It was a busy year for drug news and issues, so we've put together a list of drug-safety reports, warnings, analyses, and regulatory actions by the Food and Drug Administration that should prompt you to heed the new or updated information and advice, when applicable.
Millions of bottles and packages of over-the-counter drugs Tylenol, Benadryl, Motrin, and others have been recalled since September 2009 in one of the largest related series of drug recalls in history. (See product list here.) The recalls of these over-the-counter products, produced by Johnson & Johnson's McNeil Consumer Healthcare subsidiary, involved relatively minor side effects known so far—nausea, vomiting, and diarrhea—but any recalled drugs in your medicine cabinets could still pose dangers to you or your family.
Pay attention to recalls and routinely check to see whether the drugs your family uses have been affected by recalls. Inspect any new medication you receive, and if it looks or smells unusual or if you have any doubt as to its quality, return it. Consider purchasing all medications at a single pharmacy that keeps a medication record for you and is able to alert you if a drug is recalled.
Although it took two years to finally give it the ax, the risk of a potentially deadly heart-rhythm abnormality, even when taken at recommended doses, alarmed the FDA so much that it withdrew the prescription pain-killer propoxyphene (Darvon and Darvocet) from the market. About 10 million people took the drug last year, both as stand-alone pills, such as Darvon, and in products such as Darvocet, which combine it with acetaminophen. The FDA noted that the drug had been associated with more than 2,100 reports of serious problems—including suicide, overdose, cardiac arrest, and death—since it was first launched in 1957.
If you still take a medication containing propoxyphene, don't abruptly stop it; that can trigger withdrawal symptoms such as nausea and trembling. But contact your doctor, so you can safely and gradually switch to a different medication. Our Best Buy Drugs report on opioid pain medicines has long recommended against using products containing propoxyphene because of safety concerns.
Further underlining our general caution around weight-loss medications, the FDA also removed the popular prescription weight-loss drug Meridia (sibutramine) because of increased risks of heart attack and stroke.
Weight-loss drugs and supplements in general have marginal benefits and often risky or troublesome side effects, which prompted us again to advise skipping another, different popular diet pill, Xenical (orlistat), and its over-the-counter version, Alli. The FDA also warned of counterfeit versions of Alli being sold. And we shouldn't forget the multitude of weight-loss products tainted with harmful prescription drug ingredients reported by the FDA last year. (The FDA cracked down on all tainted supplements recently because of severe adverse events reported with some.)
Avoid weight-loss drugs and supplements in general, especially those purchased online, where you can't be confident in what you're getting. If you need to lose weight, increasing exercise and limiting food-portion size are better options.
We've long advised that the prescription diabetes drug rosiglitazone (Avandia, Avandamet, and Avandaryl) carries too many risks and should be avoided if at all possible, a recommendation underlined by the FDA when it placed new restrictions on Avandia this year. (European regulators removed it from the market altogether.) In addition to concerns that Avandia increased the risk of a heart attack or stroke, it has also been associated with an increased risk of bone fractures.
When it comes to oral medicines for type 2 diabetes, newer isn't usually better. Our evaluation of six types of drugs to control blood sugar found that metformin, either alone or combined with glimepiride or glipizide, works just as well as, or better than, newer medicines at a fraction of the cost. Many people with type 2 diabetes can improve their blood-sugar control and delay the need for drugs by losing weight, eating more healthfully, getting more exercise, and making other lifestyle changes.
This year even more safety problems were revealed with this class of drugs, known as proton-pump inhibitors (PPIs), taken for gastroesophageal reflux disease (GERD) and gastric ulcers. The drugs are generally safe and effective, but longer-term use—more than 12 months—can affect the body's ability to absorb calcium properly, which can increase a person's risk of wrist, forearm, spine, and other fractures.
And because PPIs reduce the amount of stomach acid, which normally helps kill off "bad" bacteria, they can increase your risk of infection with Clostridium difficile, a bacteria that can cause severe diarrhea. In addition, studies show PPIs can increase the risk of contracting pneumonia and reduce the effectiveness of clopidogrel (Plavix), a blood thinner used to prevent clots after heart attacks and stent placement.
If you are one of the 15 million Americans who suffer from heartburn and if you take a PPI, such as esomeprazole (Nexium) or omeprazole (Prilosec, Prilosec OTC, and generic), consider asking your doctor for a lower dose or stopping the drugs altogether to reduce those risks. Lifestyle changes such as eating smaller meals, cutting down on fatty or spicy foods, reducing alcohol and caffeine, not lying down for 3 hours after eating, and quitting smoking can help. And for temporary relief of heartburn, first turn to over-the-counter antacids such as famotidine (Pepcid AC and generic) or ranitidine (Zantac 150 and generic). For more detailed analysis of those medications, see our Best Buy Drugs report on drugs to treat heartburn, acid reflux, and GERD.
This year the FDA warned that the popular class of prescription medications used to preserve and build bone—called bisphosphonates—increases the risk of thigh fractures and esophageal cancer. The drugs include alendronate (Fosamax, Fosamax Plus D, and generic), ibandronate (Boniva), risedronate (Actonel, Actonel with Calcium, Atelvia, and generic) and zoledronic acid (Reclast and Zometa).
