Drug Injury Attorney Blog

The U.S. Food and Drug Administration announced Aug. 24 that it is looking into safety problems with a popular weight-loss drug. According to the Los Angeles Times, the agency has received at least 32 reports of liver problems with orlistat, sold over the counter as Alli and as the prescription drug Xenical. The FDA is analyzing data included in those reports, as well as data from manufacturers, and said it would announce results as soon as the study is complete. The agency is not taking any enforcement action yet and did not tell patients to stop taking the drugs, but it did tell them to talk to their doctors if they see signs of liver problems.

The FDA’s press release said the agency received the 32 reports of problems with orlistat between 1999 and October of 2008. Of those patients, 27 had to be hospitalized, and six suffered liver failure. The most common liver problems reported to the FDA as side effects of orlistat were weakness, abdominal pain and jaundice, which is a yellowing of the eyes and skin. Other signs of liver problems include fatigue, fever, brown urine, pale stools, nausea and vomiting, itching and loss of appetite.

Orlistat helps patients lose weight by stopping the digestive tract from absorbing about 25% of the fat they eat. The 2007 approval of the over-the-counter version, Alli, was widely anticipated by the weight-loss community because of its apparent effectiveness. However, Alli was not without side effects even before the recent reports of liver problems. In fact, the drug is somewhat famous for having an embarrassing, though minor, side effect -- fecal incontinence, or loss of control over the bowels, especially in people who eat too much fat. Alli’s manufacturer, GlaxoSmithKline, went so far as to tell users to carry a change of clothes for the first few days they use the drug, in case of an “accident.” Long-term studies have also linked orlistat to cancer, although not definitively.

As a dangerous drug lawyer, I am much more concerned about these new reports of possible liver damage than I am about fecal incontinence. Liver problems can lead to liver failure, and liver failure is a serious, life-changing health problem with a high chance of death. People with liver failure require hospitalization, close monitoring, special diets and, in cases where the organ cannot recover, liver transplants. This is an unacceptable risk to exchange for the opportunity to lose a few pounds. Orlistat is very popular, with more than 22 million users worldwide. That means that even if only a fraction of those users develop serious liver problems, thousands of people could still develop life-threatening illnesses or lifelong, disabling organ damage -- all to lose a few pounds.

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Barr Laboratories is recalling one lot of its generic Adderall due to a serious manufacturing defect, the Los Angeles Times reported Aug. 14. The laboratory is recalling lot number 311756 of the 20-mg, 110-count bottles of Adderall, a mixture of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate. The manufacturer started the recall after finding that some of the pills in the lot were oversized, which can lead to an overdose causing heart arrhythmia, heart palpitations, high blood pressure, anxiety, insomnia and other side effects. Patients who have this lot of the drug are advised to stop taking it and return it immediately to their pharmacy, or call Barr Laboratories for more information at 1-888-742-5578.

Adderall is a drug used in children and adults with attention deficit hyperactivity disorder (ADHD). It is a mixture of several salts from the amphetamine family of drugs, which also contains the street drug methamphetamine. Like methamphetamine, Adderall is a stimulant that can cause severe adverse effects in an overdose, including mental health problems as well as potentially serious effects on the heart and cardiovascular system. Barr Laboratories’ press release lists potential physical effects of an overdose such as increased heart rate, high blood pressure, heart palpitations, tremors, dizziness, insomnia and nausea. Possible psychological side effects of the oversized pills include anxiety, euphoria, mania and agitation.

Fortunately, the manufacturer and the FDA did not report hearing of any dangerous side effects from the oversized, defective pills. But as a dangerous prescription drug lawyer, I know ADHD drugs and stimulants generally have a troubled history when it comes to safety. Adderall and other stimulants are not prescribed to people with a history of heart problems, seizures or drug abuse because they can be dangerous or even fatal for all of those groups. Furthermore, studies have shown that they can cause changes in vision and stunt children’s growth, at least temporarily. And in 2006, an FDA advisory panel voted to put a black box warning on the drug’s label about potential cardiovascular and mental health side effects in children -- a recommendation the FDA ignored.

