Diabetes and Fasting:

 Dr.Naina Mohamed Pakkir Maideen

ª  The risks associated with Fasting in Diabetes patients include…

Ø Hypoglycemia

Ø Hyperglycemia

Ø Diabetic Ketoacidosis

Ø Dehydration

Ø Thrombosis

ª   The healthcare professionals should be aware of potential risks associated with fasting in diabetics and appropriate measures to mitigate those risks.

ª   The diabetics should undergo Pre-Ramadan medical assessment 1-2 months before Ramadan.

ª   During assessment, the diabetics should be informed about the risks associated with Fasting, advice to monitor them and changes in diet or medication regimen.

ª   Ramadan-focused structured education should be targeted both the healthcare professionals and the diabetics.

ª   The healthcare professionals should be trained to achieve safer fasting in diabetics. The education program should include informations on basics of “Diabetes and Fasting” such as

Ø Glucose monitoring

Ø Meal planning to avoid hypoglycemia and dehydration

Ø Meal choices to avoid postprandial hyperglycemia

Ø Timing and intensity of physical activity during fasting

Ø Use of diabetes-related medications and their potential risk during fasting

FDA's warning against “Toxin Discharged Tea”:

More Presentations from Dr.Naina Mohamed Pakkir Maideen

§  On 17^th June 2014, the Food and Drug Administration (FDA) is advising consumers not to purchase or use “Toxin Discharged Tea”.

§  Toxin Discharged Tea is a product promoted and sold for weight loss on various websites and in some retail stores.

§   FDA laboratory analysis confirmed that “Toxin Discharged Tea” contains Fluoxetine.

§  Fluoxetine is a Selective Serotonin Reuptake Inhibitor (SSRI) and is approved to treat depression, bulimia, obsessive-compulsive disorder (OCD), panic disorder, and premenstrual dysphonic disorder (PMDD).

§  SSRIs including Fluoxetine are not approved by the U.S. Food and Drug Administration (FDA) for weight loss.

§  Due to the content of Fluoxetine, Toxin Discharged Tea may cause some serious Adverse effects including Serotonin syndrome, Suicidal thoughts, Depression, worsening, Mania, Prolonged QT interval, Serious Bleeding, Seizure, etc.

§  Due to the content of Fluoxetine, Toxin Discharged Tea use is contraindicated in patients taking…

Ø Metoclopramide

Ø MAO Inhibitors (Linezolid, Nialamide, Toloxatone,  Methylene Blue (IV), Clorgyline, etc)

Ø CYP2D6 substrates (Thioridazine, Pimozide, Iloperidone)

Ø QT Interval Prolonging Drugs like Terfenadine, Mesoridazine, etc.

§  Toxin Discharged Tea (Fluoxetine) may also have major interaction with drugs such as…

Ø  Tricyclic antidepressants (Imipramine, Desipramine)

Ø Serotonergic agents (Sumatriptan, Rizatriptan or other antidepressants)

Ø Class Ia Antiarrhythmic Agents (Quinidine, Procainamide, Disopyramide)

Ø Phenothiazines (Chlorpromazine, Fluphenazine)

Ø Anticoagulants (Warfarin)

Ø Antiplatelets ( Clopidogrel, Ticlopidine,  Prasugrel)

Ø NSAIDs (Ibuprofen, Aspirin)

§  The concomitant use of Toxin Discharged Tea (Fluoxetine) and Metoclopramide is contraindicated due to increased risk of Extrapyramidal reactions or Neuroleptic malignant syndrome (Fever, sweating, confusion, Muscle stiffness).

§  It is contraindicated to use Toxin Discharged Tea (Fluoxetine) and MAO Inhibitors (Linezolid, Nialamide, Toloxatone,  Methylene Blue (IV), Clorgyline, etc) due to CNS toxicity or serotonin syndrome (Restlessness, myoclonus, changes in mental status, hyperreflexia, diaphoresis, shivering, and tremor).

§  CYP2D6 substrates like Thioridazine, Pimozide, Iloperidone may interact with Toxin Discharged Tea (Fluoxetine) and risk of additive QT-interval prolongation which leads to the contraindication.

§  Coadministration of Toxin Discharged Tea (Fluoxetine) and QT Interval Prolonging Drugs like Terfenadine, Mesoridazine, Bepridil, Sertraline, Erythromycin, Telithromycin, is contraindicated due to increased risk of cardiotoxicity (QT prolongation, torsades de pointes, cardiac arrest).

§  FDA advises the Consumers to exercise caution before purchasing any product typically promoted for sexual enhancement, weight loss, and body building, and are often represented as being “all natural”.

FDA's warning against “Dick’s Hard Up”:

More Presentations from Dr.Naina Mohamed Pakkir Maideen

vOn 2^nd June 2014, The Food and Drug Administration (FDA) is advising consumers not to purchase or use “Dick’s Hard Up”.

vDick’s Hard Up is a product promoted and sold for sexual enhancement on various websites and in some retail stores.

vFDA laboratory analysis confirmed that “Dick’s Hard Up” contains tadalafil.

vTadalafil is a Phosphodiesterase 5 (PDE 5) inhibitor and is approved for the treatment of Erectile Dysfunction (ED).

vUndeclared Tadalafil may pose a threat to the people taking Nitrates, Protease inhibitors and other CYP3A4 inhibitors.

vConcomitant use of Dick’s Hard Up (Undeclared Tadalafil) and nitrates (Nitroglycerin) is contraindicated due to the possible reduction of blood pressure to dangerous levels.

