Articles Posted in Defective Drug

Florida Pharmacy ErrorsCompounding pharmacies were only a fairly obscure $2 billion a year niche-industry regulated by state regulatory agencies until a recent outbreak of fungal meningitis caused by tainted pain relieving injections placed the industry firmly in the national spotlight.

Last year the outbreak killed 53 people, sickened over 720, and may have exposed as many as 14,000 patients to a relatively rare form of fungal meningitis.

Many were shocked to find out that, although compounding pharmacies make customized medications for doctors and medical institutions nationwide, the U.S. Food and Drug Administration (FDA) does not regulate the industry. Rather, the pharmacies are overseen by state agencies that rarely, if ever, communicate with each other. Each state has varying sets of rules with varying degrees of expertise and oversight powers when it comes to regulating compounding pharmacies.

According to a report issued by Congressman Ed Markey (D-MA), many of these state agencies don’t even know basic information such as which pharmacies are compounding drugs or how much medication they make.
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The Florida pharmaceutical defect attorneys at Farah & Farah have learned that the U.S. Food and Drug Administration (FDA) has announced that all lots of the anemia drug, Omontys, which is used in conjunction with kidney dialysis, have been recalled due to allergic reactions that have injured – and even killed – some patients.

The FDA says it received 19 reports of anaphylaxis, a severe allergic reaction, and that three patients had died as a result. The others required hospitalization or prompt medical intervention to save their lives.

Takeda Pharmaceutical and Affymax, which jointly market the drug, have claimed that “hypersensitive reactions” from the use of Omontys are rare and according to their findings occur in two out of every 1,000 patients. Strangely, the companies reported that five deaths had been linked to allergic reactions caused by the drug – a discrepancy from the three deaths reported by the FDA.
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Florida Lipitor RecallThe largest manufacturer of generic Lipitor, Ranbaxy Pharmaceuticals, has ceased production of the drug while it sorts out why glass particles may have ended up in its pills.

Although there have been no reported injuries due to the pills contaminated with the sand-grain-sized glass particles, The U.S. Food and Drug Administration (FDA) reported the company would stop manufacturing the active ingredient made at one of the company’s plants in India. Earlier this month, Ranbaxy recalled 40 lots of pills that had been contaminated with glass.
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FL FDA Defective Drug ApprovalA recent report in the Journal of the American Medical Association (JAMA) is calling into question whether the U.S. Food and Drug Administration’s (FDA) expedited drug approval process is doing more harm than good.

The JAMA report stated that medicines are getting onto the market without proper safety analysis and that is compromising prescription drug safety. The authors, two well-known drug safety experts, cited three drugs in particular that have exposed patients to unforeseen risks. They are: Caprelsa, a drug that treats advanced thyroid cancer; Gilenya, a medication used to prevent multiple sclerosis relapse; and Pradaxa, an anticoagulant used for stroke prevention.
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FL Defective Drug IllnessEvery year, thousands of Americans overdose on prescription opioid painkillers like morphine, methadone, and oxycodone – which lead to thousands of consumer injuries and fatalities in the United States.

After years of issuing warnings about the prescription painkillers, the U.S. Food and Drug Administration (FDA) has announced it is taking its first step toward curbing this epidemic of overdoses by requiring drugmakers to fund training programs that target U.S. doctors who prescribe the painkillers.

The FDA says firms that sell the drugs must offer two to three hours of training to prescribers. However, the drug companies will not design the courses, but will be required to hand off that responsibility to companies that provide continuing education for health professionals- presumably to avoid conflict of interest issues.
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Americans may not know that about 80 percent of the active ingredients in many of their medications are produced at 3,700 foreign plants in China, India, and other countries. With less oversight overseas, pharmaceutical companies and device manufacturers can make more product faster and cheaper. China and India do not have the standards of the U.S. Food and Drug Administration (FDA) and it has cost in a lack of American confidence every time there is a drug recall over a contaminated imported drug, such as the contamination of the blood thinner heparin that was linked to 81 deaths. In the heparin case, the Chinese government refused to open the plant to FDA inspectors.

