Medicines safety update proton pump inhibitor

The TGA has concluded that there is no evidence of a causal association between Prevenar and deaths in children in Australia. The TGA's finding is consistent with that of a Japanese advisory panel, which also found no direct causal association between the deaths and the vaccines.

The suspension of these vaccines is expected to be lifted in Japan. This is an example of many similar investigations the TGA conducts using the Adverse Drug Reactions Database and other resources in response to safety concerns raised internationally and nationally, to determine the appropriate action required, if any, in Australia. In early May, the TGA launched its new website at www. The website improves access to important information on the safety and regulation of medicine in Australia.

The new site makes it easier to find the 'blue card' adverse reaction reporting form and links to information about reporting online or to the Adverse Medicine Events Line for consumers. From the home page, click on 'Report a problem' on the right of the page, or choose 'Reporting problems' from the 'Safety Information' menu at the top of the page. A medicine can be recalled when a deficiency is identified in its quality, safety or efficacy. There are about 40 medicine recalls each year in Australia.

Medicines are recalled when a deficiency is identified in their quality, safety or efficacy. This might include simple labelling or packaging errors, or a more serious increase in unexpected side effects. Recalls in Australia are often initiated by sponsors when they become aware of a problem with a product.

Companies wishing to recall their medicine in Australia contact the TGA to discuss their proposed recall strategy and communication plan. The Australian company has the prime responsibility for the conduct of the recall by contacting suppliers and recovering product.

The TGA's role isto review reports on the recall supplied by the company. The TGA can take further action if the recall is not progressing satisfactorily. Most recalls can be traced back to a single incident within the product's manufacturing site. The majority of recalls are batch-specific and companies are readily able to supply replacement batches that are not defective.

In most cases, defective batches are recalled from wholesalers or pharmacies. If the risks posed by the product defect are unacceptable the company will attempt to recover product from consumers. In such recalls companies normally place recall notices in national newspapers and provide information to pharmacists and doctors who may have sold or prescribed the medicine. For example, in , batches of two medicines were recalled because of concerns that cartons may have included tablets of a different strength.

In both cases, letters were sent to pharmacists and notices were placed in newspapers. In December , Pfizer Australia Pty Ltd initiated a recall of sitaxentan Thelin , used for pulmonary hypertension, following a safety review that found that the benefits of sitaxentan no longer outweighed the risks.

In the first stage of the recall, wholesalers were notified to cease distribution of the medicine to pharmacies, and the sponsor informed pharmacies and prescribers of the need to start switching patients to alternative therapies.

In the second stage, a recall notice was issued to retail and hospital pharmacies requesting them to return the product. Additional Information for Healthcare Professionals. The cases from the literature included patients on diuretics when either a change in diuretic was not associated with an improvement in serum magnesium level, or b when increase in serum magnesium level occurred with documented PPI discontinuation.

However, because hypomagnesemia is likely under-recognized and under-reported, the available data are insufficient to quantify an incidence rate for hypomagnesemia with PPI therapy. Hypomagnesemia has been reported in adult patients taking PPIs for at least three months, but most cases occurred after a year of treatment. Approximately one-quarter of these cases required discontinuation of PPI treatment in addition to magnesium supplementation.

Some cases cited both positive dechallenge as well as positive rechallenge i. After discontinuing the PPI, the median time required for the magnesium to normalize was one week.

After restarting the PPI, the median time to develop hypomagnesemia again was two weeks. In most cases reviewed the patients did not continue on PPIs after the hypomagnesemia was treated. Examples of positive dechallenge in two patients include a year-old woman and a year-old man who were both treated with PPIs for 6 and 11 years, respectively. Both patients presented with seizures and hypomagnesemia. Although both patients' hypomagnesemia partially resolved with intravenous replacement, in both cases discontinuation of PPI treatment was necessary to stop ongoing symptoms and to stop magnesium loss.

Clinically serious adverse events were consistent with commonly reported signs and symptoms of hypomagnesemia, which are similar to the signs and symptoms reported with hypocalcemia. The serious events included tetany, seizures, tremors, carpo-pedal spasm, atrial fibrillation, supraventricular tachycardia, and abnormal QT interval. Hypomagnesemia also produces impaired parathyroid hormone secretion which may lead to hypocalcemia.

In cases where comprehensive clinical laboratory data were available, most patients had concomitant hypocalcemia and normal parathyroid hormone levels. Therefore, these findings confirm hypomagnesemia as the primary deficit. The mechanism responsible for hypomagnesemia associated with long term PPI use is unknown; however, long term use of PPIs may be associated with changes in intestinal absorption of magnesium.

OTC PPIs are labeled for 14 days of use, and this treatment course may be repeated every 4 months, up to 3 times per year. FDA acknowledges that consumers, either on their own, or based on a healthcare professional's recommendation, may take these products for periods of time that exceed the directions on the OTC label. In children, abnormal heart rates may cause fatigue, upset stomach, dizziness and lightheadedness.

Tell your healthcare professional if you have ever been told you have low magnesium levels in your blood, or if you take the drug digoxin, diuretics, or other drugs that may cause hypomagnesemia. Your healthcare professional may occasionally check your serum magnesium level a blood test while you are taking your prescription PPI drug.

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website. Overview Proton pump inhibitors PPI are widely used for treatment of gastro-oesophageal reflux GERD , Helicobacter pylori eradication, prophylaxis of gastrointestinal ulcer, as well as in patients who are taking non-steroidal anti-inflammatory drugs NSAIDs.

Advice for Healthcare Professionals Be alert on the risk of microscopic colitis associated with the use of proton pump inhibitors. Diarrhoea is one of the symptoms of microscopic colitis. Avoid unnecessary treatment with PPIs to reduce the possible risk of microscopic colitis and discontinue the therapy where appropriate. Ernest H. Law et al. Association between proton pump inhibitors and microscopic colitis: Implications for practice and future research.

Annals of Pharmacotherapy.