Drug Safety Update

Health Care Comments Off

SGLT2 inhibitors

Citing concerns raised by the US FDA and Health Canada regarding safety of SGLT2 inhibitors used for type 2 diabetes, the DCGI has issued a safety warning (F. No. 12-74/13-DC dated 25.3.19) and asked manufacturers of SGLT2 inhibitors to include the following warning in the package insert and promotional literature of these drugs:

“Warning: Cases of a rare but serious infection of the genitals and area around the genitals have been reported with this class of type 2 diabetes medicines i.e. sodium-glucose cotransporter-2 (SGLT-2) inhibitors. This serious rare infection, called necrotizing fasciitis of the perineum, is also referred to as Fournier’s gangrene.”

  • Health Canada: On 20.7.18, a Summary Safety Review concluded that there may be potential risk of acute pancreatitis with SGLT2 inhibitors
  • US FDA:On 29.08.2018, a safety communication warned about the risk of rare but serious infection of genitals and areas around the genitals – necrotizing fasciitis of the perineum, also referred to as Fournier’s gangrene.

New side effects with ofloxacin and cefotaxime

Ofloxacin and injectable cefotaxime are commonly used antibiotics. However, two serious adverse effects – Stevens Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN) and angioedema – have been reported with the use of these drugs, following which the DCGI has now recommended that these adverse effects be also mentioned in the package insert or promotional literature of both these drugs.

  • Ofloxacin has been found to cause a severe skin reaction called Stevens Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN).
  • Injectable cefotaxime has been found to cause angioedema.

Dabigatran and sertraline

The Pharmacovigilance Programme of India (PvPI) has alerted about risks of alopecia with dabigatran (anticoagulant) and maculopathy with the use of sertraline (antidepressant).

The Indian Pharmacopoeia Commission (IPC) which is the National Coordination Centre (NCC) for Pharmacovigilance Programme of India (PvPI) has directed healthcare professionals and institutions across the country to monitor for and report adverse drugs reactions with dabigatran and sertraline at its website http//www.ipc.gov.in.

(Source: CDSCO, ET Health, Pharmabiz)

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA

Diabetes may double the risk of acquiring lifetime tuberculosis

Health Care, Heart Care Foundation of India, Medicine Comments Off

Every case must be notified, and treatment provided accordingly

New Delhi, 19 March 2019: The World Health Organization has indicated that about 15% of the global tuberculosis (TB) burden is now attributed to diabetes. A recent review pointed out that diabetes can double the lifetime TB risk. As per a review paper published in Diabetes Metabolism Research and Reviews recently, the prevalence of TB in diabetes and diabetes in TB was at least two-three times higher than that found in the general population.

In TB infections, the stress responses by the body result in impaired glucose tolerance, a risk factor for diabetes. TB drugs (namely, rifampicin) also make it more difficult to maintain glucose control. People with diabetes should seek treatment if they have a cough lasting more than two weeks, fever, night sweats and/or weight loss.

Speaking about this, Padma Shri Awardee, Dr KK Aggarwal, President, HCFI, said, “To control TB, it is important to prevent diabetes. This is true especially in a country like India where rates of TB are amongst the highest and the incidence of type 2 diabetes is also rising sharply. Diabetes can go undiagnosed for a long period, so it makes sense to do proactive screening for diabetes in all patients with TB. Conversely, diabetes should be on the clinical radar when caring for people with TB. If an elderly develops TB, rule out diabetes and if an elderly develops diabetes, rule out TB. Rule out TB in every case of uncontrolled diabetes.”

India has the highest TB burden country in the world in terms of the absolute numbers of incidence cases each year. Mortality due to TB is the third leading cause of years of life lost (YLLs) lost, in the country.

Adding further, Dr Aggarwal, who is also the Group Editor-in-Chief of IJCP, said, “All open TB patients need to be immediately identified, and treated till they become sputum negative and non-infective. Most TB-positive patients do not disclose their TB status due to the fear of social stigma and so keep spreading the disease to others. The public needs to be informed that every open case of TB will cause 15 new cases of TB, if not treated in time. TB is a curable disease. Full and adequate treatment is important for complete recovery.”

