Monday, May 30, 2011

New drugs approved in India in April 2011


Tioconazole Vaginal Gel 65mg per gm

For the local treatment of vulvovaginal candidiasis in adult patients.

Ilaprazole Tablets 5mg/10mg

For the treatment of duodenal ulcer in adults only.

Tapentadol Hydrochloride tablets 50mg/75mg/100mg

For relief of moderate to severe acute pain in adults 18 years of age or older.

S-Bupivacaine Hydrochloride Injection 2.5mg/5mg/7.5mg per ml

For surgical anaesthesia in adults for epidural (including caesarean section), intrathecal, peripheral nerve block.

Gatifloxacin and Tegaserod banned

DCGI banned the manufacture, sale and distribution of Gatifloxacin for human use by oral or injectable route.
http://cdsco.nic.in/PRohibited_gatifloxacin_tegaserod.pdf

DCGI also banned the manufacture, sale and distribution of Tegaserod for human use.
http://cdsco.nic.in/PRohibited_gatifloxacin_tegaserod.pdf

Drugs banned in India

Link to DCGI website which mentions the drugs banned in India.
http://cdsco.nic.in/html/Drugsbanned.html

Sunday, May 29, 2011

Azilsartan/chlorthalidone combo bests olmesartan/HCTZ in stage 2 systolic hypertension

Heartwire reported on 24th May, 2011 that the use of the combination therapy azilsartan medoxomil (Edarbi, Takeda Pharmaceuticals) and chlorthalidone resulted in a more effective reduction in systolic blood pressure (SBP), including ambulatory measures of blood pressure, when compared with combination therapy of olmesartan (Benicar, Daiichi Sankyo) and hydrochlorothiazide (HCTZ) in patients with hypertension, according to the results of a new study.
Presenting the data this week during the late-breaking clinical trials session at the American Society of Hypertension (ASH) 2011 Scientific Meeting, lead investigator Dr William Cushman (Veterans Affairs Medical Center, Memphis, TN) noted that azilsartan, a new angiotensin-receptor blocker (ARB) approved by FDA in February this year, is a highly effective, long-acting agent that is currently in development as a fixed-dose combination with chlorthalidone, a thiazidelike diuretic.
Speaking with the media during a press conference announcing the results, Cushman said chlorthalidone was selected as the second agent with azilsartan and partnered in development because there is growing evidence the drug is more effective than HCTZ. The purpose of the study was to compare the effectiveness of the azilsartan/chlorthalidone combination with the maximum approved dose of olmesartan/HCTZ, that being 40/25 mg.

Saturday, May 28, 2011

Celecoxib should not be used in FAP

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has finalised that existing evidence of safety and efficacy does not support the use of celecoxib in the reduction of the number of adenomatous intestinal polyps in familial adenomatous polyposis (FAP).
This review follows Pfizer’s voluntary withdrawal of the marketing authorisation of its celecoxib-containing orphan medicine, Onsenal, which had been authorised for use in FAP patients. The reason for the withdrawal was that Pfizer was unable to provide confirmatory data regarding clinical benefit due to slow enrolment in a clinical trial. These data had been requested by the CHMP at the time of granting of the marketing authorisation for Onsenal.
Celecoxib-containing products are currently authorised in the European Union for the treatment of the symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. This review was initiated because of concerns that celecoxib may be used off-label in the FAP indication following the withdrawal of Onsenal.
The CHMP concluded that the benefit of celecoxib in FAP patients had not been sufficiently demonstrated and did not outweigh the increased risk of cardiovascular and gastrointestinal side effects, which would result from high dose and long-term treatment used in FAP patients.


FDA approves injectable gel to treat fecal incontinence


The U.S. Food and Drug Administration today approved a sterile, injectable gel to treat fecal incontinence in patients for whom other therapies such as diet change, fiber therapy or anti-motility medications failed.
Fecal incontinence is the involuntary loss of bowel control. It can have different causes including nerve damage, weakened anal sphincter associated with aging, or rectum muscle damage.

The Solesta gel is injected into a layer of tissue beneath the anus lining and may help build tissue in that area. By growing the surrounding tissue, the opening of the anus narrows and the patient may be able to better control those muscles.
Solesta is approved for use in patients ages 18 and up.

It should not be used in patients who have active inflammatory bowel disease, immunodeficiency disorders, previous radiation treatment to the pelvic area, significant rectal prolapse, active infections, bleeding, tumors or malformations in the anorectal area, rectal distended veins, an existing implant in the anorectal region, or allergy to hyaluronic acid based products.

