Sandoz suspends some drug production after U.S. warning

Share

Multinational generic drug giant Sandoz has suspended or discontinued production of several drugs at its Quebec-based plant following a warning letter from the U.S. Food and Drug Administration, creating new uncertainty for Canadian patients and physicians already grappling with unexpected shortages.

Sandoz Canada, which makes generic injectable drugs to treat problems such as abnormal heart rhythms and nausea experienced by chemotherapy patients, called the "significant reduction" temporary in a statement, and said it would shift production at the plant to "medically necessary" products. But the company is the leading supplier of those medications to Quebec and other parts of Canada, and it failed to clarify Sunday which products would be impacted and the length and depth of the shortages.

Coming after more than a year of production problems for the industry in both Canada and the United States, the slowdown is yet another blight for pharmaceutical companies who have been accused of abandoning drugs that are no longer profitable and failing to give proper warning that pharmacy shelves will be empty when patients go to get their prescriptions filled.

Diane Lamarre, president of the Quebec Order of Pharmacists, predicted that some Sandoz production lines may be reduced by as much as 50 per cent, and suggested that it's hard not to foresee an impact, particularly as doctors have to turn to other medications to cover shortfalls with others.

"There is a real emergency to plan so we can manage it so patient care is not impacted," said Ms. Lamarre, who hopes to meet with Sandoz Monday to get more information.

Timely information has been a long-standing problem with drug companies, who are often reluctant to release any details they consider proprietary and are only under voluntary guidelines to give notice of pending shortages. That means patients may only learn that their drug isn't available when they go to the drugstore.

Deirdre Floyd, for instance, a 49-year-old Halifax woman who suffers from epilepsy, learned that her long-term medication was on back order last fall when she tried to refill her prescription. Shortages of anti-convulsants have become more common in Canada since last year, when several companies stopped reducing older medication, some of which have been in use for more than 50 years. Changing or stopping medication is especially dangerous for epileptics who can suffer breakthrough seizures during the transition.

In Ms. Floyd's case, she had enough pills to last until the production issue was corrected. "But it was stressful," says Ms. Floyd, who, as president of the Epilepsy Association of Nova Scotia, says she knows of many other patients in the same position. "We are still hearing about these problems on short notice."

John Haggie, president of the Canadian Medical Association, points out that there is no official process to inform doctors when certain drugs have been discontinued, let alone when an sudden equipment breakdown or problem inspection causes a temporary shortage. Last fall, in response to Health Canada concerns, pharmaceutical companies created websites to disseminate this information. But Dr. Haggie says, "it relies on the GP having time to go check the list and see if it is up to date, and sometimes it presents an alternative medication, but it's patch. Therein lies a whole set of procedure steps that are fraught with the problems."

At the drugstore, the situation is little better. "Pharmacists are spending a lot of time just calling around looking to find supply wherever they can," says Jeff Morrison, spokesman for the Canadian Pharmacists Association, adding the significant issue is that, with too few specifics from drug companies, it is hard to know how severe the shortage will be, or how long it may last.

"Often times the public is left in the dark."

In the case of Sandoz Canada, the FDA conducted three separate investigations last summer of its Boucherville, Que., plant, following up with a "warning letter" on Nov. 18 about a year after Sandoz launched a company-wide improvement program. No products were recalled, but the letter accused the Quebec plant – intended by the company to be a "worldwide centre of excellence for injectable products" – of not following proper procedure to prevent contamination of sterile drug products, and said it failed to investigate crystals that appeared in the finished product of a drug sold only in the United States. The company was also criticized for not alerting the FDA to any problems quickly enough.

"We remind you that you are responsible for ensuring that your firm's drug manufacturing operations comply with applicable requirements," the FDA said, threatening to withhold approval of any new drug applications.

Health Canada completed its own inspection later that month, and found no issues with the company's Canadian products. In a company statement to The Globe and Mail, Sandoz, a unit of Switzerland-based Sandoz International GmbH owned by Novartis, said it was intensifying efforts "to ensure high quality standards," and stood by the safety it products.

The statement said the company would attempt to restore production levels to normal "as soon as possible" at the facility, and the slowdown would not impact the 800 people employed there.

The company did not respond to a request for more clarification on Sunday.

"In light of the company's decision to reduce production of other drugs, Health Canada will be following up to determine the full scope of the company's actions, and what impact, if any, it will have on Canadians," said Steve Outhouse, director of communications for Health Minister Leona Aglukkaq.