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Saturday, April 11, 2009

Raptiva Joins List of Drugs with Deadly Side Effects

April 2, 2009. By Heidi Turner

Baton Rouge, LA: If you have been taking Raptiva for psoriasis, you can be forgiven if you are a bit hesitant the next time you have your injection. After all, the link between Raptiva and PML, Progressive Multifocal Leukoencephalopathy, is a scary one. Most people would probably think twice before using a medication that can cause brain infections. Although the FDA has taken some action against Raptiva, it has allowed the drug to stay on the market, leaving some critics wondering why, especially when there are other treatments available for psoriasis.

Psoriasis is a chronic immune system disorder that causes inflammation of the skin. This inflammation results in skin problems such as redness, itching or burning. Patients with psoriasis experience a situation in which their immune system sends faulty signals that increase the rate at which skin cells are grown. According to the National Psoriasis Foundation, psoriasis has been associated with diabetes and heart disease.

Psoriasis can be treated with Raptiva which is an injection given once a week. It can also be treated with topical products, light therapy and alternative therapies.

So far, at least 3 deaths have been linked to Raptiva and PML, while a fourth is considered likely related to the drug. PML is a rare but usually fatal virus that attacks the brain and causes weakness, loss of coordination and personality changes. Although the reaction is rare, because it is often fatal there is a genuine concern for the safety of patients taking Raptiva. The concern is strong enough that other countries have pulled the drug off the shelves.

As with any other drug that has come under fire recently for causing serious side effects, people are now questioning whether or not the company that makes Raptiva—Genentech—knew about the risks, or should have known about those risks, before the drug was released on the market. Issues with Raptiva highlight difficulty with drug testing. So far, according to reports, all deaths linked to Raptiva occurred after 3 years or more of using the medication. If these signs do not show up until after 3 years, then perhaps the company did not know about the risks. However, the issue then becomes one of how long testing should be conducted before a drug is approved for use.

PML is not just a minor side effect like nausea or headaches—it is usually fatal. This is a very serious side effect for a drug to carry, even if the risk is rare and even if it does not appear until after the drug has been used for 3 years. However, the question must be asked if drugs should undergo more long-term testing before they are approved. Of course, the downside is that vital drugs would take longer to get approval, but in the case of drugs that are used for a condition that already has other treatment options, perhaps further testing should be considered. The question then becomes, how long is long enough? Unfortunately, all drugs come with side effects and it is impossible to know what the magic date after which side effects can appear is for each drug.

So, what should you do if you are taking Raptiva and are concerned about the side effects? A good first step would be to discuss your concerns with your doctor, especially if you have been taking Raptiva for more than 3 years.

If you develop any of the signs of neurological problems, including confusion, dizziness, loss of balance, seizures or difficulty walking or talking, seek medical help immediately.


1 comment:

  1. Too many drugs have come to market bearing pedigrees which imply that they've been clinically tested, through peer review, and through rigorous FDA evaluation. And then after millions of patients take the drug, it proves dangerous or even deadly. Bummer!