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Vascular Solutions Zerusa Recalls Hemostasis Valves Due to Risk of Serious Injury, Death

Vascular Solutions Zerusa Recalls Hemostasis Valves Due to Risk of Serious Injury, Death

Sep 26, 2007 | Parker Waichman LLP

Unapproved drugs, many with dangerous side effects, are being prescribed all across the country.  According to the Food & Drug Administration (FDA) unapproved drugs account for nearly 2% of all prescriptions written in the US.   What’s worse, the FDA says that it has linked these dangerous medications to dozens of deaths in the last several years.   Unfortunately, the agency does not have enough resources to pull all of these  medications off the market, so for now, the FDA will only be targeting the “most dangerous” unapproved drugs.

The FDA says that thousands of drugs commonly prescribed today include unapproved ingredients.   The makers of these drugs never submitted scientific data to prove their safety and effectiveness.    What’s worse, most physicians – let alone patients – have no idea that some of the medications that are being prescribed have not been approved by the FDA.  Shockingly, all of these unapproved drugs are listed in the Physician’s Desk Reference, the “bible” doctors regularly use when making treatment decisions.

Many of these drugs have been in use since before 1962, when laws were changed to require proof of safety and effectiveness before drugs could be granted FDA approval.   The manufacturers of these medications claim that going through the FDA approval process would cost millions, increasing the costs of the medications.   They also contend that these drugs are already proven safe just by the fact that they have been on the market for so long.   If these drugs had safety issues, they say, they would be known by now.  

But that claim doesn’t stand up to scrutiny, as many of these unapproved drugs have been linked to serious injuries, and even deaths.   For instance, there is the case of products containing the antihistamine carbinoxamine.   Twenty-one children under the age of 2 have been killed by drugs containing this ingredient. There are only two approved carbinoxamine-containing drugs on the market, Palgic and Carbinox Maleate, and both of these drugs’ labels warn that they are not to be used in children under two.  But the unapproved varieties may not contain such warnings.   On September 7, the FDA ordered the makers of all unapproved carbinoxamine medications to seek approval or stop productions.

But the FDA doesn’t always take such action.   Right now, URL/Mutual Pharmaceuticals is going to court to force unapproved versions of its anti-malarial drug Qualaquin off the market.   These drugs contain quinine sulfate, which can cause potentially fatal irregular heartbeats.   While the URL/Mutual Qualaquin label does include warning about these side effects, most unapproved quinine sulfate medications do not.  According to URL/Mutual, at least 29 deaths have been linked to the unapproved versions, yet the FDA has not acted.  In August, URL/Mutual took the seven manufacturers of unapproved quinine sulfate drugs to court, and so far all but one have agreed to stop marketing their versions.  

The FDA says it simply does not have the resources to go after every unapproved drug on the market.   Instead, the agency is taking a more targeted approach, seeking to stop production of those drugs deemed the most dangerous.   Unless the FDA decides to take more comprehensive action against dangerous unapproved drugs, patients will have no assurances that the medications their doctors prescribe have been proven safe and effective.

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