Most common side effects are injection area pain and bleeding.
Infection and inflammation of anal tissue are more serious risks, but are less common.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm257112.htm

FDA approves treatment for Clostridium difficile infection

The U.S. Food and Drug Administration recently approved Dificid (fidaxomicin) tablets for the treatment of Clostridium difficile-associated diarrhea (CDAD).
The safety and efficacy of Dificid has been demonstrated in two trials that included 564 patients with CDAD that compared Dificid with vancomycin, a common antibiotic used to treat CDAD. The clinical response was similar in the Dificid group compared with the vancomycin group in both studies. In some patients with CDAD, symptoms can return. In the Dificid trials, a greater number of patients treated with Dificid had a sustained cure three weeks after treatment ended versus those patients treated with vancomycin.
Dificid, a macrolide antibacterial, should be taken two times a day for 10 days with or without food.
To maintain the effectiveness of Dificid, and to reduce the development of drug-resistant bacteria, the drug should be used only to treat infections that are proven or strongly suspected to be caused by C. difficile.
The most common side effects reported with Dificid included nausea, vomiting, headache, abdominal pain, and diarrhea.
People at risk of developing the bacterial infection include the elderly, patients in hospitals or nursing homes, and people taking antibiotics for another infection. The most effective way to prevent CDAD is thorough handwashing with soap and warm water.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm257024.htm

Friday, May 27, 2011

Addition of Boceprevir beneficial in HCV infection

Addition of boceprevir to standard therapy with peginterferon-ribavirin, as compared with standard therapy alone, significantly increases the rates of sustained virologic response in previously untreated adults with chronic HCV genotype 1 infection according to a study published in New Engl Journal of Medicine 2011 Mar 31;364(13):1195-206
Poodhar F, M.D. from Cedars–Sinai Medical Center, Los Angeles, US evaluated Boceprevir, a potent oral HCV-protease inhibitor, as an additional treatment in phase 1 and phase 2 studies. In  a double-blind study previously untreated adults with HCV genotype 1 infection were randomly assigned to one of three groups. In all three groups, peginterferon alfa-2b and ribavirin were administered for 4 weeks (the lead-in period). Subsequently, group 1 (the control group) received placebo plus peginterferon-ribavirin for 44 weeks; group 2 received boceprevir plus peginterferon-ribavirin for 24 weeks, and those with a detectable HCV RNA level between weeks 8 and 24 received placebo plus peginterferon-ribavirin for an additional 20 weeks; and group 3 received boceprevir plus peginterferon-ribavirin for 44 weeks. Nonblack patients and black patients were enrolled and analyzed separately.
The investigators found that a total of 938 nonblack and 159 black patients were treated. In the nonblack cohort, a sustained virologic response was achieved in 40% in group 1; 67% in group 2 (P<0.001), and 68% in group 3 (P<0.001). In the black cohort, a sustained virologic response was achieved in 23% in group 1, in 42%  in group 2 (P=0.04), and in 53% in group 3 (P=0.004). In group 2, a total of 44% of patients received peginterferon-ribavirin for 28 weeks. Anemia led to dose reductions in 13% of controls and 21% of boceprevir recipients, with discontinuations in 1% and 2%, respectively.
The authors concluded that the addition of boceprevir to standard therapy with peginterferon-ribavirin, as compared with standard therapy alone, significantly increased the rates of sustained virologic response in previously untreated adults with chronic HCV genotype 1 infection. The rates were similar with 24 weeks and 44 weeks of boceprevir.
http://www.ncbi.nlm.nih.gov/pubmed/21449783?dopt=Abstract

Wednesday, May 4, 2011

Rare atypical fractures of the femur: a class effect of bisphosphonates

European Medicines Agency has concluded a class review of bisphosphonates and atypical fractures
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that rare atypical fractures of the femur are a class effect of bisphosphonates.
The CHMP confirmed that the benefits of bisphosphonates in the treatment and prevention of bone disorders continue to outweigh their risks, but that a warning of the risk of atypical femoral fractures should be added to the prescribing information for all bisphosphonate-containing medicines in the European Union. Such a warning had already been included in the product information for alendronate-containing medicines across Europe, following a review by the CHMP’s Pharmacovigilance Working Party in 2008. It will now be extended to the whole bisphosphonate class.
Prescribers of bisphosphonate-containing medicines should be aware that atypical fractures of the femur may occur rarely. If an atypical fracture is suspected in one leg, then the other leg should also be examined. Doctors who are prescribing these medicines for osteoporosis should regularly review the need for continued treatment, especially after five or more years of use.
Patients who are taking bisphosphonate-containing medicines need to be aware of the risk of this unusual fracture of the femur. They should contact their doctor if they have any pain, weakness or discomfort in the thigh, hip or groin, as this may be an indication of a possible fracture.
http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2011/04/WC500105281.pdf

