New Drug Update 2009-2010 - LAFP

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have received 3 doses of PCV7 before age 12 months are recommended to receive 1 dose of PCV13, given at least 8 weeks after the last dose of PCV7. No additional PCV13 doses are recommended for children aged 12--23 months who received 2 or 3 doses of PCV7 before age 12 months and at least 1 dose of PCV13 at age ≥12 months. Similar to the previous ACIP recommendation for use of PCV7, 1 dose of PCV13 is recommended for all healthy children aged 24--59 months with any incomplete PCV schedule (PCV7 or PCV13). For children aged 24--71 months with underlying medical conditions who have received any incomplete schedule of
about PCV2, a contaminant in RotaTeq. Gordon Allan, PhD, a professor at The Queens University Belfast in Belfast, Northern Ireland, rang an alarm bell with what resembled a passing remark about how the virus triggers postweaning multisystemic wasting syndrome. "PCV2 in a lot of ways is a strange virus," Dr. Allan said. To get "good disease in pigs with PCV2," one must infect them with the virus and then stimulate their immune system, either by reinfecting them with the virus or vaccinating them. He raised the possibility of this chain of events occurring with sequential doses of rotavirus vaccine. May 14, 2010 FDA Revises Recommendations for Rotavirus Vaccines The U.S. Food and Drug Administration today revised its recommendations for rotavirus vaccines for the prevention of the disease in infants and has determined that it is appropriate for clinicians and health care professionals to resume the use of Rotarix and to continue the use of RotaTeq. The agency reached its decision based on a careful evaluation of information from laboratory results from the manufacturers and the FDA’s own laboratories, a thorough review of the scientific literature, and input from scientific and public health experts, including members of the FDA’s Vaccines and Related Biological Products Advisory Committee that convened on May 7, 2010 to discuss these vaccines. The FDA also considered the following in its decision: • Both vaccines have strong safety records, including clinical trials involving tens of thousands of patients as well as clinical experience with millions of vaccine recipients. • The FDA has no evidence that PCV1 or PCV2 pose a safety risk in humans, and neither is known to cause infection or illness in humans. • The benefits of the vaccines are substantial, and include prevention of death in some parts of the world and hospitalization for severe rotavirus disease in the United States. These benefits outweigh the risk, which is theoretical. March 28, 2010 FDA warns that of the 4 million prescriptions for nitroglycerine tablets sold in the US last year, that most were not FDA approved nor was their safety or effectivenss vetted by the FDA. The FDA notified the two major unapproved manufacturers Glenmark Generics and Kronec tthat they had not meet the rules of the FDA and that they should discontinue manufacturing in the nest 90 days and marketing of these unapproved nitroglycerine tablets in the next 6 months. The companies said that they would comply but they took issue with the FDA saying that these products were pre 1938 FDA regulations and thus grandfathered and not required for FDA review. The FDA has not evaluated these products but they are NOT FDA approved and thus we are ordering them off the market. Pfizer’s Nitrostat is the only FDA approved nitroglycerine tablet and it is priced slightly above the other two $21.99 vs. $19.99 May 2010 FDA Action against Johnson and Johnson and McNeil Consumer Healthcare Ingredients used by Johnson & Johnson in some of the 40 varieties of children's cold medicines recalled last week were contaminated with bacteria, according to a report by the Food and Drug Administration. Agency officials said Tuesday none of the company's finished products tested positive for the contaminants, though such testing is not definitive. "We think the risk to consumers at this point is remote," said Deborah Autor, director of FDA's drug compliance office. The FDA report, which was posted online, lists more than 20 manufacturing problems found at the McNeil Consumer Healthcare plant in Fort Washington, Pa., where the formulas were made. The recalled products include children and infant formulations of Tylenol, Motrin, Zyrtec and Benadryl. FDA inspectors visited the plant in mid-April and wrapped up their inspection Friday. J&J issued its "voluntary" recall later that night. Among other problems, FDA inspectors said the company did not have laboratory facilities to test drug ingredients and failed to follow up on customer complaints. J&J did not investigate more than 46 complaints received in the last year about "black or dark specks" in Tylenol products, according to the FDA's report. Additionally, inspectors found some pieces of equipment covered with thick layers of dust, while others were held together with duct tape. In a statement Tuesday, J&J called the problems cited by the FDA "unacceptable to us, and not indicative of how McNeil Consumer Healthcare intends to operate." The FDA reiterated that serious medical problems with the products are unlikely, but advised consumers to stop using the medicine as a precaution. Parents are instructed to use generic alternatives instead. J&J has said some of the recalled medicines may have a higher concentration of the active ingredient than listed on the bottle. Others may contain particles, while still others may contain inactive ingredients that do not meet testing requirements. "That warning letter brought us to the point where we thought it was necessary to sit down with management and discuss our concerns," Autor said. FDA officials said they are considering taking additional action against J&J, ranging from issuing more warning letters to pursuing criminal action. 15