The current recall should not be a cause for alarm for all patients taking Adderall; only one lot is affected. But because an overdose of amphetamines can be very serious, patients who purchased the oversized pills are at risk of health- or life-threatening side effects. Like all drug manufacturers, Barr Laboratories is strictly liable for the damage its products cause if they have a manufacturing defect -- even if they didn’t know about the problem ahead of time. Any patients who are seriously harmed by the oversized pills would have the right to hold the manufacturer legally responsible with a defective prescription medication lawsuit.

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The FDA is studying data from ongoing safety tests of the asthma medication Xolair, the agency’s August 2009 MedWatch Safety Alert said. Xolair (omalizumab) is an injected medication that controls asthma in patients with year-round allergies who don’t respond well to inhaled treatments. The alert said the FDA has data showing that Xolair increases patients’ chance of developing cardiovascular problems, including potentially fatal heart attacks and strokes. The agency has not yet made a decision and suggests that patients continue taking the medication, but talk to their doctors about its risks and benefits and the ongoing study.

That study, named EXCELS, compares 5,000 patients taking Xolair to a control group not taking the drug. Preliminary results suggest that the group taking Xolair had a disproportionate rate of adverse events involving the heart and brain compared to the control group. Those adverse events included ischemic heart disease, heart arrhythmia, heart failure, high blood pressure, blood clots and strokes. Xolair already has a black box warning, the strongest available, warning patients about the risk of a life-threatening allergic reaction called anaphylaxis. That threat, while rare, led to a requirement that doctors administer the drug -- which was previously self-administered by patients -- and observe patients for two hours after.

As a defective prescription drug attorney, I suspect that another black box warning may be ordered if the study turns up strong evidence of a link between Xolair and cardiovascular problems. The FDA has already signaled that it plans to pursue safety issues more thoroughly than it did under the last presidency, and the problems the study allegedly turned up include potentially life-threatening and disabling health problems. A stroke can not only kill, but leave patients partially paralyzed or with permanent, lifelong problems with speech and memory. (That’s on top of the known risk of anaphylaxis, which can kill very quickly if the patient does not get treatment.) The drug is not used widely, but with side effects this serious, Xolair maker Genentech and distributor Novartis could face huge liability from patients who are killed or permanently disabled by what they thought was a life-saving allergy medication.

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The U.S. Food and Drug Administration has ordered the strongest safety warning possible for a class of prescription drugs called TNF blockers, HealthDay reported Aug. 4. The FDA ordered the warning for children and teenagers using these anti-inflammatory drugs after an analysis of current users showed that the drug increased their risk of cancer, including fatal cancer. The FDA said it was working with manufacturers to better understand the cancer risk of these drugs. It also included information in the black box warning about reports of psoriasis associated with TNF blockers.

The affected patients are children and teens using TNF blockers to treat juvenile rheumatoid arthritis, inflammatory bowel disorder, Crohn’s disease and other chronic inflammatory diseases. Common drugs that will get the new safety warning include Remicade (infliximab), Humira (adalimumab), Enbrel (etancercept), Cimzia (certolizumab pegol) and Simponi (golimumab). All of these drugs are tumor necrosis factor-alpha blockers or inhibitors, which means they stop the action of a body chemical that promotes inflammation of tissues. Too much of that chemical is believed to be responsible for the inflammation and tissue damage involved in conditions like rheumatoid arthritis, which can be crippling.

The FDA’s study found that children and teens using these prescription drugs had an increased risk of cancer, though they did not specify how much greater the risk was. The cancers began an average of 30 months after treatment, and about half of the cancers were lymphomas, a type of immune system cancer. Some of the cases were fatal. This study was launched in June of 2008, a month before the New England Journal of Medicine published the case of an adult woman who developed lung cancer after taking TNF blockers for Crohn’s disease. When she stopped the drug, her cancer vanished. A doctor with the Arthritis Foundation told HealthDay that patients should weigh the risks of taking TNF blockers against the benefits, which include preventing disability and deformation in children with juvenile rheumatoid arthritis.

The same doctor mentioned that patients with inflammatory illnesses are already at an increased risk of cancer. Given that fact, adding an even greater risk of cancer by using TNF blockers sends up red flags for me, as a dangerous prescription drug attorney. Current and future patients can talk to their doctors about risks versus benefits -- but for children and teens who have already developed cancer because of taking TNF blockers, it’s too late to make an informed decision. These kids may already have developed life-threatening lymphomas or other cancers, and their families may have racked up many thousands of dollars in medical bills to fight the cancer.

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