The Safety Spotlight Has Been On Big Pharma In Recent Years; What Have These Lesser Known Manufacturers Been Getting Away With?

(Posted by Tom Lamb at DrugInjuryWatch.com)

A little more than two weeks ago I wrote a post entitled “FDA Needs To Assure Us That There Is Quality Control For Generic Medications Sold In U.S.”, where I discussed some recent generic drug fiascoes discovered by the FDA involving the companies Actavis, ETHEX, and Ranbaxy.

Recently Health Canada, also, discovered a quality control problem involving some generic morphine tablets, but it seems that a U.S. generic drug company is to blame for it.

On July 9, 2008 Health Canada issued a press release, “Warning: Ratio-Morphine Tablets Recalled in Canada Due to Risk of Accidental Overdose”, which provided this information:

Health Canada is warning consumers not to use the prescription drug ratio-Morphine SR in 15 milligram (mg), 30 mg, and 60 mg formats. Some tablets may contain more morphine than the label indicates, exposing patients to the potential risk of accidental overdose. Oversized tablets that are noticeably thicker than the regular tablets, and which may contain more morphine than the strength indicated, have been found on the Canadian market. Ratio-Morphine SR tablets are taken orally for the relief of severe pain….

The Canadian distributor, ratiopharm, has initiated a recall of the affected lots after two separate complaints were received by the U.S. manufacturer, KV Pharmaceutical.

What do we know about KV Pharmaceutical?  According to the company’s web site:

KV Pharmaceutical, with headquarters in St. Louis, Missouri, is a leading specialty pharmaceutical company that develops, manufactures and markets innovative branded, quality generic/non-branded and unique specialty ingredient products, utilizing proprietary drug delivery technologies. In addition to its comprehensive research & development and manufacturing processes, KV has broad marketing and sales capabilities through its three wholly owned subsidiaries, Ther-Rx Corporation, marketing branded products, ETHEX Corporation, marketing generic/non-branded products, and Particle Dynamics, Inc., participating in the value-added specialty ingredient marketplace  (accessed 7/31/08)

So KV Pharmaceutical is the same generic drug company that appears to be responsible for the June 2008 recall Of ETHEX morphine sulfate extended release tablets made during the June 2006 to May 2008 period due to the potential for oversized tablets.

But it gets better — or worse, really.

On July 30, 2008 we learned the following about KV Pharmaceuticals and ETHEX from an in-PharmaTechnologist.com online article, “Generic Drugs: Expectorant seizure easy to swallow for KV”:

FDA officials have impounded nearly $24m (€15.4m) worth of guaifenesin-containing timed-release (TR) cough and cold medicines made by US specialty drugmaker KV Pharmaceuticals.

The products, which are sold by KV’s Ethex subsidiary, were seized as part of the Food and Drug Administration’s (FDA) clampdown on unapproved uses of the muscle relaxant, which is employed as an expectorant in prescription and over-the-counter (OTC) cough remedies.

Earlier this year, an inspection of several of St-Louis-based KV’s manufacturing facilities revealed that the firm had continued to manufacture TR products containing guaifenesin after the August 27, 2007 deadline issued by the FDA.

The seizure came as a result of a civil suit filed by US attorney Catherine Hanaway who commented that: “American consumers are entitled to have safe and effective drugs.”… (italics in original)

More details about this latest generic drug problem can be found in the FDA’s July 30, 2008 press release, “Federal Agents Seize more than $24 Million in Unapproved New Drugs Products made after the FDA required an end to production”.

It seems to me that the FDA needs to take a closer look at the production of generic medications sold in the U.S. going forward, as more and more people are using generics instead of brand name drugs for financial reasons.