Does your doctor know all the potential side effects of your new prescription?

“One of the unfortunate realities involving new drugs is that many of them are found to have side effects, some life-threatening, that no one was aware of at the time of their approval by the FDA.”

That quote begins an article written by two M.D.s from the University of Washington School of Medicine. The article, entitled “Recently Discovered Side Effects of New Medications,” appeared in the journal Emergency Medicine, presumably because these side effects could send you to your local emergency room. But as the article points out, the ER doctors may not know that your symptoms are a side effect of a medication you’re taking.

New drugs have been coming out so quickly and in such great numbers, it’s difficult to keep up with the information. In addition, doctors and pharmacists are flooded with post-approval reports detailing updates and changes. “Educating health care providers about these newly discovered side effects is always difficult,” admit the article’s authors.

And the FDA is not required to inform the public of post-approval reports – they rely on doctors and pharmacists to get the word out. But if doctors can’t even keep up with all the reports, how can we assume that they will inform each and every one of their affected patients?

Let’s face it – YOU are the one at risk from these newly approved drugs, not your doctor or pharmacist. And you deserve access to this information as it is uncovered so you can identify symptoms and assess your risk.

That’s why I thought it was so important to bring this information directly to you — and why we will continue to monitor this issue on a regular basis.
There isn’t room here to list all the side effects of all the drugs listed in the article. (There are seven specific drugs or classes of drugs in all – all approved by the FDA in the last five years.) In this e-Alert, I’ll tell you about a few of the most common drugs on the list, and the side effects and contraindications to look for. But don’t stop there – follow the link at the end of the e-Alert to view the entire list from the article, to make sure you and your family are protected.

Angina, altered mental state can be side effects of heart medication

An anti-platelet agent called clopidogrel (brand name: Plavix) is often prescribed to patients who have recently had a heart attack or stroke, or to those who have a history of peripheral vascular disease. New evidence shows it may cause a serious disease called thrombocytopenic purpura (TTP). Patients with TTP experience dangerously low platelet levels, kidney failure, fever, and altered mental status. TTP is also associated with a condition called microangiopathic hemolytic anemia, in which fragments of damaged red blood cells are found in the blood stream. Studies leading up to clopidogrel’s approval in 1997 did not show any increased risk of TTP, even though related drugs were known to cause the condition. But since clopidogrel’s approval, new evidence has emerged that shows the drug may cause TTP, even after only a few weeks of treatment. The article recommends that patients taking clopidogrel be closely monitored for signs of TTP. Common symptoms like angina or altered mental status may be red flags, and should not be dismissed as normal manifestations of cardiovascular disease or age.

Drug for RA and Crohn’s may cause MS

Etenercept (brand name Enbrel) was approved in October of 1998 to treat the symptoms of rheumatoid arthritis (RA). It has also been used to treat Crohn’s disease, although it’s not approved by the FDA for that use. It is usually injected under the skin twice a week. Originally patients were warned about the possibility of allergic reactions at the injection site and minor infections. But since its approval, the FDA has revised its recommendations, advising doctors not to prescribe etenercept to any patient with an active infection. Also, recent reports have associated etenercept with disorders of the central nervous system, like multiple sclerosis (MS) and Guillain-Barre syndrome, a condition characterized by temporary loss of movement and sensation. These disorders are both linked with the destruction of the myelin sheaths that surround and protect the nerves.

Antibiotics can cause tendons to rupture

Quinolones, the class of antibiotics that includes Cipro, Norfloxacin, and Floxin, is often used to treat bacterial infections. While they are generally regarded as safe, drugs in this family showed some side effects even at the time of approval. There is some evidence that the quinolones can cause agitation, confusion, and delirium, particularly in elderly patients. They are also known to increase sun sensitivity, even up to three weeks after the medication is discontinued. The quinolone trovafloxacin has been associated with liver failure; sparfloxacin, gatifloxacin, and moxifloxacin can cause an abnormal heartbeat when taken in conjunction with tricyclic antidepressants or drugs to prevent cardiac arrhythmia.

