Health

Adverse Effects of Anticoagulant Drugs Very Alarming, ISMP Reports

Anticoagulant drugs, which include Xarelto, Pradaxa, and Coumadin, have been reported by the Institute for Safe Medication Practices (ISMP) as having the highest and most serious adverse events among drugs that are being monitored due to safety issues. For the year 2012 alone, about 762 deaths were attributed to these drugs. In total, adverse reports received by the Food and Drug Administration (FDA) for the same period was an astounding 5,897 cases. ISMP mentioned in its report that these figures may only represent a small fraction since not all medical practitioners or patients report adverse effects.

lawsuit1Already, lawsuits have been filed by patients injured by these drugs against the manufacturers. Recent reports have it that the manufacturer of Pradaxa is in the process of settling over 4,000 lawsuits in the United States for an estimated amount of $680 million. Closely behind are the lawsuits being filed against Bayer AG and Janssen Pharmaceutica for the injuries sustained as a result of using Xarelto. Updates from www.xareltoclassaction.us show that more cases are expected to be filed as patients seek representation for legal remedies that may include class action lawsuits or individual claims.

Fatal Complications Attributed to Anticoagulant Drugs
It was noted in the ISMP report that over a million patients, particularly those diagnosed with artial fibrillation or those who has undergone hip or knee surgeries are given anticoagulant drugs to reduce any possible complications. It is very regrettable that majority of these patients experience serious and fatal hemorrhages and other severe adverse effects.

This has led the ISMP to classify Xarelto and the other anticoagulant medications as a top priority drug safety issue. To support this were the very high number of adverse reports received by the FDA for the year 2012. Aside from the high volume when compared to other drugs under the watch-list, these medications stand out for the severe and dangerous side effects. Not only were patients exposed to fatal internal bleeding, but there was a substantial number of deaths reported.

Xarelto Outnumbers Pradaxa in Adverse Reports
The partial report of ISMP for the year 2013 may only be considered as very disturbing especially in the case of Xarelto. While adverse reports in 2012 showed Pradaxa with the most number of complications by a ratio of 3:1 against Xarelta, the first quarter of the year 2013 showed Xarelta outnumber Pradaxa. The number of adverse reports against Xarelto is expected to increase further considering that prescriptions for this drug account for one million every quarter. Various sectors have expressed grave concern on this unfortunate trend and are wary of the attempts of the manufacturers to increase the coverage of Xarelto in terms of medical conditions to be treated by this medication.

References:
ismp.org/quarterwatch/pdfs/2012Q2.pdf
ismp.org/quarterwatch/pdfs/2013Q1.pdf
reuters.com/article/2014/06/14/us-bayer-suit-idUSKBN0EP0HW20140614

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