Altogether, "prescription drug deaths monitored by the state Medical Examiner's Office continued to climb to 2,488 last year." Meanwhile, "deaths caused by some illegal drugs declined."
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