Safety Concerns Mount for New Blood Thinners
Three medicines from various manufacturers are considered the forefront of treatments agains stroke and other conditions caused by clotting. They are Bayer and Johnson & Johnson’s Xarelto, apixaban by Pfizer and Bristol-Myers Squibb, and Pradaxa by Boehringer Ingelheim.
These new drugs hope to occupy space in the market for blood thinners that has been taken by warfarin. However, doctors have noted confusion over safety data. Common among the three new drugs is a concern about the potential for causing bleeding and complications resulting from it.
FDA Study Finds No Link Between ADHD Drugs and Cardiovascular Events
FDA recently notified the public that it studied the medical histories of over 1 million children and young adults to determine whether there was a link between stimulants commonly prescribed to treat ADHD and increased risk for stroke, heart attack, and sudden cardiac death. The study found no increased risk of cardiac events as a result of using these drugs.
The study comes as the first of three related to the relation of stimulant use to cardiac events. The next two studies focus on adults. Although the study found that major cardiac events were not more likely as a result of using ADHD drugs, it did note that increased blood pressure and heart rate have been observed in patients.
Painkiller Deaths on the Rise
The Centers for Disease Control and Prevention report that overdoses from prescription painkillers have overtaken the number of fatal overdoses for heroin and cocaine. Most people who are abusing painkillers use hydrocodone, methadone, oxycodone, and oxymorphone. CDC reports that users obtain these drugs through a number of channels including seeking doctors that will comply with their requests, illegal purchase, prescription forgery, and via pill mills. CDC presents prescription medication abuse as a public health crisis through a number of statistics.
Experts’ Legal Certainty
Expert testimony on the issue of causation can have a dramatic impact on juries. Experts are distinguished from lay witnesses partly because they can offer opinions on matters of fact that the jury is tasked with deciding. In practice, one limitation on the ability to offer an expert opinion is that the opinion-based testimony must be presented as an opinion and not as fact.
In a recent criminal appeal, the D.C. Court of Appeals held in Jones v. U.S. that expressions of ‘absolute certainty’ on issues of opinion were harmless error. The Court looked into government witnesses’ testimony on pattern matching – a way of linking spent ammunition cartridges to a firearm. At trial, the lower court allowed over objection the witness to testify that he was absolutely certain that the cartridges matched the firearm. The Court of Appeals held that the error was harmless for two reasons. First, the defense had the opportunity to cross-examine and used that opportunity to question the experts’ certainty. Second, the defense did not provide an expert to rebut the testimony of the government’s witness. Although the holding narrowly relies on the facts, the case offers an interesting glimpse into how an appellate court viewed an expert’s testimony.
Wyeth Limited by Expert Rules
A federal court held that a woman’s treating doctors could not be called upon to testify as to the causation of her breast cancer. The plaintiff sued Wyeth after developing breast cancer about four years after she started hormone replacement therapy to alleviate the symptoms of menopause.
During depositions, lawyers for Wyeth called upon the plaintiff’s treating doctors as fact witnesses. Through a motion to strike their testimony, the plaintiff’s lawyer argued that because Wyeth had not qualified the treating doctors as experts, they should not be allowed to testify as to causation of breast cancer. The judge held that testimony on causation of an injury alleged to be related to a pharmaceutical drug qualified as exactly the type of evidence for which Rule 702 was written. Because stating that type of causation requires speculation and opinion, reasoned the judge, the treating physicians could not testify as to the cause of the plaintiff’s breast cancer unless qualified as experts.
Off-Label Antipsychotic Use on the Rise
Recent findings published in the Journal of the American Medical Association show that off-label use of atypical antipsychotics is rising. Drugs such as Risperdal, Abilify, Seroquel, and Zyprexa are atypical antipsychotics are generally approved for more extreme psychiatric conditions such as bipolar disorder and schizophrenia.
The findings show that doctors are increasingly writing prescriptions to patients with anxiety, obsessive compulsive disorder, eating disorders, substance abuse, post-traumatic stress disorder, and personality disorders despite not being approved for such uses. The authors looked at studies where patients with non-approved conditions were given atypical psychotics. Although some benefits appeared from the off-label use of atypical antipsychotics, the authors found that patient outcomes were no better with an atypical antipsychotic than with a placebo, yet still exposed the patient taking the atypical antipsychotic to the risk of side effects.
Misuse Found in Blood Cell Boosters
Erythropoiesis-stimulating agents (ESAs) are approved for courses of therapy lasting two to fourteen weeks in cancer patients undergoing chemotherapy. ESAs are very expensive and present risks to users.
However, studies have found that ESAs are being prescribed off-label. This practice is suspected to expose patients to unnecessary risks while providing speculative benefits. The most common misuse of ESAs is suspected to be treatments lasting less than two weeks. Some experts note that incorrectly prescribing ESAs is also a financial drain on insurers and payment programs that foot the bill.
FDA Warns of Allergy to Antipsychotic Medicine
FDA provided a safety announcement in response to 52 reported cases of hypersensitivity to the atypical antipsychotic drug Saphris. Saphris (asenapine maleate) is an antipsychotic drug indicated to treat schizophrenia and bipolar disorder. However, some sites report that off-label use of Saphris as a treatment for post traumatic stress disorder is growing in popularity.
FDA’s Adverse Event Reporting System classified the following as incidents of hypersensitivity: severe allergic reaction, angioedema, low blood pressure, rapid heart rate, swollen tongue, difficulty breathing, wheezing, and rash. Some of these incidents arose after just the first use of Saphris.
In its announcement, FDA urged physicians to educate users how to recognize the possible side effects. The agency also signaled a lack of data around this aspect of the drug’s safety profile and urged physicians to report cases of hypersensitivity.
Renal Failure Risk Highlighted in Labeling Change
Reclast is marketed by Novartis as a way to prevent osteoporosis and restore bone mass lost to the disease. Reclast’s active ingredient is zoledronic acid, also sold under the name Zometa, which is approved for cancer related indications.
Recent cases have been reported to FDA where Reclast users suffered kidney failure resulting in a need for dialysis as well as death. These cases have led FDA to approve an updated label and medication guide that more carefully spells out the risk. Zometa’s labeling will not be changed because it appears to adequately address kidney failure and provide dosing instructions.
Reclast’s label was revised in 2009 to include instructions regarding testing and monitoring for underlying conditions that would raise the risk of renal failure in patients taking Reclast. FDA has received more data relating to factors it believes can lead to renal failure and believes testing and monitoring is the appropriate way to minimize the risk in patients taking Reclast.
Celexa Labeling Modified
FDA announced a safety risk related to a commonly prescribed antidepressant, citalopram hydrobromide, sold under the name Celexa as well as several other generic names. Forest Laboratories makes and markets Celexa in the U.S.
The agency required modifications to Celexa’s labeling that would warn physicians to limit the daily dosage to 40 mg. The previous maximum dosage was 60 mg. Higher dosages of the drug were linked to abnormal changes in heart activity most likely to occur in patients with preexisting heart conditions or low potassium levels. Scientists believe higher dosages of the drug may disrupt electrical pulses leading to heart arrhythmia.