Some tips from HCFI

TB is a notifiable disease and therefore, the approach should be based on DTR “Diagnose, Treat & Report”: Diagnose early, using sputum GeneXpert test; Treat: Complete and effective treatment based on national guidelines, using FDC; and Report: Mandatory reporting.”

  • Wash your hands after sneezing, coughing or holding your hands near your mouth or nose.
  • Cover your mouth with a tissue when you cough, sneeze or laugh. Discard used tissues in a plastic bag, then seal and throw it away.
  • Do not attend work or school.
  • Avoid close contact with others.
  • Sleep in a room away from other family members.
  • Ventilate your room regularly. TB spreads in small closed spaces. Put a fan in you window to blow out air that may contain bacteria.

Abstinence from drinking alcohol is harm reduction

Health Care, Heart Care Foundation of India, Medicine, Social Health Community Comments Off

Excessive consumption can case heart problems, liver disease, and even mortality in the longer term

[New Delhi, 17th February 2019: As per WHO estimates, worldwide, 3.3 million (~6%) deaths every year result from harmful use of alcohol. The harmful use of alcohol is a causal factor in more than 200 disease and injury conditions. Overall 5.1% of the global burden of disease and injury is attributable to alcohol, as measured in disability-adjusted life years (WHO).

The diseases that moderate alcohol use prevents (such as coronary heart disease, ischemic stroke, and diabetes) are most prevalent in the elderly, men, and people with coronary heart disease risk factors. For these groups, moderate alcohol use is associated with a substantial mortality benefit relative to abstention or rare drinking. Avoiding or reducing alcohol consumption is also a way of harm reduction as was discussed in the first-ever conference on the subject organized on 30th January 2019.

Speaking about this, Padma Shri Awardee, Dr KK Aggarwal, President, HCFI, said, “That alcohol has negative health is a fact known to all. Yet, excessive alcohol consumption, which includes binge drinking and heavy drinking, is very prevalent and is becoming a public health problem.  There is consensus that non-drinkers should not start and the ones who drink can continue provided they do so in moderation and in the absence of contraindications. People who have been lifelong abstainers cannot be easily compared with moderate or even rare drinkers. Recommending alcohol intake to them even if they would agree to drink is not justified. Men can tolerate more alcohol than women. The ideal therapeutic dose of alcohol is around 6 gms per day. Medically safe limits are 10 g in one hour, 20 g in a day, and 70 g in a week (50% for the women).”

Abstinence is the best solution but not every individual will be able to achieve the same and they may be put on controlled drinking to reduces risk to patients.

Adding further, Dr G K Mani Padma Shri Awardee said, “There is no value for controlled drinking, lower the better. Restrict to minimum amount for least days in a week. Controlled drinking is more likely for people with a mild disorder (or at-risk drinking) and may not be a more severe disorder. In non-pregnant women and patients without other co-morbidities the ideal dose of alcohol for mortality benefit is around 6 g (about one-half of a standard drink) per day.”

Some recommendations

·         Understand why you want to stop and put it in writing. Write what you want to achieve for example will feel healthier; will sleep better, will improve my relationships. For the initial few weeks, keep track of every drink. Note the situations you are most likely to drink in and try avoiding them.

·         Those who are cutting back should set a limit as per their health. Most healthy people should limit to less than 40 ml in one hour, 80 ml in one day and less than 240 ml in a week. Women should take less than half of this amount. Even better would be not keep alcohol within your reach. Observe spiritual retreats as this will help you revisit your commitment to not drink.

·         Eat your drink. Drinking slowly can help. Sip and do not gulp. Sip soda, water, or juice after each drink. This is called Mindfulness drinking. Never drink on an empty stomach.

·         Keep busy. Take a walk, play sports, go out to eat, or catch a movie. When you’re at home, pick up a new hobby or revisit an old one.

·         Ask for support. Let friends and family members know that you need their support.Stay away from people and places that make you want to drink. Learn to say no. Do not drink just because others are, and you shouldn’t feel obliged to accept every drink you’re offered. Lastly, be persistent.

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