Page 1 and 2: New Drug Update 2009-2010 C. Wayne
Page 3 and 4: FDA MedWatch Information 9/9/2006 C
Page 5 and 6: 2002, to March 31, 2004. They ident
Page 7 and 8: The AGREE (Acute Gout Flare Receivi
Page 9 and 10: DM Only Group Total patients (n) Ca
Page 11 and 12: • Change the name of Maalox Total
Page 13: trivalent influenza vaccine (Fluzon
Page 17 and 18: June 13, 2010 Modest lung-cancer si
Page 19 and 20: The primary analysis of efficacy wa
Page 21 and 22: Vaccine-related Injection-site and
Page 23 and 24: SAXAGLIPTIN - Onglyza (Bristol-Myer
Page 25 and 26: change from baseline (95% CI) (−1
Page 27 and 28: NNT—A 1c < 7% (compared with glyb
Page 29 and 30: exposure, but no change in exposure
Page 31 and 32: Liraglutide - Victoza by Novo-Nordi
Page 33 and 34: Difference from glimepiride + metfo
Page 35 and 36: Add-on to Metformin and Thiazolidin
Page 37 and 38: Headache 9.1 9.3 Influenza 7.4 3.6
Page 39 and 40: patient loses at least 3 percent of
Page 41 and 42: ZOLEDRONIC ACID INJECTION in Paget
Page 43 and 44: direct health care costs, found zol
Page 45 and 46: than a month after drug infusion. A
Page 47 and 48: Zoledronic acid and risedronate in
Page 49 and 50: Patients received either febuxostat
Page 51 and 52: NICE technology appraisal guidance
Page 53 and 54: lansoprazole. 1 In other pharmacody
Page 55 and 56: information recommends discontinuin
Page 57 and 58: GERD, the recommended dosage is 30
Page 59 and 60: MILNACIPRAN - Savella by Forest/Cyp
Page 61 and 62: Observed cases 2.12 (95% CI, 1.33 t
Page 63 and 64: pain score. On patient global asses
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eduction is recommended. Hyponatrem
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Palpitations 2% 8% 7% 7% Upper resp
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Agent Table 10. Dosage Forms for th
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19% unchanged in urine 3% unchanged
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Percentage rating study drug “goo
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Acute intoxication Warnings and Pre
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DOSING: Tapentadol may be taken ora
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In elderly patients with psychosis
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Investigations Weight increased
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3 mg tablets of repspiridone are $2
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Table 2. Pharmacokinetics of the Be
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haloperidol (P = 0.006). No differe
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Priapism X X X X Cognitive and moto
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Flatulence 1.9% 1.3% 1.6% 5.1% 2.3%
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adjustment in hepatic impairment re
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dosing, inhibition of platelet aggr
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thrombocytopenic purpura has been r
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“Despite the thumbs-up, the panel
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dronedarone and its N-debutyl metab
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ANDROMEDA Study (Increased Mortalit
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In clinical trials, patients treate
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Dronedarone was developed to lack a
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BENZYL ALCOHOL 5% LOTION - Ulesfia
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Table 2. Contraindications, Warning
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pediculocides, to improve outcomes.
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adolescents (ages 13-17), respectiv
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with TS+ADHD, aged 8 to 16 years. T
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HOW SUPPLIED/COST/STORAGE AND HANDL
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Pitavastatin - Livalo by Kowa and L
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Sipuleucel - T - Provenge by Dendre
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Women who are not pregnant and use
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Ketorolac tromethamine Nasal Spray-
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DENOSUMAB - Prolia by Amgen INDICAT
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71% for the pooled denosumab groups
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The most frequently observed advers
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New Drug Update 2009-2010 - LAFP

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