vIt is contraindicated to use Dick’s Hard Up (Undeclared Tadalafil) in patients taking protease inhibitors such as Saquinavir, Ritonavir, Indinavir, Nelfinavir, Amprenavir, Fosamprenavir, Lopinavir, Atazanavir, , Tipranavir and Darunavir to prevent the risk of sildenafil adverse effects (hypotension, visual changes, priapism).

vThe risk of sildenafil adverse effects (hypotension, visual changes, priapism) is elevated due to the co-administration of Dick’s Hard Up (Undeclared Tadalafil) and CYP3A4 Inhibitors like  Macrolide antibiotics (Telithromycin, Erythromycin, Clarithromycin) and Antifungals (Voriconazole, Itraconazole, Ketoconazole)

vFDA warns the Consumers should stop using this product immediately and throw it away. 

vFDA advises the Consumers who have experienced any negative side effects should consult a health care professional as soon as possible. 

vFDA announces to the public of a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals.  These products are typically promoted for sexual enhancement, weight loss, and body building, and are often represented as being “all natural.” 

vFDA claims that they are unable to test and identify all products marketed as dietary supplements on the market that have potentially harmful hidden ingredients. 

vFDA advises the Consumers to exercise caution before purchasing any product in the above categories.

Olmesartan induced “Enteropathy”:

 Dr.Naina Mohamed Pakkir Maideen

§  Olmesartan is an Angiotensin II receptor blocking (ARB) agent.

§  Since Olmesartan has a longer half-life and a greater effect on systolic blood pressure than other ARB agents, it is widely prescribed for the management of hypertension.

§  FDA warns that Olmesartan can cause intestinal problems known as sprue-like enteropathy (severe, chronic diarrhea with substantial weight loss).

§  Health care professionals should advise their patients to contact them if they develop severe, chronic diarrhea with substantial weight loss while taking an olmesartan-containing product, even if it takes months to years for symptoms to develop.

FDA's warning against “B-Perfect”:

More Presentations from Dr.Naina Mohamed Pakkir Maideen

§  On 05^th June 2014, the Food and Drug Administration (FDA) is advising consumers not to purchase or use “B-Perfect”.

§  B-Perfect is a product promoted and sold for weight loss on www.icanb-perfect.com  and possibly sold in some retail stores.

§   FDA laboratory analysis confirmed that “B-Perfect” contains Sibutramine and Phenolphthalein.

§  The undeclared ingredient (Sibutramine), increase the risk of Nonfatal myocardial infarction and nonfatal stroke in patients with preexisting cardiovascular diseases by inhibiting the reuptake of mono amines (Serotonin, Noradrenaline and Dopamine).

§  Sibutramine is contraindicated in patients with heart and vascular diseases.

§  Due to the content of sibutramine, B-Perfect may interact with many drugs including…

Ø MAO Inhibitors (Selegiline, Rasagiline, Clorgyline, Pargyline, etc)

Ø Antidepressants (SSRI (Escitalopram, Fluoxetine), SNRI (Venlafaxine, Duloxetine) & Tricyclic antidepressants (Amitriptyline, Imipramine)

Ø NSAIDs (Ibuprofen, Diclofenac, etc.)

Ø Decongestants (Ephedrine or Pseudoephedrine)

Ø CYP3A4 enzyme inhibitors (Ketoconazole, Erythromycin, etc.)

§  Serious, sometimes fatal, reactions  such as Excitement, hypomania, restlessness, loss of consciousness, confusion, disorientation, anxiety, agitation, motor weakness, myoclonus, tremor, hemiballismus, hyperreflexia, ataxia, dysarthria, incoordination, hyperthermia, shivering, pupillary dilation, diaphoresis, emesis, and tachycardia may occur due to the interaction of sibutramine and MAO Inhibitors which increase the plasma levels monoamines (Serotonin (5-HT), Noradrenaline and Dopamine).

§  Excessive serotonergic stimulation and Increased risk of serotonin syndrome (Hypertension, Hyperthermia, Myoclonus, Mental status changes) may be resulted due to the interaction of sibutramine and antidepressants.

§  The risk of upper gastrointestinal (GI) Bleeding may be increased by the concomitant use of sibutramine and NSAIDs.

§  The Blood pressure and Heart rate may be elevated by the coadministration of sibutramine and decongestants.

§  Sibutramine toxicity may be resulted by concomitant use of sibutramine and CYP3A4 enzyme inhibitors.

§  Phenolphthalein is a chemical that is not an active ingredient in any approved drug in the United States.

§  Studies have indicated that Phenolphthalein presents a cancer-causing risk. 

§  FDA advises the Consumers to exercise caution before purchasing any product typically promoted for sexual enhancement, weight loss, and body building, and are often represented as being “all natural”.

Mefloquine associated “Psychiatric side effects”:

More Presentations from Dr.Naina Mohamed Pakkir Maideen

ª  Mefloquine hydrochloride is indicated for the treatment of mild to moderate acute malaria caused by mefloquine-susceptible P. falciparum and P. vivax, and prevention of malaria infections by P. falciparum (including chloroquine-resistant P. falciparum) and P. vivax.

ª  FDA is advising the public about strengthened and updated warnings regarding neurologic and psychiatric side effects associated with Mefloquine hydrochloride.

ª  Physicians who continue to prescribe mefloquine must exercise caution.

ª  If a patient develops neurologic or psychiatric symptoms, mefloquine should be stopped, and an alternate medicine (e.g., doxycycline) should be used.