Comparison of Dalteparin to unfractionated heparin in decreasing incidence of proximal DVT

The investigators of PROTECT trial tested the superiority of dalteparin over unfractionated heparin in a multicentric trial by randomly assigning 3764 patients to receive either subcutaneous dalteparin (at a dose of 5000 IU once daily) plus placebo once daily (for parallel-group twice-daily injections) or unfractionated heparin (at a dose of 5000 IU twice daily) while they were in the intensive care unit.
The primary outcome, proximal leg deep-vein thrombosis, was diagnosed on compression ultrasonography performed within 2 days after admission, twice weekly, and as clinically indicated.
There was no significant between-group difference in the rate of proximal leg deep-vein thrombosis, which occurred in 5.1% receiving dalteparin versus 5.8%   receiving unfractionated heparin.
The proportion of patients with pulmonary emboli was significantly lower with dalteparin (24 patients, 1.3%) than with unfractionated heparin (43 patients, 2.3%).
There was no significant between-group difference in the rates of major bleeding or death in the hospital. In prespecified per-protocol analyses, the results were similar to those of the main analyses, but fewer patients receiving dalteparin had heparin-induced thrombocytopenia.
The authors concluded that among critically ill patients, dalteparin was not superior to unfractionated heparin in decreasing the incidence of proximal deep-vein thrombosis.
http://www.nejm.org/doi/full/10.1056/NEJMoa1014475?query=oncology-hematology

FDA approves Zytiga for late-stage prostate cancer

U.S. Food and Drug Administration has approved Zytiga (abiraterone acetate) in combination with prednisone (a steroid) to treat patients with late-stage (metastatic) castration-resistant prostate cancer who have received prior docetaxel (chemotherapy).

Abiraterone acetate (CB7630) is an orally administered inhibitor of the steroidal enzyme CYP17 (17α-hydroxylase/C17,20 lyase), a cytochrome p450 complex that is involved in testosterone production and estrogen production Zytiga has been approved ahead of the product’s June 20, 2011 regulatory goal date.
Zytiga’s safety and effectiveness were established in a clinical study of 1,195 patients with late-stage castration-resistant prostate cancer who had received prior treatment with docetaxel chemotherapy. Patients received either Zytiga once daily in combination with prednisone two times a day or a placebo twice daily in combination with prednisone.
The study was designed to measure overall survival, the length of time from when the treatment started until a patient's death. Patients who received the Zytiga and prednisone combination had a median overall survival of 14.8 months compared to 10.9 months for patients receiving the placebo and prednisone combination.
The most commonly reported side effects in patients receiving Zytiga included joint swelling or discomfort, low levels of potassium in the blood, fluid retention (usually of the legs and feet), muscle discomfort, hot flashes, diarrhea, urinary tract infection, cough, high blood pressure, heartbeat disorders, urinary frequency, increased nighttime urination, upset stomach or indigestion and upper respiratory tract infection.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm253055.htm

Tuesday, May 3, 2011

FDA approves Linagliptin for Type 2 Diabetes

The U.S. Food and Drug Administration today approved Tradjenta (linagliptin) tablets, used with diet and exercise, to improve blood glucose control in adults with Type 2 diabetes.
Linagliptin is a dipeptidyl peptidase-4 or DPP-4 enzyme inhibitor. Thus it prevents the degradation of the incretins and ultimately increase the level of insulin after a meal.
Tradjenta was demonstrated to be safe and effective in eight double-blind, placebo-controlled clinical studies involving about 3,800 patients with Type 2 diabetes. The studies showed improvement in blood glucose control compared with placebo.
Tradjenta has been studied as a stand-alone therapy and in combination with other Type 2 diabetes therapies including metformin, glimepiride, and pioglitazone. Tradjenta has not been studied in combination with insulin, and should not be used to treat people with Type 1 diabetes or in those who have increased ketones in their blood or urine (diabetic ketoacidosis).
The most common side effects of Tradjenta are upper respiratory infection, stuffy or runny nose, sore throat, muscle pain, and headache.
Other DPP-4 inhibitors in the market are Sitagliptin and Vildagliptin.
Exenatide is the incretin mimetic available as a drug.
The DPP-4 inhibitors and incretin mimetics are approved for use alongwith diet control and exercise.