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About 2 to 4 million US residents suffered from severe, debilitating, and fatal injuries caused by prescription drug side effects in 2011, according to the Institute for Safe Medication Practices, which monitors drug adverse events in the United States. The annual data published by its QuarterWatch surveillance program shows that the FDA got 179,855 serious drug side effect injury reports in 2011, which include 21,002 reports directly from healthcare professionals and consumers through the MedWatch system and 158,853 adverse events corroborated by manufacturers. The numbers released are 9.4 percent or 15,386 instances more than annual drug injury cases reported in the previous year.
The Institute for Safe Medication Practices has identified 10 drugs that led the list of adverse events associated with prescription medication in 2011. Anticoagulant medication Pradaxa, produced by German drug maker Boehringer Ingelheim, tops the list, followed by warfarin-based anticoagulant Coumadin - manufactured and marketed by Bristol-Myers Squibb. Antibiotic Levaquin, Cipro, and Bactrim, chemotherapy drugs Carboplatin and Cisplatin, ACE inhibitor Zestril, anti-cholesterol drug Zocor, and antidepressant Cymbalta complete the remaining places on the list of 10 drugs most frequently reported for their safety issues, target of consumer groups, and subject to litigations.
The most reported drug for side effect injuries, oral anticoagulant Pradaxa was approved for marketing in October 2010. Within a year of introduction, the blood thinner was blamed for 542 deaths and 2,367 instances of hemorrhage. The FDA has also received 644 complaints linking the drug to heart stroke, 291 reports citing acute renal failure, and 15 others claiming liver failure. In February 2012, the FDA asked manufacturer Boehringer Ingelheim to update drug label warnings to include risks of death caused by internal bleeding, cardiovascular disorders, and kidney failure caused by Pradaxa side effects. Close to 200 Pradaxa lawsuits await trial in California, Illinois, Connecticut, and other federal and state courts.
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Warfarin-based blood thinner Coumadin was next to Pradaxa in the number of side effect injury complaints made to the FDA. Introduced in 1954, the blood thinner has consistently been reported for fatal hemorrhage, severe internal bleeding, skin necrosis, and reduced bone mineral density. In 2011, the FDA received 1,106 Coumadin side effect injury reports that led to 72 deaths and 731 cases of hemorrhage. The FDA added a black box warning to Coumadin in October 2006, citing the potential risk of "major or fatal bleeding."
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Ranked third among the most reported drugs for side effects, Johnson & Johnson’s antibiotic drug Levaquin was named in 976 complaints. Introduced in 1996, the antibacterial drug has been linked to liver damage, Stevens-Johnson syndrome, cardiovascular disorders, neurological problems, renal impairment, acute pancreatitis, and tendon ruptures. More than 3,000 Levaquin lawsuits filed in various US courts on the drug side effect injuries are awaiting trial.
Sold as generic Carboplatin and brand name Paraplatin, the chemotherapy drug was subject to 516 complaints in 2011. First introduced in 1989, the cancer drug causes toxicity that adversely impacts kidney functioning, leading to renal impairment. It also decreases platelet and white blood cells that puts users at the risk of infections and various complications.
With over 625 known reports of serious complications, the ACE inhibitor has been linked to hepatoxicity and serious liver failure in users. Used for the treatment of high blood pressure and congestive heart problems, Zestril by British-Swedish pharmaceutical AstraZeneca also impacts kidney functions and causes allergic reactions.
The chemotherapy drug marketed by Cadila Healthcare was first introduced in 1978. The FDA received about 450 Cisplatin side effect injury reports in 2011. The drug has been linked to kidney damage, nerve damage, hearing loss, metabolism disturbances, bone marrow suppression, and other serious side effects.
Merck’s cholesterol lowering drug Zocor was mentioned in over 550 side effect injuries reported through the MedWatch system. Introduced in 1991, Zocor is linked to cognitive disorders, diabetes, kidney failure and death, hypertension, and muscle injury. The drug carries FDA warning for myopathy and rhabdomyolysis risks. Hundreds of product liability lawsuits have been filed in various US courts following Zocor side effect injuries.
In 2011, the FDA received more than 1,000 voluntary and manufacturer-made adverse event reports associated with antidepressant Cymbalta. Produced by Eli Lilly and introduced in 2004, the drug reportedly does not offer any significant benefit over its traditional competitors. It causes serious central nervous system disorders, suicidal thoughts, hepatitis, liver injury, cholestatic jaundice, and urinary incontinence.
In the market for the last four decades, the antibiotic drugs cause a number of side effect injuries. Cipro, brand name of Ciprofloxacin, was mentioned in over 500 MedWatch reports in 2011. Bactrim was named in over 300 complaints.
Osteoporosis drug Fosamax, bone cancer medication Zometa, cancer drug Avastin, and antidepressant Lamictal rank high among other drugs reported for causing widespread side effects. Though the FDA received less than 200 direct reports on each of these drugs through its MedWatch system, the manufacturers disclosed to have noticed over 1,000 adverse event reports each for Fosamax and Zometa and 500 cases each for Avastin and Lamictal.
Arthritis drug Remicade had the infamous distinction of becoming the most reported drug for causing severe liver injury and liver failure. Paracetamol-class drug Tylenol was second with 139 complaints, 20 less than Remicade. According to the IMS report, epilepsy drug Lamictal caused the maximum number of skin problems reported. Antipsychotic drug Seroquel and anti-smoking drug Chantix led the maximum number of suicidal and self-injury reports.
Most of the aforementioned drugs carry FDA black box and other warnings. But their label warning and public health cautions have failed to improve the safety of consumers, who continue to suffer from serious side effects, including fatal injuries. Consumer groups are up in arms against manufacturers of these drugs for their failure to adequately research on medication side effects and convey consumers about potential injury risks. Hundreds of product liability lawsuits have also been filed in various federal and state courts across the United States against drug manufacturers, citing breach of trust, drug injury, and endangering public safety for commercial gains. The plaintiffs are livid over failure of manufacturers to warn consumers or withdraw the drugs despite thousands of confirmed reports of drug injury.
The FDA received 179,855 drug adverse event reports in 2011. Experts are unanimous that only 1 out of every 100 side effect injury reports reach the FDA MedWatch program and 99 go unreported. Measuring on this, we can count that there were at least 18 million serious reactions caused by prescription drugs in 2011. Even if a conservation estimate takes a lower estimate of about 10 percent, at least 1.8 million people stands affected. Failure of manufacturers to adequately warn about side effects affecting such a vast number of people is a cause of concern for public health and human resource in the country.
Instead of taking steps to address safety concerns, the drug manufacturers are aggressively promoting their products and making claims detrimental to the FDA guidelines. The federal justice department has found several instances where manufacturers are resorting to unjust marketing practices, including bribes to healthcare professionals and promotion of drugs for unapproved treatments.
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