Red Alert

Sildenafil should be avoided in valve disease with residual pulmonary hypertension

Sildenafil should not be used to treat residual hypertension in patients with valvular heart disease, according to a latest research find up. Pulmonary hypertension refers to increased blood pressure in the pulmonary artery. In patients with long-standing valvular disease, the high pressure in the left side of the heart is transmitted backwards to the lung vessels which react by thickening. This process may not revert after valve treatment, resulting in persistent pulmonary hypertension.

 Ibuprofen associated with blood pressure risein arthritis patients at cardiovascular risk

Ibuprofen is associated with increased blood pressure and hypertension compared to celecoxib in patients with osteoarthritis or rheumatoid arthritis and increased risk of cardiovascular disease, according to a new research findings. Nonsteroidal anti-inflammatory drugs (NSAIDs), both non-selective and selective cyclooxygenase-2 (COX-2) inhibitors, are among the most widely prescribed drugs worldwide, but are linked with increased blood pressure and adverse cardiovascular events.

 Use of ACE inhibitors with ARBs Risky

Combined use of two drugs that act on renin angiotensin system (RAS) i.e. a member of ACE inhibitors along with a member of Angiotensin II Receptors Blockers (ARBs) is associated with increased risks of hypotension, hyperkalaemia and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors (such as enalapril or lisinopril with losartan or telmisartan) do not obtain any additional benefit compared to monotherapy. Hence, combined or concurrent use of Ace inhibitors with ARBs should be avoided. Use of drugs that act on the RAS during second and third trimesters of pregnancy reduce foetal renal function and increase foetal and reonatal morbidity and death.

 No benefit of Paracetamol with Ibuprofen FDC

The Fixed Dose Combination (FDC) of paracetamol with Ibuprofen is no better than either paracetamol or ibuprofen taken alone in relief of musculo-skeletal pain according to a double blind, randomized controlled trial undertaking at the Department of Emergency Medicine, Stony Brook University, New York. A total of 90 patients were administered either ibuprofen 800mg or paracetamol 1g or FDC of both. There was no difference in the relief of pain among the three groups. Side effects of FDC are more by consuming two drugs together than individual ingredients.

Oral Ketoconazole banned in Europe

Due to risk of severe liver injury oral ketoconazole has been banned in all the member states of the European Union. The decision was taken after detailed review following the drug’s ban by the French medicine regulator, the National Agency for the Safety of Medicines and Health Products (ANSM). Though hepatotoxicity is a class effect with azole antifungals but incidence and seriousness is higher in case of ketoconazole including hepatitis, cirrhosis and liver failure with fatal outcome requiring liver transplantation. The onset of hepatotoxicity has been reported as early as one month after use. The efficacy studies on ketoconazole are limited. Safer alternatives are available.

 Do not use Repaglinide & Clopidogrel together

Health Canada has warned prescribers and patients against concurrent use of Repaglinide (indicated in the treatment of diabetes sold under trade names of Regan, Repilin etc.) and Clopidogrel, (a medication meant to prevent heart attacks & strokes sold in India under the trade names of Plavix, Clopilet, Clopid, Noklot etc.) under any circumstances due to risk of severe hypoglycaemia levels due to a drug-drug interaction. In a study conducted with healthy volunteers, co-administration of clopidogrel (300mg on day 1, followed by 75mg daily for 2 consecutive days), and repaglinide (single dose of 0.25mg on day 1 and day 3) resulted in an increase in repaglinide systemic exposure by 5.1 fold and 3.9 fold on day 1 and day 3 respectively. Hypoglycaemia was noted in health volunteers on day 1 (3.3mmol/L) and on day 3 (3.9mmol/L).

Increased risk of Bladder Cancer in Pioglitazone-containing medicines

As a result of an updated review, the FDA has concluded that use of the type 2 diabetes medicine pioglitazone (Actos, Actoplus Met, Actoplus Met XR, Duetact, Oseni) may be linked to an increased risk of bladder cancer. FDA alerted the public about the possible risk of bladder cancer in September 2010 and June 2011 based on interim results from a 10-year epidemiologic study. Health care professionals should not use pioglitazone in patients with active bladder cancer, and should carefully consider the benefits and risks before using pioglitazone in patients with a history of bladder cancer.

Aspirin-containing over-the-counter antacid products

The US FDA has warned consumers about the risk of serious bleeding when using over-the-counter (OTC) aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach. A search of the FDA Adverse Event Reporting System (FAERS) database identified eight cases of serious bleeding events associated with these products after the warning was added. All of these patients were hospitalized. As a result, the FDA will continue to evaluate this safety concern and plan to convene an advisory committee of external experts to provide input regarding whether additional actions are needed.

PPIs may increase risk of CAP

Proton pump inhibitors (PPIs) are commonly prescribed for certain gastrointestinal conditions. It is suspected, however, that in altering the acidity of the stomach, the drugs may promote bacterial overgrowth and colonization leading to pneumonia. U.K. and Saudi researchers teamed up to investigate this potential association. The study population included 160,000 adults with a new PPI prescription and individually matched control patients. Observational data was analyzed using three different analytic approaches. While a multivariable Cox regression model indicated that risk for community–acquired pneumonia (CAP) was 1.67 times higher among PPI users than non–users, a self–controlled case series and a prior event rate ratio analysis pointed to lower risk in the 30 days and 12 months, respectively, after PPI prescription than in the 30 days and 12 months before.

FDA issues warning for anesthetic drug use in young children

The USFDA has issued a drug safety communication for young children and pregnant women regarding the use of general anesthetic and sedation drugs during surgeries or procedures. The new warning indicates that these drugs may cause damage to the development of children’s brains with repeated or lengthy use. Label warnings will now be required by the FDA to inform the public about the potential risk to children’s brain development. The use of general anesthetic and sedation drugs will continue to be monitored by the FDA for further information about adverse events. The FDA encourages health care professionals to assess appropriate use of these drugs and balance the benefits against potential risks with each patient, especially for procedures taking longer than 3 hours or in multiple procedures required for children younger than 3 years old.

Levetiracetam and methotrexate

Health Canada has recommended that the product information for levetiracetam and methotrexate products is updated to provide information about drug-drug interaction, which could lead to greater amounts of methotrexate in the blood. Product labelling now recommends that blood methotrexate and levetiracetam levels should be carefully monitored in patients treated with the two drugs at the same time. The manufacturer of levetiracetam provided 13 international reports of a potential interaction between levetiracetam and methotrexate. Of these 13 reports, five noted that patients who were taking both levetiracetam and methotrexate at the same time had greater amounts of methotrexate in their blood. Health Canada's safety review concluded that there is a potentially greater risk of adverse effects when levetiracetam and methotrexate.

Direct-acting antiviralsfor hepatitis C

The US Food and Drug Administration (FDA) has requested that a boxed warning about the risk of hepatitis B virus (HBV) reactivation is added to the drug labels of direct-acting antivirals for hepatitis C (DDAs). This warning should also be included in the patient information leaflets or medication guides for these medicines. The FDA identified 24 cases of HBV reactivation from reports submitted to the FDA. Of the cases reported, two patients died and one required a liver transplant. Health-care professionals are recommended to screen all patients for evidence of current or prior HBV infection before starting treatment with DAAs, and to monitor patients using blood tests for HBV flare-ups or reactivation during treatment and post-treatment follow-up.

  Dhaka -

Saturday 20 Jan 2018

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