The New York Times reports that a landmark agreement, expected to receive Congressional approval, should offer a solution. A number of generic drug companies will provide $299 million every year to fund U.S. inspections of foreign plants. The move is long overdue. The FDA can barely keep pace with domestic plants and the Times reports that about 64 percent of foreign drug manufacturing plants have never been inspected by U.S. regulators.
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Kaiser Permanente researchers, in a study published in the Archives of General Psychiatry, have found that antidepressant use, particularly during the first trimester of a pregnancy, tripled the risk of autism. The risk was doubled among mothers taking an antidepressant at any time one year prior to delivery.

The study, funded by the Centers for Disease Control and Prevention (CDC), included 1,805 children and measured the prenatal use of serotonin reuptake inhibitors (SSRI) which include Prozac, Zoloft and Celexa. In a population-based study among 1,507 children with autism spectrum disorder from Northern California, a survey was taken of the mother’s drug use and mental health history. After adjusting for a number of factors, the mothers of children with autism were twice as likely to have taken an antidepressant sometime the year before birth. Mothers who took the SSRI in the first trimester were three times as likely to have a child with autism. However, researchers suggest women not change their drug regimen without first talking to their doctor.
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Chantix, the smoking-cessation drug, has been in the news for causing vivid dreams and devastating personality-altering effects in some users. Now there is more bad news for Chantix. The drug, made by Pfizer, is the subject of a published report in the Canadian Medical Association Journal. Authors conducted a meta-analysis on Chantix and found a 72 percent increase in the risk of congestive heart failure along with stroke and other problems.

Consumer Affairs reports the U.S. Food and Drug Administration (FDA) just last month, ordered a stronger warning for the Chantix label and medical guides. The study comes out of Johns Hopkins School of Medicine and concludes these findings are “another reason to consider avoiding Chantix altogether.”
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The consumer group Public Citizen wants the Food and Drug Administration (FDA) to warn consumers and doctors about a link between the osteoporosis drug Aclasta and serious renal toxicity, which can be fatal. Canada warned the public five months ago, and in a letter to the FDA, Public Citizen’s Health Research Group reports that Canada took action after it was revealed there have been 265 cases of kidney impairment after taking Aclasta, known as Reclast in the U.S. Even though it has a different name from the drug sold in Canada, the drugs are identical.

While Canada has reacted by requiring Novartis, the drug maker, to issue additional and more serious warnings, Dr. Sidney Wolfe wrote to FDA Commissioner Margaret Hamburg that the FDA has failed to require Novartis to alert the public to the possibility of a life-threatening adverse events.
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The Food and Drug Administration (FDA) has just issued a Recall and Safety Alert concerning the serious side effects that appear to be linked to a class of osteoporosis drugs called bisphosphonates. Use of the drugs is linked to an uncommon fracture – atypical fractures of the femur – which are seen in less than 1 percent of all hip and femur fractures. The femur fractures are called subtrochanteric and diaphyseal and for several years have been linked to patients taking bisphosphonates.

Bisphosphonates are marketed as the prescription drugs, Fosamax (alendronate sodium), Actonel (risedronate sodium), Boniva (ibandronate sodium), Atelvia (risedronate sodium), Reclast (zoledronic acid), and their generic equivalents. The FDA says a positive association has not been established, however, healthcare professionals are warned to look for atypical femur fractures in osteoporosis patients under treatment with these drugs and should continue monitoring these patients. Patients under treatment for more than 5 years should be re-evaluated as to whether bisphosphonate therapy should be continued. Symptoms might include a dull groin or thigh pain which can occur sometime in advance of the fracture. The new information will be included in the drugs’ labeling and Medication Guide that comes with the prescription.
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