Non-Steroidal Anti Inflammatory Drugs (NSAIDs):

More presentations from Naina Mohamed Pakkir Maideen

Ø Non-Steroidal Anti Inflammatory Drugs (NSAIDs) relieve pain and inflammation by inhibiting the synthesis of Prostaglandins (PGs) through the blockade of Cycloxygenase (COX) enzyme.

Ø  NSAIDs are classified as…

·       Salicylic acid derivatives (Aspirin, Diflunisal)

·       Propionic acid derivatives (Ibuprofen, Ketoprofen, Naproxen)

·       Acetic acid derivatives (Diclofenac, Aceclofenac, Ketorolac,  Indomethacin)

·       Enolic acid derivatives (Meloxicam, Piroxicam, Tenoxicam)

·       Fenamates (Mefenamic acid, Meclofenamic acid)

·       Butylpyrazolidines (Phenylbutazone)

·       Cox 2 inhibitors (Celecoxib, Etoricoxib)

·       Anilides (Paracetamol (Acetaminophen))

Ø NSAIDs are indicated in Inflammation, Pain, Fever, Cardioprotection, Patent Ductus arteriosus (PDA), Bartter Syndrome and Systemic mastocytosis.

Ø NSAIDs except Cox 2 inhibitors block both COX 1 and COX 2 enzymes. Inhbition of COX 1 by NSAIDs is responsible for the GI side effects.

Ø The Adverse Drug reactions (ADRs) of NSAIDs include

·       Gastro intestinal ulceration (Anorexia, nausea, dyspepsia, abdominal pain, and diarrhea)

·       Hypersensitivity reactions (Pseudoallergic and allergic reactions)

·       Risk of Hemorrhage

·       Risk of Thrombosis

·       Early closure of Ductus Arteriosus

·       Renal Ischemia

·       Risk of Edema

Ø NSAIDs are contraindicated in the following conditions

·       Active gastric or duodenal ulcer

·       Bronchial Asthma

·       Third trimester of pregnancy

·       Hypersensitivity to NSAIDs

Ø The risk of bleeding is increased by the concomitant use of NSAIDs and Anticoagulants, Antiplatelets or Fibrinolytics.

Ø Co-administration of NSAIDs and Leflunomide, Teriflunomide or Lomitapide increase the risk of liver damage.

Ø The risk of kidney damage is elevated by the concomitant use of NSAIDs and Adefovir, Cidofovir, Tenofovir, Tacrolimus, Sirolimus, Sodium Biphosphate or IV Immunoglobulins.

Ø GI complications may be increased with the use of NSAIDs and Corticosteroids or SSRIs.

Adverse Drug Reactions (ADRs):

More presentations from Naina Mohamed Pakkir Maideen

Ø Unwanted or harmful reaction experienced after the drug administration is termed as “Adverse Drug Reactions (ADRs)”.

Ø Risk Factors for Adverse Drug Reactions (ADRs):

·       Multiple Drug Therapy

·       Age

·       Gender

·       Pregnancy and Breastfeeding

·       Intercurrent disease

·       Drug allergy

Ø Classification of ADRs:

·       Type A (Augmented) reactions

·       Type B (Bizarre) reactions

·       Type C (Chronic) reactions

·       Type D (Delayed) reactions

·       Type E (End-of-use) reactions

Ø Type A (Augmented) reactions:

o  Related to Pharmacological actions of drugs

Ø Type B (Bizarre) reactions:

o  Unrelated to Pharmacological actions of drugs

Ø Type C (Chronic) reactions:

o  Persist for a long time

Ø Type D (Delayed) reactions:

o  Become apparent sometime after the use of a medicine.

Ø Type E (End-of-use) reactions:

o  Associated with the withdrawal of a medicine

Ø “Pharmacovigilance” is the science and activities relating to the detection, education, understanding and prevention of adverse drug reactions or other drug related problems.

Ø Pharmacists and Prescribers play major roles in the reporting of ADRs.

FDA's notification on SWAG (Sex With A Grudge)

 Dr.Naina Mohamed Pakkir Maideen

Ø On 16^th Apr 2014, The Food and Drug Administration (FDA) is advising consumers not to purchase or use S.W.A.G (Sex With A Grudge).

Ø S.W.A.G is promoted and sold for sexual enhancement on various websites, including www.SexWithAGrudge.com, and in some retail stores.

Ø  FDA laboratory analysis confirmed that S.W.A.G contains Sildenafil.

Ø Sildenafil is a Phosphodiesterase 5 (PDE 5) inhibitor, useful for the treatment of Erectile Dysfunction (ED).

Ø Undeclared Sildenafil may pose a threat to the people taking Nitrates, Protease inhibitors and other CYP3A4 inhibitors.

Ø Concomitant use of SWAG (Undeclared Sildenafil) and nitrates (Nitroglycerin) is contraindicated due to the possible reduction of blood pressure to dangerous levels.

Ø It is contraindicated to use SWAG (Undeclared Sildenafil) 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).

Ø The risk of sildenafil adverse effects (hypotension, visual changes, priapism) is elevated due to the co-administration of SWAG (Undeclared Sildenafil) and CYP3A4 Inhibitors like  Macrolide antibiotics (Telithromycin, Erythromycin, Clarithromycin) and Antifungals (Voriconazole, Itraconazole, Ketoconazole)

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

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

Ø FDA 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.” 

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

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

FDA’s Notification on “Infinity”

 Dr.Naina Mohamed Pakkir Maideen

·       On 10^th Apr 2014, The Food and Drug Administration (FDA) is advising consumers not to purchase or use “Infinity”.

·       Infinity is promoted and sold for weight loss on various websites, and in some retail stores.

·       FDA laboratory analysis confirmed that Infinity contains Sibutramine.

·       Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. 

·       Undeclared ingredient (Sibutramine) may inhibit the reuptake of mono amines (Serotonin, Noradrenaline and Dopamine) and increase the risk of Nonfatal myocardial infarction and nonfatal stroke in patients with preexisting cardiovascular diseases.

·       Concomitant administration of “Infinity” (Undeclared ingredient (Sibutramine))  and MAO inhibitors, may be contraindicated due to serious, fatal reactions.

·       “Infinity” (Undeclared ingredient (Sibutramine)) may interact majorly with SSRIs, SNRIs and tricyclic antidepressants and increase the risk of Serotonin syndrome.

·       The risk of upper gastrointestinal (GI) bleeding may be increased by the co-administration of “Infinity” and NSAIDs.

·       “Infinity” may interact with decongestants and increase the blood pressure and heart rate.

·       Sibutramine toxicity may be increased by the coadministration of “Infinity” and CYP3A4 enzyme inhibitors (Ketoconazole, Erythromycin, etc.).

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

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