Low blood testosterone linked with poor outcomes in dialysis

Higher serum testosterone levels are linked with significantly reduced risk of death, with a 42% reduced risk per 10-ng/dL increase as per a study of 623 men initiating dialysis. In the study patients were followed for a median of 20 months. Higher levels of testosterone were also associated with significantly higher health-related quality of life scores. The findings are published in the American Journal of Kidney Diseases.

 Dr Sanjay Gupta changes stance on medical marijuana

In an op-ed written for the CNN website, Dr. Sanjay Gupta apologizes for his anti-marijuana stance and says that he now endorses the medicinal use of the drug, which “doesn’t have a high potential for abuse” and has “very legitimate medical applications.”

Pio is back, update

1. THE GAZETTE OF INDIA EXTRAORDINARY: Pioglitazone and all formulations containing Pioglitazone for human use is allowed to be manufactured for sale, sale and distribution subject to the condition that the manufacturers shall mention the following on their package insert and promotional literature of the drug;

1. The drug should not be used as first line therapy for diabetes,

2. The manufacturer should clearly mention following box warning in bold red letters.

Advice for healthcare professional:
•   Patient with active bladder cancer or with a history of bladder cancer and those with uninvestigated haematuria should not receive pioglitazone.
•  Prescribers should review the safety and efficacy of pioglitazone in individuals after 3-6 months of treatment to ensure that only patient who are deriving benefit continue to be treated. Pioglitazone should be stopped in patients who do not respond adequately to treatment (e.g. reduction in glycosylated haemoglobin, HbA1C.
•  Before starting pioglitazone, the following known risk factors for development of bladder cancer should be assessed in individuals: age, current or past history of smoking, exposure to some occupation or chemotherapy agents such as cyclophosphamide, or previous irradiation of the pelvic region.

• Use in elderly patients should be considered carefully before and during treatment because the risk of bladder cancer increases with age. Elderly patients should start on the lowest possible dose and be regularly monitored because of the risks of bladder cancer and heart failure associated with pioglitazone. [F.NO. 4-01/2011-DC/Piogl, ARUN K. PANDA, Jt. Secy]
 
2. MINISTRY OF HEALTH AND FAMILY WELFARE, Department of Health and Family Welfare, NOTIFICATION, New Delhi, the 31st July 2013
G.S.R. 520(E)-Whereas the Central Government was satisfied that the use of the drug Pioglitazone and all drug formulations containing Pioglitazone was likely to involve risk to human beings and whereas safer alternatives to the said drug are available;
Whereas the Central Government was satisfied that it was necessary and expedient to regulate by way of suspension, the manufacture for sale, sale and distribution of the said drug in the country in public interest, and accordingly in exercise of the powers conferred by section 26A of the Drug and Cosmetic Act, 1940 (23 of 1940) the Central Government suspended the manufacture for sale, sale and distribution of  Pioglitazone and all formulations containing Pioglitazone for human use through the notification number G.S.R. 379 (E) dated 18TH June 2013;
Whereas, the Drug Technical Advisory Board has examined the issue of suspension of manufacture and sale of the said drug on 19th July, 2013 and has recommended that the suspension of the drug should be revoked and allowed to be marketed subject to certain conditions the manufacturers shall mention on their package insert and promotional literature of the drug;
Now, therefore, on the basis of the recommendations of the Drugs Technical Advisory Board, the Central Government hereby revokes the notification G.S.R. 379(E) DATED 18TH June 2013 subject to the following condition as recommended by the Drugs Technical Advisory Board.