Bisphosphonates are prescribed for those diagnosed with osteoporosis but also for those with osteopenia, or pre-osteoporosis. In those cases, we urge trying alternative methods of bone- and strength-building measures and fall-proofing your home and surroundings as much as possible, instead of medication. Bisphosphonates offer modest benefits in building bone and preventing fractures, yet they pose additional side-effect risks, including throat or chest pain and difficulty swallowing, as well as heartburn, indigestion, and nausea. Joint, bone, and muscle pain are rare but can be severe. Other risks include an abnormal heart rhythm (atrial fibrillation) and bone loss in the jaw (osteonecrosis).
As many as 10 percent of people who take a prescription statin to lower their cholesterol experience muscle aches, soreness, tenderness, or weakness. New information about the dangers of high doses of statins put that issue back in the spotlight. The FDA warned that the maximum intended dose of 80 milligrams of simvastatin (Zocor and generic) could cause muscle damage, a reminder that consumers of statins should try to reduce their dosage, and treat any muscle pain seriously. As the statin dose increases, so does the likelihood of experiencing many adverse effects, a principle that applies to all statins, including atorvastatin (Lipitor), fluvastatin (Lescol and Lescol XL), lovastatin (Altoprev, Mevacor, and generic), pravastatin (Pravachol and generic), rosuvastatin (Crestor) or simvastatin/ezetimibe (Vytorin).
Higher statin doses are also linked to an increased risk of a life-threatening form of muscle breakdown called rhabdomyolysis, which can lead to permanent kidney damage, coma, and even death. A recent survey found that 87 percent of the time, people with statin-related muscle pain and other side effects said their doctors dismissed or ignored their concerns, so you might insist that your doctor reconsider your statin dose.
Ask your doctor whether any muscle pain you feel might be related to your dose of statin. It might affect your ability to do one thing you really need to do to prevent heart disease: daily exercise. Other recommended activities to help reduce cholesterol include quitting smoking and eating a heart-healthy diet. For more detailed information on when to consider taking statin medication, see our Best Buy Drugs Special Report on those drugs.
This year a report on the increase in emergency-room visits from abuse of the over-the-counter cough suppressant dextromethorphan (found in more than 120 products, such as Coricidin, Nyquil Cough, Robitussin DM, and Vicks 44) put the focus on the issue of cough-syrup abuse. Dextromethorphan is not very effective at controlling the most common coughs caused by cold or flu, and standard doses of it can cause agitation, muscle spasms, and allergic reactions. Overdosing can bring hallucinations, rapid heartbeat, loss of coordination, and reportedly a ''high'' similar to that of psychotropic drugs such as PCP. Until the FDA brings in restrictions to curb the problem, parents need to be aware of the risk of cough-medicine abuse.
Replace your dextromethorphan products with remedies that are more effective to treat a cough—such as using steam, drinking hot liquids, or using nonmedicated throat lozenges. If you have a young person at home, be aware of the signs of overdose, for example: shallow, slow, or labored breathing; convulsions; drowsiness; dizziness; hallucinations; muscle twitches; and vomiting.
The FDA warned yet again this year that the prescription malaria drug quinine (Qualaquin) taken "off label" for nighttime leg cramps puts people at risk for serious and life-threatening side effects. The FDA received dozens of reports of people who developed severe adverse effects while taking the drug, including permanent kidney impairment and two deaths. Because Qualaquin (no generic available) is approved only for treating malaria, using it for nighttime leg cramps or restless-leg syndrome is an unapproved—and potentially dangerous—use of the drug.
Talk with your doctor about all drug and nondrug treatments for leg cramps. The risk of serious or life-threatening side effects from prescription quinine and the lack of convincing evidence for its use outweigh the potential benefit of the drug for any condition except malaria.
This year the FDA issued new safety notices on a certain type of prescription asthma medication that contains a drug known as a long-acting beta agonist, or LABA (such as Foradil or Serevent). When those drugs are inappropriately used, they could lead to serious medical problems, hospitalization, and even death in children and adults. LABAs should be used only with other medications.
Two products that combine a LABA and an inhaled steroid (Advair and Symbicort) should be used for the shortest time possible to reduce the chance that they could severely worsen asthma symptoms. LABAs do not relieve sudden-onset asthma symptoms, and a rescue inhaler, such as albuterol, should be used instead. The new FDA restrictions apply to four drugs: salmeterol (Serevent) and formoterol (Foradil), which contain only a LABA, and the combination medications, fluticasone/salmeterol (Advair) and budesonide/formoterol (Symbicort), which contain a LABA and an inhaled corticosteroid.
If you are using a LABA (such as Foradil or Serevent), never use it alone. All LABAs, including Advair and Symbicort (which combine a LABA with an inhaled steroid) should be used for the shortest time possible to reduce the chance that they could severely worsen asthma symptoms.
These materials were made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by the multistate settlement of consumer-fraud claims regarding the marketing of the prescription drug Neurontin.
If you think you have experienced an adverse event with this drug or any drug, especially if it is of a serious nature, it is important to 1) tell your doctor immediately and 2) report the event to the Food and Drug Administration via the FDA's MedWatch Web site at www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm or by calling 1-800-FDA-1088.