We also knew that quinolones could cause joint aches and pains in about one percent of the population. But since the drug class was approved, it’s shown a far more disturbing side effect – tendonitis so severe that it leads to tendon rupture. According to the article, the FDA has received more than 1,000 reported cases of quinolones-related tendonitis. In most cases, the drug use was discontinued before it was too late. But when the patient continued to use the quinolone after the pain and swelling appeared, it sometimes led to tendon rupture. The reports suggest that older people and those taking steroids at the same time are most at risk. In some cases, the rupture occurred as late as 120 days after the patient stopped taking the drug.

As you can see, this article is not talking about minor side effects like nausea or a bad taste in the mouth. We’re talking about major effects that could disable or even kill you. There are four other drugs that were detailed in the journal article; more information is listed below.

These certainly weren’t the first drugs to exhibit serious side effects after they received FDA approval – and they won’t be the last. At HSI, we’ll do our best to stay on top of this information, and bring it to you as quickly as possible. You can also check for post-approval reports on your own, through the FDA’s MedWatch website (www.fda.gov/medwatch).

Please pass this information along to anyone you know who may take one of these medications. Everyone needs to know the risks of the drugs they’re taking – not just the doctors and pharmacists who prescribe and dispense them.

Elderly and diabetics at higher risk for complications from COX-2 inhibitors

COX-2 inhibitors, like the much-advertised Vioxx and Celebrex, are a new class of non-steroidal anti-inflammatory drugs (NSAIDs) designed to minimize gastrointestinal side effects. While COX-2 inhibitors do seem to cause fewer GI problems than traditional NSAIDs, the article shows that the drugs can cause other serious side effects in many people. For example, older patients, as well as those with heart failure, diabetes, cirrhosis, or dehydration, can experience reduced kidney function as a result of COX-2 inhibitors. As the article states, “The same caution used in prescribing traditional NSAIDs for patients at increased risk for renal toxicity (kidney poisoning) should be exercised in prescribing COX-2 inhibitors.” Also, people who are allergic to aspirin or traditional NSAIDs can still experience reactions to the new COX-2 inhibitor drugs.

Type II diabetes drugs can cause liver damage

Thiazolidinediones are a new drug class that helps improve glycemic control in Type II diabetes patients. One of the first drugs in this class, troglitazone, was withdrawn from the market in March of 2000 because it was linked with 61 liver failure deaths and seven liver transplants. Newer thiazolidinediones, like rosiglitazone (Avandia) and pioglitazone (Actos), were thought to be safer – but according to the article, they still pose a serious risk to patients with pre-existing liver problems.

Since their approval, there have been only two reported cases of liver failure from rosiglitazone and none from pioglitazone. But the article suggests that their improved safety record is not due to changes in the drug’s makeup, but rather increased screening and monitoring by prescribing doctors. People with previous signs of liver impairment should not take these drugs, and all people should be tested for pre-treatment levels of alanine transaminase before they begin taking them. (Alanine transaminase is an enzyme, high levels can indicate liver problems.) The article also recommends that patients taking these drugs have their alanine transaminase levels rechecked every two months during the first year of thiazolidinedione therapy, followed by periodic monitoring thereafter.

HIV drugs can cause life-threatening allergic reactions, ph imbalances, and more

Abacavir (known by the brand name Ziagen) is a drug used to treat infection with HIV, the virus believed to cause AIDS. But since its approval in 1998, there have been many reports of severe allergic reaction to the drug. New estimates indicate that two to five percent of patients treated with abacavir will exhibit the reaction. Signs of the allergy include rash, fever, malaise, fatigue, and nausea. Some patients also experience respiratory symptoms like coughing. The reaction usually occurs within the six weeks of beginning abacavir therapy.

Since its approval, abacavir has also been associated with a serious condition called lactic acidosis, an imbalance in the blood’s pH levels. Symptoms include weakness, nausea, abdominal pain, vomiting, and shortness of breath. Women seem to be at increased risk for this side effect, as well as people who are obese or have taken the drug for long periods of time.

Another HIV drug made the list, exhibiting similar side effects. Nevirapine (known by the brand name Viramune) can also cause serious allergic reactions. In trials during the approval process, nevirapine caused life-threatening skin reactions in nearly seven percent of treated patients. The drug can cause liver damage and ultimately, complete liver failure. These two side effects can occur together or separately. Most side effects were seen during the first six to eight weeks of therapy.